Delhi High Court
Roche Products (India) Pvt Ltd & ... vs Drugs Controller General Of India ... on 25 April, 2016
Author: Manmohan Singh
* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Judgment pronounced on : April 25, 2016
+ I.A. Nos.2371/2014, 2988/2014, 2990/2014, 4649/2014,
4677/2014, 5956/2014, 14533/2014, 11224/2015, 12830/2015,
12862/2015, 16703/2015, 16704/2015 & CCP(O) No.69/2015 in
CS(OS) No.355/2014
ROCHE PRODUCTS (INDIA) PVT LTD & ORS ..... Plaintiffs
Through Mr.Rajiv Nayar and Mr.Sandeep
Sethi, Senior Advocates with Ms.Niti
Dixit, Mr.Darpan Wadhwa,
Ms.Samiksha Godiyal, Mr.N.
Mahavir, Ms.Roshni Namboodiry,
Mr.Tanmay Singh, Mr.Anugrah
Robin Frey, Advs.
versus
DRUGS CONTROLLER GENERAL OF INDIA AND ORS
..... Defendants
Through Mr.Sanjay Jain, ASG with Mr.Amit
Mahaan, CGSC and Mr. Krishanu
Barua, Adv. for D-1/UOI.
Mr.Harish Salve, Dr.Abhishek M.
Singhvi and Mrs.Pratibha M. Singh,
Senior Advocates with Mr.Vijay K.
Sondhi, Mr.Mayank Grover,
Ms.Cauveri Birbal, Mr.Anshul
Sehgal, Mr.Arjun Sawhney,
Ms.Pallavi Sharma & Ms. Suhasini
Raina, Advs. for D-2.
Dr.C.S Vaidyanathan and Mr.Amit
Sibal, Senior Advocates with
CS (OS) No.355/2014 Page 1 of 227
Mr.Nirupam Lodha, Ms.Gayatri Roy,
Mr.Ayush Dhawan and Ms. Rhyea
Malik, Advs. for D-3 & 4.
Ms. Rameshwari, Adv. for
intervenors in I.A. No.3955/2015
CORAM:
HON'BLE MR.JUSTICE MANMOHAN SINGH
MANMOHAN SINGH, J.
1. The plaintiffs filed the present suit for injunction against four
defendants. By this order, I propose to dispose of the abovementioned
pending applications.
2. The plaintiff No.1, Roche Products (India) Private Limited, a
company incorporated under the Companies Act, 1956, as amended
(the "Companies Act"), is an affiliate of plaintiff No.2, and is the
importer and marketer of innovator molecule Trastuzumab in India.
Trastuzumab is stated to be a biological drug used primarily for the
treatment of HER 2 positive breast cancer. In India, Trastuzumab is
sold under the brand names HERCEPTIN®, HERCLON™ and
BICELTIS®. It is stated that Trastuzumab has become the accepted
biological treatment for HER 2 positive breast cancer on a worldwide
basis and enjoys a global reputation.
Plaintiff No.2, F. Hoffmann-La Roche AG, a joint stock company
incorporated under the laws of Switzerland is an affiliate of plaintiffs
No.1 and 3, and the manufacturer of innovator molecule Trastuzumab.
Plaintiff No.3, Genentech Inc., a corporation incorporated in the State
of Delaware, USA, is an affiliate of plaintiff No.2. Plaintiff No.3 is the
innovator of the biological drug Trastuzumab and is the only entity
worldwide entitled to claim the right to manufacture the biologic
Trastuzumab. It is also the registered proprietor of the trademark
HERCEPTIN® worldwide (including India). Plaintiff No.3 obtained
registration of the trade mark HERCEPTIN® in India under Class 5 -
Registration No. 358259 dated April 23, 2005 valid up to October 9,
2018.
Plaintiff No.3 was granted a secondary, formulation patent in
relation to Trastuzumab from the Controller General of Patents, in
India, which was effective from May 3, 1999 and it has been lapsed on
May 3, 2013. All the three plaintiffs hereinafter collectively referred to
as the "plaintiffs".
3. Defendant No.1, the Drug Controller General of India, Central
Drugs Standard /Control Organization, Ministry of Health and Family
Welfare, Government of India, is responsible for the approval of new
drugs under the Drugs and Cosmetics Act, 1940, as amended (the
"Drugs Act") and the rules framed thereunder. (hereinafter referred to
either defendant No.1 or DCGI)
The defendant No.2, Biocon Limited, a company incorporated
under the Companies Act, with its registered office at Bangalore,
Kamataka - 561229, is a co-developer of a purported biosimilar version
of Trastuzumab, along with defendant No.3, Mylan Inc., a corporation
incorporated in the State of Pennsylvania, USA, with its principal office
at Pennsylvania 15317, USA, who conducts business in India, through
Mylan Pharmaceuticals Private Limited (defendant No.4 herein), Mylan
Laboratories Limited and Mylan Laboratories India Private Limited.
Defendant No.2 after filing of the suit markets its purported biosimilar
Trastuzumab in India under the brand name CANMAb.
4. Defendant No.4, Mylan Pharmaceuticals Private Limited, a
company incorporated under the Companies Act, with its registered
office at Mumbai, is a subsidiary of defendant No.3 and pursuant to the
co-development agreement between defendant No.2 and defendant
No.3, has now launched a purported biosimilar version of Trastuzumab
in India under the brand name HERTRAZ. Defendants No.1, 2, 3 and
4 are hereinafter (referred to as the "defendants").
5. Originally the suit was filed on account of imminent threat of the
introduction of purported biosimilar version of plaintiff No.3's biological
drug Trastuzumab, which is claimed to have been jointly developed by
defendants No.2 and 3, under the brand names CANMAb (150 mg/440
mg) by defendant No.2 and HERTRAZ (150 mg/440 mg) by defendant
No.1. CANMAb and HERTRAZ are together referred as the
defendants' drugs. It was the plaintiffs' contention at that time that the
defendants' drugs are, inter alia, being misrepresented as
"Trastuzumab", "biosimilar Trastuzumab" and a biosimilar version of
HERCEPTIN® without following due process in accordance with the
Guidelines on Similar Biologics for the purpose of obtaining
appropriate approvals.
6. The pleadings in the interim applications and in the main suit are
almost same. Thus, the facts are narrated from the pleadings of the
main suit.
Brief facts as per unamended plaint
7. In 1990, plaintiff No.3 developed a biological drug containing the
active ingredient Trastuzumab, a monoclonal antibody, which is used
primarily in the treatment of HER 2 positive breast cancer. Biological
drugs are synthesized by cells or living organisms as opposed to
chemical drugs which are produced by chemical synthesis.
7.1 It is claimed that between 1992 and 1998, extensive clinical trials
(Phase I, Phase II and Phase III) were carried out by plaintiff No.3 to
test the safety and efficacy of Trastuzumab. Trastuzumab has
received manufacturing and marketing approvals worldwide after
rigorous tests to confirm its safety and efficacy.
7.2 Among other approvals, Trastuzumab was approved by the U.S.
Food and Drug Administration in September 1998 and by the
European Medicines Agency in August 2000. This biological drug has
been sold by the plaintiffs worldwide since 1998, inter alia, under the
well-known trademark HERCEPTIN®.
7.3 The medical community has become accustomed to associating
Trastuzumab for treatment of HER 2 positive breast cancer with the
plaintiff No.3's trademark HERCEPTIN®. As a result, the brand
"HERCEPTIN®" has acquired extensive goodwill and a distinctive
reputation. In India, the innovator molecule Trastuzumab has been
marketed under one of the brand names HERCEPTIN® for almost 12
years. HERCEPTIN® has been recognised as a targeted therapy for
the treatment of HER 2 positive breast cancer.
Further, under a brand user agreement with plaintiff No.2,
Emcure Pharamceuticals Limited distributes Trastuzumab in India
under the brand name BICELTIS®. Plaintiff No.3 is the registered
proprietor of BICELTIS® in India (under Class 5-Registration No.
945910 dated February 22, 2011 valid up to April 23, 2019).
7.4 The plaintiffs obtained approval for the import and marketing of
innovator Trastuzumab in India in the year 2002. The said approval
was granted by the defendant No.1 on October 11, 2002 under Rule
122A of the Drugs and Cosmetics Rules, 1945, as amended ( for short
"the Drugs Rules"). Trastuzumab is presently imported into India by
plaintiff No.1 from the manufacturing facilities of plaintiffs No.2 and 3.
7.5 The plaintiffs were the first to introduce a targeted treatment for
the patients of HER 2 positive breast cancer with the launch of
HERCEPTIN® in 1998. HERCEPTIN® has a well-established and
documented track record of quality, safety and efficacy; has become
the accepted biological treatment for HER 2 positive breast cancer, a
particularly aggressive form of the disease, on a worldwide basis and
enjoys a global reputation. It is now the standard of care for women
with HER 2 positive breast cancer.
7.6 As per averments, the plaintiff No.2's Annual Reports for the
years 2011, 2012 and 2013, the global sales for HERCEPTIN® were
as follows:
Year Sales in US$
2011 5.7 billion
2012 6.4 billion
2013 6.75 billion
Case set up by the Plaintiffs against the Defendants
8. It is alleged in the plaint that defendants No.2 and 3 have stated
in their press statements that they have entered into an exclusive
strategic collaboration for the development, manufacturing, supply and
commercialization of multiple, high value generic biologic compounds
for the global marketplace. According to the terms of this collaborative
arrangement available in the public domain, thus defendant No.3 has
exclusive commercialization rights in respect-of the purported
"biosimilar" drug in the USA, Canada, Australia, New Zealand including
India; defendants No.2 and 3 enjoy co-exclusive commercialization
rights with each other. As a part of the collaborative arrangement
between them, defendants No.2 and 3 have purportedly jointly
developed a drug which they claim is biosimilar to Trastuzumab. Based
on press releases issued by defendants No.2 and 3. Defendant No.2's
press release specifically states that CANMAb will become available in
India in the first week of February 2014. Further, defendant No.3's
press release refers to the imminent launch of HERTRAZ.
9. It is averred in the plaint that under the procedure for the
approval of new drugs by defendant No.1 in India, after NDAC (NEW
DRUGS ADVISORY COMMITTEE ) has reviewed an application for a
new drug and given its recommendation, on 18th October, 2013 it
refers such application to a Technical Committee (the "TC"), along with
its recommendation, for consideration. After the TC has endorsed the
recommendation made by NDAC, it refers the application to the Apex
Committee, and only after both TC and the Apex Committee have
endorsed the recommendation of the NDAC, should defendant No.1
consider granting its approval to such application. This is usually a
time consuming process and the consideration by the NDAC, the TC
and the Apex Committee is unlikely to be completed in a short span of
five days i.e. on 23rd October, 2013. The undue haste with which the
approval was granted by defendant No.1 suggests that all factors
relevant to the approval of a biosimilar drug under the Guidelines on
Similar Biologies and under other internationally recognised standards
were not taken into consideration at the time of granting such approval.
It is also uncertain whether the TC and the Apex Committee were
provided an opportunity to endorse the NDAC's recommendation
before approval was granted by defendant No.1. In the European
Union, while defendant No.3 started Phase III clinical trials for a
purported biosimilar Trastuzumab on November 27, 2012, no approval
for such purported biosimilar has been granted as yet. It is stated in the
unamended plaint that the plaintiffs reserve their right to challenge the
marketing authorisation granted by defendant No.1 to defendant No.2.
10. In the subsequent paras of the plaint, it is stated that the
defendants No.2 to 4 have made many misrepresentations to the
public about the approvals and making their product without any basis.
The said approvals are contrary to guidelines of biosimilar and in
breach of provisions. The proposed drug of the defendants is mis-
branded drug.
Main defence as per written statement by defendant No.1
11. In its written statement, the defendant No.1 alleged that due
procedure has been followed for Grant of approval to defendant
No.2 to manufacture and / or import new drugs including vaccines and
Recombinant DNA derived products are governed under the regulatory
provisions as provided in the Drugs and Cosmetics Act, 1940 and Drugs and
Cosmetics Rules, 1945. There is a specific provision in the Schedule
under which the toxicological and clinical data requirements for grant of
permission of new drugs or to undertake clinical trials, may be
abbreviated, deferred or omitted, as deemed appropriate by the
Licensing Authority. The defendant No.2's application for manufacture
of its drug was in conformance with the statutory requirements as
contained in the relevant rules read with schedule Y. Under the Drugs
& Cosmetics Act & Rules, the term "Similar Biologics" has not been
defined. However, the defendant No.1 along with the Department of
Bio Technology has prepared "Guidelines on Similar Biologics:
Regulatory Requirement for Marketing Authorization in India" in the
year 2012. These guidelines are not statutory under the Drugs and
Cosmetics Act and the Rules made thereunder.
11.1 At the time of application made by the defendant No.2, neither
the firm applied for permission to conduct Phase I and Phase II clinical
trials nor these were necessary as per requirement specified in the
Drug Act and Rules. However, the defendant No.1 is obliged to
strictly act in terms of relevant provisions of the Drugs and Cosmetics
Rules, in particular the provisions of Rules Rule-122 A, 122B & 122D.
In terms thereof, no new drug shall be imported or manufactured
except under, and in accordance with, the permission granted by the
Licensing Authority as defined in clause (b) of Rule 21 (i.e. DCGI).
Apart from the procedure and safeguards specified in the Drugs and
Cosmetics Rules, in case of products produced by recombinant
technology, prior approval of RCGM (Review Committee on Genetic
Manipulation) under Department of Biotechnology is required before
granting the clinical trial permission by the office of Drugs Controller
General India.
It is submitted that the applications for approval for
manufacture/import of new drugs are evaluated in consultation with
New Drug Advisory Committees or Investigational New Drug
Committees as the case may be. The Technical Committee and Apex
Committee are involved only for the evaluation of proposals for
conduct of clinical trial and not for evaluation of any proposal for
approval of new drugs for manufacture and market in the country.
11.2 As far as Trastuzumab, being a monoclonal antibody, is
concerned, it is produced by recombinant DNA technology. The drug is
indicated for the treatment of patients with metastatic breast cancer.
M/s Roche Switzerland is the innovator of the drug. The innovator's
drug is being marketed globally in various countries under different
brand names viz. "Herceptin", "Herclon" or "Biceltis". The drug
Trastuzumab is already listed in United States Pharmacopeia which is
a book of standard for drug followed in the USA and Martindale-the
complete drug reference which provides details of various drugs. It is
denied by the defendant No.1 that there was any deviation from the
statutory requirements or that there was any undue haste in dealing
with the defendant No.2's application for manufacture of its drug.
11.3 It is also pleaded in the written statement that under Rule 122
DC, "any person aggrieved by an order passed by the licensing
authority under this part, may within 60 days from the date of such
order, appeal to the Central government, and the Central government
may after such enquiry into the matter as is considered necessary,
may pass such order in relation thereto as it thinks fit". In terms of the
provision, it is open for the plaintiffs to invoke the said provision and
file an appeal with the Central government. Instead of doing so, the
plaintiffs have approached the court without exhausting the statutory
remedy.
11.4 The original plaint does not seek any relief against the
defendant No.1 qua the permission to manufacture granted by it to the
defendant No.2. A bare averment has been made that "the plaintiffs
reserve the right to challenge the marketing authorisation granted by
defendant No.1 to defendant No.2." The pleas regarding alleged
infirmities in the procedure adopted by the defendant No.1 for granting
permission to manufacture to the defendant No.2. From the conduct of
the plaintiffs, it is evident that the plaintiffs have sought monopoly and
to interfere with the statutory prerogatives conferred on defendant
No.1 to grant permission to manufacture for the drug in question, such
actions on the part of the plaintiffs are contrary to public interest. The
price of the plaintiffs' product is high and there is no justification for
blocking other potential manufacturers in the guise of absurd
interpretation/application of statutory provisions. These are the main
defences raised by the defendant No.1 who has also dealt with each
paras of the plaint in its written statement.
The defence of defendant No.2 as per written statement.
12. Several pleas raised by defendants No.2 to 4 are common as
pleaded by the defendant No.1 by filing of separate written statements.
For the sake of brevity, the same are not repeated. It is stated in the
written statement filed by the defendant No.2 that it has been granted
all the requisite approvals, as per law, for manufacturing and marketing
its bio-similar drug CANMAb, by the defendant No.1/Approving
Authority after the drug CANMAb has being evaluated under the
stringent tests and procedures laid down under applicable laws. At the
stage of the approval process, the Expert Committees having technical
experts in multiple fields including in the field of Quality, Efficacy and
Safety, have undertaken in-depth evaluation and recommended to the
appropriate licensing and regulatory authorities for approval of the
defendant's drug. The approval process involved review by the
independent IBSC expert member, Multidisciplinary experts in RCGM,
DCGI, the Medical experts in Ethics Committee, the Oncology experts
in NDAC and the State Licensing Authority. Further, NDAC (New Drug
Advisory Committee) comprising of renowned oncologists from leading
hospitals all over India have monitored and approved the results
establishing similarity between Bmab-200/ CANMAb and plaintiffs' drug
HERCEPTIN.
The entire basis of the approvals granted to Bmab-200/CANMAb
was on the basis that the said drug successfully established bio-
similarity to Herceptin in terms of safety, efficacy and quality. The
defendant No.2 is entitled to refer to its drug Bmab-200/CANMAb by its
International Non Proprietary Name (hereinafter referred to as the
"INN") i.e. `Trastuzumab'. The defendant No.2 is entitled to claim as
similar to the 'Reference Product i.e. Herceptin and bio-similar to
Trastuzumab marketed as Herceptin.
12.1 The 2012 Guidelines on Similar Biologics (hereinafter referred
to as the "2012 Guidelines") are not statutory. Notwithstanding the
fact that the said guidelines merely consolidate the existing regime
and procedure for approval of a similar biologic under the Drugs Act
and Drugs Rules and are only for the purpose of providing guidance to
the pharmaceutical industry. The process took over 5 (five) years for
the defendant to undergo the entire procedure and to obtain the
manufacturing and marketing approval for its bio-similar drug Bmab-
200/CANMAb. The entire procedure was regulated, supervised and
approved by experts having scientific and technical knowhow.
Therefore the plaintiffs cannot allege that the said authorizations "could
not have been" in accordance with law.
12.2 It is admitted that during the course of obtaining approvals for
conducting Phase III trials, the defendant No.1 vide letter dated May
03, 2011 sought a justification from the defendant No.2 for directly
carrying out Phase III trial without any Phase I/II trial. After response
by exercising its discretion under Sub-Rule 3 of Rule 1 of Schedule Y
of the Drugs Rules, the defendant No.1 by its letter dated August 19,
2011 granted permission to the defendant No.2 to directly conduct the
Phase III trial. Thus, there has been no omission in not conducting or
registering Phase I and Phase II trials. In fact the defendant No.2
conducted a combined study of Phase I and Phase III trial after
obtaining requisite permission from the defendant No.1. It was also
denied that the marketing approval was granted in haste.
12.3 It is alleged that Reference Product i.e. Herceptin of plaintiffs
by the defendant cannot be said to constitute an action of passing off.
The instant case is not a case where any confusion is created as to the
source and hence no action for passing off is made out. An action for
passing off is not maintainable as the defendant No.2 nowhere
represented or misrepresented its drug to be of the plaintiffs. The
defendant has only made statements like "CANMAb, jointly developed
by Biocon and Mylan under a global partnership, is the world's first
biosimilar version of Herceptin". Such statement was made with honest
and bonafide practices to convey that there are two different drugs in
the market which come from two independent sources and the
defendant's drug CANMAb is a product which is 'like' plaintiffs' drug
Herceptin.
12.4 The defendant No.2's drug is biosimilar to the plaintiffs'
Herceptin as the defendant No.2 has established comparable safety,
efficacy and quality with the Reference Product- Herceptin is justifiable
after the grant of an approval to the defendant No.2 to manufacture
and market the Bmab-200/ CANMAb by the defendant No.1, therefore
the plaintiffs are not entitled to any relief. A reference to the reference
biologic is necessary for the understanding of the prescribing
oncologists, doctors, dispensing chemists as also the patients. Hence
the defendant No.2's drugs cannot create confusion regarding the
nature of the drug and cause patients and medical practitioners to use
the drug incorrectly.
12.5 There is a bar to the jurisdiction of Civil Court for monitoring
and governing the process and procedure for obtaining requisite
approvals in relation to the drug in dispute once the remedy to
challenge the approvals as granted is available with the plaintiffs. Rule
122 DC of the Drugs Rules provides for a remedy to any person
aggrieved by an order of the Licensing Authority/ Approving Authority
to challenge the grant of approvals. The suit for injunction is not
maintainable.
The plaintiffs in the present suit with the sole motive of stifling
competition under the garb of public safety and health for an
illegitimate and mischievous attempt to retain monopoly by the
plaintiffs over sale of its drug(s) HERCEPTIN, HERCLON and
BICELTIS.
12.6 The reason behind the present suit is that for many years the
plaintiffs had been the only manufacturer for the drug used in the
treatment of HER2 positive metastatic breast cancer and therefore
enjoyed a monopoly over the pharmaceutical industry in this segment.
But soon after the defendant No.2's announcement on a similar drug,
the plaintiffs realized that they will no longer enjoy the monopoly and
control over the treatment of HER2 metastatic breast cancer, therefore,
in order to maintain the monopoly and restrict the entry of the
defendant's drug, the plaintiffs filed the present suit under the garb of
lack of approvals.
The defence as per written statement of defendants No.3 and 4
13. In addition to the written statement of defendants No.1 and 2, it
is alleged that the entire suit is entirely speculative and nothing more
than a fishing expedition, the plaintiffs do not have any locus standi to
initiate and prosecute the present civil action before a court of law. It is
submitted that the Drugs and Cosmetics Act, 1940 ("Drugs Act") does
not create any civil right of action in the plaintiffs. The present suit is
barred by law.
13.1 Defendant No.3 is one of the world's leading generics and
specialty pharmaceutical companies and defendant No.4 is its Indian
subsidiary. The defendant No.2 is a company engaged in the business
of manufacturing biotechnological products that cater to the healthcare
segment. Defendant No.2, in collaboration with defendant No.3, has
developed a biosimilar trastuzumab, the International Non-proprietary
Name (as recognized by the World Health Organization) for a
biological molecule used primarily for the treatment of HER-2 positive
breast cancer.
13.2 The relief of passing off is not sustainable in the nature i.e. to
restrain the defendants from "relying upon or otherwise referring to
HERCEPTIN®.." or "relying upon or otherwise referring to data relating
to Trastuzumab marketed as HERCEPTIle" or "claiming any similarity
with HERCEPTIN®."
14. When the suit and applications were listed before Court on first
date i.e. 5th February, 2014, after hearing, limited interim order was
passed against the defendants No.2 to 4 and they were restrained
from relying upon or otherwise referring to HERCEPTIN®, HERCLONTM
or BICELTIS® or any data relating to Trastuzumab marketed as
HERCEPTIN®, HERCLONTM or BICELTIS® including data relating to its
manufacturing process, safety, efficacy and sales, in any press
releases, public announcements, promotional or other material for the
defendants' drugs, i.e. CANMAb and HERTRAZ and from claiming any
similarity with HERCEPTIN®, HERCLONTM or BICELTIS®.
15. The order dated 5th February, 2014 was challenged by the
defendants No.2 to 4 by filing two appeals under Order XLIII read with
Section 151 CPC and Section 10 of Delhi High Court Act, 1966, being
FAO (OS) 91/2014 and FAO (OS) 92/2014, which were listed before
the Division Bench and disposed of on 14th February, 2015 by direction
to hear the interim application and application filed by defendants No.2
to 4 which were ordered to be treated as applications under Order
XXXIX Rule 4 CPC on behalf of the appellant and they be re-
numbered as such. The matters be listed before the learned Single
Judge today itself at 2:15 pm."
16. By order dated 14th February, 2014, the earlier order passed by
the Court on 5th February, 2014 was modified to the extent that if
defendant No.2 has already obtained the approval of Package Insert in
question, the same can be used as the interim applications were under
consideration, however, it was clarified that the remaining interim order
already passed would continue. The order was modified for the reason
as the statement was made on behalf of defendant No.2 that on 13th
December, 2013 the defendant No.2 also obtained the approval from
the Drugs Controller General of India with regard to the Carton, Labels
and Package Insert.
17. During the completion of hearing of interim applications, large
number of applications are filed by both parties in view of subsequent
events i.e. for discovery of documents, rejection of plaint, contempt
petitions, amendment of plaint. The matter was heard from time to
time wherein common submissions were advanced by the parties on
all applications. It may be mentioned here that though common
arguments were addressed by both parties, however, the defendants
No.2 to 4 were stressing time and again that the issue of
maintainability should be decided first. The arguments addressed in
the amendment applications by the defendants No.2 to 4 were without
prejudice. Even the day when the order was reserved after hearing,
two fresh applications, being I.A. No.16703/2015 and I.A.
No.16704/2015, were filed by the defendants No.2 and 3 to 4. The
defendants No.3 and 4 also filed an application, being I.A.
No.18578/2015, after the reserving the order for review of order dated
13th August, 2015. It was ordered that since all the relevant issues
involved in the matter have been addressed by all the parties, no
correction or modification of any nature is necessary.
18. Before pronouncing the orders in the above said application,
draft of which was almost ready, another suit, being CS(OS)
No.3284/2015, Genentech Inc and Ors. v. Drugs Controller General Of
India and Others, was filed along with interim application against third
party having the same common case. The said suit was listed before
Court on 2nd November, 2015 and after hearing limited ad-interim order
was passed not to launch the drug which was yet to be introduced.
The said order was challenged by the defendant No.3 in appeal before
the Division Bench, being FAO (OS) 625/2015. During the pendency
of the application, both sides completed the pleadings and concluded
their arguments and the order was reserved on 13th January, 2016 in
the application, being I.A. No.23041/2015 under Order XXXIX Rule 1
and 2 CPC. Subsequently, the appeal filed by the third party i.e.
Reliance was disposed of mainly on the reasons that the order has
been reserved. As facts and legal issues in both the cases are
common, therefore, this Court was of the view that both orders should
be pronounced together. Therefore, the delay has occurred in passing
the orders.
19. The details of pending applications filed by the parties are given
as under:
i) I.A. No.2371/2014 (under Order XXXIX Rule 1 & 2 CPC by
plaintiffs)
The above mentioned application has been filed by the plaintiffs
under Order XXXIX Rule 1 and 2 CPC seeking the interim orders
against the defendants.
ii) I.A. No.2988/2014 and I.A. No.2990/2014 (under Order XXXIX
Rule 4 CPC by defendants No.2 to 4)
The above mentioned two applications are treated as filed
under Order XXXIX Rule 4 read with Section 151 CPC filed by
defendants No.3 and 4 and defendant No.2 respectively for vacation
of the interim orders passed on 5th February, 2014 in I.A.
No.2371/2014. The same are numbered in view of orders passed in
appeals, being FAO (OS) 91/2014 and FAO (OS) 92/2014. The
grounds taken in the said applications are similar to the pleas raised
in the written statements filed by the defendants, therefore, the same
are dealt with my order while disposing of interim applications.
iii) I.A. No.4649/2014 dated 28 th February, 2014 (under Order
VI Rule 17 CPC by the plaintiffs)
The above mentioned application has been filed under Order VI
Rule 17 read with Section 151 CPC for amendment of the plaint by the
plaintiffs. In the unamended plaint, admittedly the plaintiffs had
expressly reserved their right to challenge the purported approvals
granted in connection with the defendants' Drugs and modify the
plaint and / or to enlarge the reliefs sought against the defendants. It
is mentioned that after the filing of the plaint, the plaintiffs have been
provided certain documents by defendant No.2, including copies of
the purported approvals issued in connection with Bmab-200, Based
on the documents provided by defendant No.2 to the plaintiffs,
additional factual information has become available to the plaintiffs.
iv) I.A. No.4677/2014 (under Order XXXIX Rule 2A CPC)
The above mentioned application has been filed by the plaintiffs
under Section 94(c) read with Order XXXIX Rule 2A read with Section
151 CPC for breach of interim order passed on 5th February, 2014.
v) I.A. No.5956/2014 dated 28th March, 2014 filed by plaintiffs
The above mentioned application is filed under Order XI Rule 12
and 14 read with Section 151 CPC by plaintiffs for discovery and
production of documents by defendant No.2.
vi) I.A. No.14533/2014, filed by plaintiff on 25 th July, 2014
The above referred application under Section 94(c) read with
Order XXXIX Rule 2A and with Section 151 CPC has been filed by
the plaintiffs for breach of orders passed on 5 th February, 2014 and
modified order dated 14th February, 2014 and order dated 28th
February, 2014 alleging that despite knowing, the defendants have
intentionally and wilfully disobeyed the directions issued by this
Court in its order dated February 28, 2014 wherein it was observed
that neither of the parties will, till further orders, go to the media on
the safety or undesirability of the product of the other.
vii) I.A. No.11224/2015 dated 21st May, 2015 by the plaintiffs
The plaintiffs have filed the present amendment application to
amend the suit to bring on record facts relating to the grant of approval
to Bmab-200, based on the above referenced manufacturing and
marketing authorisation dated October 23, 2013, for additional
indications, namely ER2+ early breast cancer and HER2+ metastatic
gastric cancer (the "Additional Indications") during the pendency of
the present suit, and to seek appropriate reliefs in view of such facts.
Such reliefs arise from the cause of action identified in the plaint.
viii) I.A. No.12830/2015 dated 30th June, 2015 by defendant
No.2
The above said application is filed on behalf of the defendant
No.2 under Order VII Rule 11(a) and (d) read with Section 151 CPC for
rejection of plaint on the main ground that the plaint does not disclose
a cause of action.
ix) I.A. No.16703/2015 dated 12th August, 2015 by defendant
No.2 listed on 13th August, 2015
The above said application is filed on behalf of the defendant
No.2 under Section 151 CPC for adjudication of the following:
i. Application bearing IA. No.2990 of 2014 filed by the defendant
No.2 under Order XXXIX Rule 4 CPC ('Application for Vacation
of Injunction');
ii. Application bearing IA. No.2371 of 2014 filed by the plaintiffs
under Order XXXIX Rules 1 & 2 CPC ('First Application for
Injunction');
iii. Issue of jurisdiction of the Court recorded by the Court vide its
order dated 31.03.2014.
x) I.A. No.16704/2015 dated 12th August, 2015 by defendants
No.3 and 4 listed on 13th August, 2015
The above mentioned application has been filed on behalf of the
defendants No.3 and 4 under Section 151 CPC on the similar grounds
as raised in I.A. No.16703/2015 filed by the defendant No.2.
xi) CCP(O) No.69/2015 dated 30th June, 2015 by defendant
No.2
The above referred contempt petition has been filed by the
defendant No.2 under Sections 11 and 12 read with Section 2(c) of the
Contempt of Courts Act, 1971 for contempt of orders dated 5th
February, 2014, 14th February, 2014, 28th February, 2014, 5th May,
2015 and 28th May, 2015 passed by this Court in view of letter dated
10th June, 2015 on behalf of the plaintiffs to the defendant No.1.
xii) I.A. No.12862/2015 dated 30th June, 2015 by defendants
The above mentioned application has been filed under Order
XXXIX Rule 1 and 2 CPC read with Section 151 CPC praying to
restrain the plaintiffs from issuing letters, press releases, publication
and/or material in any form or manner in relation to the present
proceedings and also to withdraw the letter dated 10th June, 2015 or
any other letter of such nature and demand issued to the DGCI.
xiii) I.A. No.3955/2015 (filed by third party i.e. stranger)
The above mentioned application has been filed by the third
party i.e. for impleading as party in the present suit on various grounds.
20. On behalf of plaintiffs, the matter was argued by Mr.Rajiv Nayar
and Mr.Sandeep Sethi, Senior Advocates, from time to time.
Mr.Darpan Wadhwa has also made his submissions on 13th August,
2015 at the time of rejoinder arguments. Mr.Sanjay Jain, learned ASG,
made his submissions on behalf of defendant No.1. Mr.Harish Salve,
Dr.A.M. Singhvi, Ms.Prathiba M. Singh, Senior Advocates made their
submissions on behalf of the defendant No.2. Dr.C.S.Vaidyanathan
and Mr.Amit Sibal, Senior Advocates, made their submissions on
behalf of the defendants No.3 and 4 on various dates.
21. After analysing the pleadings of the parties along with the
documents filed therewith and submissions advanced by the learned
counsel for the parties at length on the applications, the points of
contentions can be summarised. On the basis of unamended plaint
the following questions are framed. The pleas which are not covered in
the following questions are dealt with separately in the present order.
For the sake of convenience, the following questions can be said to be
sufficiently answering the contentions raised by the parties in the facts
of the present matter:
i) Whether the plaintiffs have any right of action in the
present case or not? If yes whether the suit is
expressly or impliedly barred in law in view of the
provisions of Drugs and Cosmetics Act 1945?
ii) If the suit is maintainable, whether this Court is within
its powers to embark upon the approvals granted by
the Drug controller in relation to the drugs in case it
impinges the civil rights of the plaintiffs in order to
protect the said civil rights or not?
iii) What is the impact of the Guidelines on Similar
Biologics framed in the 2012 under the aegis of Drug
Controller of India/ defendant No.1 and the
government of India, Ministry of Bio technology and
whether these guidelines would have any bearing in
relation to the grant of the marketing and
manufacturing approvals by the defendant No.1
especially granted after the framing of the said
guidelines or not?
iv) Whether the approval granted by the defendant No.1
to the defendant No.2 by omitting the requirements of
the clinical trials phase I and II would have any
bearing upon the already granted approvals in the
case of the similar biologics product or not and
whether the defendant No.2 has conducted all the
clinical trials of drug as required under the strict
provisions of the Act and Rules and Bio-similar
Guidelines of 2012?
v) Whether the common law remedy can be pursued by
the plaintiffs for misrepresentation and false
information allegedly made by the defendants No.2 to
4 in view of peculiar circumstances of the present
case?
22. Maintainability / Jurisdiction of Civil Court:
Objections of all defendants
Submissions on behalf of defendant No.2
a) The first and foremost objection raised by all defendants is with
regard to the jurisdiction of Civil Court on the grounds that the
Drugs and Cosmetics Act, 1940 is a complete code itself. There
exists a bar to the jurisdiction of Civil Courts (having original
jurisdiction). The Drugs and Cosmetics Rules, 1945 (hereinafter
referred to as the 'Rules') specifically provide for a mechanism of
filing an 'Appeal' for challenging the Approvals granted under the
Act. It is stated that Rule 122 DC as amended (the Drug Rules)
and Section 37 of the Act as amended provide for a remedy to
any person aggrieved by an order of the Licensing Authority. As
the Act expressly provides for a mechanism for challenging the
orders of the Licensing Authority, plaintiffs cannot be allowed to
continue with the present proceedings before Civil Court. If the
plaintiffs wanted to challenge the approvals, they should have
filed a writ petition, the other remedy which is available to them,
but the suit is impliedly barred.
b) It is argued by all defendants that if a civil court would start to
examine the grant of Approvals, it will undermine and / or usurp
the powers of the defendant No.1 and its various constituents
comprising of expert bodies and committees (Institutional Bio-
safety Committee - IBSC, Review Committee on Genetic
Manipulation- RCGM, New Drug Advisory Committee- NDAC
etc.) who have examined and approved the drug before grant of
manufacturing and marketing license under the Drugs Act and
Rules. The present suit is an attempt to take upon themselves
the role of a Drug Regulator where a statute expressly/impliedly
provides a provision for an alternate remedy. Unamended plaint
does not challenge the approval for manufacturing and marketing
authorisation dated 23rd October, 2013.
c) Mr.Sanjay Jain, learned ASG, appearing on behalf of the
defendant No.1 referred the following decisions:
a) State of A.P. v. Manjeti Laxmi Kantha Rao (dead) by Lrs
and Others (2000) 3 SCC 689
b) Raja Ram Kumar Bhargava (dead) by Lrs. v. UOI (1998) 1
SCC 681
In these judgments, it has been laid down that the test
adopted in examining such a question is (i) whether the
legislative intent to exclude arises explicitly or by necessary
implication, and (ii) whether the statute in question provides
for adequate and satisfactory alternative remedy to a party
aggrieved by an order made under it. and wherever a right,
not pre-existing in common law, in created by a statute and
that statute itself provided a machinery for the enforcement
of the right, both the right and the remedy having been
created uno flatu and a finality is intended to the result of
the statutory proceedings, impliedly barred."
d) It is argued by defendant No.2 that the relief of injunction as
claimed in the instant suit falls within the domain of the Specific
Relief Act, 1963 and is discretionary relief which is circumscribed
by the provisions of the Specific Relief Act, 1963 and is to be
available only when there is no alternative efficacious remedy
available as the defendant No.2 has been granted all the
requisite approvals, as are required under law, for manufacturing
and marketing its bio-similar drug CANMAb, by the defendant
No.1. The said approvals have been granted after following due
procedure as prescribed under the Act by the defendant No.1
after the defendant No.2's drug CANMAb being evaluated under
the stringent tests and procedures laid down under applicable
laws.
e) The following decisions are referred by the defendants No.1 and
2 on this aspect:
i. N.D. Jayal & Anr. v. Union of India & Ors. (2004) 9 SCC
Para 20. "This Court cannot sit in judgment over the
cutting edge of scientific analysis relating to the safety
of any project. Experts in science may themselves
differ in their opinions while taking decisions on
matters related to safety and allied aspects. The
opposing viewpoints of the experts will also have to
be given due consideration after full application of
mind. When the Government or the authorities
concerned after due consideration of all viewpoints
and full application of mind took a decision, then it is
not appropriate for the court to interfere. Such matters
must be left to the mature wisdom of the Government
or the implementing agency. It is their forte. In such
cases, if the situation demands, the courts should
take only a detached decision based on the pattern of
the well-settled principles of administrative law. If any
such decision is based on irrelevant consideration or
non-consideration of material or is thoroughly
arbitrary, then the court will get in the way. Here the
only point to consider is whether the decision-making
agency took a well-informed decision or not. If the
answer is "yes", then there is no need to interfere.
The consideration in such cases is in the process of
decision and not in its merits."
ii. Systopic Laboratories (Pvt.) Ltd v. Dr Prem Gupta 1994
Supp(1) SCC 160
Para 21: "... As to whether clinical trials should have
been conducted or not was primarily for the experts to
decide and if the experts felt that in respect of the
drugs in question such clinical trials were not
necessary, it is not possible to hold that there has
been no proper evaluation of the material that was
submitted by the manufacturers before the Experts
Committee..."
f) In addition, it is argued on behalf of the defendant No.2 that the
defendant No.2 has not skipped Phase I trial as the objective of a
Phase I trial is to establish comparative pharmacokinetics (pK)
and this pK data was generated by defendant No.2 as the initial
part of the Phase III trial. Defendant No 2 did the Phase I and
Phase II trials as part of the same sequential study since it was
necessary to do the pK study in patients and not in healthy
volunteers. The Phase II study as dose finding and POC studies
are not required for follow-on products (biosimilars or generics).
The said justification was accepted by the defendant No.1. The
allegations of the plaintiffs that the approval was granted to the
defendant No.2 without conducting Phase I, Phase II trials is
contrary to law. Even at the time of obtaining the ex-parte order
Mr.Rohatgi conceded that if approval is granted, the same would
be challenged by the plaintiffs as per law and in the present case
the suit does not challenge the approval granted to the defendant
No.2. Therefore, the plaint is liable to be rejected on account of
lack of cause of action.
g) Mr.Amit Sibal, learned senior counsel on behalf of defendant
no.3 and 4 by raising the similar objections as argued by the
defendant No.2, in addition, he argued that the plaintiffs have
failed to establish and even aver in the plaint about the breach of
any statutory duty by the defendant No.1. He referred the case
of Rohtas Industries Staff Union and Ors. v. State of Bihar
and Ors., reported in AIR 1963 Pat 170, the Patna High Court
wherein while considering the question as to whether under the
Industrial Disputes Act, 1947 employers had a legal right to claim
damages from employees who had taken part in an illegal strike
and after discussing the English case laws, came to the
conclusion that the employers have no right of Civil action for
damages against the employees participating in an illegal strike
within the meaning of Section 24(1) of the Industrial Disputes
Act." [emphasis supplied]
The said decision of the Patna High Court was upheld by a
three Judge bench of the Supreme Court in Rohtas Industries
Ltd. and Anr. v. Rohtas Industries Staff Union and Ors.,
reported in (1976) 2 SCC 82.
h) Mr.Sibal has also referred the decision of the Supreme Court in
the case of Premier Automobiles Ltd. Vs Kamlekar
Shantaram Wadke & Ors., reported in 1976 1 SCC 496,
wherein the plaintiffs, who were individual workmen suing in a
representative capacity, filed a civil suit seeking a declaration
that a certain Settlement Agreement arrived at between Premier
Automobiles Ltd. and the Association Union under Section 18(1)
of the Industrial Disputes Act, 1947 was not binding upon them
and further for a permanent injunction restraining Premier
Automobiles from enforcing or implementing the terms of the
impugned Settlement Agreement. The Supreme Court in this
case observed as under, before giving its finding to the same
effect at paragraph 23(3) of the judgment has held that the civil
court will have no jurisdiction to try and adjudicate upon an
industrial dispute if it concerned enforcement of certain right or
liability created only under the Act. The civil court will have no
jurisdiction even to grant a decree of injunction to prevent the
threatened injury on account of the alleged breach of contract if
the contract is one which is recognized by and enforceable under
the Act alone be referring the quotation referred in Doe v.
Bridges at page 859 are the famous and oft-quoted words of
Lord Tenterden, C.J. saying "Where an Act creates an obligation
and enforces performance in a specified manner, we take it to be
a general rule that performance cannot be enforced in any other
manner.''
i) Lastly he submits that the challenge to the grant of approval is
available under Rule 122DC of the Drugs Rules. In the present
case DCGI is the appropriate statutory authority to grant
manufacturing and marketing approvals to new drugs under the
Drugs Act. The plaintiffs have not availed of the remedy
provided under Rule 122DC of the Drugs Rules to challenge the
approvals granted to defendant No.2. The nature of the reliefs
sought by the plaintiffs cannot be granted by the Civil Court
though a writ petition under Article 226 may be maintainable
against a remedy available under a statute but a civil suit is
barred.
He has referred the following decisions:
i) In State of Bihar v. Dhirendra Kumar, reported in (1995)
4 SCC 229, it was held by the Supreme Court of India that:
''...Thus, it could be seen that the Act is a complete
code in itself and is meant to serve public purpose.
We are, therefore, inclined to think, as presently
advised, that by necessary implication the power of
the civil court to take cognizance of the case under
s.9 of CPC stands excluded, and a civil court has no
jurisdiction to go into the question of the validity or
legality of the notification under s.4 and declaration
under s.6, except by the High Court in a proceeding
under Article 226 of the Constitution. So, the civil suit
itself was not maintainable. When such is the
situation, the finding of the trial court that there is a
prima facie triable issue is unsustainable.''
The said dicta was affirmed in Commissioner, Bangalore
Development Authority & Anr v. Briiesh Reddy & Anr.,
reported in (2013) 3 SCC 66, wherein the Supreme Court, in
view of the assertions made by the authority (defendant) in their
written statement on the process followed under the Land
Acquisition Act held that the suit is not maintainable as the Act
was a complete code and jurisdiction of the civil court is impliedly
barred.
ii) The judgment of seven-Judge Bench of the Supreme Court
of India in Kamala Mills Ltd. v. State of Bombay, reported in
AIR 1965 SC 1942, is also referred by Mr.Sibal wherein the
Supreme Court discussed the issue of exclusion of jurisdiction of
a civil Court under a special statute. The Bench held in the
context of Section 20 of Bombay Sales-Tax Act, 1946 that:
"It would thus be seen that the appropriate authorities
have been given power in express terms to examine
the returns submitted by the dealers and to deal with
the questions as to, whether the transactions entered
into by the dealers are liable to be assessed under
the relevant provisions of the Act or not. In our
opinion, it is plain that the very object of constituting
appropriate authorities under the Act is to create a
hierarchy of special tribunals to deal with the problem
of levying assessment of sales tax as contemplated
by the act. If we examine the relevant provisions
which confer jurisdiction on the appropriate
authorities to levy assessment on the dealers in
respect of transactions to which the charging section
applies, it is impossible to escape the conclusion that
all questions pertaining to the liability of the dealers to
pay assessment in respect of their transactions are
expressly left to be decided by the appropriate
authorities under the Act as matters falling within their
jurisdiction. Whether or not a return is correct;
whether or not transactions which are not mentioned
in the return, but about which the appropriate
authority has knowledge fall within the mischief of the
charging section; what is the true and real extent of
the transactions which are assessable; all these and
other allied questions have to be determined by the
appropriate authorities themselves; and so, we find it
impossible to accept Mr. Sastri's argument that the
finding of the appropriate authority that a particular
transaction is taxable under the provisions of the Act,
is a finding on a collateral fact which gives the
appropriate authority jurisdiction to take a further step
and make the actual order of assessment. The whole
activity of assessment beginning with the filing of the
return and ending with an order of assessment, falls
within the jurisdiction of the appropriate authority and
no part of it can be said to constitute a collateral
activity not specifically and expressly included in the
jurisdiction of the appropriate authority as such. "
j) It is argued by Mr.Amit Sibal, learned Senior counsel, that the
reasoning in the Kamala Mills Case (supra) applies with equal
force in the instant case. The Drugs Act and Drugs Rules is a
special statute that regulates the import, manufacture and
distribution of drugs including biologic drugs. The said act
contains an entire machinery for the determination of inter alia
new drug approvals right upto the Central Government. The
present civil suit has been filed to make a civil court examine the
approvals admitted in the plaint to have been granted by a
regulatory authority (i.e. DCGI) pursuant to the Drugs Act and
Drugs Rules The DCGI under the Drugs Act and Drugs Rules is
vested with the jurisdiction to determine Bmab-200's
biosimilarity/comparability to HERCEPTIN, and to subsequently
grant manufacturing and marketing authorizations thereon to
defendant No.2 in exercise of its powers under Rule 122B of the
Drugs Rules. Additionally, the remedy of an appeal to the Central
Government is provided to any "aggrieved person" under Rule
122DC of the Drugs Rules. In this background it cannot be
gainsaid that the jurisdiction of a civil court to entertain the
present dispute has been ousted even under the provision in
Section 37 of the Drugs Act mandates that "No suit, prosecution
or other legal proceeding shall lie against any person for anything
which is in good faith done or intended to be done under this Act"
k) Mr.Sibal submits that if Section 37 of the Drugs Act with Rule
122DC of the Drugs Rules is read conjointly, the jurisdiction of a
civil court is barred. He referred the decision of the Supreme
Court in Public Prosecutor, Madras v. R. Raju and Anr.,
reported in (1972) 2 SCC 410, in which the Supreme Court was
also concerned with examining a section excluding the
jurisdiction of the civil courts. He submits that the language of
Section 40(2) of the Central Excises and Salt Act, 1944 is similar
to section 37 of the Drugs Act.
"Section 40(2): No suit, prosecution or other legal
proceedings shall be instituted for anything done or
ordered to be done under the Act after the expiration
of six months from the accrual of the cause of action
or from the date of the act or order complained of "
However, when pointed out the factual position, Mr.Sibal
admits that the Supreme Court, while deliberating on the
appellant's contention that sub-section (2) of Section 40 was
confined only to the government officers.
23. Before dealing with the submissions on behalf of the defendants,
it is necessary to refer the specific averments made in the plaint. It is
alleged in the plaint, after approval granted to the defendant No.2 in
October 2013, on 26th November, 2013 defendant No.2 issued a press
release in relation to the marketing authorisation for the purported
biosimilar Trastuzumab developed jointly with defendant No.3 for the
treatment of HER 2 positive metastatic breast cancer. But the press
release made no reference to a manufacturing licence received by
defendant No.2 in this regard. The plaintiffs were awaiting a response
to the above referenced letter dated October 11, 2013 at this stage.
Thereafter, on January 18, 2014, defendant No.2 announced that
CANMAb would be introduced in India for the treatment of HER 2
positive metastatic breast cancer in the first week of February, 2014.
Defendant No.2's press release of January 18, 2014. Therefore, the
present suit for quia timet action was filed. The issue in hand is being
considered by this Court mainly on the reason that the defendants
No.1 and 2 are alleging that upon approvals the defendant No.2 has
acquired legal rights to claim as similar to the reference product of the
plaintiffs. They are entitled to use all references, data, INN i.e.
Trastuzumab and to promote the same in hospitals, doctors and public
at large that their drug is similar with the drug of the plaintiffs. If that is
not the situation, then the position would have been different while
dealing with this issue. The plaintiffs have made specific averments in
the plaint, the details of which are given as under:
i) In the plaint it is mentioned that defendants No.2 to 4 have
misrepresented the nature of the defendants' drugs as
"biosimilar Trastuzumab", a Trastuzumab" and a "biosimilar
version of HERCEPTIN®. Such misrepresentations are likely
to deceive the patients using Trastuzumab regarding the
efficacy and safety of the defendants' drugs as "Biosimilars"
are biological products that are similar to the innovator
biopharmaceutical product can only be similar to the innovator
biopharmaceutical product; it cannot be a generic equivalent
of the innovator biopharmaceutical product. Although
biosimilars are gaining popularity in Indian and international
markets, biosimilars are not in the nature of generic drugs.
Rather these are unique molecules for which only limited data
is available at the time of approval, and as such, the concerns
and risks associated with the long term safety, efficacy and
immunogenicity of biosimilars are significantly higher
compared to those associated with a generic drug.
ii) As these products are very complex molecules, in the interest
of patient safety, factors such as robustness of the
manufacturing process, structural similarity to the innovator
molecule, level of understanding of the mechanism of action,
quality of the pharmacodynamic procedures utilised,
demonstrated comparability in pharmacokinetics and
immunogenicity and quality and quantity of clinical data, need
to be necessarily considered before marketing approval is
granted to biosimilars.
iii) The defendant No.2's protocol and study for testing for Bmab-
200 was filed with and approved by defendant No.1 prior to
the Guidelines on Similar Biologies becoming effective,
defendant No.2 was already conducting Phase III clinical trials
in relation to Bmab-200 (which is the last stage of tests to be
conducted on a new drug prior to grant of marketing
authorisation). Therefore, the tests carried out by defendant
No.2 to compare the efficacy, safety and immunogenicity of its
drug and other studies including product characterisation and
pre-clinical studies could not have been in accordance with
the Guidelines on Similar Biologies, and Bmab-200 cannot be
considered a "biosimilar" under the Guidelines on Similar
Biologies. The marketing authorisation was granted by
defendant No.1 after the Guidelines on Similar Biologies
became effective and these guidelines were not complied with
in granting the marketing authorisation. Since defendant No.3
claims to have co-developed the purported biosimilar
Trastuzumab.
iv) The defendants' drugs have not been tested against the
standards set forth in the Guidelines on Similar Biologies and
the marketing authorisation for Bmab-200 is not issued under
the Guidelines on Similar Biologies. Defendants No.2 to 4
have falsely and wrongly represented the defendants' drugs
as the first biosimilar version of Trastuzumab and a biosimilar
version of HERCEPTIN® in various press statements. Further,
even the marketing and promotional material for the
defendants' drugs by defendant No.2 represent such drugs as
"Trastuzumab for Injection" and "biosimilar Trastuzumab".
v) By referring to the defendants' drugs as a "biosimilar" product,
defendants No.2 to 4 have misrepresented the nature of the
tests to which the drug was subjected for the purpose of
testing its safety and efficacy and thus compromised the
safety of prospective patients. Such misrepresentation is in
the nature of passing off since they seek to pass of the
defendants' drugs as being of the same quality and class as
HERCEPTIN®.
vi) By referring to the defendants' drugs as a "Trastuzumab",
defendants No.2 to 4 have misled the consumers into
believing that the active ingredient of the defendants' drugs is
Trastuzumab itself. This is false to the knowledge of
defendants No.2 to 4 since Trastuzumab is a biological
product and there cannot be a generic equivalent of
Trastuzumab. Another biological drug can at best contain an
active ingredient similar to Trastuzumab.
vii) The defendants No.2 to 4, by misrepresenting the defendants'
drugs as a "biosimilar version of HERCEPTIN®" and by
linking and likening the defendants' drugs to Trastuzimiab and
HERCEPTIN® in various public statements, have sought to
create a false impression regarding the quality, safety and
efficacy of its drug in the minds of the public. Defendants No.2
to 4 have misrepresented that the defendants' drugs are
comparable in quality to HERCEPTIN® and equally effective,
even though this claim has remained unverified under the
Guidelines on Similar Biologies. Even by comparing the
price, storage conditions and formulation of the defendants'
drugs with HERCEPTIN®, defendants No.2 to 4 are seeking
to promote the unverified advantages of their product.
Misleading, unfair and deceptive advertisements, as in the
present case, are not permissible and should be enjoined. The
advertiser in this case does not have reasonable basis for the
assertions made in the advertisement and it is not permissible
to make an unsubstantiated, false and misleading claim that
the advertiser's goods are similar to or better than a
competitor's. Confusion in the case of medical products may
be fatal or could have serious consequences on public health
and safety. As such, deception and misrepresentation in the
case of medical products' is especially dangerous and a
stricter approach is adopted while testing the possibility of
confusion of one medical product for another by consumers.
viii) Each of the defendants' drugs is a misbranded drug under
Section 17 of the Drugs Act since the labels for the products
falsely and misleadingly describes it as 'Trastuzumab for
Injection'. Further, the marketing material for CANMAb falsely
and misleadingly describes it as the 'first Trastuzumab
biosimilar'. The defendants' drugs are not Trastuzumab and
the representation to the contrary in defendants No.2 and 3's
advertisements and marketing material is false, misleading
and a misrepresentation. Accordingly, under Section 18 of the
Drugs Act the manufacture and sale of each of the
defendants' drugs is presently prohibited.
ix) The claim is made by defendants No.2 to 4 that in the trade
Bmab-200 is developed for the treatment of HER 2 positive
metastic breast cancer, it competes directly with the plaintiffs'
biological drug HERCEPTIN® which is used for the treatment
of HER 2 positive breast cancer throughout the world. They
are aware (a) of the reputation enjoyed by HERCEPTIN® in
the relevant market; (b) of the popularity of HERCEPTIN® for
the treatment of HER 2 positive breast cancer; (c) that
HERCEPTIN® and Bmab-200 target the same restricted
market. As such. Defendants No.2 to 4 stand to gain
significantly by relying on the reputation and goodwill of
HERCEPTIN® while promoting their product and making
misleading and false comparisons with the plaintiffs' product.
In the present case, it is not necessary for defendants No.2 to
4 to indicate or imply any kind of connection between
HERCEPTIN and the defendants' drugs or to refer to data
relating to the nature and sales of HERCEPTIN® in order to
market their product in a fair manner.
x) By linking the defendants' drugs to HERCEPTIN® and
referring to data relating to HERCEPTIN® including data
relating to its price and sales in the promotional material for
the defendants' drugs, defendants No.2 to 4 have sought to
take unfair advantage of the reputation and goodwill of the
trademark HERCEPTIN®, which has been developed by the
plaintiffs over several years in the Indian market and
worldwide. This is evident from the fact that although the
plaintiffs market Trastuzumab under two other brand names in
India, being HERCLON™ and BICELTIS, defendants No.2 to
4 have sought to link the defendants' drugs only with the
widely recognised and world renowned HERCEPTIN®. By
relying on the fact that HERCEPTIN® is a well-recognised
biological drug for the treatment of HER 2 positive breast
cancer in India and making misleading references to and
comparisons with HERCEPTIN®, defendants No.2 to 4 are
seeking to gain an unfair advantage in the Indian
pharmaceutical market and obtain an unfair and unjust
commercial benefit on the basis of the reputation and goodwill
of the plaintiffs' brand HERCEPTIN®.
xi) As Bmab-200 has not been sufficiently and adequately tested
to be termed as a biosimilar product, as claimed by
defendants No.2 to 4, there are reasonable apprehensions
regarding the safety and efficacy of this drug. Moreover, as
defendants No.2 to 4 have unfairly and incorrectly linked the
defendants' drugs with HERCEPTIN®, any deficiency
discovered in their product is likely to be imputed to the
plaintiffs' brand HERCEPTIN® leading to a dilution of their
reputation and goodwill built over many years.
xii) Therefore, defendants No.2 to 4 should be restrained from
introducing the defendants' drugs in the Indian market as a
biosimilar product until appropriate tests and studies as
prescribed under the Guidelines on Similar Biologies have
been conducted and appropriate approvals have been
obtained. Defendants No.2 to 4 ought to be further restrained
from using the plaintiffs' trademark HERCEPTIN®, and the
reputation and goodwill attached to it, for their commercial
benefit.
24. It is also mentioned in the plaint that the averments made and
the reliefs sought in the present suit are based on the records available
with the plaintiffs and the information available in the public domain.
Based on such information, the plaintiffs have, inter alia, through the
letter of October 11, 2013 written to defendant No.1 regarding the
inadequacy of the clinical trial design for the purported biosimilar
Trastuzvmiab. The plaintiffs were awaiting a response to such letter.
The plaintiffs seek leave of this Court under Order II, Rule 2 of the
Code of Civil Procedure, 1908, as amended, to modify the plaint and /
or to enlarge the reliefs sought against the defendants. The defendant
No.2 has refused to give the inspection or discover the documents on
the basis of which the approvals were obtained.
25. The unamended plaint and pleadings of the plaintiffs disclosed
that Bmab-200 has not been adequately and/or appropriately tested,
inter alia, under the provisions of the Biosimilar Guidelines and that the
approval granted to defendant No.2 is, therefore, invalid and cannot be
acted upon. The cause of action disclosed even in the unamended
plaint is, inter alia, the improper grant of the manufacturing and
marketing authorisation to defendant No.2 in the absence of adequate
testing and reliefs have been sought in the unamended plaint on the
basis of this cause of action.
26. The plaintiffs alleged that they became aware of the details of the
inadequacy in the approval process and copyright violation subsequent
to filing the suit (i.e. when defendant No.2 filed additional documents
and Bmab-200 was launched in the market). As such, these details
could not have been included in the unamended plaint.
27. After the filing of written statement, reply and documents, the
plaintiffs filed the first application for amendment on the basis of
disclosure of few details, yet the defendant No.2 refused to share any
information with the plaintiffs with regard to tests and approvals
granted on the basis of the said documents.
28. The second application for amendment was filed on the basis of
another approval sought by the defendant No.2. Even at that time also
the plaintiffs were not aware about the actual position. The factual
position came to the knowledge of the Court and the plaintiffs only
during the last week of May, 2015 that the defendants have also
obtained approval of further two indications.
Both the applications were filed on the basis of the subsequent
events. Those were not decided in between the hearing of interim
applications though submissions were made because as and when two
pending two applications of the plaintiffs for amendment of the plaint,
discovery of documents and three contempt petitions, are taken up by
this Court, the defendants No.2 to 4 insisted for giving the decision of
the interim applications by referring the orders passed by the Division
Bench on 14th February, 2014 in FAO (OS) 91/2014 and FAO (OS)
92/2014 as well as the objections raised by them about the
maintainability of the suit. Even replies to the amendment applications
were filed by the defendants No.3 and 4 without prejudice.
Arguments addressed on behalf of plaintiffs
29. Mr.Rajiv Nayar and Mr.Sandeep Sethi, learned senior counsel
appearing on behalf of the plaintiffs, inter alia, argued that since the
approvals are contrary to the provisions of the Act, Rules and
Guidelines of 2012 by Government and the defendants are making
misrepresentations to the doctors, hospitals and patients in the
absence of requisite tests, the plaintiffs have no other remedy but to
file the suit. They submit that despite of expiry of patent rights in 2013,
the plaintiffs are manufacturing and marketing the drug in question and
they are still market leaders in the entire world and the drug is one of
the best drugs for the purpose of cancer treatment although they are
not claiming data exclusively for comparison purposes at the time of
obtaining the approval or any right on the molecule which was the
subject matter of patent after its expiry. But the defendants on the
basis of said approvals are trying to destroy the business of the
plaintiffs and are also cheating the public at large by making
misrepresentation in order to earn easy amount on the basis of
spreading false information to the hospitals, doctors and patients
providing the similar data and tests admittedly not conducted by them.
The said illegal activities of the defendants have compelled the
plaintiffs to file the suit. They argued that the drug of the defendant
No.2 is not bio-similar. If they otherwise manufacture and market the
cancer drug in question without claiming bio-similarity, the defendants
No.2 to 4 are free to do so. They also argued that all the defendants
have admitted before the Court that the defendant No.1 is not
empowered to hear the grievances of the plaintiffs as per rules, thus,
the suit filed by the plaintiffs is maintainable.
It is also argued that once the defendants are guilty of violations
of the rights of the plaintiffs and false information of biosimilar product
in the public, the civil court has the jurisdiction to entertain the suit as
the legal rights of the plaintiffs can only be decided by the civil court
who has the jurisdiction to pass the interim orders for illegal activities of
the defendants No.2 to 4 and the plaintiffs have become aggrieved
parties as the defendants are insisting their product as reference
product of the plaintiffs. They argued that none of the decisions
referred by the defendants are applicable to the facts of the present
case. The facts in the cases referred by the defendants are materially
different.
30. Let me now first decide the issue of maintainability of the suit.
The same is being decided on the basis of averments made in the
unamended plaint and also on subsequent events. In the famous
Wednesbury case, 1948 (1) KB 223, it is rightly held that the Court
should not interfere with the administrator's decision unless it was
illegal, contrary to law, failed to follow conditions in the statute, illogical
or suffer from procedural impropriety or was shocking to the
conscience of the Court or it is in defiance of moral standards whole
deciding the objection raised by all defendants. These principles are to
be kept in mind in the facts of the present case while deciding the
issue in hand.
31. The plaintiffs in the unamended plaint sought the following
reliefs:
(a) an injunction restraining Defendants No.2 to 4 from
launching, introducing, selling, marketing and/or
distributing the Defendants' Drugs, or any other
biosimilar version of Trastuzumab, in the Indian
market until appropriate tests and studies as
prescribed under the 'Guidelines on Similar Biologies:
Regulatory Requirements for Marketing Authorization,
in India' issued jointly by the Department of
Biotechnology, Ministry of Science and Technology,
Government of India and the Central Drugs Standard
Control Organization, Ministry of Health and Family
Welfare, Government of India, which became
effective from September 15, 2012 (the "Guidelines
on Similar Biologies") have been conducted and
appropriate approvals have been obtained;
(b) an injunction restraining Defendants No.2 to 4 from
representing the Defendants' Drugs as 'biosimilar
Trastuzumab' until appropriate tests and studies as
prescribed under the Guidelines on Similar Biologies
have been conducted and appropriate approvals have
been obtained;
(c) an injunction restraining Defendants No.2 to 4 from
representing the Defendants' Drugs as 'Trastuzumab'
or 'Trastuzumab for Injection' in any press releases,
public announcements, promotional or other material
for the Defendants' Drugs; and
(d) an injunction restraining Defendants No.2 to 4 from
relying upon or otherwise referring to the Plaintiffs'
trademarks HERCEPTIN®, HERCLON™ or
BICELTIS®, or any data relating to Trastuzumab
marketed as HERCEPTIN®, HERCLON™ or
BICELTIS® including data relating to its
manufacturing process, safety, efficacy and sales, in
any press releases, public announcements,
promotional or other material for the Defendants'
Drugs and from claiming any similarity with
HERCEPTIN®, HERCLON™ or BICELTIS®.
32. In case the prayers made in the plaint are examined, it is evident
that the plaintiffs were seeking an injunction for launching, introducing
the drug by the defendants No.2 to 4, an injunction from representing
as bio-similar products until appropriate tests and studies are
conducted including guidelines on similar biologics and injunction from
press releases and relying upon or referring to the plaintiffs trade mark
claiming similarity of two drugs. The plaintiffs are not alleging that the
defendants No.2 to 4 is infringing their trade mark or their rights in
respect of expired patent in 2013. Their main concern is that without
establishing the safety and efficacy as required under the Act, Rules
and Guidelines 2012, they are not entitled to claim that it is a biosimilar
drug of the innovator and would not be entitled to use the data of the
plaintiffs and give references in its package insert, carton and publicity
materials by making the false statement and misrepresentation.
Otherwise, independently, they are entitled to market drug in question
without any such references. If the clinical trials are not conducted, the
Regulatory Authority is liable to take action under Rule 122 DB. But if
the references of biosimilar are made by the defendants No.2 to 4 for
promoting and selling the drug in question, the plaintiffs are entitled to
file the suit.
33. It is settled law that Section 9 of the Code provides that civil court
shall have jurisdiction to try all suits of a civil nature excepting the suits
of which their cognizance is either expressly or impliedly barred. To put
it differently, as per Section 9 of the Code, in all types of civil disputes,
civil courts have inherent jurisdiction unless a part of that jurisdiction is
carved out from such jurisdiction, expressly or by necessary implication
by any statutory provision and conferred on other Tribunal or Authority.
Thus, the law confers on every person an inherent right to bring a suit
of civil nature of one's choice, at one's peril, howsoever frivolous the
claim may be, unless it is barred by a statute. Even as per the
decision referred by defendant No.1 in the case of State of Andhra
Pradesh (supra) it is held that the normal rule of law is that the civil
courts have jurisdiction to try all suit and such exclusion is not readily
inferred and the presumption to be drawn.
34. It is trite and debated time and again that the rule of pleadings
postulate that a plaint must contain material facts. When the plaint read
as a whole does not disclose material facts giving rise to a cause of
action which can be entertained by a civil court, it may be rejected in
terms of Order 7, Rule 11 of the Code. Similarly, a plea of bar to
jurisdiction of a civil court has to be considered having regard to the
contentions raised in the plaint if averments disclosing cause of action
and the reliefs sought.
a) In Smt. Ganga Bai v. Vijay Kumar & Ors. (1974) 2 SCC 393,
this Court had observed as under:
"There is an inherent right in every person to bring
suit of a civil nature and unless the suit is barred by
statute one may, at ones peril, bring a suit of one's
choice. It is no answer to a suit, howsoever frivolous
the claim, that the law confers no such right to sue. A
suit for its maintainability requires no authority of law
and it is enough that no statute bars the suit."
b) In Dhannalal v. Kalawatibai & Ors. (2002) 6 SCC 16, relying on
the afore-extracted observation in Ganga Bai's case (supra), this
Court had held as follows:
"Plaintiff is dominus litis, that is, master of, or having
dominion over, the case. He is the person who has
carriage and control of an action. In case of conflict of
jurisdiction the choice ought to lie with (1974) 2 SCC
393 (2002) 6 SCC 16 the plaintiff to choose the
forum best suited to him unless there be a rule of law
excluding access to a forum of plaintiff's choice or
permitting recourse to a forum will be opposed to
public policy or will be an abuse of the process of
law."
35. Originally the suit was filed as Quia Timet Action. It is settled law
that such an action is maintainable. If a party fears or apprehends,
then the injunction may be passed by the court on some threatened act
being done in future, would cause him substantial damage where
monetary relief would not be an adequate or sufficient remedy. In a
quia timet action, the Court can pass an injunction as a preventive
measure so as to prevent the future occurrence of the wrong on the
basis that the reasonable apprehension of the injury to be occurred in
future rather than waiting for the perfection of the wrong. In the case of
Kuldip Singh v. Subhash Chander Jain & Ors., AIR 2000 SC1410 in
para 7 it is held that "A quia timet action is a bill in equity. It is an action
preventive in nature and a species of precautionary justice intended to
prevent apprehended wrong or anticipated mischief and not to undo a
wrong or mischief when it has already been done. In such an action
the Court, if convinced, may interfere by appointment of receiver or by
directing security to be furnished or by issuing an injunction or any
other remedial process "
36. It has been stated in paras 16 to 18 of the plaint that from the
press releases issued by defendants No.2 and 3, limited information
available in the public domain about the clinical trials available with the
plaintiffs, though as per notification No." F.No. 12-01/09-DC-(Pt-32)
issued by defendant No.1 (effective from June 15, 2009), registration
of all phases of a clinical trial with the Clinical Trials Registry - India
(the "CTRI") is mandatory. There is no publicly available record of
registration of Phase I and Phase II clinical trials by defendants No.2 or
3 for the purported biosimilar Trastuzumab and on the basis of such
information, the quia timet action was filed. The plaintiffs reserved
their right to amend the plaint after information disclosed.
37. Thus it appears that on the date of filing of a suit the plaintiffs
were not fully aware and in view of the proposed launch of the product
by the defendants. They wanted to exercise their right to approach the
court by seeking an immediate injunctive relief. The plaintiffs have
averred the procedural lapses in process of grant of the approval which
are apparent on face of it. Thus, the said action premised on quia
timet is permissible and reasonably justify the plaintiffs position that the
plaintiffs were not having all the facts in hand while exercising the
remedy and the amendments are necessitated in view of the facts as
they are divulged during the course of the litigation and does not
prevent the plaintiffs from seeking an amendment in view of the
subsequent events and also does not bar the suit in the present form.
38. It is not disputed that there is no specific bar of civil court
jurisdiction in the Act and Rules. It is also admitted position that the
main dispute is between the private parties i.e. plaintiffs and
defendants No.2 to 4. It is not denied by the defendants that the suit is
not filed against any government employees who were involved in the
process of approvals. It is admitted by the defendant No.1 that as per
Act and Rules there is no procedure for cross-notice or to hear the
grievances of the plaintiffs that the authority has not considered the
clinical trials properly or to send the copy of the approvals and backed
up documents who claimed himself as an aggrieved party.
39. In view of the attendant circumstances discussed above, I have
already observed as to how the plaintiffs have an enforceable right to
seek an interdict the court and the court can exercise the jurisdiction
not merely on the basis of private lis between the parties but by
invoking the public interest doctrine which also guide the courts, still, I
am discussing the provisions of Section 9 of the Code of civil
procedure in order to discuss the plea raised by the defendant in
relation to the ouster of the jurisdiction. Section 9 of the Code of Civil
Procedure ("CPC") mandates that civil courts have the jurisdiction to
determine all disputes of a civil nature, unless their jurisdiction is
barred under a statute, either expressly or by necessary implication. It
is settled law that if the appropriate authority has acted in violation of
the fundamental principles of judicial procedure that may tend to make
the proceedings illegal and void, then Civil Court's jurisdiction may not
be taken away which has under those circumstances have the
jurisdiction to examine the non-compliance with such provisions of the
statute. There is inherent right in every person to bring a suit of a civil
nature unless the suit is barred expressly and impliedly. (See
Dhulabhai v. State of Madhya Pradesh and Anr. (1968) 3 SCR 662,
Abdul Gafur and Anr. v. State of Uttarakhand and Ors. (2008) 10
SCC 97, Dwarka Prasad Agarwal v. Ramesh Chander Agarwal
(2003) 6 SCC 220, Harbanslal Sahnia and Anr. v. Indian Oil
Corporation and Ors. (2003) 2 SCC 107, State of Madhya Pradesh
and Anr. v. Bhailal Bhai (1964) 6 SCR 261, State of Kerala v.
Ramaswami Iyer and Sons (1966) 3 SCR 582, Secretary of State v.
Mask and Company (1940 40 LR 222).
40. It is also settled law that the exclusion of the jurisdiction of the
civil courts is not to be readily inferred, but that such exclusion must
either be explicitly expressed or clearly implied. Even if jurisdiction is
so excluded, the civil courts still have jurisdiction to examine into cases
where the provisions of the Act have not been complied with, or the
statutory tribunal has not acted in conformity with the fundamental
principles of judicial procedure. If consequence of the same is that, it
affects the civil right of the party, then the civil suit is maintainable. In
the case of Mohammad Din and Ors. v. Imam Din and others, AIR
1948 PC 33 it laid down the principle that where the tribunals do not
act in conformity with the fundamental rules of judicial procedure or
where the rules of the law are not followed, the civil court has
jurisdiction and to this extent no ouster can be inferred)
41. The decision in the case of Mohammad Din (supra) has been
followed by the courts in India from time to time including the High
Courts of Punjab and Haryana in the case of and also by Allahabad
High Court recently in 2010 in the case of Shivdhesar Singh v. Union
of India, 2011 2 AWC 1202 wherein the learned judge while affirming
the said principle observed thus:
" In Mohammad Din and Ors. v. Imam Din and others, : AIR
1948 PC 33, it was clearly laid down that where the
authorities/executive acts beyond its jurisdiction, civil court
has power to entertain suits challenging such actions. It
implies that the final order passed ultimately in the
departmental remedies is always open to challenge by
means of a civil suit for which at least there is no bar either
express or implied" (Emphasis Supplied)
42. I have already observed that on scheme of Drugs Act, there is no
express or implied bar which can be inferred for the suit of the present
nature as the proposition in the present case is that the approvals have
been granted by the defendant No.1 are without jurisdiction and
consequently they affect the civil rights of the plaintiffs. It is the case of
the plaintiffs in the plaint as well that the defendant No.1 acted in haste
and overlooked the objections of the plaintiffs by granting the approval
within three days time. Under such circumstances, it becomes a case
where the tribunal has not followed the fundamental judicial procedure
and acted by overlooking its own guidelines. The said issue is raised in
the plaint and thus requires determination.
43. Applying the dictum of Mohammad Din (supra) which still holds
the field and followed by the courts, the present suit cannot be said to
be barred in the present form. I find that the judgments cited by
Mr.Sibal on the breach of the statutory duty are also distinguishable in
the facts of the present case as it is not merely the case of the breach
of any statutory duty but also the violation of the rules of the judicial
procedure by not following the guidelines framed by the controller on
his own and granting the approvals on the basis of different regime in
an undue haste when the Supreme Court order also mandated the
conducting of the clinical trial. All this have the bearing on the rights of
the plaintiffs giving them right to enjoin the defendants till the time the
defendants accomplish the onerous task of seeking approvals as per
the bio similar regime framed in the form of the guidelines.
44. In the unamended plaint and prayers made therein, it is avered
that the defendants have not conducted the requisite trials as per the
drugs and cosmetics Act and the guidelines passed on similar
Biologics so as to attribute their drug as bio similar to that of the
plaintiffs drug HERCEPTIN and the defendants should be prevented
from doing till the time all the requirements are complied to call it
biologically similar products as it effects their reputation. The plaintiffs
have alleged the cause of action on the basis of the passing off, act of
unfair competition and thereby sought an injunction. After more
discussion, it is necessary to refer the important aspect of regime of
bio-similar.
Regime of Bio-Similar
45. Let me now deal with the latest trend of regime of Bio-similar
drug. Admitted position is that when the patent for the original
molecule expires, other companies can launch follow-on versions of
the same. If the molecule is chemically synthesized, the follow-on
molecule is called a "generic" whereas when the molecule is a
biological (like a monoclonal antibody), the follow-on molecule is called
a biosimilar. 'Generics' and 'Biosimilars' are developed by comparing
their properties to the original molecule, which is called a reference
product. Any follow-on biological product that is approved based on
evaluation of comparative data to the reference product is called a
biosimilar.
46. In view of the development and growth of the market for
biosimilars in India and the international standards for approval of such
products, the Guidelines on Similar Biologies were issued in 2012.
These guidelines lay down specific standards for development and
evaluation of similar biologies; these are in addition to the general
standards for evaluation of new drugs that exist under the Drugs Act
and the Drugs Rules and seek to ensure comparability of safety,
efficacy and quality between the innovator biologic and the biosimilar,
prior to the approval of such biosimilar.
47. The Guidelines on Similar Biologics provide a detailed and
structured process for comparison of the similar biologic with the
reference biologic to test the safety, efficacy and immunogenicity of the
similar biologic as against the reference biologic at each stage
including the product characterisation, the pre-clinical studies and
clinical trials. Under these guidelines demonstration of similarity of
biologics is a sequential step-wise approach. This process is aimed at
ensuring that the similar biologic is comparable inquality to the
reference biologic and can be safely used in the treatment of specified
disease or disorder.
48. After the issuance of the Guidelines on Similar Biologics on 15th
September, 2012, all applications for manufacturing and marketing
authorisation of similar biologies in India are required to be evaluated
on the basis of the standards set forth in the Guidelines on Similar
Biologies. The Guidelines on Similar Biologies ensure that adequate
tests are conducted prior to the approval of biosimilars. These may not
be statutory in nature but as per guidelines of the Government from
time to time, it is essential that they are also followed at all stages in
order to ensure the safety of patients. In the case of life saving drugs,
no one can deny that at thorough consideration should be given to the
scientific basis of the study design, objectives, study end-points,
sample sizes and study duration of the applicant's product before
approval is granted under the Guidelines on Similar Biologics and only
products which have been approved under the Guidelines on Similar
Biologics should be allowed to be represented as biosimilar products.
The said 2012 Guidelines provide that similar biologics are regulated
as per the Drugs & Cosmetics Act, 1940 and the Drugs and Cosmetics
Rules, 1945 so that the approval of biosimilar products of parties must
satisfy all the stringent regulatory requirements before manufacturing
and marketing its product.
49. The 2012 Guidelines provide that similar biologics are regulated
as per the Drugs & Cosmetics Act, 1940 and the Drugs and Cosmetics
Rules, 1945. In nutshell, the 2012 Guidelines stipulate that the
approval of biosimilar products of a party must satisfy all the stringent
regulatory requirements and having been duly approved is entitled to
manufacture and market its product.
50. The Biosimilars have existed even prior to the 2012 Guidelines
and then the application of the applicant was to be tested on a case-
by-case evaluation governed under "Notification Regarding Adoption
Of The Recommendations Of The Task Force On R-Pharma Under
The Chairmanship Of Dr R A Mashelkar, DG-CSIR With Effect From
1.4.2006". It is alleged by the defendant No.1 in the written statement
that under the Drug and Cosmetics Act and Rules made the term
"Similar Biologics" has not been defined. The defendants admit that
the procedure laid down in the Act and Rules are to be applied
stringently.
51. It is submitted on behalf of defendant No.2 that the protocol for
tests provided by the Biosimilar Guidelines is similar to the standards
laid down by the Mashelkar Committee Report (2006) ("Mashelkar
Committee Report"), which was followed by defendant No.2 for the
approval of Bmab-200. Several biosimilars have been approved in
India even before the Biosimilar Guidelines were issued (under the
existing statutory regime and on the basis of the standards laid down in
the Mashelkar Committee Report)'. It is stated by the defendants that
not much importance is required to be given by the Court to the 2012
guidelines as basic Guidelines are already in place in 2006 which are
being followed by the defendant No.1.
52. I have seen the Mashelkar Committee Report relied upon by the
defendants and the said report appears to give some indication as to
development of LMO (which is living modified organism) by way
recombinant DNA technology. The report provides certain protocols
for the development of indigenous product where end product is LMO
which is starting point for someone who is attempting to development
Living modified organism. To that extent, the defendant is right that the
concept and mechanism to take approval of the biotechnology
products and artificially engineered modified genetic sequences was
available. But, by placing reliance on the said report to say that the
biosimilar guidelines were already in place and the new guidelines
have no role to play wherein an applicant/ defendant engineers his
own biological compound and attempts to ascribe the same quality,
efficacy, safety norms, dosage, potency of the compound with other
characteristics same as the base compound which means that two
persons are artificially engineering the genetic sequencing arriving at
the same conclusion and also the same characteristics so as to call
their products as clones or biologically similar to each other was not
specifically provided for in the Malshekar report and if so provided still
the guidelines operate in the field which regulate the entire process of
the study of the biosimilar products prior to the grant of the approval
and fill the gaps in the entire regulatory procedure of the grant of the
approval of bio similar by insistence of the clinical trials and other
relevant steps which were not earlier not provided for by looking from
greater degree of care and attention as is evident from that of the
preface of the guidelines.
53. Thus, even if the starting point of the discussion in guidelines on
similar Biologics of 2012 is Malshekar report, still, the defendant's plea
that the system was already placed on the date of approval of drug of
the defendant No.2 and the bio similar were already approved on the
face of it a contradictory argument by defendant No.1 especially when
the defendant No.1 is the head of the CDSCO (Central Drugs Standard
Control Organisation) which is the central drug authority under the Act
and has passed the guidelines with the close connection with Ministry
of Science and Technology. The defendant No.1 by authoring the
guidelines to say that the said biosimilars are to be treated distinctly
with greater degree of care and circumstance as against the ordinary
regime of bioequivalence cannot justify the contrary position by urging
that the guidelines have no role to play or are not statutory in character
and thus can be conveniently bypassed as non binding or there is
nothing new about the approvals in biosimilar products as they were
being granted earlier. All these stands are contradictory to the preface
of the guidelines to which the defendant No.1 is participant and thus
cannot plead to contrary before this court.
54. As regard binding nature of the guidelines, it is well settled
principle of law that the guidelines are in the nature of the directions
issued by the government and till the time the said guidelines and
directions are not in contradiction but are mere addition to the already
existing rules and regulations, it cannot be said that the said guidelines
are not having legal validity and are not required to be adhered to
being non binding in character. The reference is invited to the case of
Bant Singh v. Man Singh, AIR 1976 P&H 102, wherein the Division
Bench of the High Court observed thus:
"There are no rules which may regulate the supply of canal
water for gardens and orchards. The rules which are in
existence make a provision for regulating the supply of
canal water to lands only, The Government in its wisdom
thought of issuing some instructions for the purpose of
regulating extra supply of canal water for gardens and
orchards and those instructions with suitable amendments
made off and on, bold the field till today. Obviously, these
instructions were issued to supplement the rules in
existence, which were silent on the question of supply of
canal water to the gardens and orchards. By issuing these
instructions, a complete and detailed procedure has been
prescribed for the supply of canal water for the gardens and
orchards. These instructions do in no way amend,
supersede or alter the existing rules; rather the same have
the effect of filling the gap and supplementing the existing
rule." (Emphasis Supplied)
55. Likewise, it is also a settled law that the guidelines/ directions
issued by the department though not statutory but are in contravention
to the provision of the Act and rules framed thereunder cannot be said
to be not to be complied with or non enforceable by the court of law.
The Supreme Court in the case of Virendra Hooda v. State of
Haryana, AIR 1999 SC 1701observed as under:
"The view taken by the High Court that the administrative
instructions cannot be enforced by the appellant and that
vacancies became available after the initiation of the
process of recruitment would be looking at the matter from
a narrow and wrong angle. When a policy has been
declared by the State as to the manner of filling up the post
and that policy is declared in terms of rules and instructions
issued to the Public Service Commission from time to time
and so long as. These instructions are not contrary to the
rules, the respondents ought to follow the same."(Emphasis
Supplied)
56. The Constitution Bench of Supreme Court in the case of Sant
Ram Sharma v. State of Rajasthan (1968) IILLJ 830 SC , has
pointed out at p. 1914 SC that the Government cannot amend or
supersede statutory Rules by administrative instructions, but if the
rules are silent on any particular point Government can fill up the gaps
and supplement the rules and issue instructions not inconsistent with
the rules already framed.(Emphasis Supplied)
57. The aforesaid ruling of Sant Ram(supra) has been reiterated in
paragraph 9 of the judgment by a three Judge Bench of Supreme
Court in the case of Union of India v. K.P. Joseph [1973] 2 SCR 752,
as under:
Generally speaking, an administrative Order confers no
justiciable right, but this rule, like all other general rules, is
subject to exceptions. This Court has held in SantRam
Sharma v. State of Rajasthan and Anr. (1968)IILLJ830SC,
that although Government cannot supersede statutory rules
by administrative instructions, yet, if the rules framed under
Article 309 of the Constitution are silent on any particular
point, the Government can fill up gaps and supplement the
rules and issue instructions not inconsistent with the rules
already framed and these instructions will govern the
conditions of service.(Emphasis Supplied)
58. From the reading of the aforementioned observations of
Supreme Court in the case of the Sant Ram (Supra) and also K.P.
Joseph (supra), it is clear that the administrative orders, directions or
guidelines do not create any justiciable right is a rule not without
exception and in the cases where the guidelines are framed with aim to
fill the gaps in the legal framework or regulatory measures or are
supplemental rules, the courts can proceed to enforce them in the form
of legally justiciable right in such circumstances. The law laid down in
the case of Sant Ram (supra) and K.P. Joseph (supra) has been
further given imprimatur of Supreme Court in the case of Dhananjay
Malik v. State of Uttaranchal, (2008) 4 SCC 171.
59. It is also trite law that the judicial interference is permissible in
the cases the deviations from the guidelines so framed by the
government are fundamental in nature and is totally contrary to the
object sought to be achieved by the said guidelines and directions
issued and the public interest so required. In the case of Narendra
Kumar Maheshwari v. UOI, AIR 1989 SC 2138, the Supreme Court
observed thus:
"The Court would be inclined to perhaps overlook or ignore
such deviations, if the object of the statute or public interest
warrant, justify or necessitate such deviations in a particular
case. This is because guidelines, by their very nature, do
not fall into the category of legislation, direct, subordinate or
ancillary. They have only an advisory role to play and non-
adherence to or deviation from them is necessarily and
implicitly permissible if the circumstances of any particular
fact or law situation warrants the same. Judicial control
takes over only where the deviation either involves
arbitrariness or discrimination or is so fundamental as to
undermine a basic public purpose which the guidelines and
the statute under which they are issued are intended to
achieve." (Emphasis Supplied)
60. Applying the said principle of laws to the facts of the present
case and testing the case of the parties upon touchstone of the law laid
down by the courts with respect to the court's insistence of the
adherence of the guidelines/ directions and their validity and
enforceability, it can be said that the present qualifies all the tests
which enable this court to interfere and insist on the due compliance of
the guidelines as enforceable one as against permitting the deviations
from the same.
It is important to mention that the defendant No.1 in the present
case has specifically taken the stand that the guidelines are not
statutory in nature and it is not confirmed by defendant No.1 that they
have been applied at the time of approval. It is contended by the
defendant No.2 in the present case that those are not applicable but in
second connected matter, being CS(OS) 3284/2015, defendant No.2
has argued that the approvals have been granted by defendant No.1
as per guidelines. However, the stand of defendant No.1 in connected
suit remains the same.
61. After having considered the submissions and guidelines of 2012
and other material placed on record, I am of the opinion that the
guidelines are to be considered at the time of approvals. My reasons
for the same are enumerated as under:
Firstly, as seen above, that the existing rules framed under
the Drugs and Cosmetics Act do not provide the exhaustive
mechanism for the dealing the dealing with the Bio Similar
products as there are certain additional aspects which the
guidelines insist to be taken into consideration in the
process of the grant of the approval in the cases involving
similar biologics. The said additional aspects include
additional requirements for the clinical trial applications as
per CDSCO guidelines which is evident from the reading of
the guidelines, additional steps like product
characterstization as per clause 6.3.2 of the guidelines,
conducting of the quality comparability study as per 6.4 of
the guidelines, insistence of the clinical studies and
additional data requirements for the studies etc. All these
aspects have been specifically provided for the in the
guidelines with the preface that the similar biologics are
required to be provided with the regulatory pathway
keeping in mind the safety, efficacy and quality of a similar
biologic to an authorized reference biologic as against the
previous pathway which was the abbreviated one. Thus,
the existing rules were silent or were not adequate to
provide for the pathway for regulating the regime of the
control and approval of the bio similar/ similar biologic
products in India for the reason of new and latest regime
and the guidelines were therefore framed supplemental to
the rules so that the requirements provided therein should
be taken into consideration while approving the similar
biologics based on the referenced products. Thus, the
guidelines were supplemental to the rules framed under the
Act and thus cannot be pleaded or stated to be irrelevant or
non binding on the office of the defendant No.1 when the
CDSCO is headed by the defendant No.1. The guidelines
of 2012 thus qualify the test that the same are
supplemental to the rules and are not aimed to replace or
supplant the existing rules.
Secondly, the guidelines of 2012 was aimed at providing
the regulatory pathway for the similar biologics in India
considering the safety, efficacy and quality of the similar
biologic in consideration. Thus, the object sought to be
achieved is to ensure the public health and safety so that
the public should be provided with the medicines that are
safe, efficacious and quality wise appropriate and at par
with the innovator drugs which are based on artificially
engineered micro-organism. Thus, considering the object
which was sought to be achieved by the said guidelines
which is in consonance with the objects and purposes of
Drugs and Cosmetics Act, it cannot be said that the
guidelines on similar biologics can be ignored and can be
bypassed by defendant No.1. In the absence of the
defendant's complying the same, the outweighing public
interests and the purpose sought to achieve by the said
guidelines clearly allow this court to interdict in such matter
as the deviation from the said guidelines in such a matter
would be detrimental to the larger public interest and would
be against the objects and reasons of the guidelines which
are sought to be achieved at the time of the framing of the
same.
Thirdly, it is only the case of the defendant No.1 and other
defendants that by mere fact that the guidelines are not
statutory in nature but are issued by CDSCO, therefore the
defendant No.1 despite being participant in framing the
guidelines can ignore them (the argument which though I
have already rejected separately). None of the defendants
have argued or canvassed any submissions that the said
guidelines are in contradiction with any rules and
regulations framed under the Drugs and Cosmetics Act or
ultra vires the Act. In absence any such successful plea of
the said contradiction and considering that the guidelines
are merely supplemental to the rules and do not aim to
replace the rules but to apply them strictly along with the
additional requirements considering the distinct nature of
the regime of biosimilar products involved which require
greater degree of regulatory measures, it cannot be
assumed on a priori basis that the guidelines on similar
biologics are empty formality or useless exercise and
cannot be implemented by the defendant No.1. On this
ground again, the inference to be drawn is towards the
validity and enforceability of the guidelines as against non
binding character.
62. Accordingly, I reject the argument of the defendants that the
guidelines are of non binding character, not applicable being non-
statutory and are thus non enforceable and can be conveniently
bypassed by the defendants while granting the approvals for
manufacture of medicinal products based on similar biologic. Prima
facie I am of the view that bio-similar guidelines of 2012 are applicable
and the same are to be considered at the time of grant of approvals of
bio-similar product.
Passing Off
63. As far as the common law principle of passing off is pretty clear
on the subject for more than 200 years ago when the court of appeal in
the case of Frank Reddaway v. George. Barham (1896) A.C. 1990
speaking through Lord Hersehell observed on page 209 that if the
defendants were entitled to lead purchasers to believe that they were
getting the plaintiffs' manufacture when they were not and thus to
cheat the plaintiffs of some of their legitimate rights, it would be
regretable to find that the law was powerless to enforce the most
elementary principles of commercial morality....". The passing off as a
principle originally had emerged on the basis of the general statement
of law has been developed from time to time and in the modern form
includes the use of the signs, trade names, domain names, logos,
shape of the products or any indication which allows the consumers to
attach the product of the competitor with that of the rival trader in order
to deceive them.
64. The action of passing off is an action in deceit which has been
recognised by the Supreme Court of India in case of Laxmikant V.
Patel v. Chetanbhat Shah and Another, reported in (2002) 3 SCC
65, wherein the Supreme Court while considering a plea of passing off
and grant of ad interim injunction held in no uncertain terms that a
person may sell his goods or deliver his services under a trading name
or style which, with the passage of time, may acquire a reputation or
goodwill and may become a property to be protected by the Courts. It
was held that a competitor initiating sale of goods or services in the
same name or by imitating that name causes injury to the business of
one who has the property in that name. It was held that honesty and
fair play are and ought to be the basic policy in the world of business
and when a person adopts or intends to adopt a name which already
belongs to someone else, it results in confusion, has the propensity of
diverting the customers and clients of someone else to himself and
thereby resulting in injury.
65. The passing off is action in deceit. From the observations of
Lord Hershell in the case of Redway (supra) at the time of the nascent
stage of the evolution of law of passing off, it is clear that the law is not
powerless to prevent the most elementary principles of commercial
morality and the trading has to be fair and not unfair and in case there
is an element of unfairness and deceit to the consumers, the court can
always interdict in order to protect the consumer interests and prevent
the deceit. Once the Court would notice that the party is trying to
make misrepresentation or making a false statement on comparison of
two drugs of the parties about the approvals of the product and it may
affect the right of the suing party and if the said party alleged that the
rival party is trying to disparage the product, the action of passing off
would lie. It is immaterial at the initial stage whether any strong case
for passing off is made out or not.
66. Even in the case of N.P.Ponnuswami v. The Returning Officer,
Namakkal Constituency, Namakkal, Salem Dist. And others, AIR
1952 SC 64, the Supreme Court held as under:-
"12. It is now well-recognized that where a right or liability
is created by a statute which gives a special remedy for
enforcing it, the remedy provided by that statute only must
be availed of. This rule was stated with great clarity by
Willes J. in Wolverhampton New Water Works Co. v.
Hawkesford, 6 C.B. (N.S.) 336, 356 in the following
passage :-
"There are three classes of cases in which a liability
may be established founded upon statute. One is
where there was a liability existing at common law,
and that liability is affirmed by a statute which gives a
special and peculiar form of remedy different from the
remedy which existed at common law; there, unless
the statute contains words which expressly or by
necessary implication exclude the common law
remedy, the party suing has his election to pursue
either that or the statutory remedy. The second class
of cases is, where the statute gives the right to sue
merely, but provides no particular form of remedy;
there, the party can only proceed by action at
common law. But there is a third class viz., where a
liability not existing at common law is created by a
statute which at the same time gives a special and
particular remedy for enforcing it...... The remedy
provided by the statute must be followed, and it is not
competent to the party to pursue the course
applicable to cases of the second class. The form
given by the statute must be adopted and adhered
to."
The rule laid down in this passage was approved by the
House of Lords in Neville v. London Express News Paper
Limited (1919) A.C. 368 and has been reaffirmed by the
Privy Council in Attorney-General of Trinidad and Tobago v.
Gordons Grant & Co. (1935) A.C. 532 and Secretary of
State v. Mask & Co (1940) 44 C.W.N. 709; and it has also
been held to be equally applicable to enforcement of rights :
see Hurdutrai v. Official Assignee of Calcutta (1948) 52
C.W.N. 343, 349. That being so, I think it will be a fair
inference from the provisions of the Representation of the
people Act to state that the Act provides for only one
remedy, that remedy being by an election petition to be
presented after the election is over, and there is no remedy
provided at any intermediate stage."
Submission on Package Insert
67. Mr.Rajiv Nayar, learned Senior counsel appearing on behalf of
the plaintiffs, submits that package insert used by the defendants No.2
to 4 makes misrepresentation as they are making the incorrect
statement in order to create confusion and deception. Thus, the
plaintiffs had no option but to approach the civil court with regard to
misrepresentation, false information and violation of legal rights of the
plaintiffs. He submits that it is evident from the package insert used by
them that they have referred to data relating to the sales and price of
HERCEPTIN in their distribution and marketing materials. They have
reproduced data relating to the plaintiffs' Trastuzumab in the Summary
of Product Characteristics (SmPC) for Bmab-200 and the package
inserts for CANMAb and HERTRAZ. The plaintiff's case is that they
have made grave misrepresentations regarding the nature, quality,
safety and efficacy of Bmab-200, in order to deceive doctors, hospitals
and patients.
68. He has referred the comparison of two package inserts used by
the parties and argued that without valid approvals from defendant
No.1 the defendants No.2 to 4 cannot make misrepresentations and
false information to the doctors, hospitals and patients. The details of
the same are given as under:-
(i) SmPC for Bmab-200and the package inserts indicate that it
may be used for treatment of (i) metastatic breast cancer,(ii)
early breast cancer and (iii) metastatic gastric cancer. However,
Bmab-200's approval is only for metastatic breast cancer. This
misrepresentation could result in inappropriate switching of
patients from the plaintiffs' Trastuzumab to Bmab-200 with grave
consequences. Admittedly, the approval of early breast cancer
and metastatic gastric cancer was never granted at the time of
use of package insert of metastatic gastric cancer.
(ii) The package insert use the plaintiffs' clinical trial data
regarding safety and efficacy and no comparative test results are
included in the package inserts. It suggests that no independent
tests have been done to establish safety and efficacy of Bmab-
200. Further the data for the plaintiffs' Trastuzumab has not been
segregated from data for Bmab-200, as it is done by the
defendants No.2 to 4 with the intention to pass-off Bmab-200 as
having the same safety and efficacy as the plaintiffs'
Trastuzumab. In fact, the package inserts do not use the name
'Bmab-200' or the term 'biosimilar' anywhere; the drug is referred
to as 'Trastuzumab'.
(iii) Sample size is represented as being much larger than the
actual sample size of 132 - ''detected in 1 of 903 patients" and
page 1001 - "data from studies 1 and 2 were obtained from 3206
patients" and "study 4 reflect exposure to Trastuzumab as part of
adjuvant treatment regimen from 2124 patient". The package
inserts cite results of pre-clinical studies conducted on
cynomolgus monkeys but the tests conducted by defendant No.2
admittedly on Swiss albino mice and New Zealand white rabbits.
As per record of defendant No.1 overall 135 patients were
randomized in to THE study, out of total 67 in the Bmab-200 arm
and 68 in Herceptin arm.
(iv) The package inserts state that the composition of the
clinical trial population was: "84% of patients were White, 7%
were Black, 4% were Hispanic, and 4% were Asian" but
defendant No.2's clinical trial protocol shows that clinical studies
were conducted over 23 sites in India. It is mentioned that the
drug has been clinically tested "in combination with paclitaxel or
an anthracycline" and also "in combination with anastrozole" but
Bmab-200 was only tested in combination with docetaxel.
(v) Defendants claim that they used data from "Phase I, Phase
II and pivotal Phase III studies" but defendant No.2's clinical trials
only covered Phase III studies. Even the defendant No.1 in its
written statement has made the specific statement that the test of
phase I and phase II have not been registered with the defendant
No.1.
(vi) In package inserts it was claimed that the median treatment
duration in the defendants' clinical studies was 51 weeks but the
clinical studies were actually conducted over a period of 24
weeks. Not only that, they have claimed part post marketing
experience with Trastuzumab in their package inserts. Since
defendants' drugs were launched only after the impugned order
dated February 5, 2014, it could not have generated post
marketing data as yet. It was also claimed in the package insert
that they have conducted an open label study. Defendant No.2's
letter dated August 9, 2011 to the DCGI mentions that their
clinical trial protocol does not contain an open label study.
Therefore, it is submitted that since the defendants are
comparing their drug with the drug of the innovator, the plaintiffs
become aggrieved party who are entitled to know about the drug in
question.
69. In view of above, I am of the view that prima facie the objection
raised by the plaintiffs' counsel with regard to package insert during the
course of hearing is a matter of civil nature and disputed question of
fact. I have been informed later on that the defendant No.2 has
amended certain portion of the package insert. The Court has to see
the conduct of the party on the date of filing of the suit.
70. These are the main reasons that I do not agree with the
submission of Mr.Sibal, learned senior counsel for the defendants No.3
and 4 that the plaintiff would not have any civil right in the case in hand
and the Drugs and cosmetics act would be exhaustive of all the
remedies available to the plaintiff. I would rather say after analysing the
scheme of the Drugs Act that remedies prescribed under the Drugs
and Cosmetics Act would merely allow the plaintiffs to contest the
grant or refusal of the approval granted by the defendant No.1 by way
of the appeal (though the participation of the plaintiffs before the drug
controller appears to be minimal which is only to the extent of the using
the referenced product and nothing more). The civil right of the
plaintiffs being the owner of the drug and only parting with the
innovated product in a regulated regime so that the rival trader can
merely make the biologically similar product for safety, efficacy and
another reasons and should not pass off the defendants' products as
those of the plaintiffs when they do not have such characteristics, can
only be tested in the court of law and can be enforced therein and not
before the drug controller. Thus, the judgments cited by Mr. Sibal in
order to infer the ouster of civil court's jurisdiction for implicit bar or
express bar are distinguishable.
71. The other circumstance is that the plaintiffs have filed the quia
timet action as the time of the presentation of the suit, the plaintiffs
were not sure about the launch of product of the defendants No.2 to 4.
The said product was in fact was launched on 5th February, 2014 after
filing the suit. The plaintiffs admittedly reserved their right to amend
the plaint. The application under Order II Rule 2 was filed.
72. The arguments addressed on behalf of the defendants are not
sustainable in view of the decision of the Division Bench in the case of
Ganga Ram Hospital Trust v. Municipal Corporation of Delhi,
2001(60) DRJ 549. It was held as under:-
"16. Section 169 provides for a remedy of appeal against
levy or assessment of any tax under the Act while section
170 lays down conditions subject to which the right of
appeal conferred by section 169 can be exercised. Neither
of these two sections contain any provision barring a civil
suit to challenge levy and assessment of tax under the Act.
At best it may be argued that in view of the remedy of
appeal provided under section 169 of the Act a party should
have recourse to the said remedy. But a party filing a civil
suit to challenge the levy and assessment of tax under the
Act may like to urge that the levy and assessment of tax is
not in accordance with the Act or is violative of the
provisions of the Act. In other words it may be the case of a
plaintiff that the authorities under the Act have not acted in
accordance with the provisions of the Act while levying and
assessing tax and, therefore, it is entitled to exercise its
inherent right to challenge such a levy and assessment by
way of a civil suit. Availability of an alternative remedy may
be treated as a bar by the court while exercising its writ
jurisdiction because writ jurisdiction under Article 226 of the
Constitution of India is a matter of exercise of discretionary
jurisdiction of the court but it is not the same case while
entertaining a civil suit. Exercise of jurisdiction to entertain
civil suit is not a discretionary matter before the civil court.
A civil court may reject the plaint as per law or dismiss a
civil suit on merits. It cannot refuse to entertain the suit
unless barred by law. The DMC Act does not contain any
such bar to a civil suit in matters of levy and assessment of
tax."
73. In the case of Norma (India) Ltd. v. Sameer Khandelwal and
Ors., reported in 2007(93) DRJ 318, in para 14, it was held as under:-
"14. It is settled law that jurisdiction of the company law
board under the Companies Act in relation to Section 397
of the said Act is a concurrent jurisdiction which may be
exercised by civil courts where allegations pertaining to
oppression and mismanagement partake the character of a
civil dispute. Thus, it was the duty of the plaintiff to have
made averments in the plaint or in the injunction
application, giving material particulars of the dispute
pending before the company law board. In particular,
plaintiff ought to have disclosed about CA No. 39/2006 filed
under signatures of Shri Gautam Khandelwal."
74. In the case of K.G. Khosla Compressors Ltd. and Ors. v.
Khosla Extraktions Ltd. and Ors., 1986 (6) PTC 211 (Del.), this
Court in para 31 held as under:
"31. It is not disputed and may it could not be disputed that
Civil Courts has jurisdiction in the suit. If any authority is
needed reference may be made to decision of this Court in
Bhandari Homeopathic Laboratories (supra). The Central
Govt. has certainly no power to grant any injunction as
prayed for in the present suit though a person disobeying
the directions issued under sub-s. (1) of S. 22 of the Act
might entail punishment. But, then in the present suit the
plaintiff has also based its cause of action on passing off of
the name of defendant No.1 as that of the plaintiff. I would
rather say that the jurisdiction of the Central Government
under Ss.20 and 22 of the Act and the jurisdiction of the
Civil Court operate in two different fields. Further the
Central Govt. has to act within the guidelines laid down
under S. 20 of the Act, while there are no such limitations
on the exercise of jurisdiction by the Civil Court."
75. With regard to other objection raised by the defendants about the
exclusivity of civil jurisdiction impliedly bar under Rule 122DC. Rule
122DC does not cover appeals against approvals granted under Part
XA - this rule is limited to appeals against orders passed by the DCGI
under Part XA of the Rules. The terms "order" and "approval"/
"permission" have distinct meanings under Part XA of the Drugs Rules
(refer to Rule 122DAB(3), Rule 122DAB(7), 122DAC(3), 122DAC(4),
122DB and Rule 122B(2A)). In the present suit, the plaintiffs have not
challenged any "order" passed by defendant No.1 under Part XA of the
Drugs Rules. It does not confer a right on a third party to challenge an
approval granted under Rule 122B - Rule 122DC applies to a person
who is immediately and directly aggrieved by an order of the licensing
authority, inter alia, refusing to grant licence to himself or to renew
licence, and not to one who is consequently aggrieved, like the
plaintiffs in the present case.
76. No doubt as Rule 122DC contains the appeal provision, the
benefit of the appeal would be accrued only to a person who is before
the regulator in the first instance and who would, therefore, have the
knowledge of the order issued by the regulator. The said party is
expected to file an appeal within 60 days from the date of the order, as
contemplated under Rule 122DC. In the present case, approval for
drug of defendant No.2 was not made available to the plaintiffs.
Accordingly, this provision is not applicable to the plaintiffs in the
present case. The approvals of bio-similar in favour of defendant No.2
of innovator drugs are admittedly never notified of approvals granted or
given any information available to manufacturers of innovator drugs.
77. The said Rule does not protect or enforce the right of the
innovator drugs. Even Mr.Sanjay Jain, learned ASG appearing on
behalf of the defendant No.1, has admitted that the procedure of
granting approvals to manufacturers for biosimilar drugs does not
involve a lis between the manufacturer of the innovator drug and the
manufacturer of the biosimilar drug. Defendant No.1 does not
determine the rights of such parties at the time of granting approvals to
drug manufacturers. Therefore, the plaintiffs (i.e. the manufactures of
the innovator drug in the present case) are entitled to file a civil suit to
protect their rights in relation to the plaintiffs' Trastuzumab as
efficacious remedy under this Rule is not available. (See Ganga Ram
Hospital v. Municipal Corporation of Delhi (2001 (60) DRJ 549 at
paragraph 20).
78. The next argument of the defendants is that a writ petition should
have been filed to challenge an action under the Drugs Act and the
Drugs Rule have also no force as an alternative remedy under a
statute may be treated as a bar by the court while exercising its writ
jurisdiction because writ jurisdiction under Article 226 of the
Constitution of India is discretionary. Writ jurisdiction is not intended as
an alternative remedy for reliefs which may be obtained in a suit. An
infraction of the State's duty to act in public interest is amenable to
examination either in a civil suit or in writ jurisdiction (see Dwarkadas
Marfatia and Sons ((1989) 3 SCC 293) at paragraph 21).
79. Even in the judgment of Systopic Laboratories Pvt. Ltd. v. Dr.
Prem Gupta & Ors. ((1994) Supp (1) SCC 160) referred by the
defendants, the writ petitions were not dismissed as non-maintainable
on the ground that executive decisions of the expert committee could
not be reviewed by courts - in fact, the Supreme Court reviewed the
facts in detail to determine that the matter had been properly examined
by the expert committee and did not require judicial interference.
80. It is settled law that Section 34 of the Specific Relief Act is not
exhaustive in nature and does not circumscribe the jurisdiction of a
court to grant declaratory reliefs in appropriate cases falling outside
this provision (See Vemareddi Ramaraghava Reddy v. Kondru
Seshu Reddy AIR 1967 SC 436 and Supreme General Films
Exchange Limited v. His Highness Sir Brijnath Singhji and Others
(1975) 2 SCC 530).
81. Therefore, the decisions in the matters of Delhi Science Forum
v. Union of India ((1996) 2 SCC 405), Jasbhai Motibhai Desai v.
Roshan Kumar, Haji Bashir and Others ((1976) 1 SCC 671), N.D.
Jayal v. Union of India ((2004) 9 SCC 362), NDMC v. Satish Chand
((2003) 10 SCC 38), Rajasthan State Road Transport Corporation
v. Bal Mukund Bairwa ((2009) 4 SCC 299) and State of Andhra
Pradesh v. M/s. Pioneer Builders (AIR 2007 SC 113) do not support
the defendants' arguments in relation to the maintainability of the
present suit. The facts appearing in the present case are entirely
different.
82. It is also wrong to allege that the suit should be dismissed on the
basis that the plaintiffs failed to provide the defendant No.1 two months
notice prior to the filing of the suit, as required under Section 80 of the
CPC as the plaintiffs' application for exemption under Section 80(2) of
the CPC was allowed pursuant to the order dated February 5, 2014.
Further, while notice on this application was issued to the defendant
No.1 on February 5, 2014, no reply has been filed by the defendant
No.1 as yet. The said non issuance of the notice is to be considered
when the application shall be considered, in the absence of the reply,
merely contending that the notice is the bar to the suit is untenable
plea which shall be fully examined in the trial.
83. The argument of the defendants No.2 to 4 is totally baseless and
misleading that at the time of obtaining the ex-parte ad-interim
injunction, Mr.Mukul Rohatgi at the first date conceded that the
unamended suit does not challenge the manufacturing and marketing
authorisation granted to defendant No.2.
At the time of hearing, the counsel was not aware about the
complete details and nature of approvals granted in favour of
defendant No.2 including the approval of package insert. IT was a
quia timet action. The plaintiffs were not aware about the requisite
documents in their possession. He had argued at that time if the
approval are validly granted, the defendant No.2 may continue to sell
the drug in the meanwhile after notice if it was found otherwise, the
same would be challenged as per law. Even at the time of modification
of order dated 14th February, 2014, no record from the office of
defendant No.1 was produced. An impression was given to the Court
that all the approvals were granted as per Act, Rules and Guidelines.
84. Even otherwise present dispute involves complicated questions
of fact and evidence, the summary procedure in a purported appeal
before the defendant No.1 or in writ proceedings is not the appropriate
remedy. The defendants themselves are admitting that the present
dispute is commercial dispute between the two set of parties. As the
defendant No.1 has filed its written statement and has placed its stand
before Court and produced the record of approvals of drug of
defendant No.2. Further appearance in the matter is not necessary,
hence the defendant No.1 is deleted from the array of the parties. The
plaintiffs to file the amended memo of parties within four weeks from
today. If so required they are entitled to summon the representative of
defendant No.1 as one of the witnesses.
85. In the light of the above prima facie, it appears that the suit is not
barred by law and this Court has also got the jurisdiction to decide the
issue involved particularly when the serious allegations of
misrepresentation about the approvals granted in favour of defendant
No.2. The said information being provided by the defendants No.2 to 4
to the public at large and certain material is filed before Court. There is
allegation that they are also providing the wrong information to the
doctors, hospitals and patients. These issues are required to be
decided by the Civil Court that is competent to pass the interim order if
the valid case is made out before Court.
86. When disputed questions of facts are involved, the same have to
be determined in civil matter. Prima facie the objections of the
defendants are not sustainable and the suit is not barred and the same
is maintainable. Accordingly I.A. No.12830/2015, I.A. No.16703/2015
and I.A. No.16704/2015 are disposed of as the same have become
infructuous in view of my detailed discussion in this order. Once the
suit filed by the plaintiffs is held to be maintainable, there is no
impediment to consider the pending applications in which the
submissions were already made and the judgments were cited by both
parties.
87. Now I shall deal with the other pending applications:
I.A. Nos.4649/2014 & 11224/2015 (u/o VI R.17 CPC, by plaintiffs)
The first application, being I.A. No.4649/2014, was filed by the
plaintiffs on 1st October, 2014. Admittedly, in the plaint the plaintiffs
had expressly reserved their right to challenge the purported approvals
granted in connection with the defendants' drugs and modify the plaint
and to enlarge the reliefs sought against the defendants. It is alleged
in the application that after the filing of the suit, along with the copies of
the purported approvals issued in connection with the impugned drug,
the documents were also provided by defendant No.2 to the plaintiffs.
In view of the additional information, the application was filed. The
contention of the plaintiffs is that these are the subsequent
developments which have come to the knowledge of the plaintiffs after
filing the suit. It is stated that the defendants No.2 to 4 have
commercially launched the products after filing of the suit. The
amendments were sought in various paras of the plaint, the details of
which are given in para 3 of the application. It is submitted by the
plaintiffs in the application that the said amendments are necessary for
the purpose of deciding the real question of controversy between the
parties and no prejudice would be caused if the same is allowed.
88. Reply to this application was been filed by the defendants. It was
contended in the reply that the said amendments cannot be allowed,
as one of the reliefs for declaration sought in the amendment
application may give rise to alternative remedy prescribed under the
Drug Rules, 1945. This Court has no jurisdiction to entertain the relief
for declaration that the defendants' drugs have not been tested and/or
approved as a bio-similar drug under the applicable law. The plaintiffs
have an alternative remedy. The application was also opposed on the
ground that the allegations of infringement of copyright are not
sustainable on various reasons mentioned in para 7 of the reply.
Besides, it is stated that the present amendment is not maintainable as
the same is an abuse of the process of the law and the same deserves
to be dismissed.
89. There is also no force in the argument of defendants No.2 to 4
that the unamended plaint does not contain any allegations against the
DCGI and does not contain a categorical assertion that the DCGI has
violated the legal rights of the plaintiffs and as per amended plaint
seeks a declaration that the manufacturing and marketing authorisation
granted to defendant No.2 was invalid, the plaintiffs have not sought
the consequential relief that such approval should be withdrawn.
Accordingly, the declaratory relief sought by the plaintiffs cannot be
granted under Section 34 of the Specific Relief Act, 1963, as amended.
90. The plaintiffs have, in addition to the declaration of invalidity of
the manufacturing and marketing authorisation, sought an injunction
against defendants No.2 to 4 from acting in furtherance of such
authorisation.
91. In the second application for amendment filed by the plaintiffs
being I.A. No.11224/2015, in para 4 thereof, it is stated that during the
pendency of the suit, defendant No.2 has obtained approval for two
additional indications, namely, HER2+ early breast cancer and HER2+
metastatic gastric cancer. Learned counsel for the plaintiffs in support
of his submissions has referred the order dated 28th May, 2015.
92. The said fact has not been denied by the learned counsel for
defendant No.2 that they have already obtained the approval from
defendant No.1 with regard to the additional indications. They have
also not denied the fact that their application for approval of specimen
of the carton, labels and package insert is still pending for proposed
additional indications. Learned counsel for defendant No.1 has
admitted the said position. He has, in fact, on 28th May, 2015 as well
as on 1st July, 2015 has informed that the application for such approval
for specimen of the carton, labels and package insert will be
considered as per its own merits and as per the rules and regulations.
He submits that the same will be considered after going through the
pleadings of the parties and the orders passed by the Court from time
to time.
93. The fact of the matter is that the approval of additional indications
on drug was granted to defendant No.2. However, the approval of
specimen of the carton, labels and package insert for the proposed
additional indications is granted in July, 2015 by defendant No.1.
94. The case of the plaintiffs is that for the purpose of determining
the real question of controversy between the parties, the amendment
of the plaint in terms of the proposed amendments as set out in this
application is necessary. It is submitted that the information given in
the said applications is subsequent event which is not denied by the
defendants, as the application for approval of additional indications on
drug was filed in the month of August, 2014 when the matter was being
heard on merits in the interim applications therefore no prejudice would
be caused to the defendants if the subsequent events be brought on
record by allowing the application, otherwise grave injustice, harm and
loss would be caused to the plaintiffs.
95. Both these applications are opposed by defendants No.2 to 4 on
the ground that the plaintiffs are seeking to challenge the very approval
granted by defendant No.1 and if the same is allowed, that would
change the nature of the case. It is stated that in the original plaint filed
on 4th February, 2014, the plaintiffs chose not to challenge the
approvals granted by defendant No.1 and even, in the order dated 5th
February, 2014 the Court did not grant ad-interim injunction with
respect to the sale or marketing or distribution of the defendant No.2's
drug in question. The only restraint on the said defendant is with
respect to making use of the plaintiffs' trademarks and references as
prayed for. There is also no restraint on the defendants from obtaining
the approvals of additional indications as required under the law. It
was also stated in the reply that the reading of both the applications for
amendment would show that the plaintiffs are belatedly attempting to
extend the scope of the plaint by changing the nature and character of
the suit. Therefore, both the applications are liable to be dismissed. It
is further stated in the reply that such relief of declaration would not be
agitated before this Court in view of the alternative remedy prescribed
under the Drug Rules, 1945 and it imposes bar on the jurisdiction of
this Court. The present amendments would go beyond the scope of
the original plaint, therefore, the same cannot be allowed. The
defendants No.2 to 4 in their replies have also repeated the same
objections as taken in the written statements and other applications
filed from time to time.
96. It is also argued by the defendants that by virtue of the
amendments sought in the first application, the plaintiffs are seeking
relief of declaration by challenging the approval granted to defendant
No.2 by defendant No.1. As far as the other amendments are
concerned, which are subsequent events in nature, the same have
occurred after filing of the suit about the application for additional
indications. The same have to be considered by the Court at the time
of deciding the interim applications as during the course of the
arguments, the defendant No.2 did not point out the said fact either to
the Court or to the other side. As and when it has come to the notice
of the plaintiffs, the fresh application has been filed.
97. The plaintiffs propose to make the amendments in the plaint to
(i) Replace paragraph 1 of the plaint, (ii) Insert the following sub-
paragraphs before paragraph 2(a) of the plaint, (iii) Since defendants 2
to 4 have already launched and introduced the defendants' drugs,
delete the words "launching, introducing," from the first sentence of
paragraph 2(a) of the plaint, (iv) Insert the following sub-paragraphs
after paragraph 2(d) of the plaint,(v) Delete the last sentence of
paragraph I6(e) of the plaint, (vi) Insert the following new paragraphs
after paragraph 17 of the plaint, (vii) Insert the following new
paragraph after paragraph 29 of the plaint, (viii) Insert the
following new paragraph after paragraph 30 of the plaint, (ix)
Insert the following new paragraph after paragraph 34 of the
plaint, (x) Replace paragraph 42 of the plaint, (xi) Replace paragraph 44
of the plaint, (xii) Insert the following new prayers before prayer
(a) in the plaint,(xiii) Delete the words "launching, introducing," from
the first sentence of prayer (a) in the plaint and (xiv) Insert the
following new prayers after prayer (d) in the plaint.
98. It is submitted that for the purpose of determining the real
questions in controversy between the parties, the plaint should be
amended in terms of the proposed amendments mentioned in this
application. No prejudice, harm or loss would be caused to the
defendants if this application is allowed. On the contrary, grave
injustice, harm and loss will be caused to the plaintiffs if this
Application is not allowed, and the balance of convenience is in
favour of the plaintiffs.
99. In the second application, being I.A. No.11224/2015, the plaintiffs
propose to make the following amendments to the plaint, as amended
pursuant to the First Amendment Application (the "Amended Plaint")
i.e.(i) Insert the following sub-paragraphs before paragraph 2(a) of the
plaint, (ii) Insert the following new paragraph after paragraph 10 of the
Amended Plaint, (iii) Insert the following new paragraph after
paragraph 13 of the Amended Plaint, (iv) Insert the following new
paragraphs after paragraph 17C of the Amended Plaint, (v) Replace
paragraph 29 of the Amended suit, Replace paragraph 29A of the
Amended suit, (vii) Since defendants No.2 to 4 have started marketing
and selling the defendants' drug in India after the filing of the present
suit, replace paragraph 46 of the Amended Plaint and (viii) Insert the
following new prayers before prayer (a) in the Amended Plaint.
100. It is submitted by the defendants that prior to filing of the
present application, the plaintiffs had filed earlier application for
amendment of plaint on 14th March, 2014 (I.A. No.4649 of 2014) which
is yet to be adjudicated by this Court and currently the plaint that exists
as on date is the original plaint filed by the plaintiffs at the time of
instituting the present suit. Without any orders of this Court on the first
application for amendment (I.A. No.4649 of 2014), the plaintiffs have
mischievously amended the plaint by incorporating paragraphs from
the first application for amendment. A perusal of the proposed plaint
which the plaintiffs now propose to introduce by way of IA. No.11224 of
2015 reveals that the plaintiffs have merged the paragraphs of the first
application for amendment with the original plaint without any
directions of this Court on the same. If amendment is allowed, it would
amount to this Court allowing the I.A. No.4649 of 2014 without any
adjudication of the same.
101. The prayer of second application is also opposed in the
similar way as opposed in the first application. It is stated that in the
original plaint filed on 4th February, 2014, the plaintiffs chose not to
challenge the approvals granted by the defendant No.1 to the
defendant No.2. Further, even in order dated 5th February, 2014,this
Court did not grant any ad interim injunction with respect to the sale or
marketing or distribution of the defendant No.2's drug CANMAb.
102. It is stated on behalf of the defendants that the restraint
with respect to making use of the plaintiffs' trademark HERCEPTIN,
HERCLON, BICELTIS in press release and public announcements
which is also the basis of the plaintiffs' entire claim. It is submitted that
there is no restrain against the defendant No.2 from obtaining requisite
approvals on additional indications as required under law in relation to
its drug CANMAb. The present Application for amendment of pleadings
filed by the plaintiffs is an abuse of the process of law and is not
maintainable. It is submitted that the proceedings are at the stage of
rejoinder arguments on the applications under Order XXXIX Rules 1 &
2 CPC and Order XXXIX Rule 4 CPC wherein only the plaintiffs are left
to address their rejoinder arguments. However, the plaintiffs are
procrastinating their rejoinder arguments by filing one application after
the other with no valid cause of action and thereby delaying an order of
this Court on the injunction and vacation of injunction applications.
103. It is mentioned in the replies that the plaintiffs had wrongly
reserved their right to challenge the purported approvals granted in
connection with the defendants' drug and modify the plaint and/or to
enlarge the reliefs against the defendants as the plaintiffs have, inter
alia, through the letter of October 11, 2013 written to defendant No.1
regarding the inadequacy of the clinical trial design for the purported
biosimilar Trastuzumab. The plaintiffs are awaiting a response to such
letter. The plaintiffs were obtaining the leave under Order II, Rule 2 of
the CPC wrongly even.
Thus, the amendment is not liable to be allowed. It would
change the nature of the case and such amendment would also
prejudice the defendants No.2 to 4. In the guise of the proposed
amendments, the plaintiffs are now seeking to challenge the approvals
granted by the defendant No.1 and if allowed, would positively change
the nature of the case.
104. It is argued on behalf of the defendants No.2 to 4 that it is a
settled law that when interim orders are obtained on particular
pleadings, the confirmation / vacation of such an order must only be on
the basis of such pleadings and consideration of an application for
amendment under Order VI Rule 17 CPC must await the determination
of the applications under Order XXXIX Rule 1 & 2 and Order XXXIX
Rule 4 CPC. Counsel for the plaintiffs referred Revajeetu Builders
and Developers v. Narayanswamy and Sons and Ors - (2009) 10
SCC 84 and Rajveer Food Marketing (I) Pvt. Ltd. v. Amrit
Banaspati Company Ltd - (2010)42 PTC147 (Del) (DB), as in the
present case, the plaintiffs are attempting to disown the statement of
their counsel recorded in the order of this Court dated February 5,
2014. The approvals ought to have been granted under applicable law
and the Guidelines on Similar Biologies, 2012. In case the approvals
had not been granted in this manner, the plaintiffs would take steps to
challenge such approvals. His clients had expressly reserved their
right to challenge such approvals under Order II Rule 2 of the CPC in
paragraph 42 and paragraph 16(e) of the Plaint, which has been
admitted it in paragraph 1 of the preliminary submissions of the reply.
Counsel for the plaintiffs submits that it is wrong on the part of
defendant No.2 to suggest that although the plaintiffs expressly
reserved their right to modify the plaint, the plaintiffs' application should
be rejected on the basis that "there was not even a whisper regarding
any reservation of right to challenge the approvals granted in
connection with the defendants' drug." The amendments sought in the
plaintiffs' application and the first amendment application do not
change the nature of the suit and necessary pleadings relating to the
inadequacy of the tests conducted in relation to Bmab-200, the
process of grant of approval for Bmab-200 and the basis of the
additional reliefs sought pursuant to the plaintiffs' application and the
first amendment application are already included in the original plaint.
The arguments were addressed on behalf of defendants No.2 to 4
without prejudice as they were pressing that once the suit was not
maintainable, the question of amendment of plaint does not arise.
105. The necessary pleadings relating to the inadequacy of the
tests conducted in relation to Bmab-200 and the process of grant of
approval for Bmab-200 are already included in the original plaint.
However, the facts sought to be included in the plaint pursuant to the
plaintiffs' application arose subsequent to the filing of, and during the
pendency of, the present suit. The plaintiffs could not have included
these assertions in the original plaint and have taken prompt steps for
amendment of the plaint to ensure a comprehensive determination of
the real questions in controversy.
106. It is the admitted fact that the approval for Additional
Indications granted after filing of the suit and during the course of
hearing of injunction applications clearly establishes that defendant
No.2 relied upon data relating to the plaintiffs' Trastuzumab, and
claimed similarity with the plaintiffs' Trastuzumab in pursuing
applications for approval of Bmab-200 for the Additional Indications,
contrary to the directions and injunctions contained in the above
referenced orders. Since Bmab-200 is claimed by the defendants to be
biosimilar to the plaintiffs' Trastuzumab, no application for approval of
Bmab-200 for the Additional Indications could have been made by
defendants No.2 without reliance upon the data relating to the
innovator drug in such application. Further, Bmab-200 has admittedly
been granted the Approval for Additional Indications solely on the basis
of the data relating to the plaintiffs' Trastuzumab since admittedly no
pre-clinical or clinical trials have been conducted on Bmab-200 for the
Additional Indications by defendants No.2, as required under
applicable law.
107. It is settled law that the parties to a suit are permitted to
amend their pleadings at any stage of the proceedings for the purpose
of determining the real question in controversy between them, if the
amendments sought do not change the basic nature and character of
the suit. It is equally settled law that the merits of the amendments are
not to be gone into while deciding the amendment application. At this
stage, it is not to be decided that the suit for infringement of copyright
would not be maintainable if amendment is allowed. The said aspect
has to be considered on merit. The plaintiffs might have weak case on
that issue but at present it cannot be concluded that suit would not be
maintainable as the Court is not examining the issue on merit.
108. The amendments proposed to be made are on the basis of
information received by the plaintiffs after the filing of the suit which
was either under the possession of defendant No.2 or under control of
the defendant No.1. Even the defendant No.1 has granted fresh
approvals for two additional indications without providing the
information to the court uptil the end of May, 2015 or to the plaintiffs.
Thus, the defendant No.2 on the other hand concealed the said factum
and also obtained the approval concerning the package inserts
contrary to the interim orders. All these necessitated a separate factual
foundation which the plaintiff is attempting to incorporate in the plaint
as the further developments take place. The said facts were intended
to be brought on record on the basis of subsequent events. Even first
amendment application was pending. There is no harm if both
applications for amendment of plaint can be decided together.
109. The plaintiffs seek to amend the original plaint to bring on
record facts relating to the grant of approval to Bmab-200 for additional
indications, namely HER2+ early breast cancer and HER2+ metastatic
gastric cancer (the "Additional Indications"), which approval was
sought and granted clandestinely during the pendency of the suit, and
to seek appropriate reliefs m view of such facts. Pursuant to the
plaintiffs' application, the plaintiffs are seeking to add and amend
pleadings relating to the inadequacy of the approval granted to
defendant No.2 for the Additional Indications (the "Approval for
Additional Indications"). The Approval for Additional Indications was
admittedly linked to the marketing and manufacturing authorisation
granted for Bmab-200 on October 23, 2013 (the "Marketing
Authorisation") and the invalidity of the Marketing Authorisation is
indisputably the subject matter of the present suit.
110. The court's power to allow amendments is wide and can be
exercised at any stage of the proceedings. The main purpose of
allowing amendments is to minimise litigation and avoid multiplicity of
proceedings, and it is for the court to consider whether the amendment
sought is imperative for proper and effective adjudication of the
disputes and whether disallowing the amendment would in fact lead to
injustice or multiple proceedings. If the necessary factual basis for the
amendment is already contained in the unamended plaint, seeking
additional reliefs on the basis of those facts will not change the nature
of the suit.
111. A change in the nature of relief claimed will not be
considered as a change in the nature of the suit and the power of
amendment should be exercised in the larger interest of doing full and
complete justice between the parties and the courts have to be liberal
in allowing amendments if the application for amendment is filed prior
to the commencement of the trial.
112. The application for the Additional Indications has been
pursued by defendants No.2 and granted by defendant No.1, without
information to this Court, during the pendency of the suit, pursuant to
which the validity of the original approval of Bmab-200 for HER2+
metastatic breast cancer had been challenged before this Court and is
subjudice. These actions of the defendants are in complete disregard
of the terms of the above referenced orders and the directions issued
by this Court.
113. If the necessary factual basis for the amendment is already
contained in the unamended plaint seeking additional reliefs on the
basis of those facts is permitted, in the interest of preventing
multiplicity of proceedings, the prayer in the amendment application
can be allowed. This Court has noticed that there was no delay in
filing of applications for amendment of plaint. It is also not denied by
any of the defendants that these two applications were filed on the
basis of subsequent events. The mere objection raised by the
defendant was that once the original suit filed by the plaintiffs was not
maintainable, the question of amendment in the subsequent stage
does not arise. In the present case, I have already held that the suit
filed by the plaintiffs is maintainable. The said objection has therefore
no force.
114. Even otherwise, it is not in dispute in the present case that
the relief sought by way of amendment by the plaintiffs could be
claimed by way of a separate suit. It is held in the case of Abdul
Rehman and another v. Mohd. Ruldu and others, reported in (2012)
11 Supreme Court Cases 341,that an amendment seeking declaration
of title shall not prejudice the case of the other side unless the reliefs
claimed are not barred by limitation. It was observed in the case
referred that no prejudice would be caused to the respondents if
amendments were allowed. In order to avoid further litigation, the
same should be allowed as all amendment which are necessary for the
purpose of determining the real questions in controversy between the
parties should be allowed if it does not change the basic nature of the
suit. A change in the nature of relief claimed shall not be considered
as a change in the nature of suit and the power of amendment should
be exercised in the larger interests of doing full and complete justice
between the parties.
115. The Supreme Court in the case of Rajesh Kumar
Aggarwal and others v. K.K.Modi and others¸ reported in (2006) 4
Supreme Court Cases 385 held in para 18 and 19 as under :
"18. .........the real controversy test is the basic or cardinal
test and it is the primary duty of the Court to decide whether
such an amendment is necessary to decide the real dispute
between the parties. If it is, the amendment will be allowed;
if it is not, the amendment will be refused. In cases like this,
the Court should also take notice of subsequent events in
order to shorten the litigation, to preserve and safeguard
rights of both parties and to sub-serve the ends of justice. It
is settled by catena of decisions of this Court that the rule of
amendment is essentially a rule of justice, equity and good
conscience and the power of amendment should be
exercised in the larger interest of doing full and complete
justice to the parties before the Court.
19. While considering whether an application for
amendment should or should not be allowed, the Court
should not go into the correctness or falsity of the case in
the amendment. Likewise, it should not record a finding on
the merits of the amendment and the merits of the
amendment sought to be incorporated by way of
amendment are not to be adjudged at the stage of allowing
the prayer for amendment. This cardinal principle has not
been followed by the High Court in the instant case."
116. In any event, a change in the nature of relief claimed will
not be considered as a change in the nature of the suit and the court
may exercise its power to amend pleadings in the larger interest of
doing full and complete justice between the parties as this Court has
already that the suit filed by the plaintiffs is maintainable in view of
facts and circumstances of the present case.
117. It is settled law that the application under Order VI, Rule 17
of the CPC can be decided before an earlier application under Order
XXXIX, Rule 4of the CPC. Counsel for the plaintiffs referred to Shivraj
Gupta v. Rajendra Gupta, (judgment of the Delhi High Court dated
March 11, 2010) at paragraphs 9and 10 and Mohun Bagan Athletic
Club v. Deba Prasad Mukherjee (AIR 2003 Cal 298 at paragraphs 30
to 33). Case of Rajveer Food (supra) does not apply to the present
matter - the amendment application in that matter was not considered
at the stage of considering the Order XXXIX applications since the
plaintiffs had deliberately suppressed facts in the unamended plaint.
The court held that allowing the amendment application at the Order
XXXIX stage in those facts would enable a party to rush to court post
haste without making a full disclosure of all the facts within its
knowledge and subsequently seek incorporation of the said facts by
way of an amendment while in the meantime continuing to enjoy the ex
parte order obtained fraudulently and dishonestly. Such is not the case
here where the plaintiffs have deliberately concealed something in
order to gain advantage over the defendants and are malafidely
sustaining the same. On the contrary, it is a case where the plaintiffs
have discovered certain facts during the progression of the case which
they want to incorporate or elaborate in the plaint.
118. As I have already observed that the un-amended plaint
contained sufficient averments as to challenge the approval which the
plaintiffs could have made at the relevant time. The plaintiffs are
merely elaborating the said challenge more in the relevant paragraphs
sought to be amended in the plaint. Rather, the plaintiffs' endeavour to
seek amendment to the plaint is in consonance with the statement
made by plaintiffs' counsel that the approval would be challenged in
accordance with the law before this court. If on account of the advise, if
the plaintiffs are guided to seek amendment in the plaint to elaborate
their challenge and seek a declaratory relief, then there is no reason as
to why the said amendment is not in consonance with the challenge
which was contemplated by the plaintiffs earlier to the drug approval.
119. The defendants by raising such a plea that the
amendment is impermissible because of hearing of the injunction
application has commenced along side the hearing of the
application seeking vacation of the injunction which is not the
straight jacket law but is based on case to case basis (where
malafide is to be inferred on facts) and simultaneously stating in
the hearing of the injunction application that the un-amended
plaint does not contain such a challenge cannot be allowed take
advantage of the situation by continuing to delay the proceedings
and manufacture the drugs in the meantime without adjudication
of the claim of the parties, when otherwise the claim of the
plaintiffs is maintainable and the amendments are permissible in
law and plaintiffs have justifiable reasons for seeking the
amendment. Doing this would be abuse of the process of the law as
the plaintiffs would be left in legal impediments of bringing
amendments after amendments as the developments take place.
120. I am clear in my mind that in order to decide the real
controversy between the parties, no harm or loss will be caused to the
defendants if the amendment application is allowed since the
proceedings are still at a preliminary stage and trial has not yet
commenced - pre-trial amendments are liberally allowed.
121. The other argument of the learned counsel for defendants
is that the plaintiffs were aware of Defendant No.2's application before
the DCGI since 2011 and objected to such application in October
2013. The plaintiffs were aware of the contents of defendant Nos. 2 to
4'spackaging material and product insert before filing the present suit
as the packaging material for CANMab has been reproduced in plaint.
Therefore, these are not subsequent facts and the application for
amendment of the plaint to include these facts should be rejected.
Even if that submission is to be considered at the highest as correct,
still, the question to be asked is as to whether the plaintiffs are not
entitled to amend the pleadings by suitably elaborate the challenge
even if it was known to them at the time of filing of the suit and whether
the said amendment is not essential to decide the issue between the
parties. In my view, the plaintiffs cannot be allowed to amend the
pleadings as the suit is at the initial stage and the pending applications
are being decided on the basis of original plaint and subsequent
admitted events, some of which are brought to the notice of the Court
and plaintiffs by the defendants themselves.
122. There is no much delay in filing the application. In fact, the
defendants did not care to disclose the material facts about the
approvals to the Court as well as plaintiffs after filing of the suit. The
amendments sought in both applications are in fact in the nature of
subsequent events as well as elaboration of facts already stated in the
unamended plaint and additional prayers made in the proposed
amended plaint. The defendants were not ready at any point of time to
share any information about the bio-similar products of the plaintiffs.
Even otherwise small delay i.e. three months does not mean that the
amendment application which has a merit should be dismissed. The
delay in the present matter is wholly attributed to the defendant No.2
who has obtained the approvals of second set of approvals of
additional indications in hidden manner.
123. Thus, under these facts, the prayers in both applications
are allowed. The defendants are granted four weeks time to file the
written statements to the amended plaint. However, it is clarified that
since the defendants No.2 to 4 are yet to file the written statements to
the amended plaint, the pending applications are being decided on the
basis of unamended plaint and subsequent events happened during
the course of hearing.
124. I.A. No.5956/2014 dated 28th March, 2014 filed by
plaintiffs under Order 11 CPC
Now I shall take the above referred application for discovery of
documents.
i) It is mentioned in the application that on February 10, 2014 and
February 25, 2014, defendant No.2 provided certain documents to the
plaintiffs (the "Defendant's Documents") in support of their
contention that the defendants' drugs have received manufacturing and
marketing approval from defendant No.1 and that such approval is in
accordance with the applicable law. However, the defendant's
documents do not contain the entire correspondence exchanged by
defendant No.2 with defendant No.1, the Review Committee on
Genetic Manipulation (the "RCGM"), and the Office of the Drugs
Controller, State of Karnataka (the "Karnataka Drugs Controller").
Further, the defendant's documents do not contain, inter alia, all the
Form filings, results of the product characterisation, pre-clinical and
clinical studies and other enclosures. Defendant No.2 has deliberately
sought to suppress and distort material facts in connection with the
approvals obtained for the defendants' drugs.
ii) The defendant No.2 has selectively filed certain correspondence
between defendant No.2 and other appropriate regulatory authorities,
including defendant No.1 in relation to the approval of the defendants'
drugs; it has deliberately failed to file the enclosures to such letters
(including the various application forms and the results of the tests
purportedly conducted on the defendants' drugs at each stage) before
this Court. The plaintiffs are, therefore, entitled to the discovery and/or
inspection of the entire correspondence (including form filings, test
results and other enclosures) between defendant No.2 and defendant
No.1 and the other appropriate regulatory authorities relating to the
development, testing and approval of the defendants' drugs.
iii) The plaintiffs sought discovery and production of further
documents, the discovery and production of the following documents in
particular is prayed for:
i) All the enclosures (including Form C3, draft study plans,
etc.) to Defendant No.2's letter dated May 6, 2009, to the RCGM
seeking permission to conduct preclinical studies;
ii) All the enclosures (including Form C5, etc.) to Defendant
No. 2's letter dated January 4, 2011 bearing No.
RA/BLlRCGM/ll/004, to the RCGM, seeking approval of their pre-
clinical studies data in relation to Bmab-200;
iii) Summary report on the pre-clinical study data that would
have been submitted by Defendant No.2 to Defendant No.1,
pursuant to the RCGM's letter dated February 25,2011;
iv) All the enclosures to Defendant No. 2's letter dated March
9, 2011, to DefendantNo.1 seeking permission to conduct the
clinical trials;
v) Defendant No.1's letter dated June 15,2011 bearing No. 4-
90IBIOCON/11-BDto Defendant No.2;
vi) The expert letter enclosed with Defendant No. 2's letter
dated August 9, 2011bearing No. RA/BL/DCGI/11/114 to
Defendant No.1;
vii) All the enclosures to Defendant No. 2's letter dated July 16,
2012 bearing No.RA/BL/DCGI/12/078 to Defendant No.1; and
viii) All the enclosures to Defendant No. 2's letter dated
October 10,2013 bearing No.RA/BL/DCGI/13/205 to Defendant
No.1.
It is stated in the application that if the prayer sought in this
application is not granted, the plaintiffs will suffer prejudice as
Defendant Nos. 2 to 4 will continue to market, sell and distribute the
Defendants' Drugs by relying on the purported approvals obtained by
Defendant No.2 in relation to the Defendants' Drugs.
125. Reply on behalf of the defendant No.2 has been filed to the
application filed under Order XI Rule 12 and 14 read with Section 151
CPC by the plaintiffs for discovery and production of documents by
defendant No.2. It is mentioned in the reply that the present
Application was filed by the plaintiffs in March 2014. However, the
plaintiffs chose to press this application only on 8th April, 2015. The
request for seeking sensitive information and trade secrets submitted
by the defendant No.2 to the Licensing Authority under the Act during
the process for seeking approval of its drug is barred in law.
The present application filed by the plaintiffs is aimed at
seeking to examine further documents relating to the approvals
granted to the Defendant No.2's drug. The plaintiffs can neither be
given access to the record which is lying in a sealed cover before the
Court nor can they seek the same documents from the Defendant No.2
because such documents are confidential in nature and contain
sensitive and proprietary information belonging to the Defendant No.2
and its business, it would be potentially damaging to the Defendant
No.2 if such information/documents containing sensitive, confidential
and proprietary information come in the hands of a competitor such as
the plaintiffs who would commercially exploit and utilize the said
information/ documents to the detriment of the Defendant No.2.
126. It is strongly opposed and submitted that the plaintiffs have
no locus to seek discovery of the documents as admittedly the
documents sought are directly relating to the approval of Defendant's
duly approved drug CANMAb and plaintiffs cannot be permitted to
assume the role of the Licensing Authority and usurp the role of
independently constituted, statutory or otherwise technical / expert
bodies who have evaluated the Defendant's application for grant of
approval of CANMAb. Such information is confidential in nature and is
shared with the Defendant No.1 under its fiduciary relationship. Such
information filed with the Defendant No.1 is subject to the restrictions
envisaged under the Drugs Act as also the RTI Act, 2005 in addition to
the protection available under common law for trade secrets.
127. The defendant No.2 in the present case has not only
refused to discover or produce the documents but also opposed the
request to inspect the file submitted by the defendant No.1. The
defendants have assigned various reasons not to discover and
produce the said documents. The defendant No.2 has admitted that
the plaintiffs' documents pertaining to all approvals are already in
public domain and in fact that the defendant No.2 has relied upon the
data at the time of approvals.
128. It is a matter of fact that all the approvals of three
indications on the basis of material produced before the appropriate
authorities have been granted. The defendant No.2 has also relied
upon the data and documents of the innovator. However, the
defendant No.2 all the times refused to produce the documents sought
in the application. When particular documents are known, a party
cannot ignore the said provision, subject to the condition that the
documents sought to be discovered and produced are relevant and are
in the possession and power and discovery and production of the said
documents is necessary.
129. The basis of judgment of the Supreme Court in the case of
M.L.Sethi v. R.P.Kapoor, AIR 1972 SC 2379, wherein the entire
procedure has been discussed, has been considered by the Courts
from time to time in many judgments including in the case of
Sasanandgouda v. Amarkhed, AIR 1992 SC 1163 and Rajesh
Bhatia v. G.Parimala, 2006 (3) ALD 415. The relevant paras 30 and
31 of M.L.Sethi (supra) read as under:-
"30. In M.L. Sethis's case (Supra) the Supreme Court held
that:
"Generally speaking, a party is entitled to inspection of all
documents which do not themselves constitute exclusively
the other party's evidence of his case or title. If a party
wants inspection of documents in the possession of the
opposition party, he cannot inspect them unless the other
party produces them, The party wanting inspection must,
therefore, call upon the opposite party to produce the
document. And how can a party do this unless he knows
what documents are in the possession or power of the
opposite party? In other words, unless the party seeking
discovery knows what are the documents in the possession
or custody of the opposite party which would throw light
upon the question in controversy, how is it possible for him
to ask for discovery of specific documents?..."
The Court, speaking about Order 11 Rule 12 CPC, held that:
"When the Court makes an order for discovery under the
rule, the opposite party is bound to make an affidavit of
documents and if he fails to do so, he will be subject to the
penalties specified in Rule 21 of Order 11. An affidavit of
documents shall set forth all the documents, which are, or
have been in his possession or power relating to the matter
in question in the proceedings. And as to the documents
which are not, but have been in his possession or power,
he must state what has become of them and in whose
possession they are, in order that the opposite party may
be enabled to get production from the persons who have
possession of them (see Form No.5 in Appendix C of the
Civil Procedure Code). After he has disclosed the
documents by the affidavit, he may be required to produce
for inspection such of the documents as he is in possession
of and as are relevant".
"31. The Court also held that the documents sought to be
discovered and not be admissible in evidence in the
enquiry of the proceedings and it is sufficient that the
documents would be relevant for the purpose of throwing
light on the matter in controversy. In a subsequent decision,
dealing with an election dispute, Sasanagouda V. S.B.
Amarkhed AIR 1992 SC 1163, the position vis-a-vis
production of documents on discovery and inspection was
explained, in the following terms:
"The court, therefore, is clearly empowered and it
shall be lawful for it to order the production, by any
party to the suit, such documents in his possession or
power relate to any matter in question in the suit
provided the Court shall think right that the production
of the documents are necessary to decide the matter
in question. The Court also has been given power to
deal with the documents when produced in such
manner as shall appear just. Therefore, the power to
order production of documents is coupled with
discretion to examine the expediency, justness and
the relevancy of the documents to the matter in
question. These are relevant considerations, which
the Court shall have to advert to and weigh before
deciding to summoning the documents in possession
of the party to the election petition."
130. The defendant No.2 in the present case has not only
refused to discover or produce the documents but also opposed the
request to inspect the file submitted by the defendant No.1. The
approvals which have been granted to defendant No.2 are on the basis
of certain documents produced before the Regulatory Authority who
may or may not rightly or wrongly granted the approvals. The
defendant No.2 now cannot claim the confidentiality in nature on the
grounds that the access to the said documents would damage the
case of the defendant No.1 particularly in view of the fact that the
approvals of bio-similar product were obtained on the basis of the
plaintiffs' product and their data has been used.
131. Mr.Sandeep Sethi, learned Senior counsel, appearing on
behalf of the plaintiffs, has argued that some of the documents are
most crucial tests, which the defendant No.2 is not inclined to share
with the plaintiffs, is about characterisation stage and the production
process of the similar biologic in order to demonstrate that its drug is
consistent and the testing of the similar biologic must be sufficient to
ensure that the product meets acceptable levels, safety, efficacy and
quality. It is submitted that the defendant No.2 is deliberately wants to
hide the said tests from the plaintiffs and at the same time the
defendant No.2 wants to claim that its product is bio-similar and
informed the entire world in this regard in order to take the advantage.
He says in fact the defendant No.2 does not want that the plaintiffs to
address their submissions on this issue. Therefore, the defendant
No.2 is avoiding inspection of most crucial documents. The case of
the defendant No.2 is that they have conducted all trials as per rules.
However, they are not ready to give the inspection to the plaintiffs who
have time and again mentioned that all the trials and tests required for
the purpose of approvals have not been conducted. The only
explanation is that the defendant No.1 has already examined the
documents.
It is wrongly stated by the defendant No.2 that the plaintiffs are
nobody to inspect the same. As far as the Court is concerned, the
record has been submitted, the Court may verify the same. They have
informed to the Court that these documents are confidential in nature
and the same can only be produced for satisfaction of the Court and
they are sensitive documents from the business point of view
containing the secret information and the plaintiffs may misuse the
same, therefore, these documents cannot be revealed. At the same
time, it is not denied by the defendant No.2 that it had obtained the
entire published data of the plaintiffs and relied upon before defendant
No.1 and on the basis of such data, the approval was obtained.
132. It is a matter of fact that he defendant No.2 is claiming that
the approvals have been granted as per Act and approval and all the
requisite clinical trials have been conducted. It is also stressed by the
defendant No.2 that after approvals they are entitled to refer its drug as
biosimilar to the drug of the plaintiffs and they can declare to all
hospitals, doctors and the entire world that their product is biosimilar
and can compare both drugs. In view of such circumstances, the party
has a right to know that under what circumstances the approvals were
granted to the defendant No.2 of their bio-similar product or not. The
plaintiffs are the aggrieved party. One fails to understand that once the
approval is granted why now the data used by defendant No.2 before
defendant No.1 cannot be examined by the plaintiffs. Though record
has been submitted by the defendant No.1, this Court is not an expert
for comparing characterisation of two drugs of the parties. Further the
aggrieved party is entitled to know the nature of the clinical trials
conducted by the party who intends to use the biosimilar drug of the
innovator.
133. I have gone through the submissions made by the
defendants while resisting the application for discovery of documents
filed by the plaintiffs. It appears that the plaintiffs are seeking discovery
of the documents so as to prove their case clinically and to provide the
infirmities in the defendant's approval process of the drug. The
defendant's position while resisting the injunction application has
always been that the drug of the plaintiffs is already approved in India
and thus data of the plaintiffs and its approval process can come in aid
of the defendant while seeking its approval of the drug BMAB 200
based on referenced biologic.
134. If this position taken by the defendant No.2 qua the data
and approval of the plaintiffs' drug by calling it a publically available
documents, it is beyond comprehension as to how the defendant No.2
after submitting the documents with defendant No.1 can call their
documents as confidential in nature. The defendants' stand is
surprising when they go on state that the plaintiffs cannot also inspect
the documents from the office of the defendant No.1 as it is hotly
contested matter. Off course, there is an attempt to withhold the
documents from the plaintiffs who are the aggrieved parties whose
product is referenced against by the defendant No.2 who cannot
withheld the documents which would only reveal whether the requisite
and crucial trials have been conducted by the defendant No.2 or not.
There is no force in the submission of the defendant No.2 that since
the original record is submitted by the defendant No.1, the Court may
examine the same. As a matter of fact, the plaintiffs' assistance on this
issue is required in order to find out the truth.
135. Under such circumstances, I do not find any impediment in
allowing the application seeking discovery of the documents in as
much as the moment the approval has been allowed, the document
submitted before the defendant No.1 can be examined by the plaintiffs
being aggrieved party. However, in order to strike the balance
between the parties and concerns raised by the learned counsel for the
defendant No.2 about confidentiality of the document, it would be
proper that let the documents as mentioned in the application be filed
in sealed cover within two weeks from today. The same be kept in
safe custody of Registrar General. Two lawyers and an expert from
the plaintiffs side would inspect the said documents in the presence of
two Advocates from the side of defendant No.2. They (members of
club) would be bound by confidentiality and shall not make copies or
disclose the contents of the said aforesaid documents to anyone, oral
and written communications to the press, blog publications etc. in order
to maintain the confidentiality except in the present proceedings. The
inspection can only be done through the confidentiality club members
and no copies will be made of such confidential documents. After the
inspection, the aforesaid confidential documents, the same be
resealed and again deposited with the Registrar General of this Court.
After inspection, the plaintiffs would be at liberty to amend their
pleadings if so required.
136. The application is accordingly allowed in terms as
mentioned above.
I.A. No.4677/2014 (under Order XXXIX Rule 2A CPC filed on 11th
March, 2014)
I.A. No.14533/2014 (under Order XXXIX Rule 2A CPC), filed by
plaintiff on 25th July, 2014
137. The above said applications have been filed by the
plaintiffs on respective dates. The averments made in the said
applications are mentioned as per the application. First I shall refer the
application, being I.A. No.4677/2014.
The said application has been filed by the plaintiffs under
Section 94(c) read with Order XXXIX Rule 2A read with Section 151
CPC for breach of order dated 5th February, 2014 and modified order
dated 15th February, 2014.
138. It is submitted in the application that defendants No.2 to 4
started selling CANMAb and HERTRAZ, with package inserts
containing the Applicants' data, only after the February 5 order which
prohibited the use of the Applicants' data, inter cilia, in the package
inserts. Respondents No.1 to 3 have taken no action to discontinue
the use of the Applicants' data in the package inserts for CANMAb and
HERTRAZ after date of service of the February 5 order. As such,
defendants No.2 to 4 have breached the terms of the February 5 Order
and the injunctions contained therein. It is also stated in the
application that at the hearing on February 14, 2014, the counsels for
defendants No.2 to 4 made a categorical statement that the package
insert being used by them, which was shown to the Court, could be
used by them as they had received a specific approval for such
package insert. It is in this background that the February 14 Order was
passed.
139. Despite the claims made by defendants No.2 to 4 at the
hearing on February 14, 2014, that they had approval for their
labels, cartons and package inserts, no such specific approval has
been placed on record in the above mentioned suit. It is submitted
that defendants No.2 to 4 have not obtained the approvals for the
package inserts that are being used for their respective products
even though such a statement was made to this Court. Condition 8
of the marketing authorisation granted for Bmab-200 on October 23,
2013 states that "Specimen of carton, labels, package insert that
will be adopted for marketing the drug in the country shall be got
approved from the Licensing Authority before the drugs is marketed
and the defendant No.2 has failed to produce any approval relating
to package insert for Bmab-200."
140. On February 26, 2014, the plaintiffs purchased a sample of
CANMAb from the market. The accompanying package insert is not in
compliance with the orders since it extensively refers to and relies on
the data relating to Trastuzumab marketed, inter alia, as HERCLONTM
by the Applicants. A copy of the package insert for HERCLONTM is
attached as Annexure B.
The package insert for CANMAb, inter alia, states as
follows:
"The following clinical efficacy results have been observed
in various patient populations under the treatment with
trastuzumab based on published information."
"The following undesirable effects and their frequencies
have been observed under treatment with trastuzumab
based on published information."
141. The published information referred to in the package
insert is the data for Trastuzumab which is marketed by the
Applicants as HERCEPTIN ®, HERCLONTM and BICELTIS®. By
referring to and relying on such data in the package insert for
CANMAb, after the February 5 Order, defendant No.2 has knowingly,
intentionally and wilfully disobeyed and disregarded the Orders.
Copies of the invoice dated February 26, 2014 for the purchase of
CANMAb together with the package insert for CANMAb as
purchased on this date are annexed as Annexure C (Colly.).
142. The press releases on the websites of defendants No.2 to
4 continue to make references to HERCEPTIN and rely on the sales
data for the plaintiffs' Trastuzumab despite the orders. The press
releases dated November 26, 2013 and January 18, 2014 which are
presently available on the website of defendant No.2, inter alia, state
that: "The global sales for trastuzumab stood at US$ 6.4 bn in 2012,
while in India it recorded sales of US$21 Mn." Therefore, defendant
No.1 is continuing to rely on the sales figures of the plaintiffs'
Trastuzumab despite the directions issued pursuant to the orders.
Copies of the press releases dated November 26, 2013 and January
18, 2014 are presently available on the website of defendant No.2.
The allegations are made against the defendants No.2 to
4 that they have not taken any steps to remove such press releases
from their websites, and have therefore, knowingly, intentionally and
wilfully breached the Orders.
143. In the second contempt petition, being I.A.
No.14533/2014, it is stated that the plaintiffs have become aware
that defendants defendant No.2's annual report for financial year 2013-
2014 (the "Annual Report"), as made available on the website of
defendant No.1 at http://www.biocon.com/docs/Biocon Annual Report
2014.pdf, inter alia, states:
On page 54: "CANMAb TM is being offered to HER2-
positive metastatic breast cancer patients in India at [Rs -
I 57,500 per 440 mg presentation, which is about 25%
lower than the prevailing price of the reference product. It
would be important to indicate that the reference product
price was significantly reduced to current levels by the
innovator in anticipation of competition and is now around a
third of that in Europe and the US. This means CANM_Ab's
price in India is a small fraction of global trastuzumab
prices." (emphasis supplied)
On page 100: "CANM_Ab (INN: trastuzumab) has the
distinction of being the world's lowest priced antibody for
treatment of HER2 positive metastatic breast cancer.
Launched in Q4 FY14, CANMAb has been made
available in 2 formats: 440 mg and 150 mg. Our drug can
be stored for 1 month in both of these presentations and
hence will ensure that there is no under-dosing or
wastage of drug by Indian patients, which is quite
common today." (emphasis supplied)
It is also averred in the application that these statements
are false and misleading, they in fact are also in contravention of the
terms of the February 28 Order and the directions. By making such
statements, defendant No.2 in suit has knowingly, intentionally and
wilfully disobeyed and disregarded the February 28 order. A copy of
the Annual Report is filed as Annexure C.
144. It is submitted that the press release dated January 18,
2014, which is presently available on the website of despondent No.2
at http://www.biocon.com/biocon press release details.asp?
subLink=news &Fileid=509, inter alia, state that:
"Biocon intends to make a significant difference in the
treatment paradigm for HER2-positive breast cancer in
India by enhancing access to more affordable treatment
with CANMAbT" (trastuzumab), which offers the same level
of safety and efficacy as the reference product." (emphasis
supplied)
"Unlike the product currently available in the market, both
150 and 440 mg formulations of CANM_Abn't can be stored
for 1 month which is an important offering for patients in
India, as it will ensure that there is no under dosing or
wastage of drug which is quite common today." (emphasis
supplied)
"CA_NMAbTm will be available at about 25% discount to
the current list price of the reference product in India,
which is already significantly lower than its price in
developed markets. In addition, CANMAb's 150 mg
formulation, priced at Rs 19,500/vial will allow extra
savings to patients as they can buy smaller quantities as
per their requirement."
Therefore, it is alleged that the defendant No.2 is
continuing to state that the plaintiffs' Trastuzumab is undesirable as it
is expensive and results in under-dosage and/or wastage, in their
press releases. The defendant No.2 has not taken any steps to remove
such press releases from its website, and has therefore, knowingly,
intentionally and wilfully disobeyed the orders and the plaintiffs had
also filed earlier application under Section 94(c) read with Order
XXXIX Rule 2A and Section 151 of the CPC, i.e., I.A. No. 4677 of
2014, which is pending consideration by this Court. The plaintiffs are
constrained to file this present application in view of the defendants'
continuing disregard of the orders dated February 5, 2014 and
February 14, 2014 and the subsequent disobedience of the February
28, 2014 order. The defendants conduct indicates the habitual
disregard with which the defendants treat this Court's orders. The
defendants are wilful disobedient of the directions issued by this
Court.
145. The averments made in both applications have been
examined along with documents filed. Prima facie, the case to issue
show cause notice against the defendants is made out in view of
material available on record. Thus, show cause notice is issued to the
respondents in the applications as to why the contempt proceedings
should not be taken against them for 2nd June, 2016 before the roster
Bench. Replies to the same be filed within four weeks from the date of
service. Rejoinders thereto be filed by the next date.
146. I.A. No.3955/2015 (filed by third party under Order 1
Rule 10 CPC for impleadment)
The above mentioned application has been filed by a third
party. Both the parties admit that it is a commercial dispute between
the two private parties. They are contesting their disputes strongly
before this Court. Thus, it is not necessary to implead the party as
prayed. The application is dismissed. As and when the presence of
the said party would be required by the Court, the above application
would be revived. At this interim stage, no arguments are necessary to
be addressed by the third party as the similar issues are being argued
by the defendants.
CCP(O) No.69/2015 dated 30th June, 2015 and I.A. No.12862/2015
147. The above mentioned application has been filed under
Order XXXIX Rule 1 and 2 CPC read with Section 151 CPC praying to
restrain the plaintiffs from issuing letters, press releases, publication
and/or material in any form or manner in relation to the present
proceedings and also to withdraw the letter dated 10th June, 2015 or
any other letter of such nature and demand issued to the DGCI. They
have also filed a contempt petition for taking action for writing these
letters.
148. In the present suit due to the gross contemptuous acts of
plaintiffs in a letter dated 10th June, 2015 to the Drugs Controller
Karnataka through their legal counsel directing the Authorities under
threat of contempt proceedings, to take no action with regard to the
approval vis-a-vis cartons, labels, package insert, packaging or any
other material being submitted by the defendant No.2 to the
Authorities.
149. The above mentioned application was taken up for hearing
in Court on 1st July, 2015. The contention of the learned counsel for
defendant No.2 was that despite of the order dated 28th May, 2015
passed by the Court, the plaintiffs have communicated with defendant
No.1 i.e. the Drugs Controller General of India, by misleading it and
asked the defendant No.1 not to grant the approval of the carton,
labels and package insert. On the other hand, learned Senior counsel
appearing on behalf of the plaintiffs submits that the plaintiffs have
merely informed the defendant No.1 about the interim order passed
against defendant No.2. The plaintiffs have no intention to mislead the
defendant No.1 in any manner. The plaintiffs have no objection if the
application made by the defendant No.1 for approval of the carton,
labels and package insert for additional indications be decided on
merits after considering the orders passed by the Court from time to
time and if the same is granted, the plaintiffs would challenge the same
in accordance with law. Defendant No.2 is satisfied with the statement
of the plaintiffs. There is a force in the submission of the learned
counsel for the plaintiffs. The defendant No.1 also agreed to consider
the application for approval of carton, labels and package insert after
going through the interim orders dated 5th February, 2014 and 14th
February, 2014 and the same would be decided on the basis of rules
and regulations. During the course of hearing, I was informed that
such approvals have been granted. Thus, no further order is required
to be passed. The application is disposed of accordingly.
I.A. No.12830/2015 (under Order VII Rule 11(a) and (d) of CPC
dated 30th June, 2015 by the defendant No.2
150. It is submitted in the application that in an attempt to
overcome the deficiencies in the plaint, the plaintiffs have filed various
misconceived Applications in the present proceedings. The plaint does
not disclose any cause of action.
As all pleas raised in the application have been decided in
earlier part of my order wherein it is held that at this stage the suit of
plaintiffs is maintainable. Therefore, no further orders are required to
be passed as the prayer has become infructuous. The application is
disposed of accordingly.
I.A. No.16703/2015 dated 12th August, 2015 and I.A. No.16704/2015
dated 5th August, 2015 by defendant No.3 listed before Court on
13th August, 2015
151. It is stated in the applications that the Defendant No.2 has
been constrained to file the present application as the parties have
argued at length on the Application for Vacation of Injunction (IA
No.2990 of 2014), Application for Injunction (IA No.2371 of 2014) and
jurisdiction of this Court. However, the plaintiffs are preventing the
Court by derailing the present proceedings in vacation of injunction and
to decide the issue of maintainability of the suit.
152. The above said applications have become infructuous in
view of reasons given in my order while deciding the issue of
maintainability of the suit and jurisdiction of this Court. The averment
and the issue raised in the present applications as well as large
number of applications filed by the defendants No.2 to 4 are of
repetitive in nature. No further orders are required to be passed under
these circumstances and the same are dismissed.
I.A. No.2371/2014 (under Order XXXIX Rule 1 & 2 CPC by plaintiffs)
and I.A. No.2988/2014 and I.A. No.2990/2014 (under Order XXXIX
Rule 4 CPC by defendants No.2 to 4)
153. Now I shall deal with the rival submissions of the parties in
relation to main issue involved in the matter i.e. approvals of drug
metastatic breast cancer, International Non-proprietary Name (in short
INN) Trastuzumab, concept of biosimilar drug and approvals and
package insert, extrapolation which are granted by the authorities
under the provisions of the Drug Act and Rules.
154. It is a well-settled salutary principle that if a statute provides
for a thing to be done in a particular manner, then it has to be done in
that manner and in no other manner. (See Nazir Ahmad v. King
Emperor, AIR 1936 PC 253(2); Rao Shiv Bahadur Singh v. State of
Vindhya Pradesh, AIR 1954 Supreme Court 322; State of Uttar
Pradesh v. Singara, AIR 1964 SC 358). When the State lays down
the Rules, the same are imperative to be followed.
155. Before dealing with the submissions, it is necessary to
mention that it is admitted in the written statements that in the Act
and Rules the term "Similar Biologics" has not been defined. The
defendant No.2 neither applied for permission to conduct Phase I
and Phase II clinical trials nor those were registered with the
defendant No.1.
Biologic and Generic Drugs
156. It is undisputed fact that biological drugs are synthesised
by cells of living organisms, as opposed to chemical drugs which are
produced by chemical synthesis. 'Biosimilars' are biological drugs that
are similar to the innovator biological drug. Due to Owing to the
complexity in the molecular arrangement and manufacturing process of
a biological drug, it is not possible to replicate the structure and steps
involved in the manufacture of the innovator biological drug and to
produce an identical follow-on biological drug. Biosimilars, therefore,
cannot be generic equivalents of the innovator biological drug. The
generic drugs are characterised by their chemical and therapeutic
equivalence to the original, low molecular weight chemical drugs.
These are identical to the original product and are sold under the same
chemical name.
157. The plaintiffs in their Annual Reports have acknowledged
the existence of biosimilars if the same may be safe and efficacious
alternatives to the innovator drug. They have also stated that the
WHO Guidelines on SBP's should be followed by all countries for the
development of their regulatory framework for biosimilars in order to
ensure safety and efficacy of a biosimilar product. The relevant
extracts from the plaintiff's Annual Reports have supported the
development for the approval of biosimilar products it is granted as per
law applicable to the regulatory authorities by following the WHO
guidelines on evaluation of similar biotherapeutic products.
158. All the defendants admit that the procedure laid down in the
Act and Rules are to be applied stringently. Even this Court is of the
view that all the protocol of biosimilars must be adhered to the
compliances by demonstrating to the regulatory authorities a high
degree of structural and functional similarity between their products
and the approved original product.
The party, who applies for any approval, must satisfy the
authorities that biosimilar manufacturing and marketing process is well
understood as biosimilar is a biological product that is almost and
highly similar except minor meaningful differences from the approved
biological drug in terms of safety, priority and potency otherwise it
would lose its meaning.
159. In order to avoid any confusion, it is mentioned (as
admitted by the parties also) that the approval process for generic
drugs is not the same as the approval process for biosimilars.
Biological drugs are synthesised by cells of living organisms, as
opposed to chemical drugs which are produced by chemical synthesis.
The 'Biosimilars' are biological drugs that are similar to the innovator
biological drug. It is admitted by all parties that it is not possible to
replicate the structure and steps involved in the manufacture of the
innovator biological drug and to produce an identical follow-on
biological drug. Thus, biosimilars cannot be generic equivalents of the
innovator biological drug.
The generic drugs are characterised by their chemical and
therapeutic equivalence to the original, low molecular weight chemical
drugs. These are identical to the original product and are sold under
the same chemical name.
Distinction between bio-similar and generic drugs
160. The Generic drugs are approved by testing procedures as
two drugs i.e. the applicant and innovator are identical of chemical
compound which cannot be applied to biosimilars. As it is associated
with the long term safety, efficacy and immunogenicity of biosimilars
are significantly higher when compared to those associated with a
generic drug.
161. The procedure for approval to manufacture a generic drug
for sale and distribution under the Drugs and Cosmetics Act, 1940, as
amended (the "Drugs Act") and the Drugs and Cosmetics Rules,
1945, as amended (the "Drugs Rules") is given as under:
a) Under Explanation (ii) of Rule 122E of the Drugs
Rules, generic drugs would fall under two categories - (I)
generics of chemical drugs which have been in the market
for more than 4 years and are therefore not 'new drugs'
under Rule 122E of the Drugs Rules; and (II) generics of
chemical drugs which have been in the market for less than
4 years and are therefore 'new drugs' under Rule 122E of
the Drugs Rules.
b) In case of generics of chemical drugs which have
been in the market for more than 4 years, the procedure for
approval to manufacture the generic drug for sale and
distribution is under Part VII of the Drugs Rules which is as
follows:
(i) The application for licence to manufacture
is required to be made under Rule 69 of the
Drugs Rules to the State FDA under Form 24.
(ii) The licence for such manufacture is
subsequently granted by the State FDA in Form
25 under Rules 70 and 71 of the Drugs Rules.
(iii) This procedure is similar to the procedure
for obtaining manufacturing licence for r-DNA
drugs from the State FDA under Rules 75 and
76 of the Drugs Rules in Form 28D.
(iv) However, unlike in the case of approval
for 'new drugs' under Part XA, no approval from
Defendant No.1 is required under Part VII of the
Drugs Rules prior to obtaining the State FDA
licence.
162. The generics of chemical drugs which have not been in the
market for more than 4 years are considered 'new drugs' under
Explanation (ii) of Rule 122E of the Drugs Rules. The procedure for
approval to manufacture such generic drugs for sale and distribution is
under Part XA of the Drugs Rules. In case of generics of chemical
drugs which have been in the market for less than 4 years, the generic
'new drugs' can either be generic versions of chemical drugs already
approved in India or otherwise.
163. For approval of generic versions of chemical drugs not
approved in India, the application for manufacturing authorisation has
to be made under Rule 122B of the Drugs Rules in Form 44 and has to
be accompanied by data in Appendix I to Schedule Y of the Drugs
Rules, whereas, for approval of generic versions of chemical drugs
already approved in India, an application under Rule 122B of the Drugs
Rules in Form 44 has to be accompanied by data in Appendix IA to
Schedule Y of the Drugs Rules. Appendix IA is applicable only to
generics and not biosimilars as it requires the submission of
bioavailability/ bioequivalence data to defendant No.1.
164. The defendants' drug is a Recombinant DNA (r-DNA)
derived drug. Under Rule 122E of the Drugs Rules, all r-DNA derived
drugs are treated as "new drugs" as being biosimilar, hence the
defendants' drug, which is a "new drug" under Rule 122E. The
defendants No.1 and 2 have admitted that drug of defendant No.2
developed indigenously and tests were not conducted by the
defendant No.2 globally which has also not been approved in any
country outside India. The approval granted on 23rd October, 2013 is
the first time approval of manufacturing and marketing in favour of the
defendant No.2.
165. Biosimilar drugs are 'new drugs' under Explanation (i) of
Rule 122E of the Drugs Rules, and therefore, the entire pre-clinical and
clinical data is required to be submitted for their approval. Under Rule
122B(1)(b) and 122B(2) of the Drugs Rules, the application for such
approval has to be made to defendant No.1 in Form 44 of the Drugs
Rules along with the data in Appendix I. The issue in hand does not
pertain to bioequivalence. It is in relation to bio-similarity of the drug of
innovator.
166. Under paragraph 3(5) of Schedule Y of the Drugs Rules,
bioequivalence and bioavailability studies are to be conducted in
accordance with the Guidelines for Bioavailability and Bioequivalence
Studies (March 2005) (the "Bioequivalence Guidelines"), which
reflect that such studies are applicable only to generic drugs, and not
biosimilars, for the purpose of their comparison with the reference
chemical entity. The Bioequivalence Guidelines state that:
Bioequivalence studies are conducted for comparison
of two medicinal products containing the same active
ingredient.
The two drugs should be therapeutically equivalent
(containing the same active substance and clinically
showing the same efficacy and safety) in order to be
considered interchangeable.
The Bioequivalence Guidelines deal with studies for a
generic drug.
167. A biosimilar drug is not considered the same as the
approved reference product and the procedure applied for the approval
of "new drugs already approved" in India or abroad, which is applied in
the case of generics (i.e., chemical drugs), cannot be applied to
biosimilars.
168. This Court in Bayer Corporation and another v. Union of
India and Others, (2010 (43) PTC 12 (Del) (DB)), has rightly held that
Appendix IA to Schedule Y of the Drugs Rules applies to generic
versions of a patented drug. The manufacturer of a generic version of
a patented drug is only required to satisfy defendant No.1 that its drug
is bioavailable and bioequivalent to the patented drug (as required
under Appendix IA). Even phase III clinical trials are not required for
generics under Appendix IA.
Defendant No.2 in the present case has fairly admitted that
its drug is not generic version and bio-equivalent who has admittedly
filed the application in Form 44 accompanied with data in Appendix I to
Schedule Y of the Drugs Rules and not under Appendix IA.
169. The definition of "new drug" has been specified in Rule 122E of
Drugs & Cosmetics Rules while the requirements and guidelines for
permission to Import and / or Manufacture of new drugs for sale or to
undertake clinical trials are specified in Rules 122A, 122B, 122D and
Schedule-Y of the Rules. Rule 122E of the Rules reads as under:
"Rule 122E- Definition of new drugs
(a) A drug, as defined in the Act including bulk drug
substance which has not been used in the country to
any significant extent under the conditions
prescribed, recommended or suggested in the
labeling thereof and has not been recognized as
effective and safe by the licensing authority
mentioned under rule 21 for the proposed claims:
Provided that the limited use, if any, has been with the
permission of the licensing authority.
(b) A drug already approved by the Licensing
Authority mentioned in Rule 21 for certain claims,
which is now proposed to be marketed with modified
or new claims, namely, indications, dosage, dosage
form (including sustained release dosage form) and
route of administration.
(c) A fixed dose combination of two or more drugs,
individually approved earlier for certain claims, which
are now proposed to be combined for the first time in a
fixed ratio, or if the ratio of ingredients in an already
marketed combination is proposed to be changed, with
certain claims, viz indications, dosage, dosage form
(including sustained release dosage form) and route of
administration. (See items (b) and (c) of 3[Appendix
VI] to Schedule Y.)
Explanation- For the purpose of this rule--
(i) all vaccines and recombinant DNA (r-DNA)
derived drugs shall be new drugs unless certified
otherwise by the Licensing Authority under Rule 21;
(ii) a new drug shall continue to be considered as new
drug for a period of four years from the date of its first
approval."
170. As far as the nature and quality of studies and clinical trials
are concerned, it is a matter of fact that the same are examined by
expert committees and approvals thereon are concerned, at this
interim stage, the Court does not wish to express any opinion or to
make comments thereon as this Court is aware that the scope of
judicial review would remain limited and interference is only
permissible if the approvals are granted contrary to law, procedural
impropriety and without any logic which is shocking to the conscience
of the Court. It is admitted position that the defendant No.2 in the
present matter had refused to give the inspection of said relevant
record to the plaintiffs under Order 11 CPC who claimed confidentiality
of the those documents. In fact, in view of reluctant attitude adopted
by the defendants No.2 to 4 during the hearing, it compelled the Court
to go through the record itself without any assistance of plaintiffs side.
171. In view of rival submissions addressed by both sides and
the nature of disputes and the allegation made in the unamended
plaint, it is merely necessary to consider as to (i) whether the
procedure as per rules has been followed or not at the time of grant of
approvals of the bio-similar drug to defendant No.2; (ii) whether the
clinical trials of Phase I and Phase II are necessary for the purpose of
granting the approval of drug to a biosimilar drug; (iii) whether any
Phase can be exempted or any phase can be combined with
subsequent Phase if biological drugs/ bio-similar product is involved;
(iv) whether the Guidelines of 2012 are to be followed by the Authority;
(v) whether the defendant No.1 has followed the due procedure
prescribed under the Drug and Cosmetics Act, 1940 (as amended) at
the time of granting approvals in favour of defendant No.2; (vi) If
granted whether the same are granted by lapse in the procedure and
due process, what are the consequences of inadequacy of details.
172. It is admitted by the learned ASG that the clinical trials of
Phase I and Phase II of the drug in question are not registered with the
defendant No.1, however, the approvals are granted after the
justifications are given by the defendant No.2. Learned ASG submits
that since the requisite approvals have been granted, thus the plaintiffs
are not entitled for an injunction. Even otherwise the suit filed by them
is barred by law and is not maintainable and this Court has no
jurisdiction to examine the process of approvals which were granted
after examining the Rules. The plaintiffs are trying to harass the
defendants No.2 to 4 despite of valid approvals granted. The only
remedy which was available with the plaintiffs is to file an appeal under
Rule 122 BD before the Central Government against the grant of
approvals being aggrieved party. The suit filed by them is an abuse of
the process of law. It is the clear stand of the defendant No.1 that the
guidelines are not statutory in nature and it is pertinent to mention that
the written-statement filed by the defendant No.1 does not contain any
averment that the guidelines of 2012 have been followed.
173. The main case of the plaintiffs is that the defendant No.2
has not conducted various tests required under applicable law for the
approval of the drug. Phase I and Phase II trials have also not been
registered with the defendant No.1. The defendant No.2 has also not
independently generated requisite data in order to demonstrate
similarity between the drug and the plaintiffs' Trastuzumab, both in
terms of the stages and the sample size of the tests conducted by
defendant No.2.
174. It is stated by the defendant No.2 that though the clinical
trials of Phase I and Phase II have not been registered with the
defendant No.1 but it did not skip Phase I trial as the main the
objective of a Phase I trial is to establish comparative
pharmacokinetics (pK) and this pK data was generated by defendant
No.2 as the initial part of the Phase III trial. Defendant No.2 did the
Phase I and Phase II trials as part of the same sequential study since it
was necessary to do the pK study in patients and not in healthy
volunteers. The phase III studies were also registered with the Clinical
Trial Registry-India ('CTRI'). In fact, the 2012 Guidelines also
contemplate that PD study can also be a part of Phase III clinical trials.
Defendant No.2 tried to give its justification for not doing the Phase II
study as dose finding and POC studies are not required for follow-on
products (biosimilars or generics).
175. Defendant No.2 has argued that as per Indian law and
certain other jurisdictions provide for purportedly abbreviated pathways
for follow-on biologics, pursuant to which the requirement to conduct all
stages of tests and studies for the approval of biosimilar drugs is
waived simply by virtue of the innovator drug having conducted all
such studies and tests (including all phases of clinical trials), as
applicable.
176. Defendant No.2 has relied upon the first proviso to Rule
122B (3) of the Drugs Rules to contend that local clinical trials for the
drug were exempted on the basis of data available from other
countries. Defendant No.2 also seeks to rely upon the second proviso
to Rule 122B (3) under which reduction of trial data may be permitted
for "new drugs approved and marketed for several years in other
countries". Admittedly, the drug has not been approved and marketed
in any country outside India.
177. The defendant No.1 in its written statement has admitted
that the clinical trials of Phase I and II are not registered with the
authority. The trial of Phase III has been registered with the defendant
No.1. The stand of the defendant No.2 is that the clinical trial of Phase
I is combined with Phase III and Phase II trial was skipped as many
formalities are required for the same which are not of serious nature.
178. It is also argued on behalf of the defendant No.1 stating
that from a conjoint reading of the relevant Rules and Schedule 'Y', it
emerges that Trastuzumab is a drug which has already been approved
in India as the plaintiffs themselves were granted permission under
Rule 122 A of the Drugs and Cosmetics Rules to import and market
the product Trastuzumab powder for Injection on 11th October, 2002.In
view of the above, the second proviso to Rule 122A (1) (b) is
applicable to the defendant No.2's application to manufacture the drug
in question. In terms thereof, any application of defendant No.2 is to be
accompanied by requisite fee and such information and data as
required by appendix I or appendix IA of schedule Y which does not
make it mandatory for conducting Phase I and Pphase II clinical trials
for drugs which have already been approved in India and even for
drugs approved outside India. Instead, appendix IA specifies the "Data
required to be submitted by an application for grant of permission to
import and/or manufacture a new drug already approved in the
country". Further, schedule Y also prescribes that "for new drugs
approved outside India, phase III studies need to be carried out
primarily to generate evidence of efficacy and safety of the drug in
Indian patience when used as recommended in the prescribing
information". Schedule Y does not specify number of the subjects to be
enrolled in different phases of clinical trials.
Data required to be submitted by an applicant for grant of
permission to import and / or manufacture a new drug already approved
in the country, as specified in appendix IA of Schedule Y to Drugs &
Cosmetics Rules, includes chemical & pharmaceuticals information
including structure physical, chemical properties, dosage form its
composition, test specification method of manufacture etc., stability data,
sub-acute animal toxicity data for I.V. Infusion and injectables.
179. Defendant No.1 has explained that it applied Rule 122A
(relating to permission to import new drugs) and Rule 122D (relating to
permission to import or manufacture fixed dose combination) of the
Drugs Rules, which are irrelevant in case of the defendants' drug.
180. It is submitted by Mr.Sanjay Jain, learned ASG on behalf of
defendant No.1, that even alternatively paragraph 1(3) of Schedule Y
of the Drugs Rules relates to abbreviated toxicological and clinical data
requirement for drugs indicated for serious and life threatening
diseases and is applicable to the approval of Bmab-200. As the drug
already approved in India, the DCGI reviewed the application filed by
defendant No.2 under Appendix I to Appendix lA to Schedule Y of the
Rules. There is no infirmity in the approval granted to Bmab-200 can
be inferred on this basis. He submits that it is standard practice treat
applications relating to drugs already approved in India under
Appendix l-A. The defendant No.2 supported the submissions of
Mr.Jain on this aspect is same who stated that the defendant No.1 has
exercised its discretion under sub-rule 3 of Schedule Y of the Drug
Rules.
181. Mr.Jain, learned ASG, argued that there is no harm if the
defendant No.1 suo motu treated an application filed under Appendix I
as an application under Appendix I-A. It is also not necessary to
communicate to the defendant No.2 that its application was being
considered under Appendix IA instead of Appendix I. He admits that
Appendix I-A does not require submission of clinical trial data as
required in Appendix I.
182. Let me now examine the said submissions of defendants
No.1 and 2 in this regard. It is admitted by the defendant No.1 that the
defendant No.2 on 15th October, 2013 applied to defendant No.1 in
Form-44 for approval to manufacture and market the under Appendix I-
A of Schedule Y of Rules. There is nothing on record produced before
Court by the defendant No.1 which would show that it has exercised its
discretion in writing to abbreviate the clinical trials of Phase I and
Phase II or any other clinical trial(s) under sub-rule 3 of Rule 1 of the
Schedule Y of the Drug Rules or to convert the application.
183. The Form-44 along with Appendix I was considered when
the plaintiffs protest by letter dated 11th October, 2013 was already
pending and the meeting was yet to be conducted on 18th October,
2013. In Appendix I-A, there is no requirement of clinical test of Phase
I and Phase II, the said requirement is however there in Appendix I.
184. The chart which contains the details of regulatory regime
under the Drugs and Cosmetics Rules, 1945 (the "Drugs Rules") for
approval of various categories of drugs, is as under:
185. The specimen of requirement under Appendix I of the
Drugs and Cosmetics Rules, 1945 by defendant No.2 are reproduced
as under:
186. Data required to be submitted by an applicant for grant of
permission to import and/or manufacture a new drug already approved
in the country as per Appendix I-A is as under:
1. Introduction
A brief description of the drug and the therapeutic class
2. Chemical and pharmaceutical information
2.1 Chemical name, code name or number, if any; non-
proprietary or generic name, if any, structure;
physico-chemical properties
2.2 Dosage form and its composition
2.3 Test specifications
(a) active ingredients
(b) inactive ingredients
2.4 Tests for identification of the active ingredients and
method of its assay
2.5 Outline of the method of manufacture of active
ingredients
2.6 Stability data
3. Marketing information
3.1 Proposed package insert/promotional literature
3.2 Draft specimen of the label and carton
4. Special studies conducted with approval of
Licensing Authority
4.1 Bioavailability/Bioequivalence and comparative
dissolution studies for oral dosage forms
4.2 Sub-acute animal toxicity studies for intravenous
infusions and injectables."
187. The explanation given by the learned ASG about the
converting of application from Appendix I to Appendix I-A of Schedule
Y given by the defendant No.2 is not acceptable as it appears to the
Court that the defendant No.1 was not clear regarding the legal regime
applicable to approval of biosimilars in India, that the defendant No.2
filed its application under Appendix I being new drug. It is drug which
was never earlier approved in India or abroad. Admittedly, as per
procedure the DCGI sought justification from defendant No.2 for
directly carrying out Phase III clinical trials. If defendant No.2's
application was being considered under Appendix l-A as argued by
defendant No.1, the regulator would not have asked the defendant
No.2 to conduct the clinical trials of Phase I and Phase II. There is
also no material available to show that the defendant No.1 in writing
has allowed he defendant No.2 to skip Phase I and Phase II.
188. Here, it is necessary to examine Rule 122B as well as
para1(I)(iv)(b) of Schedule Y wherein an application is to be filed for
permission to import manufacture new drugs for sale or to understand
clinical trials. The said application has to be made in Form-44
accompanying with data in accordance with Appendixes. Para 1(1)
(iv)(a) and (b) of Schedule Y reads as under:
"Para 1(1) (iv) of Schedule Y - human Clinical
Pharmacology Data as prescribed in Items 5, 6 and 7 of
Appendix I and as stated below:--
(a) for new drug substances discovered in India, clinical
trials are required to be carried out in India right from Phase
I and data should be submitted as required under Items 1,
2, 3, 4, 5 (data, if any, from other countries) and 9 of
Appendix I;
(b) for new drug substances discovered in countries other
than India, Phase I data as required under Items 1, 2, 3, 4,
5 (data from other countries) and 9 of Appendix I should be
submitted along with the application. After submission of
Phase I data generated outside India to the Licensing
Authority, permission may be granted to repeat Phase I
trials and/or to conduct Phase II trials and subsequently
Phase III trials concurrently with other global trials for that
drug. Phase III trials are required to be conducted in India
before permission to market the drug in India is granted;"
189. Rule 122B of Rules is reproduced as under:
Rule 122B Application for approval to manufacture
new drug -
"(1)(a) No new drug shall be manufactured for sale
unless it is approved by the Licensing Authority as
defined in clause (b) of rule 21
(b) An application for the grant of approval to
manufacture the new drug and its formulations shall be
made in Form 44 to the Licensing Authority as defined
in clause (b) of Rule 21 and shall be accompanied by
a fee of fifty thousand rupees:
Provided that where the application is for permission
to import a new drug (bulk drug substance) and grant
of approval to manufacture its formulation/s, the fee to
accompany such application shall be fifty thousand
rupees only.
Provided further that where a subsequent application
by the same applicant for that drug, whether in
modified dosage form or with the new claims, is
made, the fee to accompany such subsequent
application shall be fifteen thousand rupees:
Provided also that any application received after one
year of the grant of approval for the manufacture for
sale of the new drug, shall be accompanied by a fee of
fifteen thousand rupees and such information and data
as required by Appendix 1 or Appendix 1-A of Schedule
Y, as the case may be.
(2) The manufacturer of a new drug under sub-rule
(I) when applying for approval to the Licensing
Authority mentioned in the said sub-rule, shall submit
data as given in Appendix 1 to Schedule Y including
the results of clinical trials carried out in the country in
accordance with the guideline specified in Schedule Y
and submit the report of such clinical trials in the same
format given in Appendix II to the said Schedule.
(2A) The Licensing authority as defined in clause (b)
of rule 21 after being satisfied that the drug if
approved to be manufactured as raw material (bulk
drug substance) or as finished formulation shall be
effective and safe for use in the country, shall issue
approval in Form 46 and/or Form 46A, as the case
may be, subject to the conditions stated therein:
Provided that the Licensing Authority shall, where
the data provided or generated on the drug is
inadequate, intimate the applicant in writing, and the
conditions, which shall be satisfied before
permission could be considered
(3) When applying for approval to manufacture a
new drug under sub-rule (I) or its preparations, to the
State Licensing Authority, an applicant shall produce
along with his application, evidence that the drug for
the manufacture of which application is made has
already been approved by the Licensing Authority
mentioned in Rule 21:
Provided that the requirement of submitting the
results of local clinical trials may not be necessary if
the drug is of such nature that the Licensing Authority
may, in public interest, decide to grant such
permission on the basis of data available from other
countries:
Provided further that the submission of requirements
relating to Animal Toxicology, Reproduction studies,
Teratogenicity studies, Perinatal studies, Mutagenicity
and Carcinogenicity may be modified or relaxed in
case of new drugs approved and marketed for several
years in other countries if he is satisfied that there is
adequate published evidence regarding the safety of
the drug, subject to the other provisions of these
rules."
190. Rule 122B provides the procedure for obtaining the
approval for manufacturing and/or sale of the new drug. Rule 122A
pertains to the application for permission to import new drug. The
language and requirements of both rules are almost similar except for
purposes. The Rule 122B provides the procedure in two
circumstances:
a) In the first circumstances, the party seeks permission for
manufacturing of new drugs and its formulations;
b) In the second circumstances, the party seeks permission to
import new drugs (bulk drug substance) and further seeks for the
approval to manufacture using the bulk drug substance.
The procedure to be applied for first circumstance:
To get the approval for manufacturing the new drug (i.e. bulk
drug) and its formulation, the applicant is required to make an
application on Form 44 to the licensing authority. The term
"Licensing Authority" is defined in Rule 21B, which reads as:
"Rule 21(B): "licensing authority" means the authority
appointed by the Central Government to perform the
duties of the licensing authority under these Rules
and includes any person to whom the powers of a
licensing authority may be delegated under Rule 22."
191. In India the licensing authority for new drugs is "Drug
Control Authority of India". The prescribed fee that needs to
accompany Form 44 is INR 50,000. While applying for the approval
on Form 44, the applicant is required to submit data as given in
Appendix I to Schedule Y. This Appendix I to Schedule Y is attached
to this opinion.
192. The said exemptions from conducting local clinical trials
and abbreviation of tests provided under Rule 122B(3) of the Drugs
Rules are applicable only when the same drug sought to be
manufactured in India by an applicant has already been approved and
marketed in other countries for several years by the same applicant
and based on data generated in global clinical trials by the same
applicant. The exemption if any under Rule 122B(3) can only be
available to the party who has already got the approval and marketed
in other countries for the same drug. The plaintiffs are entitled to rely
on their global trial data for approvals in India. (The defendant No.2
has never said before approval authority or before this Court that it has
already obtained any previous approval in India or any other country of
the world).
193. In addition to this data the applicant is required to include
the results of clinical trials carried out in India in accordance with the
guidelines specified in Schedule Y, along with the report of the clinical
trials, which should be given in the format as shown in Appendix II.
194. On receiving the application accompanied by the (a) data;
(b) results of clinical trials and (c) the clinical trial reports, the drug
controller (Licensing Authority) must satisfy himself that the drug to be
manufactured (bulk drug substance) or in the form of a finished
formulation is effective, and safe for use in India. If the drug controller
is satisfied, he will issue an approval on Form 46. If the drug controller
is not satisfied, for instance, if the data provided or generated on the
drug is not adequate, he must intimate the applicant in writing and also
give conditions, which if fulfilled will satisfy him for the grant of the
approval.
195. The procedure to be followed for second circumstance:
In second circumstance the drug is already approved
outside India, but has not been approved in India and the applicant
seeks to obtain the grant of approval to manufacture formulations,
such an application also needs to be made on the same Form 44 and
the application procedure is the same as in first circumstance,
excepting that the information and data is required to be submitted as
per Appendix Form 1A of Schedule Y.
In the case of second circumstance, no clinical trial or
report is necessary but if the party wants to import a new drug, the
applicant needs to perform:
1) Bioavailability/ Bioequivalence and comparative Dissolution
Studies, for oral dosage form.
2) Sub-acute animal toxicity studies for intravenous infusions
and injectables.
These studies need to be conducted with the pre-approval
of the licensing authority. Other conditions of first circumstance apply.
Once, the licensing authority is satisfied, he will issue the approval on
Form 46A. There is also a further approval envisaged in Rule 122B
and that is if the same party who has obtained an approval of a new
drug wants an approval to market the drug either: (i) in modified
dosage form or (ii) with new claims.
196. In the present matter, after conducting the clinical trials of
Phase III admittedly the defendant No.2 filed fresh application which is
received by defendant No.1 on 15th October, 2013 in Form-44 of
Appendix I (which is treated by defendant No.1 as Appendix I-A) for
manufacturing and marketing authorisation for the defendants' drug
filed on October 15, 2013 submitted data under "Permission to market
a new drug" and not under "Subsequent approval / permission for
manufacture of already approved new drug". As the drug of the
defendant No.2 is biosimilar and is not identical drug to the innovator
drug, it has to be called as "new drug" discovered by the defendant
No.2 who itself submitted that it has conducted various clinical trials
independently.
197. Being the defendants' drug a new drug manufactured in
India for the first time by defendant No.2, paragraph 1(1)(iv)(a) of
Schedule Y, which mandates that all phases of the clinical trials must
be conducted in India, is applicable to the defendants' drug, therefore,
defendant No.1 had no legal basis for exempting defendant No.2 from
conducting Phase I and Phase II of the clinical trials in the present
case without assigning any valid reason. It is pertinent to mention that
pursuant to the letter dated February 25, 2011, the Review Committee
on Genetic Manipulation (the "RCGM") directed defendant No.2 to
approach defendant No.1 for obtaining approval for conducting all
phases of clinical trials (Phase I to Phase IV) in relation to the
defendants' drug.
198. If there had been no requirement under the Drugs Act and
the Drugs Rules to conduct Phase I and Phase II clinical trials,
defendant No.1 would not have sought such an explanation from
defendant No.2. In any event, in the letter dated May 27, 2011, while
explaining why defendant No.2 was directly conducting Phase III
clinical trials in relation to the defendants' drug, defendant No.2 did not
seek an exemption on the basis that the defendants' drug was a new
drug already approved.
199. The Appendix IA to Schedule Y of the Drugs Rules is not
applicable to the approval of biosimilars if the drug is new and it is not
approved in its favour in earlier point of time in India or abroad.
Admittedly the application for approval of the drug included data in
Appendix I which requires a complete set of trials to be conducted for a
'new drug' as bio-similar Appendix IA is applicable to the generic
drug/chemical compound drug which are identical in all respects or
where the drug approved in the name of the same already applicant.
Only under these circumstances, an exemption may be granted by the
Regulatory Authority. It is also discretion and not mandatory.
200. Paragraph 2(8)(iii) of Schedule Y of the Drugs Rules
relates to a drug approved outside India, which admittedly the
impugned drug is not. When defendant No.2 had applied to defendant
No.1 for permission to directly conduct Phase III clinical trial, defendant
No.1 wrote to defendant No.2 seeking an explanation from defendant
No.2 regarding the omission of Phase I and Phase II clinical trials. If
there had been no requirement under the Drugs Act and the Drugs
Rules to conduct Phase I and Phase II clinical trials for drugs,
defendant No.1 would not have sought such an explanation from
defendant No.2. Any reference to Paragraph 2(8)(iii) of Schedule Y of
the Drugs Rules does not help the case of the defendant No.2 as it is
the plaintiffs' drug which was approved outside India. The exemption if
any can only be granted to the plaintiffs under Rule 122A and 122B.
The unexplained exemptions in the data requirements granted to
defendant No.2 during the process of approval of the drug are contrary
to the Schedule Y.
Paragraph 1(1)(iv)(b) of Schedule Y of the Drugs Rules
relates to new drug substances discovered in countries other than
India and any abbreviation of clinical trials contemplated in this
provision is therefore not applicable to drug which was admittedly
developed in India, it would be applicable to the plaintiffs' Trastuzumab
which was admittedly discovered outside India.
201. The claim of defendant No.2's that the impugned drug not
being a "new drug discovered in India" is not correct as the drug is
admittedly an indigenously-developed drug. Rule 122DA read with
paragraphs 1(1)(iv)(a), 1(1)(iv)(c) and 2(6) to 2(8) of Schedule Y of the
Drugs Rules require that all three phases, i.e. phases I, II and III of
human clinical trials be conducted for a 'new drug' in a sequential
manner, i.e., the data generated in phase I clinical trials should form
the basis of phase II clinical trials and the data generated in phase I
and phase II of the clinical trials should form the basis of phase III
clinical trials.
202. Defendant No.1 has incorrectly stated that Appendix 1A of
Schedule Y of the Drugs Rules is applicable in relation to the
defendants' drug. Appendix 1A relates to data required to be
submitted by an applicant for grant of permission to import and/or
manufacture a new drug already approved in the country and the
defendants' drug (Bmab-200) is not a new drug already approved in
the country on the date of filing of application. I do not agree with the
argument of defendants No.1 and 2 and I am of the view that the data
required to be submitted for the approval of the defendants' drug is
set out in Appendix 1 of Schedule Y of the Drugs Rules. In fact,
defendant No.2's application for permission to conduct clinical trials
(filed with defendant No.1 on March 9, 2011) and for grant of
manufacturing and marketing authorisation (filed with defendant No.1
on October 15, 2013) purportedly included information in Appendix I.
As such, any reference to Appendix IA is evidently an afterthought
and defendant No.1 is only trying to justify the unexplained
exemptions in the data requirements granted to defendant No.2
during the process of approval of the defendants' drug.
203. Defendant No.1's assertions that (a) Phase I and Phase II
clinical trials are not mandatory under Schedule Y of the Drugs Rules
for drugs already approved in India or outside India; and (b) Schedule
Y prescribes that for new drugs approved outside India, Phase III
studies need to be carried out primarily to generate evidence of
efficacy and safety of the drug in Indian patients; are without any basis
and not relevant in the present case since the defendants' Drug was
neither previously approved in India nor outside India.
204. The applications filed by defendant No.2 for approval of
Bmab -- 200 contradict the contents of the written statement filed by
defendant No.1. Form 44 filed along with defendant No.2's application
for manufacturing and marketing authorisation on October 15, 2013
was filed specifically under Rule 122B of the Drugs Rules, which
relates to approval for manufacture of new drugs. Moreover, the
manufacturing and marketing approval for the defendants' drug was
granted by defendant No.1 in Forms 46 and 46A under Rule 122B of
the Drugs Rules. The entire Rule 122B along with provisos is to be
read together with Rules and requirements of Schedule Y. The proviso
of Rule 122B cannot be read in isolation. The defendant No.2 itself on
9th March, 2011 had made the application in the prescribed form of
Rule 122DA in Form-44, Appendix I of Schedule Y whereby clinical
trials of all phases are necessary. How could the defendant No.1 deal
with the application of the defendant No.2 into Appendix I-A. It is
cannot be called a technical mistake by the defendant No.2 as there is
huge different in submitting the data between the two applications
made under Appendix I and Appendix I-A. The said fact ought to have
been brought to the notice to the NDAC committee in advance at least
at the time of recommendation and approvals.
205. When these circumstances were pointed out to the
defendant No.2, it was submitted that it was entitled to follow an
abbreviated process for approval since its application related to
subsequent approval for an already approved new drug. The same is
contrary to defendant No.2's documents filed before this Court as the
defendant No.2 has applied in the prescribed Form 44 application with
Appendix I and not Appendix I-A which states that "Subsequent
approval/permission for manufacture of already approved new drug not
applicable" (emphasis supplied).
206. It is now submitted by defendant No.2 that there is the
system of abbreviated pathways in certain jurisdictions particularly on
the European model i.e. Argentina, Australia, Brazil, Canada, Japan,
Malaysia, Mexico, South Africa, South Korea, Taiwan and Turkey
which allows regulatory authorities the discretion to consider whether
certain phases of clinical trial are necessary for the application process
for the follow-on biological drug or, alternatively, may be waived if
similarity has sufficiently been established at the stage of pre-clinical
studies. No doubt, it is true that the said practice is being followed in
many countries. It is permissible subject to the condition if the
regulatory authorities are satisfied that such waiver is (a) permissible
in accordance with the rigorous standards of interchangeability and
similarity with the innovator drug under applicable laws; (ii)
scientifically justified pursuant to complete characterisation and pre-
clinical studies having been concluded to establish comparability of the
follow-on biologic drug with the innovator drug in terms of quality,
safety and efficacy. Only after the fulfilment of these conditions by the
follow-on drug manufacturer that the extent of possible reduction of
pre-clinical and clinical trial data is determined by the regulatory
authority, strictly on a case-by-case basis but never automatically.
In the present case, the defendant No.1 apparently
impliedly abbreviated many clinical tests but without any reason as
appeared from the record submitted that whenever and whatever
explanations given by the defendant No.2, the same are taken on
record by the defendant No.1 and proceeded further in the matter of
the approvals sought by the defendant No.2.
207. As per Paragraphs 5, 6(a), 7 and 8 of the WHO Guidelines
on Evaluation of Similar Biotherapeutic Products, 2009 (the "WHO
Guidelines") relied on by defendant No.2, the entire set of
characterisation and comparability studies under applicable law are to
be carried out in a step-wise manner to establish similarity of the
follow-on drug to the innovator drug in terms of quality. The conduct of
such studies is a prerequisite for possible reduction of non-clinical and
clinical data, if permitted by the drug authority. In the present case,
admittedly the defendant No.2 has not conducted studies in step-wise
manner.
208. As mentioned above, it is the specific case of the plaintiffs
that defendant No.2 has not conducted (a) comparative product
characterisation studies; (b) comparative animal pharmacology
studies; (c) comparative immune response studies; or (d) comparative
animal toxicology studies. Even if in many countries an abbreviated
pathway is allowed for biosimilar drugs and existed in India but the
drug authorities cannot permit the waiver of phases I and II of human
clinical trials for the drug on account of the inadequate characterisation
studies and pre-clinical tests undertaken by defendant No.2 for its
drug. The party who is intentionally and deliberately even not ready to
given the inspection of documents of clinical trials by making so many
excuses by claiming confidentiality by filing of application. The plaintiffs
got opportunity to address their submissions on this aspect. The
counsel for the defendant No.2 has tried to convince the Court by
given two examples of third parties for the same drug by stating that
they were exempted by the Regulatory Authority for Phase I and
Phase II trials as evidenced in the international regime and contrary to
the submissions of defendant No.2, Celltrion has separately conducted
Phase I and Phase II clinical trials in South Korea and the EU and
Pfizer has separately conducted Phase I and Phase II clinical trials in
the U.S.A. Thus, the submissions of the defendant No.2 on this aspect
are also wrong and misleading.
209. Let me now also evaluate the contention of the defendant
No.2 which relates to exemption to the clinical data requirement for the
drugs relating to life threatening diseases. Sub-Rule 3 of Rule 1 of the
Schedule Y 'Requirements and Guidelines for Permission to Import
and/ or Manufacture of New Drugs for Sale or to undertake Clinical
Trials' provides as follows:
"Paragraph 1(3) of Schedule Y -
For drugs indicated in life threatening / serious diseases or
diseases of special relevance to the Indian health scenario,
the toxicological and clinical data requirements may be
abbreviated, deferred or omitted, as deemed appropriate by
the Licensing Authority."
The above rule of the Drugs Rules indicates that only in life
threatening diseases, toxicology and clinical data requirements can be
abbreviated, deferred or omitted, as deemed appropriate by the
Approving Authority.
210. The defendant No.2 submits that it is for the defendant
No.1 to decide as to whether all phases of clinical trials are required to
be conducted in a particular case. Once a new drug is approved in
other countries, there is no requirement to conduct all phases of
clinical trials for a biosimilar drug (especially Phase I and II which are
carried out on healthy volunteers). It is argued that in India, Professor
Ranjit Roy Choudhary Committee has recommended that in case of
drugs already in the market and well regulated, only Phase IV clinical
trials should be conducted.
It is argued by the defendant No.2 that abbreviated
pathway for approval of drug needs to be followed for approval of a
follow on / biosimilar drug in view of various Guidelines and also the
Drugs & Cosmetics Rules, 1945 which vest in the authorities, the
discretion to abbreviate the pathway for approval of drugs (Refer Rule
122B read with Schedule Y: 1 (1) (iv) (b) and (c), Rule 1 (3)). Hence,
there is no requirement to conduct the clinical trials for approval of a
follow on drug.
211. It is stated by the defendants No.1 and 2 that the objective
of a Phase I trial is to establish comparative pharmacokinetics (pK) and
this pK data was generated by defendant No.2 as the initial part of the
Phase III trial. Defendant No 2 did the Phase I and Phase II trials as
part of the same sequential study, since it was necessary to do the pK
study in patients and not in healthy volunteers. The defendant No.2
submits that it has not conducted Phase II study as dose finding and
POC studies are not required for follow-on products (biosimilars or
generics).
212. I do not agree with the submissions of defendants in this
regard. Paragraph 1(3) of Schedule Y of the Drugs Rules is only
available for serious emergency situations such as an epidemic of an
unknown disease and will not be applicable to a drug targeting a
disease for which treatments are already available in the market (refer
to paragraph 7.20 of the Parliamentary Committee Report on the
Functioning of the CDSCO). In any event, defendant No.2 has not
relied upon this provision in its reply to the plaintiff's application under
Order XXXIX of the Code of Civil Procedure, 1908, as amended (the
"CPC").
The defendant No.2's reliance on paragraphs 1(1)(iv)(b),
1(3) and 2(8)(iii) of Schedule Y of the Drugs Rules would not help the
case of defendant No.2. Even there is nothing on record to indicate
that exemptions under these provisions were sought by, or granted to,
defendant No.2 while conducting clinical trials for the drug. Therefore,
the reference to such exemptions is just an afterthought defence on
the part of defendants. There is no specific order or valid reasons
available on record about exemptions passed for Phase I and Phase II
trials. The defendant No.1 has merely proceeded further with process
of approval after the explanation given by the defendant No.2 for not
conducting all the clinical trials of Phase I and Phase 2 in registration
thereof with defendant No.1.
213. Even as per paragraph 8 of the Guidelines on Similar
Biologics, 2012 (the "Biosimilar Guidelines") mandates that all
phases of comparative human clinical trials including pharmacokinetic,
pharmacodynamics, confirmatory safety, efficacy and immunogenicity
studies must be carried out for a biosimilar drug. Defendant No.2 has
tried to justify the deficiencies in the tests conducted for drug on the
basis of paragraph 6 of the Biosimilar Guidelines which states that the
extent of testing of the similar biologic is "likely to be less" than that
required for the reference biologic. The said provision envisages
possible reduction in pre-clinical and clinical data with the condition
that the testing of the similar biologic must be "sufficient to ensure that
the product meets acceptable levels of safety, efficacy and quality".
Accordingly, such reduction may be permitted only if comparability with
the innovator drug has been demonstrated at the characterisation
stage and the production process of the similar biologic is consistent.
The extensive pre-clinical and clinical evaluation is necessary for the
similar biologic if significant differences in safety, efficacy and quality
studies emerge. Paragraph 1(1) (i) to (iii) of Schedule Y relates to
chemical and pharmaceutical information and animal pharmacology
and toxicology data.
214. It is required under paragraph A.3 of the Guidelines for
Generating Pre-Clinical and Clinical Data for RDNA Vaccines,
Diagnostics and other Biologicals, 1999 (the "1999 Guidelines"),
paragraph 6.3.2 of the Biosimilar Guidelines and paragraph 8.2 of the
WHO Guidelines on Evaluation of Similar Biotherapeutic Products,
2009 (the "WHO Guidelines").
215. The defendant No.2 in the present case even not ready to
give the inspection of the documents which are used at
characterisation stage, pre-clinical and clinical evaluation in order to
allow the plaintiffs to make their submissions on merit but at the same
time, the defendant No.2 wishes to rely upon the entire data of the
plaintiffs drug for the purpose of approval as well as at the time of
marketing their product.
216. The explanation given by the defendant No.2 by placing the
reliance of para l(l)(iv)(b) of Schedule Y is not possible as the
defendants' drug is a new drug discovered in India. Para 1(1) (iv)(a) of
Schedule Y is applicable which mandates that all phases of the clinical
trials be conducted in India. No such justification was given by
defendant No.2 in its letter to the DCGI dated May 27, 2011 which is
acceptable under the Act, Rules as well as the Guidelines of Bio-
similar, 2012.
217. Paragraph 7.3 of the Biosimilar Guidelines provides that
the RCGM recommends the required phases of clinical trials based on
an assessment of the pre-clinical test results as per paragraph 10 of
the Office Order issued by the Department of Biotechnology bearing
No.BT/BS/17/175/2005-PID and dated January 2, 2006. However, in
the present case as mentioned by defendant No.2 in its application
under Order XXXIX Rule 4 CPC the RCGM recommended that all four
phases of clinical trials should be undertaking by defendant No.2. The
DCGI does not have expertise to analyse the pre-clinical (animal
study) reports and draw conclusions.
218. The defendant No.1 has incorrectly relied on Rule 122A i.e.
Application for permission to import new drugs and Rule 122D
(Permission to import or manufacture fixed dose combination), while
the only applicable provision is Rule 122B (Application for approval to
manufacture new drug) wherein the defendant No.2 itself has filed the
application on 15th October, 2013 in Form-44, Appendix I. Under the
heading "subsequent approval/permission for manufacture of already
approved new drug", in the form filed in the prescribed manner, it was
mentioned "not applicable". The defendant No.1 has treated the
application of defendant No.2 in Form 44-Appendix I as Appendix I-A
in which clinical trials of all phases are not necessary. Even no written
order was passed assigning any reason for abbreviation of Phase I
and II and converting the Appendix I to Appendix II. Merely saying that
part of clinical which are conducted have been combined with the
Phase III neither here nor there, it would be contrary to the scheme of
the Act because these are to be registered with the Regulatory
Authority under the provision of Act and Rules.
219. It cannot be said that the said enquiry and procedure of the
grant of the approval shall be as simplistic as contended by the
defendants wherein the defendant No.2 makes an application for the
conducting the clinical trial for phase 3 on presumptuous basis that the
defendant No.1 will allow the same with bare minimum justification of
the underlying purpose of the other two phases of the trials and giving
a response that the clinical trials are conducted in a combined manner
when there is no evidence of the registration of the separate trials.
Surely, the process of the similar biologic require as a matter of rule to
conduct the clinical trials with exceptions apart to reduce the
requirement of the data submission depending upon the establishment
of the similarity on the various aspects, product characterisation,
quality comparability studies and other matters discussed above.
220. Merely saying by the defendants is not enough that
sufficient safeguards have been followed in granting the approval to
the defendant No.2 in relation to the bio similar medicines. After all, it
is a matter of the safety, efficacy and quality of the medicine which is
meant for treatment of cancer and involve complex compound
requiring differential treatment prescribed by the defendant No.1 itself
and relevant department of the government.
221. The reliance of defendant No.2 is that the clinical trials of
phase I and phase II have been combined by the defendant No.2 while
seeking an approval from the defendant No.1 and in this respect, the
defendant No.2 relied upon its reply dated 27th May, 2011 addressed to
the defendant No.1 in response to letter dated 3rd May, 2011 when the
defendant No.1 asked for the justification for not conducting the clinical
trial. A mere reply for non conducting of the phase 1 and phase 2 trials
provides an evasive answer to state that both the trials have been
combined with the phase 3 trial as end points. Merely alleging that
these have been combined is not enough because as per the scheme
of Act and Rules, the same are to be registered or otherwise
abbreviations have to be sought specially in writing under the
Guidelines 2012 and the authority is supposed to give reasons for
exemption. The defendant No.1 thereafter did not pass any speaking
order ruling on the reasoning accorded by the defendant No.2 but
instead raise no objection by way of letter dated 19th August, 2011 and
implicitly allow the defendant No.2 to conduct phase 3 trials directly
and produce the same for the analysis. There is no provision in India
or internationally in relation to an 'abbreviated pathway' in the form
stated by defendant No.2 for the approval of biosimilar drugs.
222. The combining/skipping various phases of clinical trials is
not justified as it would render redundant the underlying logic of
sequential testing vis-a-vis primary end-points, target population and
sample size. Paragraph 7.3 of the Biosimilar Guidelines clearly
provides that the RCGM recommends the required phases of clinical
trials based on an assessment of the pre-clinical test results,
paragraph 10 of the Office Order issued by the Department of
Biotechnology bearing No. BT/BS/17/175/2005-PID and dated January
2, 2006 wherein the RCGM recommended that all four phases of
clinical trials should be undertaken.
223. In the present case all responses coming from Drug
controller are contrary from the guidelines on similar biologics headed
over by drug controller himself stating that the regime of the bio similar
products are required to be regulated more strictly than the ordinary
drug approvals in the case of bio equivalence and therefore strict rules
and norms are required to be followed for the approval of bio similar
products. It goes on to show that prima facie the response of the
defendant No.1 if it is to be taken on the basis of the submissions
advanced by the defendant No.1 in terms of regime relating to bio
equivalence before this court. This is due to the reason that in the
event the drug is already marketed in India, the process for
obtaining the approval in the regime of bio equivalence is
simplifiedwherein the applicant has to only show that the
medicine is bioequivalent to the medicine already marketed and
on that basis, the clinical trials requirements can be relaxed.
224. However, in the present matter, the defendant No. 1 as a
Drug Controller was dealing with new drug of defendant No.2 who
was seeking approval on the basis of claim of similarity of
biological structure, composition and other characterstics and on
the date of the granting the approval was already the participant
in the guidelines requiring the stricter approach to be adopted in
the case of the Bio Similar drugs.Thus, the question was not
really before the defendant No.1 that the drug was already
marketed in India as stated by the defendant No.1 in its written
statement which normally eases the process of approval in the
case of normal drugs, this has been admitted by the drug
controller being party to the guidelines starting point of the
guidelines commences from the departure to the approach of
bioequivalence. If that is the level of contradiction in the stand of
the defendant No.1 in the written statement, submissions
advanced before this court vis a vis the guidelines framed on the
similar biologics, then prima facie on the face of it, the approval
granted by the defendant No.1 appears to be on the basis of the
regime of the bio-equivalence on the premise that the drug is
already marketed in India would lead all others to derive the
benefit of the seeking the approval on the said basis when the
scheme of bio similar is a complete departure thus rendering the
approval contrary to its own guidelines.
225. In order to verify the exact position and objections raised by
the plaintiffs in the original plaint and refusal of giving the inspection by
the defendant No.2, with consent original relevant record has been
deposited by the defendant No.1.
226. The defendant No.2 on 17th April, 2008 filed an application
to the authority for permission to import Cell lines as part of the
development of the product. On 8th July, 2008 permission to import
from RCGM was granted. On 14th February, 2009 the defendant No.2
sought 'No Objection Certificate' to manufacture inter alia Bmab-200
formulations for the purpose of examining test or analysis.
227. The relevant details available from the record are given
below:
(i) On 1st September, 2009 NOC was issued by defendant
No.1 in favour of defendant No. 2 under Rule 89 of the
Drugs and Cosmetics Rules, 1945 for obtaining license on
Form 29 for the purpose of examination, test or analysis.
On 13th July, 2009 Review Committee on Genetic
Manipulation [RCGM] granted permission to conduct
preclinical toxicological studies to defendant No.2. On 2nd
December, 2009 license was issued by 'Drug Controller
and Licensing Authority, Govt. of Karnataka on Form 29 for
the purpose of examination, test or analysis.
(ii) On 18th March, 2011 defendant No.2 submitted application
on Form- 44 for conduct of Phase- III clinical trial under
Rule 122- DA of the Drugs And Cosmetics Rules. The
Defendant No.2 along with their application had enclosed
chemistry manufacturing control data, non-clinical data
including animal toxicity data, protocol containing details
like inclusion, exclusion criteria, primary and secondary end
points with regard to safety and efficacy assessment, the
names of the trial site, number of patients (sample size),
the names of the Investigator etc as per the Drugs and
Cosmetics Rules, 1945 for the proposed phase III clinical
trial. The trial was titled as "Comparative PK, efficacy,
safety and immunogenicity evaluation of Bmab-200 versus
Herceptin, both in combination with docetaxel in patients
with Her2+ metastatic breast cancer: A double blind,
randomized, active control, parallel assignment,
comparative, phase III clinical trial.
(iii) On February 25, 2011, the RCGM directed defendant No.2
to approach defendant No.1 for obtaining permission to
conduct all phases (i.e. Phases I to IV) of the human
clinical trials in relation to Bmab-200. However,
defendant No.2's letter to defendant No.1 dated March
9, 2011, enclosing the application in Form 44 for
permission to conduct clinical trials in relation to
Bmab-200, is restricted only to Phase III clinical trials
(and does not cover Phase I or Phase II trials).
(iv) The defendant No.1 vide letter dated 3rd May, 2011 asked
the defendant No.2 to provide justification for carrying out
Phase III study directly and to provide comparability study
to justify that Bmab 200 is similar to Herceptin.
In response to the said query, the defendant No.2 vide
letter dated 27th May, 2011 informed the defendant No.1
that it has designed a clinical trial protocol that combines
the endpoints for Phase I and Phase III into a single study.
Phase II is not required as the defendant No.2 will follow
the dosing schedule of reference product and it is incorrect
to assume that the optimal dosing schedules of both Bmab-
200 and the plaintiffs' Trastuzumab would be the same or
that the same dosing schedule can be followed. Defendant
No.2 has also stated that their clinical trial protocol
combines the end points for Phase I and Phase III into a
single study.
(v) On 9th August, 2011 the defendant No.1 issued a letter to
Dr.T.S. Sagar, Chairman and Prof., Department of Medical
Oncology, Cancer Institute Adyar, Chennai, informing that
the defendant No.2 sought the permission for conducting
Phase III clinical trial and the defendant No.2 would
combine the end points for Phase I and Phase III into a
single study.
(vi) Defendant No.2 was granted permission to conduct Phase
III trials by DCGI vide its letter dated 19th August, 2011 and
its amendment dated 16th March, 2012.
(vii) On 18th September, 2012 the defendant No.2
communicated to defendant No.1 informing that it has
completed the Phase III clinical trial of Transtuzumab
(Bmab-200) entitled "Comparative PK, efficacy, safety and
immunogenicity evaluation of Bmab-200 versus Herceptin,
both in combination with docetaxel in patients with Her2+
metastatic breast cancer: A double blind, randomized,
active control, parallel assignment, comparative, phase III
clinical trial. Protocol No.:BM200-CT3-001-11 Version 2.02
dated:04.07.2012 Supersedes 2.01 dated 10.01.12" in
India. The defendant No.2 also convened a meeting of
NDAC for the said purpose. However, no clinical trial
report was submitted.
(viii) On 27th September, 2013 the defendant No.1 had
forwarded the results of the Phase-III clinical trials to the
NDAC by the defendant No.1 requesting for expert opinion
as to whether defendant No.2 can be considered for
granting marketing authorization. Simultaneously, the
defendant No.1 also sought a clarification from the
defendant No.2 regarding administrative data, chemical
manufacturing control (CMC) and other safety data. On
18th October, 2013 New Drug Advisory Committee
(hereinafter referred to NDAC) on Oncology and
Hematology [ which is an expert body constituted vide
order dated 31.3.2011 to advise defendant No.1 in matters
relating to approval of new drugs] to advise the defendant
No.1, examined the proposal of defendant No.2. The
NDAC comprised of eminent experts and considered the
data and information famished by defendant No.2 as also
the results of the Phase-III clinical trials.
(ix) Prior to NDAC meeting, the plaintiffs on 11th October, 2013
raised serious concerns relating to the clinical trial including
inadequacy of end point of drug and insisted for
compliance of Guidelines on similar Biologics. It was inter
alia alleged by the plaintiffs that defendant No.2 has not
conducted animal pharmacology tests in relation to
drug as part of its pre-clinical studies who has also not
conducted any comparative pre-clinical studies
between Bmab-200 and the reference product.
Defendant No.2 has also not conducted a study of
immune responses in animals in relation to Bmab-200
prior to using Bmab-200 in human clinical trials. No
clinical trials of Phases I and II have been registered
with defendant No.1 or any other authority.
(x) Defendant No.2 submitted the said application to DCGI
along with Phase III Clinical Trial report as Module 5 along
with Module 1, Module 2, Module 3 and Module 4 as per
CDSCO Guidance for Industry. As per requirements
contained in Schedule Y contained in the Rules, defendant
No.2 also submitted copy of draft Summary of Product
Characteristic (SmPC), label, carton and prescribing
information.
(xi) As per record available the defendant No.1 received on
15th October, 2013 a fresh application whereby the
defendant No.2 again applied to defendant No.1 on Form
44 under Rule 122B for approval to manufacture and
market Trastuzumab. The said application was
accompanied by data as contemplated under Appendix I
of Schedule Y of the Drugs and Cosmetic Rules, although
on the said date, all the studies and clinical trials were
already circulated to NDAC.
(xii) Defendant No.2 was called to make a presentation before
the New Drug Advisory Committee (Oncology and
Hematology) (NDAC) on 18th October, 2013.
(xiii) The defendant No.2 was granted permission in Form 46
and Form 46A to manufacture Trastuzumab injection 150
mg/vial and 440 mg/vial and Trastuzumab drug substance
respectively by the DCGI vide letter dated 23rd October,
2013.
On 18th October, 2013 the NDAC recommended to allow
the manufacturing authorization with condition to submit the PSUR and
proposed Risk management plan duly after seeking approval of the
NDAC. The firm also submits CMC and other related clarifications
advised as per previous query letter issued by office of DCGI. The drug
shall be prescribed by registered Oncologist only. On 23rd October,
2013 subject to the said conditions approval was granted.
228. The corrigendum was done in the NDAC meeting held on
27th November, 2013 wherein the meeting of 18th October, 2013 was
corrected to read as "The Committee recommended to allow the
approval with conditions as imposed in the meeting held on 18th
October, 2013."
The minutes were signed on 29th November, 2013 and on
the same day it was recorded that the defendant No.2 has submitted
the Risk Management Plan of the Bmab-200 based on NDAC
recommendations. Corrigendum in this regard was signed on 10th
December, 2013.
229. It is admitted by the defendant No.1 on 27th September,
2013 that it has only sent the result of Phase III to NDAC for expert
opinion as to whether defendant No.2 can be considered for granting
marketing authorisation and as per admitted case of all the defendants
that the fresh application under Rule 122B was filed on 15th October,
2013 along with clinical trial. The recommendation of approval was
granted on 18th October. 2013 and approval letter was issued on 23rd
October, 2013. Clinical study report is itself dated 3rd October, 2013.
230. The entire approval process was completed within three
days. The approvals were recommended by the Committee on 18th
October, 2013. The approval process and clinical trials and implied
examination have not been examined by the Technical Committee and
Apex Committee nor the Guidelines of 2012 appear to be followed as
per record available. However, the defendant No.1 has granted
manufacturing approval to the defendants' drug Forms 46 and 46A
under Rule 122B i.e. Approval for Manufacture of a new drug
formulation.
231. It is evident from the record that the approval was
recommended in a very short time between the submission of Form 44
and defendant No.2's presentation dated 15th October, 2013 before the
NDAC who could not have had sufficient opportunity to study the
application before recommending the approval on October 18, 2013.
Further, defendant No.2's application could not have been reviewed by
the Technical Committee and the Apex Committee. As per earlier
Guidelines referred by defendants themselves at least 90 days period
is required to study the clinical trials. However, in the present case,
the approval was granted within three days even by ignoring the
objection raised by the plaintiffs.
232. It is necessary to mention here that the Mashelkar
Committee Report (which the defendants have relied upon extensively)
itself provides that the examination of clinical trial data and response
by the DCGI should take 90 days approximately. In the present case,
the clinical trial data for Bmab-200 was submitted to the DCGI on
October 15, 2013 and the marketing authorization was granted to
defendant No.2 on October 23, 2013 (within 8 days). It appears from
the minutes that no speaking order was passed as per record
available. Merely the recommendation was issued on the office report
prepared on 21st October, 2013. Office note does not reveal any
exemption of Phase I and Phase II or following the Guidelines of 2012.
233. With regard to Choudhary Committee Report (2013) relied
upon by defendant No.2 is not applicable to the present dispute since
the defendants' drugs were not on the market in well-regulated
countries before being introduced in India in the year 2011. Rather said
report goes against the defendants. The report recommends that
Phases I to IV clinical trials of all new entities developed in India to be
marketed in India will need to be carried out in India as per paragraph
16 on page 4 of the Report which also contemplates that only
applications concerning national emergencies or drugs/biologicals for
tropical diseases will receive priority for expedited review.
Approvals were not referred to the Technical and Apex
Committees
234. Admittedly, the defendant No.1 and NDAC have not
referred the approval process through the Apex and the Technical
Committees. The said Technical Committee and the Apex Committee
were constituted in compliance to the submissions as made by the
Union of India and its acceptance by the Supreme Court in its 3rd
January, 2013, in the matter of Swasthya Adkikar Manch v. Union of
India and Ors., WP(C) No.33/2012. It was submitted before the
Supreme Court that clinical trials of New Chemical Entity shall be
conducted strictly in accordance with the procedure prescribed in
Schedule Y of Drugs & Cosmetics Act, 1940 under the direct
supervision of the Secretary, Ministry of Health & Family Welfare,
Government of India. It was pointed out that as per notification dated
31 March 2011 of the Government of India the NDAC was constituted
to advise defendant No.1 after evaluation of pre-clinical trial data and
the protocols. As per Supreme Court order dated 21st October 2013,
NDAC is required to evaluate prior to grant of approval of clinical trials.
The Government has agreed to review the new drug discovery
applications.
235. In the said case Swasthya Adkikar Manch (supra), the
Supreme Court directed that clinical trials should be re-evaluated in
accordance with the three-tier process (NDAC, Technical Committee
and Apex Committee) because of the reason that on the date of the
order of the Supreme Court, letter by way of objection on behalf of the
plaintiffs as well as Guidelines of Bio-similars were already available
with NDAC Committee.
236. An affidavit filed by the Ministry of Health and Family
Welfare before the Supreme Court itself states "clinical trials are
necessary for the development of new drugs in the country."
237. It is argued by defendants No.1 and 2 that approval
process has gone through every step of the prevalent Regulatory
Regime and is in compliance of the procedure prescribed under law.
The procedure for obtaining biosimilar approvals began in the year
2008 and was duly completed in 2013 when the manufacturing and
marketing authorization were granted to defendant No.2. Therefore,
the Supreme Court orders in the clinical trials matter of bio-similar drug
are not applicable to the present case as the Apex Committee and the
Technical Committee were formed after defendant No.2 had started its
clinical trials. It is canvassed that the Technical Committee and the
Apex Committee were formed to examine applications for new
chemical entities and thus there was complete application of mind by
the DCGI in granting the manufacturing and marketing authorisation for
Bmab-200 who has been satisfied to grant a licence to defendant No.2.
238. Admittedly the Technical Committee and Apex Committee
have not reviewed Bmab-200's clinical trial application (as required
pursuant to Supreme Court orders and Notification No.12-01/12-DC
(Pt-133)/DFQC dated February 6, 2013 even though Bmab-200's
clinical trial was approved on August 19, 2011 during the relevant
period. On October 21, 2013, the Supreme Court directed that clinical
trials which had been approved before the order dated January 3, 2013
should have been re-evaluated in accordance with the three-tier
process (NDAC, Technical Committee and Apex Committee). The
distinction drawn between biological and clinical/chemical drugs in
relation to clinical trials, in the above referenced notification relating to
the Technical Committee and the Apex Committee is incorrect as the
Drugs Rules (Schedule Y deals with new drugs and not new chemical
entities/new clinical entities). The minutes of the Technical Committee
meeting available on the website of the CDSCO indicate that the
Technical Committee routinely provides recommendations for clinical
trials of biological drugs in pursuant to the Supreme Court order dated
January 3, 2013.
239. There is no force in the submissions of defendants No.1
and 2 that the Technical Committee and Apex Committee are only
involved for the evaluation of proposals for conducting the trial and not
for evaluation of any proposal for approval of new drugs for
manufacturing and marketing in the country. Whether it is new
chemical entity or biosimilar? One has to read the order of the
Supreme Court in context and intention of the mandate of the order. It
is a matter of fact that on the date of recommendation and approvals,
all the orders and material and circumstances were already available
which are apparently not brought to the notice of NDAC at the time of
recommendation as per record available.
240. The main approval process was started when an
application was received by defendant No.1 on 15th October, 2013 for
manufacturing and marketing. The hearing on the said matter, being
WP (C) No.22/2012, was being conducted in Supreme Court. The
Government also placed its stand before the Supreme Court by filing of
affidavit(s) as well as by making the statement in the Supreme Court.
The defendant No.1 presumably was aware about the orders at least
on the date of approval i.e. 23rd October, 2013.
241. There is no force in the submission of the defendant No.2 that
since the approval process of drug in question has taken five years,
thus, it is presumed that all the protocols have been complied with.
The said argument is wholly misleading as it is the admitted case of
defendant No.1 itself that the result of Phase III was submitted by the
defendant No.2 on 27th September, 2013. As per case of the
defendant No.1, the defendant No.2 filed the fresh application on 15th
October, 2013 for approval to manufacture and market Trastuzumab.
The drug was recommended by NDAC on 18th October, 2013. Even
while issuing the recommendation NDAC did not refer the matter to
Technical and Apex Committee to consider the Clinical Trials. After
recommendation on 18th October, 2013, the approval was issued on
23rd October, 2013.
242. Pre-clinical trials comprising (a) animal toxicology; and (b)
animal pharmacology studies are required to be conducted under Rule
122B read with paragraphs 1(1)(ii) and (iii) of Schedule Y and
Appendices I, III and IV, Schedule Y of the Drugs Rules. The
mandatory animal pharmacology studies were not conducted by
defendant No.2. It is required even as per Guidelines 2012, paragraph
B.1 of the 1999 Guidelines and Section C of the CDSCO Guidance.
243. The defendant No.1 did not recommend skipping or
combining any phase of clinical trials as per record available. Rather
the defendant No.1 sought justification from defendant No.2 as to why
Phase I and Phase II trials were being skipped. The explanation given
by the defendant No.2 is self-serving service and contrary to the
biosimilar Guidelines or Drugs Act and Rules.
244. Paragraph 8 of biosimilar Guidelines 2012 mandates that
all phases of comparative human clinical trials including
pharmacokinetic, pharmacodynamics, confirmatory safety, efficacy and
immunogenicity studies must be carried out for a biosimilar drug. As
per plaintiffs, comparative safety and immunogenicity studies were not
conducted by defendant No.2. The defendants No.1 and 2 have
admitted that the defendant No.2 has not performed a
pharmacodynamics (PD) study for drug in question neither as a
separate study nor as a part of the phase III. It is a matter of fact and
as per record no exemptions from conducting any phase of clinical trial
were available to defendant No.2.
Two Additional Indications
245. The defendant No.2 during the pendency of hearing has
obtained the approval of two additional indications of the biosimilar
drug. It was not brought to the notice of the Court at the first instant.
246. In fact after granting the approval of metastic breast cancer
as per original application was filed, the defendant No.2 applied to the
Drugs Controller and Licensing Department, Government of Karnataka
for permission to manufacture two additional indications under the
license given under Form 28D i.e. for metastic early breast cancer and
metastic gastric cancer.
247. This request was made to the State Licencing Authority on
24.10.2013for grant of additional product approval in Form-28D for
Trastuzumab Bmab and its formulations along with (revised) Specimen
Label, product general information (SmPC) & PI. CDSCO sub-zone -
Bangalore, and State Licensing Authority carried out joint inspection of
the manufacturing premises of defendant No.2 on 20th November,
2013 and submitted their report to office of CDSCO, New Delhi and
State Licensing Authority.
248. The plaintiffs during hearing rightly apprehended and
pointed out to the Court that the defendant No.2 was trying to obtain
the approval of other two indications without conducting any trials. The
plaintiffs filed two fresh applications including the application for fresh
interim injunction. On the date of filing of such applications, the
plaintiffs were not aware about the exact position. When query was
raised, the defendant No.1 informed to the Court that the approval
sought by defendant No.2 on 10th November, 2014 for two additional
indications was granted on 17th March, 2015. Cop of the same was
furnished by the defendant No.1 subsequently.
249. It is alleged by defendant No.2 that the additional
indications as sought to be approved by the defendant No.2 are not
beyond the already approved indications for which the plaintiffs'
drug/reference drug has already been approved. The said practice is
also internationally accepted. It is further submitted that by letter dated
10th October, 2013 issued to the defendant No.1 had along with
submitting the Phase-III clinical trial reports claimed for all the three
indications i.e. MBC, EBC and MGC and an approval was granted on
23rd October, 2013 for MBC to the defendant No.2 after establishing
Biosimilarity to the drug of the plaintiffs. The extrapolation of
indications is thus simply a case of administrative confirmation by the
defendant No.1 whereby the defendant No.2 is permitted to
manufacture and sell its biosimilar Trastuzumab for EBC and MGC
indication.
250. The defendant No.2 has admittedly not conducted any
studies or tests in relation to two additional indications. The defendant
No.2 has sought to extrapolate the data generated and relied on first
indication i.e. metastic breast cancer for additional indications.
251. The defendant No.2 has tried to give justification for
extrapolation of safety and efficacy data from one indication of
trastuzumab to the additional indications. It is submitted that as per
the Biosimilars Guidelines 2012, Clause 8.5, 'Extrapolation of Efficacy
and Safety Data to Other Indications' Extrapolation of Efficacy and
Safety Data of a Particular Clinical Indication (for which clinical studies
has been done) for a similar biologic to other clinical indications may
be possible if following conditions are met:
1. Similarity with respect to quality has been proven to
reference biologic;
2. Similarity with respect to pre-clinical assessment has
been proven to reference biologic;
3. Clinical safety and efficacy is proven in one indication;
4. Mechanism of action is same for other clinical
indications;
5. Involved receptor(s) are same for other clinical
indications;
252. It is submitted by the defendant No.2 that in all approved
clinical indication the involved receptor are the same and shows its
efficacy in approved clinical indication by interacting with HER2 protein
and causing cell apoptosis and interfering with downstream signals.
As all these conditions were met for the additional indications,
therefore the approval was rightly granted by DCGI on merit. The
objections of the plaintiffs are without any force.
253. As per Rule 122E(b) of the Drugs Rules, a drug already
approved by the DCGI which is proposed to be marketed for a new
indication, is a "new drug" for the purposes of the Drugs Rules. There
is no provision under the Drugs Act and the Drugs Rules permitting
exemption from conducting such tests for approval of a biosimilar drug
for new indications. As per Clause D of Form 44 of the Drugs Rules,
which form is required to be filed, inter alia, along with applications for
approval for manufacture of new drugs, the applicant should provide
therapeutic justification for the new claim and the data generated on
safety or quality parameters.
254. It is evident that the extrapolation of the clinical data
relating to one therapeutic indication to another different indication is
not automatic or unqualified and must be therapeutically justified
with safety and quality data.
255. It cannot be disputed that the appropriate clinical trial end
points for a drug targeting HER2+ early breast cancer is disease free
survival, which measures the length of time after primary treatment for
a cancer ends that the patient survives without any signs or symptoms
of that cancer.
256. It is the admitted position in the present case that the
metastatic breast cancer cannot be cured, it can only be treated to
prolong the patient's life and would be targeting metastatic breast
cancer aim to control the growth of the cancer and/or to relieve
symptoms caused by it. On the other hand, early breast cancer can be
cured in some cases and metastic gastric cancer is not distinct from
breast cancer and early breast cancer. Thus, prima facie, it cannot be
said that all the three types of cancer are meant for the disease for the
same purpose and it might be having distinct properties.
257. It is informed by the learned Senior counsel for the plaintiffs
that the approval of the plaintiffs' Trastuzumab, which is the innovator
drug in the present case, for HER2+ early breast cancer and HER2+
metastatic gastric cancer in India took almost 4 years and years
respectively from the initial approval for HER2+ metastatic breast
cancer and was based on global clinical trials conducted by the
plaintiffs.
258. It is submitted by the plaintiffs that the defendant No.2 has
not conducted any clinical trial test model which could detect potential
differences between the drug of the defendant No.2 and the plaintiff's
Trastuzumab. HER 2+ metastatic breast cancer is not a sensitive
clinical trial test model to detect potential differences in safety, efficacy
and immunogenicity. The pharmacokinetics would be affected
because of the patient's health status and tumor burden and the
international practices do not permit immunogenicity data in
immunosuppressed subjects to be extrapolated to an indication in
healthy subjects or patients with autoimmune diseases, and therefore,
data from HER 2+ metastatic breast cancer relating to tests conducted
with immunosuppressed subjects cannot be extrapolated to HER2+
early breast cancer.
259. It is also submitted that the clinical trials for HER2+ early
breast cancer would be conducted on a homogenous patient
population, which would be a sensitive clinical trial test model to show
the potential differences with the innovator biological drug and the
identification of data from a treatment-free follow-up phase which is
crucial for the comprehensive characterisation of the immune
response.
260. Admittedly the recommendation is not based on the clinical
trials purportedly conducted by defendant No.2 in relation to two
additional indications. Whatever studies and trials conducted by the
defendant No.2 on patients are only in relation to with HER2+
metastatic breast cancer for which the original application was filed for
clinical test was made for metastic breast cancer. Approval of two
additional indications was granted by without passing the speaking
orders and discussion. When the approval of first indication itself is not
granted strictly as per rules and guidelines.
261. A party is entitled to the benefit of approval of extrapolation
of clinical trial relating to one therapeutic indication to different if the
due compliance and protocol are satisfied. The Drug Authority is
supposed to examine the application for the same very carefully
because it is to be granted without clinical trials. The approval cannot
be granted in mechanical manner or on demand. The authority has to
assign reasons.
TRASTUZUMAB
262. The defendant No.2 has been granted the approval of the
name Trastuzumab which is one of the International Non-proprietary
Names (INN). The defendants No.2 to 4 are using the said name in
their carton(s) and package insert and data for the purposes of
promoting their products. The materials are shown to doctors,
hospitals and patients in order to claim biosimilar drug.
263. It is the case of the defendant No.2 that as per the 'World
Health Organization Guidelines on the use of International Non-
proprietary Names (INNs) for Pharmaceutical Substances', an INN
identifies a pharmaceutical substance by a unique name that is
globally recognized and is a public property.
264. It is argued that the aim of the INN system has been to
provide health professionals with a unique and universally available
designated name to identify each pharmaceutical substance unlike the
brand name of a particular company, the INN name is the name of the
bulk medicine itself and has to be printed on every product containing
the said drug as the generic and biosimilars of known substances are
identified with the same INN name. In the present case, the plaintiffs
cannot claim monopoly or ownership over the same as it is a public
property. It is submitted that as the defendant No.2 has obtained all
approvals for manufacturing and marketing Trastuzumab (marketed as
CANMAb) and therefore it is essential for the defendant No.2 to refer
to the INN name Trastuzumab for the convenience of the doctors and
patients across the globe.
265. The case of the plaintiffs is that the INN "Trastuzumab" has
been assigned by the WHO to the plaintiffs' innovator biologic drug.
"Trastuzumab" is a biologic drug which is a recombinant DNA-derived
humanized monoclonal antibody. INN Trastuzumab cannot be used by
any party unless comparative tests establishing biosimilarity have
been conducted.
266. Extracts from the WHO policy which are referred by
learned senior counsel on behalf of the defendant No.2 are set out
below:
"The INN Programme's purpose is to assign nonproprietary
names to medicinal substances so that each would be
recognized globally by a unique name. INNs facilitate the
identification of pharmaceutical substances or active
pharmaceutical ingredients. Each INN is a unique name
that is globally recognized and is public property. In fact,
unlike trade names, INNs do not give proprietary rights and
can be freely used since they are in the public domain. The
INNs form an essential part of the regulatory process in
many countries where a nonproprietary name is required
for licensing..." (emphasis supplied)
267. It is argued on behalf of defendants that the plaintiffs may
have goodwill in the brand name HERCEPTIN and not in
"Trastuzumab". "Trastuzumab" is an INN, it represents a drug of the
plaintiffs for the last many years which has an intrinsic goodwill
attached to such drug. The patent right in the drug in question has
expired in 2013. Originally the said name may have been exclusively
associated with the innovator drug but it cannot be called as brand
name. It is a non-proprietary name. The new concept of biosimilar
drug was based on and in relation to innovator product. Therefore, the
defendant No.2 is entitled to use the said INN name.
268. It is admitted position that the regime of biosimilar is new
one. It is still to be evolved in this country. Very few approvals have
been granted by the Regulatory Authority in new regime. The process
of approvals cannot be considered as same in the process of
approvals of generic product in chemical form wherein the chemical
drug is same, whereby and therefore risk is minimum, however,
biosimilar/biological drug is not identical, risk involved is much higher
than generic drug. Therefore, the said issue has to be handled in
careful manner.
269. The degree of similarity of the biosimilar drug has to be
maximum to the near of innovator's drug otherwise it cannot be called
as biosimilar. The clinical data has to be generated for the purpose of
new drug. Thus, heavy burden is upon the Regulatory Authority to
examine the clinical trials of biosimilar drug.
270. From the said discussion and overall facts and
circumstances, I am clear in my mind that if all the clinical trials have
been conducted by the party of biosimilar drugand all protocols are
fulfilled under the Act and Rules and bio-similar guidelines 2012.
Under those circumstances, the party/applicant would be entitled to
use identical name of INN. Otherwise in failure to do so, the party has
to use the said name with certain level of distinction in order to avoid
confusion and deception. However, the said name cannot be used or
displayed to patients, doctors, hospitals as a brand name. It is to be
used to describe its drug only. Any party under the garb of INN name
is not entitled to make the misrepresentation or to take any undue
advantage, if he does so, he is not entitled to harm the innovator party
due to reason that previously INN name was associated with the
innovator.
Package Insert
271. The defendant No.2 has claimed that the approvals of
package insert have been issued in December, 2013. The case of the
plaintiffs is that no such approvals are granted. The same is being
used by defendants No.2 to 4 contrary to the interim orders dated 5th
February, 2014 and modified order dated 14th February, 2014.
272. It is submitted by the senior counsel appearing on behalf of
the defendant No.2 that the data relating to the clinical efficacy results
of patients under the treatment of Trastuzumab / Herceptin is in public
domain. In the present case, the literature of the defendant No.2's
product is in fact a compilation of published data available in the public
domain and the results of the clinical trials conducted by the plaintiffs
which are not individually capable of being protected under Copyright
Law and thus the alleged claim for copyright infringement contended
by the plaintiff is untenable. Further, there is no law permitting data
exclusivity in India which may prohibit the defendant No.2 to make use
of data available in public domain, relating to Trastuzumab. Even
other biosimilar drugs rely upon the data and/or information of the
reference product in the package insert/ prescribing information of the
biosimilar drug. For example, Reditux manufactured by Dr. Reddy's is
biosimilar to Mabthera manufactured by the plaintiffs. It is also
submitted that the original plaint does not claim any rights for
infringement of copyright.
273. It is also submitted by the defendants No.2 to 4 that WHO
Guidelines state that "The prescribing information for the biosimilar
should as similar as possible to that of the reference product except for
product-specific aspects, such as different excipient(s). This is
particularly important for posology and safety-related information,
including contraindications, warnings and adverse events.
It is submitted that the using originator data as the basis for
Package Inserts is the normal practice for biosimilars in India and in
Europe, and is supported by WHO guidelines. WHO guidelines
recommend that the drug substance of the Reference Product and the
Similar Biologic must be shown to be similar, furthermore the
prescribing information of the Similar Biologic should be as similar as
possible to the Reference Biologic and biosimilars in India have
followed this model by also including information from prescribing
information/Package Insert of the reference product. The defendants
No.2 to 4 have used the innovator's data from published sources
including the European PI and American PI so as to contain all
available information relating to safety, contraindications, efficacy, any
special conditions, side effects, nature and other properties of the drug
etc. to assist the prescriber of the drug.
274. This Court is aware that the WHO Guidelines on Evaluation
of Similar Biotherapeutic Products, 2009 (the "WHO Guidelines")
require the prescribing information for a biosimilar product to be similar
to the prescribing information and package insert for the, reference
product, and not a verbatim (slavish copy). The WHO Guidelines state
that if the biosimilar product has been approved for fewer indications
compared to the reference product, the information relating to
indications for which the biosimilar product has not been approved
should typically be omitted. If it is necessary to include the information
relating to other indications, it should clearly stated in the prescribing
information that the SBP is not indicated for use in the specific
indication(s) and the reasons why. In the present case for example
paragraphs 2.1 to 2.7 (excluding paragraph 2.6.1.1) of HERCLON's
package insert have been copied of CANMAb's package insert and of
CANMAb's SmPC, the only change being substitution of the word
'HERCLON' with 'CANMAb' or 'Trastuzumab'.
275. The requirement that the package insert of the biosimilar
product should be "as similar as possible" to the package insert of the
innovator product as referred in paragraph 12 of the WHO guidelines
does not imply that the biosimilar manufacturer can copy the
innovator's package insert in mechanical way and by claiming the false
claim. It also does not imply that the test data in relation to the
biosimilar should not be included in the package insert. This is also
supported by the Swissmedic FAQs dated February 17, 2014''.
276. The WHO Guidelines specifically state that the prescribing
information for the biosimilar product should be as similar as possible
to the reference biologic except for product-specific aspects, such as
different expedients and the manufacturer of a biosimilar product may
choose to mention the biosimilar nature of the product and the studies
that have been performed with the biosimilar product.
277. It is stated by the plaintiffs that the defendants No.2 to 4
have not identified that the data in their package insert is the plaintiffs'
data for Trastuzumab. They have only mentioned that "following results
have been observed in various patient populations under the treatment
with Trastuzumab based on published information". They have not
specified whose published information is referred to thereby. The
defendants have also failed to prove that independent/comparative test
data is included in the package inserts and the defendants' drugs are
not even referred to as a 'biosimilar' product in the package insert.
278. It is submitted by the plaintiffs that the data relating to
indications that Bmab-200 is not approved for Metastatic gastric cancer
and Early-breast-cancer in the package insert of CANMAb approvals of
which were not granted at the time of introducing in the market yet the
defendants No.2 to 4 still included. It is argued by the plaintiffs that as
a matter of fact the defendants No.2 to 4 have included references to
indications for which Bmab-200 is not approved to misrepresent and
mislead patients and doctors and give an impression that the
defendants' drugs are the same as HERCEPTIN. In support counsel
for the plaintiffs has pointed out certain portion from the package insert
filed before start of hearing. The details of the same are already
mentioned in earlier part of my order. However, later on counsel for
the defendant No.2 had informed that it was modified. The defendant
No.2 has also been granted approval of package insert of other two
indications by the defendant No.1 without informing the Court as it was
informed to the Court when the query in this regard was made during
the hearing.
279. It was earlier argued that no approval of package insert is
required. There is no force in the argument that there is no
requirement to get a separate approval for package inserts once the
manufacturing and marketing authorization for the drug is obtained.
The said arguments of the defendants are self defeating arguments
which have no merit since admittedly the package insert proposed to
be used by defendants No.2 to 4 for the additional indications was
separately approved pursuant to letter dated July 28, 2015. Approval of
the package insert is specifically required at paragraph 8 of Form 46
and paragraph 1 (i)(vi) of Schedule Y of the Drugs and Cosmetics
Rules, 1945, as amended (the "Drugs Rules").
280. The defendant No.2 submitted the package insert to the
State FDA. The State FDA is not the appropriate authority to approve
the contents of the package insert. The manufacturing approval
granted by the State FDA on December 13, 2013 (Form 28D) cannot
be considered as the approval for the package insert. In fact, the Form
28D itself requires defendant No.2 to comply with all conditions of the
marketing authorization dated October 23, 2013 (which includes the
requirement to obtain a separate approval for the package insert).
Mere DCGI's counter-signature on Form 28D and the subsequent
submission of the package insert to the DCGI on December 13, 2013
"for information and record purposes" cannot be considered
compliance of paragraph 8 of Form 46. Contrary to paragraph l(l)(vi) of
Schedule Y of the Drugs Rules, defendant No.2 made changes to the
package insert submitted to the DCGI on October 15, 2013 (along with
their Form 44 application) without obtaining DCGI's approval for such
changes. There is no communication on record either from FDA or
defendant No.1 to show that written letter/order has been issued to
defendant No.2 in this regard.
281. The package inserts of Bmab-200 available at pages Nos.
950, 993, 996, 1001, 1003 and 1005 would indicate that the drug used
for treatment of (i) metastatic breast cancer (ii) early breast cancer and
(iii) metastatic gastric cancer. However, Bmab-200's approval available
at page No. 935 is only for metastatic breast cancer. This approval of
additional indications were granted later on at page No.993- "detected
in 1 of 903 patients" and on page No.1001- " data from studies 1 and 2
were obtained from 3206 patients" and "study 4 reflect exposure of
Trastuzumab as part of adjuvant treatment regimen from 2124 patient."
The said package inserts cite results of pre-clinical studies conducted
on cynomolgus monkeys at page No.997, but the tests conducted by
defendant No.2 were on Swiss albino mice and New Zealand white
rabbits. The said inserts state that the composition of the clinical trial
population was "84% of patients were White, 7% were Black, 4% were
Hipanics and 4% were Asian" at page No.1001, but defendant No.2's
clinical trial protocol shows that the clinical studies were conducted
over 23 site in India as mentioned at page No.914. Further in the said
inserts it is stated that the drug has been clinically tested "in
combination with paclitaxel or an anthracyclie" and also "in
combination with anastrozle" as mentioned at page No.992 but Bamb-
200 was only tested in combination with docetaxel as is disclosed at
page No.913. The package inserts state that the median treatment
duration in the defendants 'clinical studies was 51 weeks as mentioned
at page No.999, but infact conducted over a period of 24 weeks as per
the details available at page No.918. to all justifications given by the
defendant Nos.2-4 is that they have post marketing experience with
Trastuzumab in their package inserts at page No.1006. As defendants'
drugs were launched only after the filing of suit and after the impugned
order dated 5th February, 2014, it could not have generated post
marketing data as yet.
282. Prima facie, it appears that the defendant No.2 has made
contradictory averments in relation to the approval of its package
insert. On one hand, defendant No.2 has stated that no separate
approval for the package insert is required and on the other hand, it is
contended that its package insert was in fact separately approved by
the DCGI. Prima facie, it appears to the Court that the defendants
have made misrepresentation in disclosing in data from Phase I,
Phase II and pivotal Phase III studies at Page No.993, however, in fact
as per the admission made by the defendant No.1, the defendant No.2
has conducted the trials only of Phase III studies and clinical trials of
Phase I and Phase II are not registered.
283. The package insert which was originally submitted would
show that certain part of it was reproduction. The WHO guidelines
never recommend that if Phase I and Phase II trials are not conducted
and approval of two additional indications i.e. early breast cancer and
metastatic gastric cancer was yet to be granted, still a party is entitled
to claim the approvals in the package insert. The party is not entitled
to claim and cannot be allowed by the Court and Regulatory Authority
when the claims were that the pre-clinical studies are conducted on
cynomolgus monkey but in fact the tests are conducted by defendant
No.2 on white rabbit. It is correct that this Court is deciding the
application on the basis of original plaint where no relief for
infringement of copyright sought but it cannot be denied by the
defendants that there are many averments in the plaint about the
misrepresentation and false claim made by the defendant No.2 in the
package insert.
284. No law in India or WHO Guidelines or other Guidelines of
entire world can allow any party, who proposes to market biosimilar
drug, to make its claim, which is false and misleading statement, in its
package insert. Even the defendant No.1 failed to notice these
misleading statements when approval of package insert was granted.
It is the duty of the defendant No.1 to examine each and every part of
data produced before granting approvals of label and package insert
because the drug involved is meant for serious disease, otherwise, the
purpose of the scheme of the Act, Rules and Guidelines would be
frustrated and shall see that not even a single false statement is made.
285. The defendant No.2 is only entitled to rely on the plaintiffs'
data relating to Trastuzumab for the purpose of seeking approval for
Bmab-200 for comparison purposes for which the plaintiffs themselves
are not claiming any rights. However, the defendants No.2 to 4 have
no right to use identical package inserts on the basis of false claim. If
any false and misleading statement is made in the package insert,
even the data of the innovator product in order to show biosimilarity
cannot be used.
286. It is correct that when the innovator's data is also required
to be used in prescribing label and information - the WHO Guidelines
require that the prescribing information for biosimilars should be "as
similar as possible" to the prescribing information of the innovator drug
but subject to condition that all the information mentioned in the
package insert is correct about their clinical trials and in case of untrue
claims within the knowledge of a party, then the question of using any
information or reference of any kind in order to show biosimilarity for
comparison purposes does not arise.
287. The package insert should contain the correct details of a
party who propose to manufacture and market bio-similar product as
well as the clinical trials conducted. The data of innovator can be used
in the package insert for comparison purposes subject to the
conditions that the insert contains the correct details of clinical tests
which should not make any misrepresentation and misleading
statements.
288. In view of aforesaid reasons, I am of the view that if all the
clinical trials have been conducted and protocol are complied by a
party strictly as per Act and Rules of local laws and as per Guidelines,
the data package insert may be similar as possible with the original
innovator. But it shall not reproduction from the package approval of
innovators and there should not be any incorrect and misleading
statement by a party. The defendant No.1 should not compromise any
lapse or discrepancy if found at the time of granting the approval of
package insert.
Data Exclusivity
289. India has not provided for data exclusivity as a matter of
policy which would prohibit defendant No.2 from making use of data
available in public domain, relating to Trastuzumab. The approval of
defendant No 2's CANMAb which is a biosimilar is granted on the
basis of comparative data generated with respect to that of the
innovator drug.
290. In fact, the WHO Guidelines on SBP's clearly stipulate that
the prescribing information should be as similar as possible to that of
the reference biologic. The relevant extracts from the WHO guidelines
are set out herein below:
"12 Prescribing information and label
The SBP should be clearly identifiable by a unique brand
name. Where an INN is defined, this should also be stated.
WHO policy on INNs should be followed
(http://www.who.int/ medicines/services/inn/ innquidance/
en/ index.html) Provision of the lot number is essential as
this is an important part of production information and is
critical for traceability in cases where problems with a
product are encountered.
The prescribing information for the SBP should be as
similar as possible to that of the RBP except for product-
specific aspects, such as different excipient(s). This is
particularly important for posology and safety-related
information, including contraindications, warnings and
adverse events. However, if the SBP has fewer indications
than the RBP, the related text in various sections may be
omitted unless it is considered important to inform doctors
and patients about certain risks; e.g. because of potential
off-label use. In such cases it should be clearly stated in the
prescribing information that the SBP is not indicated for use
in the specific indication(s) and the reasons why. The NRA
may choose to mention the SBP nature of the product and
the studies that have been performed with the SBP
including the specific RBP in the product information and/or
to include instructions for the prescribing physician on how
to use SBP products..."
291. It is argued on behalf of the defendant No.2 that the
plaintiffs in their pleadings have unequivocally admitted that they do
not claim data exclusivity or data protection or have any issue with
regard to the use of their publicly available data for the purposes of
seeking approval of defendant No.2's biosimilar product CANMAb.
Herceptin is a publically available drug and its data relating to test
results, dosage, formulations, dosage etc is in public domain.
defendant No.2's approvals were granted after establishing similarity to
Herceptin.
292. Defendant No.2 has relied upon the Satwant Reddy Report
for the interpretation of Rule 122B of the Drugs Rules. Defendant
No.2 has also argued that it is entitled to rely upon and appropriate the
plaintiffs' published data entirely without conducting necessary tests to
generate data which is to be used in comparison with the plaintiffs'
data for establishing biosimilarity with the plaintiffs' Trastuzumab.
Counsel for the defendant No.2 has also referred The Pesticides
Management Bill, 2008 and the Intellectual Property Rights Chapter of
the TPP Treaty which are irrelevant to the present matter.
293. Counsel for the defendant No.2 has also informed that in
many countries of the world have followed the procedure of biosimilar
pathways and data and/or marketing exclusivity for innovator biologics
and as details available in public domain and as pathway in place as of
today. It is submitted that biosimilar abbreviated pathways would/can
be adopted in India in which there is condition available as of today
pertaining to Data Exclusivity for a reference product. The details
supplied would show that data exclusivity has been granted for a
reference biological product in many countries given as under:
S. No. Country Biosimilar Data/Marketing
(Abbreviated) Exclusivity for a
Pathway in Place Reference Biological
Product
5 Australia Yes Yes - 5 years
13 Canada Yes Yes - up to 8 years
14 Chile Yes Yes - up to 5 years
15 China No Yes - The "new drug
monitoring period" of
up to 5 years only
applies to locally
manufactured
innovative biologics.
No marketing
exclusivity is available
for biological products
developed outside of
China.
17 Costa Rica Yes Yes - 5 years
21 Europe Yes Yes - 8 years of data
exclusivity and up to 2
years of market
30 Japan Yes Yes - A biosimilar
applicant cannot be
approved until the
innovative product on
which application relies
has completed an
eight-year re-
examination or post-
marketing surveillance
period.
39 Malaysia Yes Yes - up to 5 years
46 New Zealand Yes Yes - 5 years
52 Peru Yes Yes - up to 5 years
56 Saudi Arabia No Yes - 5 years
57 Singapore Yes Yes- up to 5 years
60 Switzerland Yes Yes - 10 years
62 Taiwan Yes Yes- up to 5 years
66 Turkey Yes Yes - up to 6 years
68 Ukraine Yes 5 years plus 1 year
70 United States Yes Yes - 12 years
74 Vietnam Yes Yes- up to 5 years
294. The said details provided on behalf of the defendant No.2
would also show that in many countries data exclusivity has not been
granted as per Government policy of respective countries of the world.
Similarly the details of bio-similar pathway in place in many countries
are given but at the same time the said abbreviation is not possible in
few countries of the world. From the said situation in the entire world
the respective governments have taken the policy decision. In India,
as informed by both sides that as far as data exclusivity is concerned,
so far there is no government policy framed as to whether data
exclusivity can be granted to the party whose patent of innovator drug
has expired. Similar is the position of pathway/abbreviation of
biosimilar products very few approvals have been granted. With the
help of so many authorities and intellect involved, while involving
Government of India, the biosimilar guidelines of 2012 w.e.f. 15th
September, 2012 are placed for the purpose of granting the approvals.
However, in the present case, all the defendants addressed their
respective arguments by stating that the guidelines are not applicable.
As per Rules, the exemption of clinical trials and data of biosimilar
product can be granted under sub rule 3 of Rule 1 of the Schedule Y
only in life threatening and emergency condition in public interest or
where the applicant who had already got the approval of the same
drug of manufacturing and marketing for several years in India or other
countries in case the process of approvals of biosimilar drug is
involved. Certain exemptions are permissible in bio-similar products
as per Guidelines, 2012. Nothing on record is available to show that
such exemptions were sought under Guidelines, 2012 either from the
side of defendant No.2 nor it appears that the approvals were granted
by following the said guidelines, rather the stand of defendant No.1 is
very strange.
295. The allegations of the plaintiffs against the defendant No.2
are that they conducted a very limited clinical trial and cannot be
permitted to use the data and information for the plaintiffs'
Trastuzumab which is publicly available without independently
conducting the tests required under applicable law and without
complying with the Drugs Act, the Rules or the Biosimilar Guidelines.
They cannot rely upon plaintiffs' data in order to misrepresent
TrastuRel as biosimilar to the plaintiffs' Trastuzumab.
296. It is the admitted position that the plaintiffs are not claiming
data protection for the purpose of comparison of data already in public
domain with the data of the applicant at the time of approval. It is
stated on behalf of plaintiffs that the approvals have been obtained on
the basis of all clinical trials as prescribed, the plaintiffs have no
objection if the correct data available in public domain is used in
package insert. However, it is argued that the defendant No.2 ought to
have generated its own data at the time of comparison with the drugs
of the parties face to face.
297. The patent not being for the molecule per se in its
unmodified form was not a primary patent. The patent in simple terms
was for a mixture of the unmodified molecule. Accordingly, drug
manufacturers may manufacture biosimilar versions of the plaintiffs'
Trastuzumab as a consequence of the lapse of the plaintiffs' patent,
which drugs should be similar and never identical to the formulation as
admitted by the defendants. Patent linkage is not relevant to the
issues involved in the present matter since plaintiff No.1's patent in the
plaintiffs' Trastuzumab in India has lapsed. There is no separate
legislation to protect the undisclosed test data.
298. In paragraph 1.10 of the Satwant Reddy Report expressly
states that "...there are a large number of drugs which are mainly
biotech drugs e.g. the monoclonal antibodies (MAB) which are clones
of a single parent cell and which target sites in the body responsible for
diseases - like cancer, tetanus and a host of other indications. It is
difficult to make generics of such drugs. Although some of Indian
companies have succeeded in doing so, yet there is lot more to be
done in this area. In case data protection is provided, such categories
of drugs may become available early in India as the innovator
companies would have greater confidence in entering the Indian
market." (emphasis supplied)
299. The report of Satwant Reddy was issued in 2007 when r-
DNA products were not included in the definition of 'new drugs' (the
definition was amended only in 2011). If it is examined carefully, the
interpretation of Part XA of the Drugs Rules in the Satwant Reddy
Report is applicable only to new chemical drugs and not biological
drugs. As per the Report of the Satwant Reddy Committee, 2007 (the
"Satwant Reddy Report"), India does not provide data exclusivity to
pharmaceuticals and agrochemicals. There is no separate legislation
to protect the undisclosed test data which is submitted to regulatory
authorities in case of pharmaceuticals, and proprietary information is
protected unless Government of India would take the Policy decision in
this regard as in many countries of the world, they took the policy
decision respectively i.e. pathways and data and/or marketing
exclusivity for innovator biologics.
300. No doubt, defendant No.2 is entitled to rely upon the
plaintiffs' published data relating to the plaintiffs' Trastuzumab which
can be used by defendant No.2 for conducting comparative tests and
thereby establishing biosimilarity but such use cannot be extended to
defendant No.2's test dossiers and/or marketing material in the
absence of all clinical trials required.
301. In the present case, the defendant No.2 is claiming
confidentiality of data relating to the development, testing and approval
of drug which is not supported in international practice. In fact, all
holders of marketing authorisations for all medicines for human use in
the European Union and the European Economic Area are required to
electronically submit information on such authorised medicines to the
European Medicines Agency and keep such information up-to-date on
the online database of the European Medicines Agency in the public
domain. Pursuant to the mandate under Regulation (EU) No. 1235 of
2010 of the European Parliament and the Council dated December 15,
2010 amending Regulation (EC) No. 726 of 2014, the marketing
authorisation holder's responsibilities in this regard "include providing
all available information, including the results of clinical trials or other
studies." The defendant No.2 time and again refused to give the
inspection of the documents as sought by the plaintiffs about the main
clinical and pre-clinical tests mainly on the grounds of claiming the
confidentiality.
302. The reliance of decision under The Pesticides Management
Bill, 2008 would not help the case of the defendant No.2 in view of the
nature of drug involved in the present case is for cancer. The said
principles cannot be applied in the present matter.
303. After having considered the arguments of the parties, I am
of the opinion that unless Government of India frames policy to declare
as to whether after expiry of patent, the data in public domain can be
used as pathways or not, the regulatory authority can neither disclose
nor rely upon the first applicant's data at the time of granting marketing
approval to the subsequent applicants. It is for the Government to
decide that such protection for certain fixed period to the innovator
should be granted or not.
Have Guidelines 2012 been followed in the present case?
304. Now, I shall advert to the facts of the present case and
evaluate the contention as to whether guidelines can be said to be
inapplicable merely due to the reason that the defendant No.2 had
already commenced the clinical trials by the time guidelines of 2012
was passed and will it give any leverage to the defendant No.1 or the
committees framed under the rules to bypass the guidelines on that
basis and proceed to grant the approvals on the premise that the
guidelines are non est.
305. Defendant No.1 in its Written Statement has contended
that the Biosimilar Guidelines are not applicable to the defendants'
drug since the clinical trial protocol in relation to the defendants' drug
had been approved prior to the publication of the Biosimilar Guidelines.
The justification is without any substance, inter alia, on the reasons
that the Biosimilar Guidelines were implemented from September 15,
2012 and at such time the clinical trial in relation to the defendants'
drug was still ongoing. Further subsequent to receiving defendant
No.1's approval for the clinical trial protocol in relation to the
defendants' drug, defendant No.2 had been required to make
amendments to such protocol, based on recommendations received
from defendant No.1 on August 9, 2011, January 20, 2012 and July 16,
2012. The effective process of approval was started in the second
week of October, 2013. The Guidelines were operative with effect
from 15th September, 2012 which one year earlier to the start of
process.
As a matter of fact defendant No.1 should have insisted
that the protocol for the clinical trial for the defendants' Drug be
modified to be in compliance with the Biosimilar Guidelines, especially
since the Guidelines explicitly state that "comparative clinical trials are
critical to demonstrate the similarity in safety and efficacy profiles
between the similar biologic and reference biologic with few exceptions
(e.g. recombinant human soluble insulin products for which only
comparative clinical safety study is required). The design of the studies
and the clinical comparability margins of the primary efficacy endpoints
are important and should be given careful consideration
306. No doubt the defendant No.2 was still conducting clinical
trials of its product Bmab-200 when the Biosimilar Guidelines were
issued in the year 2012, However, the alteration in the regulatory
framework by passing of the guidelines during the pendency of the
application of the grant of the approval for manufacture does not allow
the defendant No.1/ DCGI to overlook the guidelines which already
came into force by 15th September, 2012. This is due to the reason
that the defendant No.1 was still in sesin of the application for the grant
of the approval and being a functionary under the Act and the rules
framed thereunder considering the object which was sought to be
achieved by the guidelines which was to ensure the safety, efficacy of
the medicines in relation to complex compounds involving biologics,
the defendant No.1 was obligated to take into consideration those
guidelines passed by CDSCO of which the defendant No.1 was part at
least, it was the duty of defendant No.1 to bring to the notice of the
Committee about the guidelines.
307. Even nothing is available on record submitted by the
defendant No.1 to suggest that the guidelines have been followed or if
the same are ignored or some speaking orders are passed. Rather
record discloses that when the request of all the clinical trials of Phase
III was submitted the guidelines of 2012 were already in place, nor it
was confirmed by the defendant No.1 during the course of hearing that
those have been considered. The recommendation of approvals was
granted on 18th October, 2013. The approval was granted on 23rd
October, 2013 by ignoring the strict adherence to the rules in relation
to the clinical trial processes and granting the approval as if it is case
of the bioequivalence which the defendant No.1 itself acknowledges is
a regime that is a departure from that of biosimilar one.
308. Even the Mashelkar report, which the defendants rely
heavily to contend that the system of approval was already in place
and there was no deviation done by the defendant No.1 while granting
the approval, also provide for the conducting of the clinical trials in
phases and mandate for 90 days period for analysis of the clinical trial
data and response thereon by the defendant No.1 and the committees
formed under the rules. Thus, the defendant No.1/ NDAC immediately
on receipt of the clinical trial data of the defendant No.2 on 18th
October, 2013 (without having clinical trial results of phase I and phase
II) could not have abbreviated the said phases without giving any
reason. The process of recommendation on 18th October, 2013 and
approval thereof on 23rd October, 2013 was done with undue haste
while analysing the said data whatever was available on that date
which was submitted and completed by the defendant No.2, three days
ago even when there are four attendant circumstances which are
staring on the face of the defendant No.1 that being; first is the time
period provided by the expert report Mashelkar report providing the
period of 90 days time to analyse the said data relating to clinical trial;
second is the notification of the guidelines on similar biologics on 15th
September, 2012 providing for the additional requirements keeping into
mind the safety and efficacy of the medicines and also insisting on the
conducting of the clinical trials and third is that the defendant No.1 was
made aware by the time about the scheme of bio similar products while
being a participant to CDSCO guidelines that the regime of
bioequivalence is totally distinct from that of the bio similar and thus
the approval for the manufacturing of the drug based on similar
biologic cannot be granted by merely demonstrating the similarity
between the two compounds as done in bio equivalent but it requires
demonstration of similarity in other terms as indicated in the guidelines.
309. In this backdrop, when the defendant No.1 was already
made aware of these circumstances, in the absence of any special
reasons to be given by the defendant No.1 to be recorded in the writing
in relation to the exemption of the requirements of the guidelines or the
requirements to conduct the clinical trials in three phases, the
defendant No.1's grant of the approval to the defendant No.2
overlooking the plaintiff's objection letter dated 11th October, 2013.
310. Under Clause 6.3.2 of the Biosimilar Guidelines complete
characterisation studies for similar biologies, including physico
chemical characterisation studies, biological activity, immunological
properties, functional assays, purity, contamination, strength and
content is required. The explanation given by the defendant No.2 is
that Biosimilar Guidelines are not applicable is hence not acceptable.
The stand of defendant No.1 that those are not statutory is contrary to
the scheme of the Act and Rules as well as the spirit of guidelines of
2012 framed by the Government.
311. Though learned ASG has informed during the course of
arguments that the defendant No.2 may have combined the Phase I
and Phase II with the clinical trials of Phase III but it is a matter of fact
which is admitted that the clinical trials of Phase I and Phase II are not
registered with the defendant No.1 even as per record.
312. It is also submitted by defendant No.1 that the defendant
No.2 may have conducted the physico chemical characterisation for
Bmab-200 but without obtaining requisite manufacturing approvals for
the purpose of examination, test and analysis as admittedly clinical
trials of Phase I and Phase II have not been registered.
313. It is a matter of surprise, on one hand the defendants are
arguing that the clinical trials of Phase I and Phase II are not required
and guidelines of 2012 are not applicable, and on the other hand, they
are canvassing that most of clinical trials applicable to Phase I and
Phase II have been combined with Phase III. If these are combined
with Phase III trial, why those Phase I and Phase II trials are not
registered by the defendant No.1 as admitted.
314. The perusal of the guidelines of 2012 would show that no
doubt that there exists a provision for the reduction in the requirement
of the clinical data in the approval process of the bio similar product on
the basis of the reference biologic. However, to counterbalance the
same, the similarity with the referenced biologic has to be establish not
merely in the manner of bioequivalence regime but also on other facets
and requirement under bio-similar as well. There are provisions for the
product characterization provided in detail for the purposes of the
studies wherein similarities and characteristics of similar biologic has to
be seen and examined on various facets including structural and
physicochemical properties, biological activities, purities and impurities
etc. Likewise, for the clinical trial application, there are additional
requirements which have been provided which are mentioned in para
6.2 of the guidelines.
315. From the reading of the guidelines holistically, it can be
said that besides establishing the similarity on the several counts, the
guidelines also lays great stress on the quality comparability studies,
process parameters, comparability of manufactured product at clinical
scale. Further, the comparative clinical trials are essential in order to
ensure safety and efficacy of the similar biologics. The said clinical
trial/ study analysis should spent sufficient amount of time so as to see
the effects of the same on substantial number of patients in order
analyse the similarity and difference between the similar biological
product vis a vis the referenced product as per the paragraphs of the
guidelines. Some of the excerpts of the guidelines are reproduced
below:
Comparative clinical trials are critical to demonstrate
the similarity in safety and efficacy profiles between
the similar biologic and reference biologic with few
exceptions (e.g. recombinant human soluble insulin
products for which only comparative clinical safety
study is required). The design of the studies and the
clinical comparability margins of the primary efficacy
endpoints are important and should be given careful
consideration and should be justified on clinical
grounds. In line with the principle of similarity, equivalence
trials with equivalence designs (requiring lower and upper
comparability margins) are preferred. If non-inferiority trials
are required they must be clearly justified and applicants
are advised to consult with CDSCO prior to study initiation.
Sample sizes should have statistical rationale and
comparability limits should be defined and justified prior to
conducting the study.
The nature, severity and frequency of adverse events
should be compared between the similar biologic and
reference biologic and should be based on safety data from
a sufficient number of patients treated for an acceptable
period of time. Efforts should be made to ensure that
comparative clinical studies have a sufficient number
of patients treated for acceptable period of time in
order to allow detection of significant differences in
safety between similar biologic and reference biologic.
(Emphasis Supplied)
316. If there are number of aspects which have been highlighted
as a matter of studies to be done prior to the grant of the approval
including the product characterization, comparability on the clinical
trials, quality comparability studies and there are additional
requirements for conducting the clinical trials with the importance of the
same being underscored, the question to be asked is can we really say
that the said process be compromised/ overlooked by proceeding to
totally exempt the clinical trial route and solely on the ground that the
drug has already been approved in India in favour of the plaintiffs
which is the substratum of the argument of the defendants, I think that
the defendant No.1 and defendant No.2 are proceeding on the
misconception of the factual and legal position as that can never be the
import of the guidelines nor can be intent of the framers of the same.
These are the reasons why the guidelines are to be read in conjunction
with the Drugs and Cosmetics Rules and the aim of the guidelines are
to achieve the safety, quality and efficacy of the similar biologic drug so
that public get the safe medicine.
317. But in the present case, the stand of defendant No.1 and 2
is otherwise, as they are alleging that the guidelines of 2012 are not
statutory and not to be applied as per defendant No.2 in his written
submissions also. Further, the defendant No.2 is not ready to give the
inspection the documents pertaining to comparative clinical trials and
studies to the plaintiffs wherein the arguments in relation to similarities
and characteristics of similar biologic are yet to be addressed.
318. The explanation of the defendant No.2 is that all the trials
have been considered by the defendant No.1 and various committees.
Therefore, the plaintiffs are not entitled to inspect the said documents
and the defendant No.2 is claiming confidentiality of those documents.
The said stand by the defendant No.2 cannot be accepted because of
reason that on one hand, the defendants No.2 to 4 claim to be entitled
as a matter of law to use the data, references and name of the
plaintiffs in order to claim biosimilar drug based on the referenced
drug, on the other hand, they do not want to give inspection of
documents of characterization and comparability on the clinical trials
so as to ascertain true and factual position between the parties.
Learned senior counsel on behalf of the plaintiffs have rightly pointed
out as to why defendants No.2 to 4 are hiding the detailed information
of the crucial clinical trials from the plaintiffs whose bio-similar drug
they intend to use after the approvals are already granted.
319. The said description of the processes by the defendant
No.2 in an elaborative form is no answer to the fundamental complaint
of the plaintiffs which is that the approval process of the defendant
No.2's drug before the defendant No.1 ought to have satisfied the
requirements of the guidelines on similar biologics framed in the year
2012 and followed the said pathway.
320. Therefore, assuming that the defendant No.2 might have
undergone the onerous processes of the seeking many approvals, but
that by itself does not ipso facto allow the defendant No.2 to contend
that the norms and requirements framed under 2012 guidelines are
fulfilled already.
321. The defendant No.1 and the authorities/ committees
framed therein ought to have taken into consideration the guidelines
when they were having time to analyse the clinical data as per the
existing rules and could have also recorded the reasons for granting
the specific exemptions as contended by the defendant No.2 before
this court if so claimed by the said defendant and could not have
straightaway proceeded to grant the approval to manufacture
biosimilar products by completely overlooking the guidelines and the
requirements to conduct the clinical trials which were aimed to ensure
the safety, efficacy and quality of the medicines based on similar
biologics.
322. In my analysis, given the distinct nature of the guidelines
framed and object sought to be achieved by them, the argument of the
defendant No.1 and defendant No.2 that the Appendix IA is applicable
in the case of the defendant No.2's drug and that is the reason for the
abbreviated information being provided and prompt approval is granted
suffers from fundamental flaw/ infirmity which no reasonable person
who is made aware of the guidelines of 2012 already would undertake
unless there is total non application of mind or other extraneous
consideration.
323. It is not sure under these circumstances as to whether the
defendant No.1 has or has not ignored the significance of the primary
end-point of different phases of clinical trials. There is no overlap of
primary end points of the four phases of clinical trials and, as stated in
paragraph 8.3 of the Biosimilar Guidelines, "primary efficacy endpoints
are important and should be given careful consideration and should be
justified on clinical grounds."
324. At this prima facie stage, I find that the combining/ skipping
various phases of clinical trials is not justified as the exemption is not
specifically granted. The exemption is neither automatic nor implied as
it would be otherwise rendered redundant the underlying logic of
sequential testing vis-a-vis primary end-points, target population and
sample size. Paragraph 7.3 of the Biosimilar Guidelines clearly
provides that the RCGM recommends the required phases of clinical
trials based on an assessment of the pre-clinical test results,
paragraph 10 of the Office Order issued by the Department of
Biotechnology bearing No. BT/BS/17/175/2005-PID and dated January
2, 2006 wherein the RCGM recommended that all four phases of
clinical trials should be undertaken. The defendant No.1 does not
have expertise to analyse the pre-clinical (animal study) reports and
draw conclusions. RCGM is the appropriate authority for this purpose.
325. I do not agree with the submissions of the defendants that
since Biosimilar Guidelines of 2012 are prospective and not
retrospective therefore defendant No.1 was not obliged to apply the
same guidelines when the approvals granted as the defendant No.2.
The relevant date for application of guidelines is of 2012, the date of
approvals is the cut off date. In the present case, the date of approval
was granted on 23rd October, 2013 when the Bio-similar Guidelines of
2012 were in place. There is no reason as to why as on the said date,
the defendant No.1 being participant to the said guidelines would not
take into consideration the same when they are in the nature of the
administrative guidelines which are considered to be binding in law.
326. I also do not agree with the defendant No.2 that the said
Guidelines do not state explicitly that the Guidelines or specific
requirements under the Guidelines are applicable for ongoing clinical
trials because of the reasons that most of the meetings relating to the
approval of defendants case held after the guidelines were at the
place. The safety and efficacy cannot be put at risk because there
may be chances of lack of rigorous trials on crucial safety and efficacy
parameters before a life saving drug is launched in India. It is
mandatory that process of approval of bio-similar should be more
stringent and rigorous than for other non-schedule drugs.
327. Therefore, it is the obligation of defendant No.1 to consider
the Guidelines of Biosimilar on the date of approval as it is a matter of
life and death of a patient(s) in case the approval is granted contrary to
rules and guidelines even those may not be mandatory in nature.
There is no force that defendant No.2 was not required to enhance the
scope of the trials which was initiated in 2011 to comply with
Guidelines.
328. As per the Drugs Act and the Biosimilar Guidelines
envisage that all phases of clinical trials are required to be conducted
by a drug manufacturer unless a particular phase is exempted in
accordance with applicable law. As such, neither the RCGM nor the
DCGI can permit the defendant No.2 to abbreviate the clinical trials'
procedure outside the purview of this legal regime.
329. The defendant No.1 is admittedly serving a public purpose
under the Drugs Act and is responsible for public safety, it is imperative
for the defendant No.1 to ensure that drugs approved by it have been
adequately tested before such drugs are introduced in the market. In
the present case, surprisingly it is mentioned in the written statement
that the price of the plaintiffs drug is extremely high and there is no
justification for blocking other manufacturers and Guidelines on bio-
similar are not statutory in nature and Schedule Y does not make
mandatory for conducting Phase I and Phase II Clinical Trials for the
drugs which have already been approved in India or outside India.
Even it is alleged in the written statement that action of the plaintiffs is
against the public interest. This defence apparently is unnecessary as
the defendant No.1 must be aware that after the grant of approvals of
bio-similar to a party, certain rights are acquired whereby a party can
declare in the entire world that its drug is bio-similar to the innovator
drug who can also rely upon the data and compare with its product.
330. Prima facie, there is no objective satisfaction recorded by
the defendant No. 1 which provide for any reason for dispensing with
the requirement of conducting of the clinical trials of Phase I and phase
II and even if as on the date of the grant of the permission to conduct
phase III trial directly, the guidelines of 2012 were very much in force
when on 27th September, 2013 the defendant No.1 had forwarded the
results of the Phase-III clinical trials to the NDAC, the said bodies
including defendant No.1 ought to have clarified for the requirements of
conducting the clinical trials of all the phases or in the alternative asked
for the reasons and justifications for not doing so once the contrary
position is emerging from the guidelines on biosimilar products of 2012
and they were already in place and in effect, if so desired, the
authorities should have passed the orders on the requirement of the
reduction of the data submission in the appropriate case or should
have insisted for the requirements or material in terms of the
guidelines, none of the said recourses have been indicated or adopted
by the defendant No.1 or expert bodies who were all aware of
evolution in this field of science and developments in the policies in the
form of guidelines on biosimilar products.
331. Obviously, when such circumstances were existing, the
defendant No.1 had to deal with the situation with the extreme level of
sensitivity and care so that the due process is followed while granting
the approval which has been on the face of it flouted and bypassed in
the present case. Therefore, I also do not agree with the submission of
the reasonableness as canvassed by Mr. Jain, learned ASG appearing
on behalf of the defendant No.1. In the present case, the process
followed is flawed and suffers from the vice of the non application of
mind and non adherence of the statutory provisions of the Act and
Rules as well as Biosimilar Guidelines by the defendant No.1 which
itself rendered it amenable to the judicial interference not merely in the
private interest but also in public interest.
332. Considering the overall facts and circumstances, I am of
the considered prima facie opinion that the defendant No.2 has not
obtained the approvals as per existing protocol of biosimilar drug. The
same are contrary to the Rules, Guidelines of Biosimilar 2012 as well
as directions issued by the Supreme Court. As per the case of
defendant No.1 that guidelines are not in statutory and remaining
defendants have canvassed that those are not applicable, the said
arguments are wholly baseless and rejected, thus, the approvals which
are in the hands of defendant No.2 granted about the drug
manufactured and marketed by the defendants No.2 to 4 are not in
accordance with the protocol of biosimilar drug and guidelines, so far
the defendant No.2 has not been able to satisfy before the Regulatory
Authority as to whether the drug manufactured and marketed by the
defendants No.2 to 4 is biosimilar. It appears that the procedure
adopted and applied in the present case by the defendant No.1 and
other authorities and committees is akin to the procedure of granted
the approval of bio-equivalent drug which is quite distinct from the
scheme of granting the approval of biosimilar drug, the same is not
correctly examined by the Regulatory Authority as to whether tests in
the present case are conducted were adequate or inadequate in
compliance with applicable law. No doubt as per guidelines under
various provisions, the regulatory authority's committees are
empowered to apply pathway of abbreviation for bio-similar drug ban
the unfortunate part of the matter is that guidelines have not been
considered at all. The power to take action to suspend or cancel the
permission/approval under Rule 122 DB is with the Licensing Authority.
333. In view of discussion held and prima facie findings arrived
by me, the question now arises as to whether the plaintiff is entitled to
any interim relief in the form of injunction as prayed for in the
application. The plaintiffs have number of grievances with respect to
the market approval granted to the defendant No.2. The said
grievances include that the defendants product claiming to be
biosimilar as that of the plaintiffs' drug bearing the trademarks
HERCEPTIN, HERCLON or BICELTIS and use of the data of the
plaintiffs drug, use the INN name and use the bio similar drug as a
word to attract the customers in the course of the trade. I have already
arrived at certain prima facie findings wherein it has been observed
that the defendant No.2 products have been granted approval without
adherence to the guidelines of 2012 and also on the premise that the
scheme of the bioequivalence is akin to bio similar when it is infact not
so. In this backdrop, it is to be really looked into as to whether it would
be befitting to altogether prevent the defendants to continue to
manufacture and market the medicine involved in the present case and
if not then to what extent the interim protection can be moulded so that
pending the final decision on the validity of approval before this court
(which the defendant No.2 already possesses) on the adherence of
the guidelines, the interests of both the parties are not affected and
simultaneously the public interest is equally upheld.
334. I am of the view that the approvals granted to CANMAb
and Hertraz (used by Mylan) product are not on the basis of the
adherence of the Guidelines of 2012 and rules framed under the Drug
Act. The final finding in this respect is yet to be arrived after the
present suit is heard upon completion of the trial. Pending the final
outcome of the suit, there is a need to arrive at interim measure by
working out certain terms between the parties by passing the following
directions:
a) The defendants No.2 to 4 may continue to
manufacture, market and advertise their product
under the name CANMAb or Bmab-200 or Hertraz
on the basis of the approvals already granted to
defendant No.2 without calling their product as "bio
similar" and/ or "bio similar to HERCEPTIN,
HERCLON, BICELTIS" or in any way ascribing any
bio-similarity with that of the plaintiffs products
HERCEPTIN, HERCLON, BICELTIS in any press
releases, public announcements, promotional or
other in printed form and from relying upon or
referring the plaintiffs' names.
b) The defendants No.2 to 4 may also manufacture
and market the drug by qualifying the INN name
Trastuzumab but not to use the said name stand
alone on the carton or package insert as a brand
name. The defendants No.2 to 4 can use the INN
name as Biocon's Trastuzumab or Mylan's
Trastuzumab wherever applicable to describe the
composition of molecule on the product as well as in
its insert and not in a prominent manner. The said
expression shall be used at the bottom part of the
carton and should be in small size letters than their
respective brand names.
c) In view of prima facie findings that the use of the
data by the defendants No.2 to 4 in the product
insert without undergoing the entire process of the
trials is misleading, the defendants No.2 to 4 are
also restrained from using the data relating to
manufacturing process, safety, efficacy and tests
conducted for the safety of the drugs as complained
of by the plaintiffs till the time the final decision on
the issue of the bio similarity is made in the present
suit.
d) In the event, the defendant No.2 intends to claim bio
similar as a description of its product or part of its
promotional campaign or otherwise in any other
form, the defendant No.2, if so advised, can re-
apply the said license before the relevant authorities
including defendant no. 1 and in which case, the
defendant No.1, the authorities and committees
framed therein shall decide the said approval
application in accordance with the Rules and
Guidelines of 2012 and also the observations made
by this court in the present order. In the alternative,
the defendant No.2 may await the outcome of the
present suit and can continue with the present
arrangement as an interim measure.
e) This interim measure is made only in view of the
peculiar facts in the present case wherein the
defendant No.2 is already in possession of
approvals granted rightly or wrongly validity of which
is questioned in this suit. All the decisions made by
the defendant No.1 and authorities and committees
made therein in connection with future approvals
shall take into consideration the guidelines of 2012
and also the findings arrived at in the present order
by this court.
335. The findings made herein above are all tentative in nature
and shall have no bearing when the main suit would be decided after
trial on merits.
336. Both the abovementioned applications are accordingly
disposed of.
337. No costs,
CS(OS) No.355/2014
List on 2nd June, 2016 before the roster Bench.
(MANMOHAN SINGH)
JUDGE
APRIL 25, 2016/jk
