Delhi High Court
Bristol-Myers Squibb Company & ... vs Mr.D. Shah & Anr. on 29 June, 2015
Author: Manmohan Singh
* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Judgment pronounced on: 29th June, 2015
+ I.A. No.15720/2009 in CS(OS) No.2303/2009
BRISTOL-MYERS SQUIBB COMPANY & ORS ..... Plaintiffs
Through Mr.Pravin Anand, Adv. with
Mr.Nishchal Anand and Mr.Aman
Taneja, Advs.
versus
MR J.D. JOSHI & ANR. ..... Defendants
Through Ms.Rajeshwari H., Adv.
+ I.A. No.5910/2013 in CS(OS) No.679/2013
BRISTOL-MYERS SQUIBB COMPANY & ANR ..... Plaintiffs
Through Mr.Pravin Anand, Adv. with
Mr.Nishchal Anand and Mr.Aman
Taneja, Advs.
versus
MR. D. SHAH & ANR. ..... Defendants
Through Ms.Rajeshwari H., Adv.
CORAM:
HON'BLE MR.JUSTICE MANMOHAN SINGH
MANMOHAN SINGH, J.
1. The plaintiffs have filed the above mentioned two suits for
permanent injunction restraining infringement of Indian Patent
No.203937 and for damages against the defendants. The invention
claimed by the plaintiffs inter alia for the treatment of cancer.
2. By way of this common order, I propose to decide the pending
injunction applications filed by the plaintiffs under Order XXXIX Rules
1 and 2 read with Section 151 CPC in both the matters. The first suit
was filed in November, 2009. The second suit was filed in April 2013
on the basis of fresh cause of action. The suit patent remains the
same.
3. Both suits are quia timet actions. The first suit, being CS
No.2303/2009, was filed against the defendants namely (i) Mr. JD
Joshi, Director of defendant No.2 and M/s MJ Chempharm Private
Limited (now known as BDR Lifesciences Private Limited) as the
plaintiffs have reasonable apprehension that the defendants are
going to launch the generic product which would infringe the claims of
IN 203937 and they may violate the exclusive rights of the plaintiffs
granted under Section 48 of the Indian Patents Act, 1970.
4. Common facts as per plaints:
i) Plaintiff No.1, Bristol-Myers Squibb Company is a company
incorporated under the laws of the State of Delaware, USA
founded under its present name in the year 1989 as a result of a
merger between two pharmaceutical companies namely, Bristol-
Myers Company founded in 1887 by William McLaren Bristol and
John Ripley Myers and Squibb Corporation founded by Edward
Robinson Squibb in 1858.
ii) Plaintiff No.2, Bristol-Myers Squibb India Private Limited, is a
private limited company incorporated in 2004 and is a subsidiary
of plaintiff No.1 and markets pharmaceutical products in the
domestic market.
iii) Plaintiff No.1 along with its subsidiaries is a leading
biopharmaceutical company dedicated to discovering,
developing and delivering innovative medicines that help
patients prevail over serious diseases. The plaintiffs have a
strong presence in various therapeutic areas including cancer,
cardiovascular disease, diabetes, obesity, psychiatric disorders,
Alzheimer's disease, hepatitis, HIV/AIDS and rheumatoid
arthritis.
iv) Plaintiff No.1 is the exclusive owner of DASATINIB and its
pharmaceutically acceptable salts, solvates, isomers and
prodrugs which is covered by the claims of IN 203937 in India.
Plaintiff No.1's patent 203937 is valid and subsisting and has a
term of 20 years from 12th April, 2000 in India. Plaintiff No.1,
enjoys patent protection for the said patent in several other
countries such as United States, Australia, New Zealand, Japan
etc.
v) DASATINIB which is the INN name of N-(2-chloro-6-
methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-
4-,pyrimidinyl]amino]-5-thiazolecarboxamide) is an anti-cancer
molecule used in the treatment of adults with chronic,
accelerated, or myeloid or lymphoid blast phase chronic myeloid
leukaemia (CML) with resistance or intolerance to prior therapy
including imatinib, as well as, in the treatment of adults who have
a particular form of acute lymphoblastic leukaemia (ALL) called
Philadelphia chromosomepositive (Ph+) ALL. In both the suits
I.A. No.11344/2014 and I.A. No.11336/2014 have been filed
stating that the plaintiff No.1 has assigned its rights, titles,
interests in the suit patent by virtue of Assignment Deed dated
1st December, 2012 in favour of Bristol Myers Squibb Ireland and
its request filed on 7th November, 2013 is pending. (Both the
applications have been allowed by separate orders passed and
assigning party is impleaded as plaintiff No.3 in the suits).
5. It is claimed that Chronic Myeloid Leukemia (CML), one of the
most common forms of leukemia, arises from the excessive
production of abnormal stem cells in the bone marrow, which
eventually suppress the production of normal white blood cells. The
development of imatinib mesylate, a small-molecule tyrosine kinase
inhibitor (TKI), was the first rationally designed drug for CML. While
imatinib mesylate has undoubtedly had, and continues to have, a
major impact in the treatment of CML, cases of 'imatinib-resistant
CML' are emerging. (Combating imatinib-resistant CML is an
important therapeutic challenge and one for which a new generation
of TKI inhibitors, such as DASATINIB, address.)
6. It is also claimed that the plaintiff No.1's invention, DASATINIB,
addresses the above challenge by reducing the activity of one or
more proteins responsible for the uncontrolled growth of the leukemia
cells of patients with CML or Ph+ALL. This reduction allows the bone
marrow to resume production of normal red blood cells, white blood
cells, and platelets. The compounds of the present invention inhibit
protein tyrosine kinases and are thus useful in the treatment,
including prevention and therapy, of protein tyrosine kinase-
associated disorders such as immunologic disorders, oncologic
disorders and diabetic retinopathy. In vitro, DASATINIB is active in
variants of imatinib mesylate sensitive and resistant leukemic cell
lines. DASATINIB inhibited the growth of chronic myeloid leukemia
(CML) and acute lymphoblastic leukemia (ALL) in cell lines over
expressing BCR-ABL.
7. It is alleged in the plaint that Dasatinib and its pharmaceutically
acceptable salts (which is the INN name of N-(2-chloro-6-
methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1 -piperazinyl]-2-methyl-4-
yrimidinyl]amino] -5-thiazolecarboxamide) is covered by claim 1 of IN
203937 and in particular claim 7. The patent specification in example
455 exemplifies Dasatinib and the method for manufacturing the
same is provided in the patent specification. (The copy of the
complete specification is filed in the present proceedings.) Apart
from the above plaintiff No.1 has also made an application in India for
crystalline monohydrate form of Dasatinib. The said application is
numbered 4309/DELNP/2006 dated 4th February, 2005 and is
currently pending before the Indian Patent Office. The monohydrate
form of Dasatinib has been granted patents in 45 countries and is an
improvement patent of Indian Patent No.203937. The said application
relates to crystalline monohydrate form of Dasatinib and if granted
would confer the plaintiff an additional layer of protection, although
the present patent and in particular claim 7 is broad enough to cover
all the salts, prodrugs, solvates isomers as explained in the patent
specification, irrespective of the fate of the pending application. It is
stated that any person who makes use, sell etc Dasatinib
monohydrate form will infringe not only Indian Patent No.203937 but
also Indian Patent Application No.4309/DELNP/2006 as and when
granted.
8. It is also stated in the plaint that the plaintiff No.1's product
DASATINIB was approved by the US Food and Drug Administration
on 28th June, 2006. It is presently sold in approximately 50 countries
throughout the world. A marketing approval for DASATINIB was also
granted by the Drug Controller General of India ("DCGI") on 30th
August, 2006 to plaintiff No.2, who has since that time been
marketing DASATINIB under the brand name "SPRYCEL" across
India.
Plaintiff No.2 has marketed SPRYCELTM in India since
November 2006. In India, SPRYCELTM is made available to patients
across the country through a Centralized Vendor System which
ensures delivery of the product at the door-step of the patients.
The plaintiffs efforts to make SPRYCELTM more accessible and
available to patients across India have lead to substantial sales which
are indicated in the table below:
Year Quantitative Sales
2006-07 21,883,437.39
2007-08 72,790,946.44
2008-09 120,563,305
2009-10 164,781,842
2010-11 224,984,638
2011-12 268,453,314
9. It is averred in the plaint that during the past five years, plaintiff
No.1 has donated nearly $260 million of medical products, valued at
wholesale, to support partner programs throughout the world. Plaintiff
No.2 has taken initiatives for addressing the specific needs of
physicians and their imatinib-resistant patients in India who may
benefit from Sprycel and runs commercial patient access
programmes with respect to Dasatinib. Dasatanib is not an Over-the
counter drug but a prescription drug. Ever since the launch of
Dasatinib in India, the plaintiffs have addressed the access and
affordability needs of the patients by an aggressive commercial
Patient Access Program (PAP) through which prices of the drug is
reduced to a fraction of the MRP. This has evolved over time thereby
consistently reducing the cost of drug to patients. The program is
available through a third party service provider, for the self paying
patients prescribed Dasatinib, by an Oncologist. The service provider
of plaintiff No.2, through a centralized call center, delivers the drug to
the prescribed patients at the door step anywhere in India with no
additional delivery cost.
The plaintiffs' Patient Access Program (PAP) is publicized to all
the oncologists of the country through regular advertisements in
medical journals like India Journal of Cancer. The availability of this
Program has been broadly communicated to help to ensure patients
do not experience treatment hurdles/interruptions. The commercial
program of plaintiffs has strong utilization and support from the
medical community. In addition to offering Dasatinib at a reduced
price, this Program also provides patient education to facilitate
compliance to therapy.
10. In the first suit, it was stated by the plaintiffs that around
December 2008, they received information that defendant No.2 ("M.J.
Chempharma Pvt. Ltd.") had applied to the DCGI for the marketing
approval for Dasatinib. The plaintiffs sent a 'cease and desist' letter
dated 12th January 2009 to defendant No.2 asking them to restrain
from infringing IN 203937. (For a long time, no response was
received from the defendants-Company.) In the meantime, plaintiffs
also filed a Right to Information ("RTI") Application with the DCGI on
12th May 2009 enquiring as to whether the defendants-Company had
filed an application seeking marketing approval for Dasatinib. The
plaintiffs received a reply from the DCGI on 25th June 2009 which
stated that two companies have applied for the marketing approval
for Dasatinib but did not disclose the name of the companies. The
plaintiffs thereafter sent a reminder to its letter dated 12th January
2009. A response was received from the defendants on 6th August
2009 in which it admitted to have applied for a marketing approval for
Dasatinib. In view of the apprehension that the defendants may not
infringe the plaintiffs' exclusive right of the patent, the plaintiffs filed a
suit being CS(OS) No.2303/2009 in the nature of a quia timet action
against the defendants on 3rd December 2009 for the infringement of
IN 203937.
11. The suit was listed before this Court on 4th December 2009
along with interim injunction application being I.A. No.15720/2009.
12. The Court while issuing the summons in the main suit
restrained the defendants by passing the following injunction:-
"I have heard the learned counsel for the plaintiffs. I am of
the view that they have made out a prima facie case at this
stage. The balance of convenience also appears to be in
favour of the plaintiffs. In the event, the plaintiffs are not
protected their interests may be jeopardized. In these
circumstances, defendants, their directors, employees,
officers, servants, agents are restrained from
manufacturing, selling, distributing, advertising, directly or
indirectly any product which infringes the plaintiffs'
registered patent 203937."
13. The defendant No.1 neither appeared nor filed the written
statement despite of service of summons in March, 2010. Defendant
No.2, i.e. the Company filed its written statement wherein it was
admitted that they have applied for the marketing approval of
Dasatinib having the same chemical structure as disclosed in
example 455 of the patent specification and claim 7 of the patent
claims. It is also stated that it would launch the generic version of
Dasatinib when it obtains the marketing approval to manufacture it
from the DCGI. The name of defendant No.2 was changed to BDR
Life Sciences Private Limited ("BDR Life Sciences") on 7th September
2010. By a separate order, the defendants' application under Order 1
Rule 10 CPC in respect thereof has been allowed.
In para 26 of their Written Statement, it was admitted that the
defendant is intending to launch the generic version of Dasatinib only
if the DCGI grants licence to the defendant to manufacture under the
provisions of DCA. In para 5 and paras 20, 21, 23, 24, 28 and 29 of
the parawise reply of the Written Statement the defendants admitted
having made an application for grant manufacturing licence for
generic DASATINIB. In paragraph 13 of the reply on merits of the
Written Statement the defendant No. 2 further admitted that their
impugned drug has the same chemical structure as that of the
plaintiffs.
14. During the pendency of the first suit, in the meantime, on 2nd
February 2012 (the defendant No.2 in CS(OS) 679/2013), BDR
Pharmaceutical Pvt. Ltd. (hereinafter referred to as the BDR or BDR
Pharma), a group company of BDR Life Sciences and under common
control and management as alleged, wrote to the plaintiffs requesting
for a voluntary license for IN 203937 to manufacture and market
Dasatinib. The extracts of the said letter are reproduced hereunder:-
"We, BDR Pharmaceuticals Int'l Pvt Ltd are a
pharmaceutical company registered under the Indian
Companies Act, 1956. We hold license under the Drugs
and Cosmetics Act, 1940 with manufacturing facilities
located at Vadodara which are GMP certified.
We are fully equipped to manufacture Active
Pharmaceutical ingredient and formulation under GMP
facilities that meets international standards. We are
interested to manufacture DASATINIB in India. We
understand that you have the know-how for manufacturing
the product and we also understand that you have been
granted patent(s) in India.
We are pleased to request you to grant us a license for
manufacturing the said product in India. In view of our
interest for in-licensing from you for manufacturing the
product in India, we request you to let us have your
confirmation as well as detailed terms and condition to
enable us to take forward this proposal, which you will
agree could help abundant availability of the said product in
India."
15. The plaintiffs responded on 13th March, 2012 asking for certain
details to evaluate its decision to grant the voluntary license. The said
details sought by the plaintiffs are produced as under :
"March 13, 2012
Mr. Dharmesh M. Shah
Chairman and Managing Director
BDR Pharmaceuticals International Private Limited
407/408, Sharda Chambers
15, New Marine Lines
Mumbai-400 020
Subject: Application for Voluntary Licence
Re: Indian Patent No. N 203937 (DASATINIB); Our Ref:
13217(G-1)
Dear Mr. Shah,
We have received your letter dated 2nd February, 2012 in
which you have requested a license for manufacturing
DASATINIB in India.
Our comments are as follows:-
1. Before we answer your request for a voluntary
license, we would naturally like to know a few facts about
your company and in particular those given below:
a) Facts which demonstrate an ability to consistently
supply high volume of the API, DASATINIB, to the
market;
b) Facts showing your litigation history or any other
factors which may jeopardize Bristol-Myers Squibb's
market position;
c) Facts showing any history of not honoring patents or
other intellectual property;
d) Capability of handling the ultimate demand for
DASATINIB;
e) Facts showing your ability to supply API for other Anti
Cancer Drugs;
f) Your ability to meet timelines;
g) Quality related facts and in particular compliance
with local regulatory standards and basic GMP
requirements;
h) Demonstrated successful technology transfer and
filings;
i) Quality Assurance Systems due Diligence (having
quality management systems that include Change
Control, Deviations, Validations, Qualifications, Training,
t•
Packaging, Labeling and Laboratory systems to include
QC Testing capability and COA management);
j) Ability to formulate and distribute;
k) Established relationships with NGOs and local
Governments and experience in navigating through
emerging market bureaucracy;
l) Ability to develop new and more efficient chemistry;
m) Financial transparency;
n) Pricing proposals;
o) Commercial supply terms;
p) History of working with pharma innovators;
q) Robust IP protection and compliance policies;
r) Safety and environmental profile;
s) Risk of local corruption;
t) Any other relevant issues that might enable us to form
a business decision.
2. We may point out that BMS is commercially working
the patent in India and the patented product is available to
the public in abundance.
In any event, we have requested information with an open
mind and look forward to receiving the same at your
earliest convenience."
16. However, the said Company did not respond for over 14
months. During this period and without informing the plaintiffs or this
Court, the said Company and BDR Life Sciences (earlier name was
M.J. Chempharm Pvt. Ltd.) applied and obtained a manufacturing
license for Dasatinib Tablets 20/50/70 mg from the Food and Drug
Control Administration Maharashtra on 18th January, 2013. BDR Life
Sciences applied for a manufacturing license for Dasatinib BULK to
the Food and Drug Control Administration Gujarat on 18th January,
2013 and obtained the same on 13th March, 2013. BDR Life Sciences
did not inform the Court of the same despite threatening to launch the
generic version of Dasatinib upon receiving approval in its Written
Statement.
On 4th March, 2013, BDR Pharma applied for a compulsory
license for IN 203937 before the Patent Controller. BDR Pharma did
not inform the plaintiffs of the compulsory licensing application but as
per the plaintiffs, they got to know about the same from newspaper
reports. In the same period BDR also started advertising and offering
for sale of Dasatinib Tablets under the head "Finished formulations"
on its website.
17. The above said acts of BDR and BDR Life Sciences created
further apprehension in the mind of the plaintiffs that BDR or BDR
Life Sciences intend to circumvent the ad-interim injunction granted in
the first suit and they may introduce the drug by infringing the suit
patent. The plaintiffs immediately filed fresh action being a suit
bearing CS(OS) No.679 of 2013 against the defendants in the nature
of a qui timet action for the infringement of IN 203937 ("Second Suit")
on 11th April, 2013.
18. In Suit No.679/2013, the defendant No.1, Mr. Dharmesh Shah,
is the Chairman and Managing Director of defendant No.2 who is
also impleaded being key person involved in making all decisions
including manufacturing and marketing of generic products. The
defendant No.1 is a key player controlling Companies and is stated to
be necessary for the purposes of the present proceedings.
19. Defendant No.2, M/s BDR Pharmaceuticals International
Private Limited, is a private limited company incorporated in 2003
under the Companies Act, 1956, having its principal place of
business at 407/408 Sharda Chambers, 15 New Marine Lines
Mumbai but carrying on business of selling and/or offering for sale
various generic pharmaceutical products and Active Pharmaceutical
Ingredients (API) across the country including at Delhi though its
office located at C4F/117, 1st Floor, Janak Puri, New Delhi-110 058.
20. In the para of cause of action, it is alleged that recently in the
last week of March, 2013 the plaintiffs came to know that defendant
No.2 company i.e. BDR Pharmaceuticals International Private
Limited, in violation of the plaintiffs' rights under Section 48 of the
Patents Act, 1970 was/is advertising and/or offering for sale
generic version of DASATINIB on their website
http://www.bdrpharma.coni/FinisliFormuations.aspx under the
heading, 'Finish Formulations. The defendants have not launched the
impugned product in the market as per admission made by the
counsel at the time of hearing.
21. Admitted position is that both the suits have been filed for
permanent injunction restraining infringement of plaintiffs Indian
Patent No.203937. The plaintiff under Section 48 of the Patents Act,
1970 has the right to take appropriate steps to restrain third parties
from the act of making, using, offering for sale, selling or importing
any product which infringes the subject matter of Indian Patent
No.203937. At the time of filing of suit the defendants were still
pursuing their application for marketing and manufacturing licence
before the DCGI.
22. In the meantime, on 5th May, 2013 the Patent Controller
considered the compulsory license application filed by BDR Pharma
and opined that the BDR Pharma had not made out a prima face
case for grant of a license as the applicant/ BDR Pharma did not
make efforts to obtain a licence from the patentee on reasonable
terms and conditions and relegated the applicant/ BDR Pharma to
approach the plaintiffs for voluntary licence. Thereby, the learned
controller by his order dated 29th October, 2013 rejected the
application filed by BDR Pharma seeking compulsory licence holding
that BDR Pharma did not follow the due procedure in law prior to
making the application under Section 84 and thus the occasion to
entertain application seeking compulsory licence has not arisen. In
the meantime, BDR Pharma again contacted the plaintiffs to revive its
negotiations for a voluntary license with the plaintiffs and they
responded to letter of 13th March, 2012 on 10th May, 2013. The
plaintiff responded to the said communication of 10th May, 2013 by
way of letter dated 1st July, 2013 are reproduced here as under:
"Our Ref: 13250 July 1, 2013
To
Mr. Dharmesh Shah
Chairman & Managing Director
BDR Pharmaceuticals International Pvt Ltd.
407/408, Sharda Chambers
New Marine Lines
Mumbai - 400 020
India
Re: Application for Voluntary licence - Indian Patent No.
IN203937 (Dasatinib)
Dear Mr. Shah,
Thank you for your letter dated 10th May 2013.
Our response is as follows:-
In the first instance, we have come to learn through
newspaper reports of a compulsory license application
having been filed by you on the 4th of March 2013. We
are surprised you have not informed us about this
application at any time during our correspondence starting
in February 2012 and terminating with your present letter
which is under reply.
Second, it appears that you had already announced the
launch of your product commercially at about the time when
you applied for a compulsory license and therefore your
application is not bonafide. As you are well aware, an
application for a compulsory license must be founded in good
faith by a person genuinely desiring to manufacture goods in
larger public Interest. On the other hand, someone who starts
infringing a patent and simply applies for a compulsory license
to test the waters not only seriously lacks bonafides but the
entire compulsory license process is vitiated by this conduct.
Your initial letter for a voluntary license was dated 2nd February
2012 and promptly responded by us by our letter of 13th March
2012. We are quite surprised that for 14 months you did not
deem it fit to respond to our letter of 13th March 2012 and all
this while you kept preparing to commercially launch the
product. Hence, even your request for a voluntary license
lacks bonafides and stands vitiated by your dubious conduct.
Without prejudice to the above, since there is an injunction
operating in civil suit being CS(OS) No. 2303 of 2009 titled Bristol
Myers Squibb Company & Anr. v Mr. JD Joshi and Anr. and a
statement given by you in civil suit being CS(OS)No. 679 of 2013
titled Bristol Myers Squibb Company & Anr. v Mr. D Shah and Anr
to the effect that you are not currently manufacturing or marketing
the drug in question, we would like you to give an undertaking
before the Delhi High Court in the pending suits being CS(OS)
No.679 of 2013 that you will not manufacture and sell the drug in
question during the time period that the dasatinib patent
(IN203937) remains in full force and effect in India and BMS has
an opportunity to fully consider your request."
The talks again continued till 20th September 2013 when BDR
abruptly ended the correspondence as they did not provide the
information asked by the plaintiffs.
23. After that, it came to the knowledge from one sources that BDR
Pharma and BDR Life Sciences had obtained manufacturing licenses
for Dasatinib Tablets and Dasatinib BULK respectively and the
plaintiffs filed an application seeking discovery in both the suits.
24. By order dated 1st October, 2013 passed in the first Suit, the
Court directed BDR Life Sciences to disclose the manufacturing
license for DASATINIB BULK.
25. As already mentioned, defendant No.1 did not appear despite
of service of summons in March, 2010 in the first suit. In April, 2010,
defendant No.2 sought time to file the written statement but the same
was filed in January, 2011. No counter claim was filed by the
defendant No.1 along with the written statement. It was filed in
November, 2013 i.e. after the expiry of three years from the date of
service of summon and positive knowledge of infringement suit.
Although, the Court directed the plaintiffs to file the written statement
to the counter-claim but the objection was raised by the plaintiffs that
it is time barred and cannot be condoned.
26. In the Second Suit, this Court recorded an undertaking of BDR
Pharma on 3rd October, 2013 that it shall not launch Dasatinib till the
injunction application is disposed of. The said undertaking has been
in operation till date. Upon clarification, the Court also directed BDR
Pharma to disclose the manufacturing license for Dasatinib Tablets
by its order dated 13th November, 2013.
27. On 28th October, 2013 the Controller of Patent rejected BDR
Pharma's application for obtaining the compulsory license. The
relevant extracts of the said decision of the Controller in his order in
paras 8, 9, 21 to 23, 29 & 30 are reproduced here as under:-
"8. In the present case, the applicant sent a letter dated
nd
2 February, 2012, to the patentee requesting for a
voluntary licence for manufacturing Dasatinib. By letter
dated 13th March 2012, the patentee raised certain queries
such as ''facts which demonstrate an ability to consistently
supply high volume of the API, DASATINIB, to the market",
"facts showing your litigation history or any other factors
which may jeopardize Bristol-Myers Squibb's market
position", "quality related facts and in particular compliance
with local regulatory standards and basis GMP
requirement", "quality assurance system due diligence",
"commercial supply teams", "safety and environmental
profile", "risk of local corruption". The applicant took this
reply of the patentee as 'clearly indicative of the rejection of
the application for voluntary licence' and did not pursue the
matter and made no further effort to arrive at a settlement
with the patentee. The present application for compulsory
licence was filed on 4th March 2013 i.e. after almost one
year from the date receiving reply from the patentee.
9. By notice dated 4th March, 2013, the applicant was
informed that a prima facie case has not been made out for
the making of an order under Section 84 of the Act as 'the
applicant has not acquired the ability to work the invention
to the public advantage', in the absence of the requisite
approval from the DCGI, and 'the applicant has also not
made efforts to obtain a licence from the patentee on
reasonable terms and conditions' (hereinafter referred to as
the 'efforts'). The applicant was informed that in
accordance with the provisions of Rule 97(1) of the Rules,
a request for being heard is required be filed within one
month from the date of this order failing which the
application shall be rejected.
21. In the present case, the applicant made the request
for a voluntary licence on 2nd February, 2012 to the
patentee who, by letter dated 13th March 2012, raised
some queries. More than four and a half months remained
unutilized out of the 'reasonable period' prescribed by the
legislature for the purpose of mutual confabulations but the
applicant chose not to take any action during this precious
time period that was available with the applicant. In fact,
after receiving the reply from the patentee, dated 13th
March, 2012, the applicant waited for 1 year to file the
present applicant, which demonstrates that the applicant
did not intend to engage in any kind of dialogue,
whatsoever, after making the initial offer to the patentee.
22. On the face of the record, I am of the view that the
applicant's contention that the said letter is 'clearly
indicative of the rejection of the application for voluntary
licence' does not hold good, as the aforementioned queries
raised by the patentee appear largely to be reasonable.
Even if the applicant was under an impression that the
patentee was engaging in delaying tactics, the omission of
not replying at all to the patentee's said letter dated 2nd
February 2012 is unexplainable as it goes against the
golden threat apparently visible in Section 84(6)(iv).
Applicant ought to have appreciated that the provisions
relating to compulsory licence are to be invoked as the last
resort, i.e if the mutual deliberations do not lead to a result
within six months, in accordance with the scheme of the
law.
In my opinion, the applicant did not make efforts to
obtain a licence from the patentee on reasonable terms
and conditions.
23. The applicant by letter dated 10th May 2013, i.e.
after receiving the notice dated 4th May 2013, replied to the
patentee's letter dated 13th March 2012. It is pertinent to
mention that this reply was sent after a delay of about 14
months. It was submitted by way of petitions under rule
137 that correspondence that took place between the
applicant and the patentee subsequent to the filing of the
application for compulsory licence, be taken on record.
29. The applicant sought to argue that the three
substantive requirements under clause (a), clause (b) and
clause (c) of sub-section (1) of Section 84 of the Act have
been met singularly and independently satisfied by the
applicant due to which any irregularity in procedure/
timeline may be either waived or condoned or declared to
be not applicable.
30. The stage of making a ruling on the applicability of
clause (a), clause (b) and clause (c) of sub-section (1) of
Section 84 of the Act on merits has not yet arrived. I am of
the considered opinion that the deliberate intent on part of
the applicant to refrain from entering into any kind of
dialogue with the patentee from the purpose of securing
the grant of a voluntary licence, and the exercise of a
deliberate choice to only invoke the provisions relating to
compulsory licences without taking the requisite steps laid
down by the law, cannot be classified as an 'irregularity in
procedure/ timeline', which can be waived or condoned or
declared to be not applicable."
28. As alleged in the plaint, defendant No.2 claims to be involved in
the field of manufacturing, selling and offering for sale generic
finished formulations and Active Pharmaceutical Ingredients (API) in
therapeutic areas such as Oncology, Cardiology, Gynecology,
Antifungal, Antibacterial etc within the domestic and global markets.
29. It is alleged in the plaint that defendant No.2 claims to be
involved in the field of manufacturing, selling and offering for sale
generic finished formulations and Active Pharmaceutical Ingredients
(API) in therapeutic areas such as Oncology, Cardiology,
Gynecology, Antifungal, Antibacterial etc within the domestic and
global markets.
30. It is not denied by the defendants about a connection between
the present defendants and M/s MJ Chempharma Private Limited
(the company which was restrained by this Court from infringing the
plaintiffs Patent No.203937 in CS(OS)No.2303 of 2009). It is pleaded
by the defendants that name of M/s MJ Chempharma Private Limited,
was changed to BDR Lifesciences Private Limited. Furthermore,
defendant No.1 J.D. Joshi in earlier suit was also one of the Directors
on the Board of the said BDR Lifesciences Private Limited who has
equity of M/s M.J. Chempharma Private Limited as appeared from
the annual report of defendant No.2 showing BDR Lifesciences
Private Limited.
31. It is contended by the plaintiff that M/s MJ Chempharm Private
Limited in order to surpass and over-reach the order dated 4th
December, 2009 passed by this Court and to disguise its infringing
activities had adopted a strategy to act through defendant No.2.It is
further submitted that defendant No.1 and 2's conduct in the past
with respect to the invention claimed in the suit patent has been
dishonest and deceitful. It is done between the defendants and its
sister concern/associate company to circumvent the orders of this
Court as it is also evident from the fact that in February, 2012,
defendant Nos.1 and 2 knowing full well that plaintiff No.1 was the
proprietor of Indian Patent No.203937 approached plaintiff No.1 for
obtaining a voluntary license for manufacturing DASATINIB in India.
Defendant Nos. 1 and 2 through their letter dated 2nd February, 2012
also requested plaintiff No.1 to send detailed terms and conditions.
32. The plaintiffs had shown their interest for entering into a
commercial transaction in order to take the matter forward requested
the said defendants to furnish certain details relating to the matter by
the letter dated 13th March, 2012. But the plaintiffs thereafter did not
receive any response from defendant No.1 and 2 with regard to the
queries raised in their letter dated 13th March, 2012 and thus,
considered the matter as closed as they may not be more interested
to deal with the plaintiffs. However, in the second week of March,
2013, after almost one year from the aforementioned
correspondence, the plaintiffs came to know that the defendants had
filed an application under Section 84 of the Patents Act, 1970 before
the Controller of Patents for grant of a Compulsory Licence with
respect to DASATINIB. As defendant Nos.1 & 2 started advertising
and/or offering for sale the impugned product on their website, the
plaintiffs had an apprehension that defendant No.1 and 2 are in the
process of manufacturing generic DASATINIB and are soon going to
sell DASATINIB across the country including within the jurisdiction of
this Court.
33. It is argued by the plaintiffs that the letter dated 2nd February,
2012 for a voluntary licence was just an eye-wash in order to conceal
the real intention of the defendants of infringing the plaintiffs' Patent.
Rather defendant Nos.1 and 2 along with their associate company/
sister concern have systematic way to violate the restraining order
dated 4th December, 2009 passed by the Court in CS(OS) No. 2303
of 2009 by using, manufacturing, selling and/or offering for sale a
generic version of DASATINIB through defendant No.2 company. It is
submitted that the impleadment of defendant Nos.1 and 2 in civil suit
being CS(OS) No.2303 of 2009 was not possible on account of the
present action being a fresh cause of action and earlier proceedings
are four years old. Therefore the plaintiffs had decided to file a fresh
suit which has been filed. The interim protection in the fresh second
suit was granted and still continues.
34. By virtue of the grant of IN 203937, plaintiff No.1 under Section
48 has the exclusive right to make use, sell, import and distribute
Dasatinib and it is pharmaceutically acceptable, salts irrespective of
the form (pro drugs, solvates, isomers).Hence, the aforementioned
acts of the defendants are prohibited by Section 48 and amount to
infringement of the plaintiffs rights. The said acts of the defendants
are in complete contravention and disregard of plaintiffs existing and
valid Patent No.203937 and give rise to an immediate cause of
action. It is averred in the plaint that if defendants were permitted to
manufacture and market its generic product in contravention of
plaintiffs patent. Further, the plaintiffs' would lose out on substantial
sales on account of the defendants acts of unfair competition by
misappropriating the plaintiffs patent, know-how, technology and
confidential information. The plaintiffs' loss of goodwill and reputation
would be incalculable and irreparable.
35. Many pleas have been taken by the defendants in both the
written statements. However, at the time of hearing, counsel for the
defendants have raised the following main points :
a) The defendant, BDR Pharmaceuticals Private Limited is a
Mumbai based Company engaged in the business of
manufacture and sale of pharmaceutical compounds. Defendant
Company originally known as MJ Chemphan Private Ltd. formed
in 2002 which was changed to BDR Life Sciences Private
Limited. BDR Pharmaceuticals and BDR Life Sciences are part
of the same group company and are engaged in manufacture of
Active Pharmaceutical Ingredients and finished formulations.
b) Credible Challenge in the form of Counter Claim raised by
defendant to the effect that Patent invalid as it obvious in view of
prior art filed along with the counter claim. The suit patent also
lacks utility and hence invalid. Thus, the plaintiffs are not entitled
for injunction.
c) The request for voluntary license by the defendant is immaterial,
therefore, there is no bar to contest the validity of patent in a suit
for infringement. The defendants have not made any admission
of validity of patent.
d) The impugned patent is a non-workable. Patentee is not entitled
to any injunction;
e) The proposed product of the defendant does not infringe suit
patent, question of injunction does not arise.
f) Public interest mandates grant of alternative remedy instead of
injunction i.e. ongoing royalty;
g) Plaintiff's patent and the claims are obvious in view of existing
prior art :
It is argued on behalf of defendants that Dasatinib is covered
by Indian Patent No.203937. Claim No.7 is drawn to Dasatinib. The
chemical name of Dasatinib is N-(2-Chloro-6-methylphenyl)-2-[[6-[4-
(2-hydrosyethyl)-1-piperazinyl]-2-methl-4-pyrimidinyl] amino]-5-
thiazolecarboxamide. The molecule Dasatinib is primarily a
thiazolecarboxamide derivative.
The same is illustrated here below:
36. It is submitted by the defendants that the impugned compound
Dasatinib is obvious to a person skilled in the art on the following
reasons:
(a) That it has been well known that tyrosine kinase (PTKs) family of
enzymes releases substances which cause cancer; therefore,
PTKs has always been a subject of study and has been used as
a target for development of anti-cancer drugs for a long time.
The entire goal is to produce chemical compounds that stop the
production of these toxic substances by the enzyme PTKs. The
plaintiff also acknowledges this fact in their patent specification.
(b) In this regard, amino-1,3-thiazole derivatives are known in the art
for a very long period. Such compounds primarily comprise a
thiazole as the basic nucleus. It is also known that such thiazole
based compounds can be used and are capable of inhibiting
tyrosine and stopping it from producing substances that cause
cancer. The defendants has quoted three examples of EP
0412404, US 5,668,161 and WO 98/28282 to show that thiazole
derivative compounds are known as useful for the treatment of
the cancer.
37. The defendants have filed the prior art in support of their
submission, the details are given as under :-
i) EP 0412404 (EP '404) - discloses many amino-thiazole
compounds for treatment of cancer: Example of a patent which
discloses amino thiazole compound is EP '404. The patent
discloses thousands of compounds which are represented in
shorthand or a Markush format. EP '404 was published around
1991. Claim 9 specifically is drawn to various compounds useful
for treatment of tumors. The compounds include amino thiazole
based compounds and compounds with chloro phenyl groups.
ii) US 5,668,161 (US '161) - discloses heterocyclic thiazole
based compounds with piperazine groups - useful for treatment
of cancer: On similar lines is US 5668161, which discloses
various thiazole based compounds. The compounds of this
patent are also used for treatment of cancer. The compounds
contemplated and proposed by the inventors of this patent
include the addition of a piperazine group and use of multiple
heterocyclic rings. The difference in the compounds covered by
the Markush claim of US '161 and Dasatinib is the presence of
hydroxyl ethanol group in Dasatinib which is absent in the
compounds of US '161.
iii) WO 98/28282 - discloses various thiazole derivatives and
some compounds similar to Dasatinib: This patent discloses
various compounds which are useful for treatment of various
thromboembolic diseases including blood cancer. The
compounds in this patent are represented by a Markush
Structure. This Markush Structure contemplates compounds
similar to Dasatinib. It envisages compounds having all the
substituents as Dasatinib. As per this patent, these compounds
are also useful in enzyme inhibition and by implication in the
treatment of cancer.
38. It is submitted on behalf of the defendants that the patent in the
Markush formula discloses several hundred compounds, some of
which bear a structure similar to Dasatinib which is claimed in the suit
patent which establishes that the claim for Dasatinib in the suit patent
obvious. It is submitted that the prior art compounds are derived from
Markush and thus there exists a motivation to make Dasatinib: All the
prior art cited by defendant disclose various compounds useful for
treatment of various diseases including cancer. The prior art cited are
broadly worded and include compounds for treatment of cancer.
Plaintiff suit patent is also drawn to multitudes of compounds for
treatment of various diseases including cancer. Markush formula is
a short hand for representing various compounds in a precise
manner. Markush formula can otherwise be written as individual
compounds and in such a case, each of the compounds disclosed
should be read as individual disclosure of each compound i.e.
individual disclosure of each of the compounds. Hence each
compound would act as prior art and make the claims of the suit
patent obvious. In such an event, as per the defendant, the suit
patent is obvious to the person skilled in art on account of the
depiction of the similarly looking structure in the earlier patents or in
Markush formula as well as the knowledge of the thiazole compounds
yielding to treatment of the cancer.
As per the defendants, the suit patent can be suffering from the
prior art and is obvious from a reading of the prior art. The suit patent
is thus vulnerable. Therefore, the interim orders already granted is
liable to be vacated and the plaintiffs be asked to prove its validity in
trial.
39. The following decisions have been referred by the learned
counsel for the defendants :
i) Bishwanath Prasad Radhey Shyam Vs. Hindustan Metal
Industries [AIR 1982 SC 1444], para 33;
ii) F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd. [2009 (40)
PTC 125 (Del.)(DB)], para 78
iii) 3M Innovative Properties Company & Anr. Vs. Venus
Safety & Health Pvt. Ltd. & Anr. [2014 (59) PTC 370 (Del)]
- Para 57;
iv) Novartis AG and Anr. v. Mehar Pharma & Anr. [2005 (30)
PTC 160 (Bom)] - Para 25;
v) Sandeep Jaidka Vs. Mukesh Mittal & Anr. 2014 (59) PTC
234 (Del) - Para 32;
vi) Glaverbel S.A. Vs. Dave Rose and Ors. 2010 (43) PTC 630
(Del)- Para 85;
40. I have gone through the submission advanced by the learned
counsel for the defendants and have also perused the patents
documents EP'404 filed on 31st July, 1990, US'161 filed on 9th July,
1996 and also perused the explanation provided by the defendant's
expert in his affidavit in relation WO 98/28282. It is indeed correct
that the three patents filed in different years disclose the existence of
the Thiazole derivates which are yielding results and/ or connecting
thiazole derivatives in inhibiting PTK to release toxic substances, also
in some references talks about tumors etc. I find that the said
information is a part of the common knowledge and for which one
need not cite any prior patents like the ones cited by the defendants.
It is on the contrary a precursor to the plaintiffs patent itself wherein in
the introductory part of the specification, the plaintiffs acknowledges
the said position. Therefore, the existence of the information that
Thiazole compounds having a role to play in curing tumors and
cancer is, I think a bare minimum information for any person skilled in
the art to arrive at the plaintiff's patent. This is my prima facie
observation by merely having a glance to the patents cited by the
defendants to lay the challenge as to obviousness. This is due to the
reason that the defendant while citing the said patents filed in Europe
and US acknowledges that the said patents were filed in the year
1990 and 1996 using thiazole derivates compounds and also talking
at some places about their role to cure cancer and tumors amongst
other diseases. If the mere nexus of use of Thiazole Derivatives as
compound to inhibit PTK is assumed to be the sole ground to infer
obviousness, then it is defendants' own argument and saying that the
Thiazole derivates are known since the year 1950 and all these
patents using Thiazole derivates and their references towards
inhibiting PTK should lead to a presumptive kind of approach that the
subsequent patents granted in the years 1990 onwards are all
obvious to the person skilled in the art. I think such is not the case
and cannot be the case and the said submission ignores the principle
operating behind improvements in the patents. It is common in the
field of the medicines that the chemical compounds are pre-existing
and there are further improvements upon treatment and workings on
the compounds so as to increase their efficacy by reacting with
chemical compounds and the group of the reactants. Therefore, the
commonality of the base compound like thaizole derivatives and its
characterstics may be one of the attending circumstance which can
act as a starting point to consider the plea of the obviousness but it
cannot be said that the said commonality is the sole basis which
yields to inference of the obviousness to the person skilled in the art.
Believing this submission of the defendants would raise questions/
concerns which are that if the compounds are so obvious then, why
did it take years together from 1990 to 1996 to arrive at the different
compounds of Thiazole derivatives as per the prior arts/ patents
quoted by the defendants and why these patents were then not
rejected on the ground of prior arts or obviousness if they are simply
on the face of it so obvious. Clearly, there is something else to it
besides the simple chain of events like commonality of the thiazole
derivates and its nexus with curing cancer by inhibiting PTK. The said
something else is the process of reactants and the role of other group
of reactants and the relevant processes in the patents. Therefore, I
prima facie do find myself to be convinced with this simplicitor theory
of the presence of Thiazole derivatives leading to obviousness to the
person skilled in art which is otherwise easy to understand but
miserably ignores the pragmatic approach that the major medicinal
patents are chemical compounds which are in the nature of the
improvements in the existing state of the art and having higher
efficacy than what was present decades ago. Thus, commonality of
few integers would not alter the position unless the cause and effect
relation between all the integers are present and indicating towards
arriving at the subject invention in the suit patent which is missing in
the present case.
41. In this context, I had an occasion to examine the obviousness
plea in the case of Hoffman La Roche v. Cipla Ltd. (supra), wherein
I took the similar view while deciding the case finally and rejected the
plea of obviousness due to the failure of the defendant to prove the
connecting factors leading to invention or making it obvious. The
relevant discussion is reproduced below:
"The said submissions are neither present in the written-
statement nor in the counter claim nor same are deposed
in the affidavit of DW1, 2 and 3 towards establishment of
the fact that the said working on the compounds is arbitrary
and based on trial and error. I find that the said
submissions cannot be believed in the abstract in the
absence of the any positive evidence coming from the
defendant's end showing some tenability of the same
clinically as to how the said invention could be arrived at on
trial and error method or selection is arbitrary. This could
have been done by the defendant by going step by step.
Firstly to show the example from the known compound,
which the defendant has done, secondly to show as to how
the said selection is not far removed not merely by relying
upon the structural similarity or generally saying that the
ethynyl or methyl could reap the similar results but by
clinically showing what is the effect of the said working of
ethynyl at the several positions and how it is not far
removed from EP'226 and lastly by showing that the entire
selection is arbitrary. All this could have been done by the
defendant in the affidavit by showing positive evidence.
Failure on the part of the defendant to establish the bare
minimum material facts would thus lead to inference as to
non obviousness.
84. In the absence of the positive evidence from defendant
to the effect that the selection of the range is arbitrary by
non application of mind which CS(OS) No. 89/2008 Page
No.85 of 275 is crucial factor in discerning whether the said
impugned patent is obvious or not, It cannot be assumed
on a priori basis that the mere fact that there exist some
similarities in the structure of ranges, the replacement of
the third position with ethynyl may follow and thus the said
patent is obvious based on trial and error method.
(Emphasis Supplied)
85. The defendant counsel has argued at length and it has
also been deposed that US' 534 along with the other
specifications establish the substitution of ethynyl and
methyl components are usual.
I find that if the evidence to show the selection is arbitrary
is not present on record and even it is established on the
record that there is a sort of inspiration taken from EP'226,
the existence of the said fact, by itself does not denote
obviousness. This is due to the reason that it is seen in the
deposition of the PW-3 Nick Thatcher and in the other
pleadings also stating that there were certain defects in the
medicine GEFTINIB and for the said reason the said
medicine was not able to cure the patients properly and
consequently was not recommended. Therefore, even if it
is shown that the starting point of the invention is EP'226
and there are changes made in the chemical structures
cited as example compounds in the said patent by reacting
the same with ethynyl later on in relation to selected range,
I do not find that such selection can be arbitrary, rather it
can be inferred that there may be some further
experimentations done in future on the Geftinib compounds
which eventually narrowed down the examples cited by the
defendant in its submissions, ultimately resulted into the
claim No.1 of the patent. All this rather indicates towards
purposeful selection rather than arbitrary one."
(Emphasis Supplied)
42. In the said suit, I am inferring this in view of totality of the
circumstances, the plaintiffs are engaging into manufacturing of the
drugs, their inventors surely are the persons skilled in the field and
are aware of quinazoline derivatives and the compounds therein. Of-
course, the inventors cannot change the main compound as the said
characteristic of curing the cancer emerges from the said very
compound which is a quinazoline derivatives.
The plaintiff's inventor being a conscious person is equally
aware of the defects in the pre-existing medicine or compound and its
inability to cure the disease properly and therefore would select the
range from the point from where the last research ended. Therefore,
there is no harm so far as taking the compounds from the previous
state of the art is concerned unless it is further backed by the
evidence that the said selection and the working thereupon is not far
removed from the known range, further that the said selection and
the working is arbitrary in nature. On the other hand, it indicates that
inventor was conscious about the existing state of art. Accordingly,
even if the range from EP'226 is selected by the plaintiffs to conduct
the further workings upon the same, unless shown contrary, it cannot
be said that the said selection to be an arbitrary one. (Emphasis
Supplied)
From the reading of the above observations and coupled with
the discussion done above, I prima facie reject the plea of
obviousness on the two prong theory propounded by the defendant
which is that the endeavor of every inventor is to find out the
compound to inhibit PTK to produce the toxic substance to cause
cancer and the commonality of the thiazole derivates both of which
are of common knowledge and yet there are different kinds of the
improved inventions existing having these common factors. Likewise,
applying the dictum of the Roche (supra), the mere some similarity of
the structure would not lead to inference as to obviousness unless it
is shown that the said selection was arbitrary one without application
of mind and thereafter the working done was also inconsequential
result which leads to workshop result and not further new
improvement. Even if the defendant intend to show on prima facie
basis, some sort of the connectors must be shown to lend prima facie
credibility to such defence. Once, this point of obviousness is
discussed threadbare and rejected on these lack of connectors
towards obviousness, then the Court has now been equipped in
evaluating the tenability of the plea at this prima facie stage.
Therefore, if it lacks material facts, there is no option but to left this
plea open ended to be proven in trial without finding force in the
same.
43. In addition to above, so far as the similarity of the structure of
the formulae in the suit patent vis-a-vis three patents quoted by the
defendants are concerned, the counsel for the plaintiff has countered
the defendant's challenge by painstakingly able to explain the
difference in the figures which were sought to be stated as same by
the plaintiffs. The counsel for the plaintiffs has explained as under:
Fig. 1
Fig. 1 explained:
i. The above is the chemical structure of Dasatinib as claimed in
claim 7 of IN203937.
ii. The Core ring of the compound is a thiazole ring linked /
substituted at 2nd position by an amino group and at 5th
position by carboxamide group.
iii. Amino group is linked further with [6-[4-(2- hydroxyethyl)-1-
piperazinyl]-2-methyl-4-pyrimidinyl]; and
iv. carboxamide group is linked further with N-(2-chloro-6-
methylphenyl).
Fig. 2
Fig. 2 explained:
i. EP0412404 teaches thiazole ring further substituted at 2nd
Position by a amino group and at 5th position by Carbonyl
phenyl [-COPh]- therefore at the core structure itself the
compound is different.
ii. US5668161 again teaches a different compound at the core
structure level. The cited compound of US'161 has thiazole
substituted further at:
a. 2nd position: by Amido-phenyl;
b. 4th position: by heterocyclic-heterocyclic; and
c. 5th position: by alkyl
Fig. 3
Fig. 3 explained:
i. WO1998/28282 is another irrelevant prior art reference. The
thiazole ring of WO'282 teaches the following substitution:
a. Claim 1 teaches wide variety of 5 membered heterocyclic
compound.
b. Claim 2 teaches a thiazole substituted with R1a, -Z-A-B
and -D-E; which is 3rd compound of first row in the above
figure.
c. Claim 3 defines the positions at which said groups are
substituted, which are 2nd and 3rd compound of second
row in the above figure :
i. R1a at 2nd position
ii. -Z-A-B and -D-E can be substituted at 4th and 5th
position i.e.:
- 4th position: -Z-A-B and
- 5th position: -D-E
OR
- 4th position: -D-E and
th
- 5 position: -Z-A-B
Thus structures of all the exhibited prior art compounds are not
similar. Furthermore, none is an analogous prior art. All the cited
patents disclose compounds for treating are not for the same
ailments. Therefore, even the hypothetical structures given by BDR
fail to establish the ground of obviousness.
In view of the above explanation, I would say that there are two
rival stands which are available so far as the similarity of the structure
of formula of the compounds are concerned which are that as per
plaintiffs there are differences of the formula present in the suit patent
with that of the prior patents whereas, the defendants continue to
maintain that the examples quoted in the EP 414, WO 098 and US'
161 are same. There is an expert report filed by the defendants in
this respect. However, I would not venture into the exercise of the
appreciation of the evidence lead by the expert at this prima facie
stage when the plaintiff is yet to lead its own expert evidence and the
parties are also yet to cross examine the experts in order to find out
the truth during the process of trial. Suffice it is to say, that in view of
the differences explained by Mr. Anand, learned counsel for the
plaintiff, there are two rival stands available on record and the
defendant's position that the similarity of the structure exists between
the prior patents and that of the one claimed in claim no. 1 and claim
no. 7 of the suit patent cannot be readily inferred and neither they are
so obvious to believe the stand of the plaintiffs or to brush aside the
same at the threshold. Rather, the plaintiffs pointed the differences
also need examination as to whether these are workshop
substitutions or there lies innovation in the said substitutions of the
positions of the chemicals. Therefore, I prima facie consider this
aspect of the similarity of the structures of the formula as a disputed
question of the fact and do not find the challenge on this count as
credible enough to doubt the validity of the patent at this stage on the
premise of the similarity of the structure of the formulae in the manner
contended by the defendants. It has been thrashed out in trial as to
what extent the formulae/ structure of the compounds stated to be
similar as examples are same/ similar to the suit patent Markush
claim. The plea of the obviousness raised by the defendants on this
ground is thus rejected. Likewise, the judgment of Biswanath
Prasad (supra), Gleverdale (supra), 3M (supra) and others relied on
by the defendants are factually distinguishable as in those cases the
common integers leads to arriving at the inventions were present in
order to infer obviousness in the form of attendant circumstances
which are missing in the present case for prima facie purposes.
Lack of Utility and challenge under section 64 (1) (g)
44. The second plea raised by the defendants is that the suit patent
discloses no utility and is void/invalid and fails for lack of utility. It is
submitted that as per the plaint, the compound of the Suit Patent is
useful for treatment of chronic myeloid leukaemia and cancer, which
is resistant to treatment by Imatinib. The patentee has failed to
demonstrate at the date of filing that he had made the invention and
knew that all the compounds would be useful against Chronic
Myeloid Leukaemia. Under Section 10(4) of the Patents Act clearly
states that the specification shall fully describe the invention, its
operation or use and the method by which it is to be performed,
describe the best method of performing the invention.
The patentee was required to disclose not only the product
which is regarded as inventive but also the practical utility of the
product otherwise as per Section 64(1)(g) a Patent can be revoked
on the ground that the invention as claimed is not useful.
45. It is argued on behalf of the defendants that in the present
cases, a plain reading of the suit patent reveals that it simply provides
a list of billions of compounds and leaves the "utility" or "evidence of
usefulness" to the imagination of a person skilled in the art. There is
not a single sentence or whisper as to how the billions of compounds
claimed in claim 1 or other claims are useful for treatment of blood
cancer or leukaemia. The mode and use of the compounds for
Chronic Myeloid Leukaemia is conspicuously missing. In the present
case there is no evidence of BCR-ABL inhibition and utility qua CML.
The plaintiffs have only made the statement that the compounds are
useful for treatment of various diseases including cancer is a self-
declaration by the plaintiffs without any evidence; even for the 580
compounds, which are shown in experiments, there is not an iota of
data to show whether all of these compounds or even one of these
compounds is useful for treatment of all the diseases under the head
"utility".
46. It is argued by the defendants that the patentee never knew on
15th April, 1999 i.e. on the priority date of suit patent that the
compounds had activity qua CML or were useful against Imatinib
which is of resistant cancer as Imatinib was approved by USFDA and
launched by Novartis in November 2001. It is therefore inconceivable
that in 1999, plaintiffs knew that Imatinib would be approved for
treatment of Chronic Myeloid Leukaemia and patients would develop
resistance and plaintiffs' compound would be used to treat such
resistance in patients - it is for this reason that there is no evidence
of utility tests in their patent. The plaintiff's sequel patent for use of
Dasatinib against CML and Imatinib resistant cancer was not filed in
India as the plaintiffs having realised that their suit patent does not
cover "treatment of Chronic Myeloid Leukaemia or Imatinib resistant
cancer" and filed a "sequel-patent" in US i.e. US 7125875 which was
not been filed in India. This patent covers case of the compounds of
suit patent for treatment of CML and Imatinib resistant cancer only.
47. There is also no evidence in the specification for a person
skilled in the art to determine which compound is most effective as
compared to other compounds. Therefore, a person skilled in the art
would have to perform unduly large number of experiments to
ascertain which compound is useful for which disease condition.
There is no evidence as to which compound is superior - hence,
patent is a merely library of compounds, insufficient and vague.
48. It is argued that validity of suit patent is wholly in doubt and
under cloud, especially in the light of challenge raised by defendants.
It is settled law that grant of patent does not guarantee its validity and
there cannot be any presumption in favour of validity of the patent
and when validity of Patent is yet to be tested, and credible challenge
is made out, no injunction can be granted.
49. From the mere reading of the aforementioned submissions of
the defendants on the aspect of the lack of utility, it can be said that
the defendants continue to insist that in order to qualify the test of the
utility, the plaintiffs ought to have disclosed numerous aspects as
narrated by the defendants above and the same are missing in the
patent. The counsel for the defendants also contend that the suit
patent contains several compounds which are claimed but does not
provide how these compounds can be used to cure the blood cancer
or leukaemia. It is further stated that the mode and use of the
compounds for chronic myeloid leukaemia is missing. It is further
argued that the details as to in vitro or in vivo studies on inhibition of
BCR- ABL. Likewise, it is also stated that the utility is assumingly
claimed only for treatment of the cancer caused by particular family of
tyrosine kinase which SRC family and not by the BCR - ABL family
which normally causes Blood cancer or leukaemia.
50. All these so called infirmities are pointed out by the defendants
in order to contend that the plaintiffs suit patent lacks utility. Further, it
is argued that the plaintiffs deliberately did not provide the statement
of utility towards the Leukaemia as in the year 1999 the plaintiffs
were themselves not aware that the compounds claimed can cure
CML as well. In this context, it has been argued that the plaintiffs
also filed sequel patent to cure CML in US but not in India bearing no.
US' 7125875. The defendants also relied upon several judgments in
this respect which proceed to hold that the patent should describe the
practical way of the exploiting it in atleast one field of the industrial
activity and it should not be vague and speculative etc.
51. Per contra, Mr. Anand learned counsel for the plaintiff refuted
the challenge laid by the defendants on the ground that the patent
lacks utility by making following submissions:
a. The patent specification has extensively discussed the
utility/industrial application of the compounds of IN 203937 as
being Protein Tyrosine Kinase Inhibitors and their use in the
treatment of cancer. The International Authorities have also
recognized the claims of the patent to possess industrial
application. The Indian Patent Office during examination of the
suit patent recognized the industrial applicability of the IN
203937. It is undisputed fact that the commercial product has
been developed from IN 203937 endorses that the compound,
Dasatinib has utility and industrial applicability, otherwise why
the defendants have sought a voluntary and compulsory license
for IN 203937 from time to time even rejected of the prayer of
the compulsory licence.
b. On the issue of utility of a patent, the Bombay High Court in
Farbewerke Hoechst v. Unichem Laboratories & Ors. [AIR
1969 Bom 255] has held:
"17. ...The first question that arises in regard to the
subject of the utility of the plaintiffs' patent is what is the
quantum of utility required to support a patent. Reference
may be made in that connection to the statement in
Patents for Inventions by T. A. Blanco White (the learned
Counsel appearing for the plaintiffs in the present case),
3rd edn., at pp. 152-153 to the effect that in the absence
of any promise in the specification that a definite degree
of advantage would result from the use of the
invention, the amount of utility required to support a
patent is very small. It is further stated in the said
passage that it is, in particular, not necessary that the
invention as described should be commercially
useful, unless the specification promises that it would
be, and that it is sufficient that that invention should, by
reason of the features that distinguish it from earlier
proposals, be of some use to the public...
...
20. As stated by Halsbury (3rd Edn.) Vol. 29 p. 59 Para.
123, "not useful" in patent law means that the
invention will not work, either in the sense that it will
not operate at all or more broadly, that it will not do
what the specification promises that it will do. If the
invention will give the result promised at all, the
objection on the ground of want of utility must fail. It
is further stated in the said passage that the practical
usefulness or commercial utility of the invention
does not matter, nor does it matter whether the
invention is of any real benefit to the public, or
particularly suitable for the purposes suggested, and
that it is only failure to produce the results promised
that will invalidate the patent, not misstatements as
to the purposes to which such results might be
applied. In Terrell on the Law of Patents, (11th Edn.) p.
98 para 248, quoting from an English case, it is stated
that if the patentee claims protection for a process for
producing a result and that result cannot be produced by
the process, the consideration fails. It is further stated
there that objections to patents on such grounds are
sometimes treated as objections for want of utility, and
when so treated, the well known rule is that the utility of
an invention depends upon whether, by following the
directions of the patentee, the result which the patentee
professed to produce can in fact be produced. Quoting
from another English case, the same proposition is
stated in another way in Terrell at p. 99, viz. that the
protection is purchased by the promise of results, and
that it does not, and ought not, to survive "the proved
failure" of the promise to produce the results. As already
stated above, the only result which the specification (Ex.
A) in the present case professed to produce was a new
class of chemical compounds having hitherto
unsuspected blood sugar lowering property, but without
the undesirable side effects of the previously known
sulphonamides. As also stated above, the defendants
have not been able to prove that a single compound
falling within the patent does not possess blood sugar
lowering properties to a greater or lesser degree. The
position, therefore, is that not only is there no "proved
failure" to produce the results promised by the plaintiffs'
patent specification (Ex. A), but there is a "proved failure"
on the part of the defendants to show that compounds
falling within the patent do not have the blood sugar
lowering properties promised by that patent. I, therefore,
hold that the objection on the ground of want of utility
must fail, and with it also the objection that the methods
of manufacture are old and known methods and,
therefore, there is no inventive step as far as the
plaintiffs' patent No. 58716 is concerned. In the result, all
the grounds on which the validity of the plaintiffs' patent
was challenged stand rejected, and issue No. 3 must be
answered in favour of the plaintiffs."
(c) The Division Bench of this Court in Merck v.
Glenmark [FAO(OS) 190/2013] (supra) has also held
the following on utility of patents:
"69. On a fair application of the above principles, as
explained above, it is concluded that prima facie there is
a concrete basis for recognizing that the contribution of
the suit patent could lead to practical application in the
industry. As long as Sitagliptin is recognized to have a
therapeutic effect in humans, it is practically applicable,
even if it is not commercially successful due to an
ineffective carrier..........The utility here refers to the
function alleged to be performed by the compound,
which in this case is the inhibition of the DPP-IV enzyme
- clearly a beneficial addition to the medical industry that
has been used as a fictional ingredient. Justice
Blackwell remarked, "happy the inventor whose
patent is infringed‟ for that is the surest sign that he
has devised something of utility and worth."
52. By examining the aforementioned rival submissions raised by
the parties, it can be said that it is the case of the defendants that the
plaintiffs have not sufficiently disclosed the working of the each and
every compound contained in the suit patent and there exists a
vagueness in the disclosed process/ working of the patent which
does not allow the person skilled in art to arrive at the compounds
contained in the patent. On the contrary, the plaintiffs counter the
said plea by negating the position taken by the defendants and by
stating that the minimum level of the utility required to be disclosed
and the same is present sufficiently in the suit patent. I find that the
argument of the sufficiency and inadequacy of the utility raised by the
defendants not potent enough to raise any doubts as to the validity of
the patent at this prima facie stage. Again, this is a bald defense
raised by the defendants at their own whims and understanding of
the invention in the suit-patent and its utility. The points which the
defendants insist must be present in the suit patent or required to be
appropriately described further require an in depth enquiry in to
several questions to be examined from various perspective and few
of them can be posited as under :
What is the extent of the disclosure so far as the working/
operation of the compounds as claimed in the suit patent is
concerned?
Whether such operation of the compound is in consonance
with the promises made by the specification or not?
Whether the workings of the few of the compounds are
present in the suit patents as against others or not?
Whether the absence of the workings of the few compounds
in the suit patents would effect the disclosure of the utility
relating others which are most relevant and closely
connected with the claims or not?
Whether such absence of the workings or manner to arrive at
the few compounds depicted in the suit patent would be fatal
to the entire patent when such compounds are merely
forming part of the larger whole?
53. Till the time answers to these concerns/question emerging
immediately after hearing the submissions of the parties on lack of
the utility are conclusively determined/ ascertained by appreciation of
facts and in depth analysis of the patent specification, no prima facie
opinion to the challenge as to lack of utility of the patent can be
formed merely upon the insistence of the defendants that certain
elements ought to have been present in the suit patent and the same
are missing. Suffice it is to say that there is a statement of the utility
contained in the patent specification and the same has to be read
along side the other paragraphs of the specification meaningfully in
order to analyze the disclosure of the working of the compound,
which is claimed in the suit patent. Prima facie, such disclosure has
to be considered for the purposes of considering the plea of the
utility. Now, if the defendants' questions the utility on certain facts and
insisting that those set of facts must find place in the specification
and the plaintiffs dispute the said position by contending to the
contrary, the same is again the question which cannot be determined
at this stage. Neither, the said question of lack of utility is such which
is so clinching enough to immediately arrive at the view that the
patent lacks utility. This obviously requires an indepth enquiry into
further facts, the elaboration of which is necessary in advance stage
of the proceedings. Therefore, I do not find that the plea of lack of
utility such which raises a credible challenge as to the validity of the
patent warranting the modification of the interim order already
granted on the said ground.
54. It is noteworthy to mention here that the challenges which can
be raised under the provisions of the Section 64 of the Patents Act
1970 (as amended in the year 2005) are in the nature of the
questions dependent on facts or the mixed question of facts and
laws. Where in the case after applying the facts in the form of
challenge and legal position, it can be prima facie readily inferred that
the good ground for the challenge is made out which raises a credible
challenge to the validity of the patent, then such inference can be
drawn prima facie to state that the credible challenge to the validity is
raised. As against the same, there are certain questions within the
challenges which requires the enquiry into more facts or complicated
questions on which no opinion by the preference one set of facts over
the other can be formed at the prima facie stage till the time those
facts are ascertained in the trial as they are disputed question of the
facts. Those are merely the defences raised by the defendants
though not credible enough to raise prima facie doubts as to validity.
Those questions can be deferred to trial for further enquiry into facts
as against straightaway presuming that they raise prima facie
challenge to the validity when they actually do not. I find that the
challenge as to utility is such which cannot be by mere asking of the
defendants be assumed to be raising a doubt as to the validity of the
patent till the time answers to relevant concerns/questions are
provided during the trial. Therefore, I prima facie do not find the plea
of the lack of utility as convincing to raise any credible
challenge to the validity of the suit patent though it may be a defence,
which is yet to be substantiated with more facts during the course of
the trial.
Objection under Section 3 (d) of Patents Act, 1970
55. Learned counsel for the defendants has raised the objection
under Section 3(d) of the Patents Act by contending that the
compounds claimed are mere derivatives, and not patentable under
Section 3(d) as the plaintiffs, as of the date of filing, never knew that
the compounds could be used for treatment of Chronic Myeloid
Leukaemia. It is pertinent to note that use of a compound for
treatment of Chronic Myeloid Leukaemia is demonstrated by its
efficacy against the enzyme BCR-ABL. Use of the compounds for
treatment of CML is a new use, not covered by suit patent and not
enforceable. The plaintiffs have failed to give any answer as to why
the compounds do not fall within 3(d) and are patentable.
56. I have gone through the objection taken by the defendants on
the count of applicability of Section 3 (d) of the Act. I find that the
objection/ challenge of the defendants is founded on the premise the
suit patent is merely a derivative of thiazole compounds and thus
does not enhance the efficacy and is not patentable. I have already
given some of my prima facie observations that the defendants have
not been able to prima facie explain as to how the commonality of
thiazole compounds in the respective prior arts would not lead to one
patent being far removed from another and how these patents are
valid if the commonality of Thiazole compounds would be sole reason
for obviousness. The said observations atleast indicate that the
defendants are not able to lay their challenge properly by explaining
each and every integer involved in the suit patents and in prior arts
which differ in respective compounds from each other atleast for
prima facie purposes.
57. Even assuming that Section 3 (d) of the Act is peculiar to Indian
law and the observations of mine on obviousness would only be
relevant for the said head and Section 3 (d) is distinct from the aspect
of obviousness, the question still remains that if the suit compound is
a mere derivative of known elements/ integers, then why the suit
patent and claimed compound is so successful in curing the cancer
and leukaemia. Further, the connected question still remains
unanswered which is that if the suit compounds lacks efficacy in
curing the cancer, then why the defendants are proposing to launch
the product if it is lacking efficacy. Certainly, it requires a fact finding
in the trial. But one cannot adopt the presumptive kind of approach by
mere saying of the defendants that the patent lacks efficacy.
Therefore, even assuming for the sake that the defendants plea that
the suit patent compound is a derivate of the known compound, still
Section 3 (d) cannot be pressed in to service till the time the
compound involved in the patent is efficacious. It is true that the
plaintiffs have not proved this position by way in vitro or in vivo tests
to show the efficacy, but that is the stage of the evidence to show and
prove that the product is indeed efficacious in nature. At this prima
facie stage, the wholistic reading of the plaints along side the written
statement and the attendant circumstances where in the defendants
are also equally inclined to launch this product itself shows that the
efficacy is involved in the product in treating the ailment including
cancer for prima facie purposes though more elaborate proof of
efficacy shall be ascertained in the trial. Therefore, the objection
under Section 3 (d) of the Act raised by the defendants is also
rejected.
Non Compliance of Section 8
58. Learned counsel for the defendants has raised the objection
under Section 8 of the Act in the written submissions by contending
that the suit patent violates the said provision by not disclosing the
following :
Non-Compliance of Section 8 - Revocation Under Section 64(1)(N) :
It is submitted that as per Hoffman-La-Roche vs. Cipla, the
plaintiff is required to disclose to the Controller any patent
application which is pending in any country outside India in
respect of the same or similar application.
In the present case, the plaintiff filed further application for
Chronic Myeloid Leukaemia in US and Europe, which
application is drawn from the present suit patent. However, this
is not disclosed to the Patent Office under Form-3 i.e. filing of
US 7,125,875 and EP 1610780 not disclosed to Patent Office,
same is not refuted by plaintiff.
The European Patent No.1610780 stands revoked which is not
refuted by plaintiff.
The Chinese Patent which is corresponding to the suit patent
stands withdrawn.
However, these are not disclosed to the Patent Office and not
disputed by plaintiff.
In view of the above, there is substantial non-compliance of
Section 8 and on this ground, the suit patent is liable to be
revoked.
I have gone through the objection taken by the defendants as
to non compliance of the provisions of Section 8 of the Act. Although,
the said plea raised by the defendants is not argued at the time of
hearing. Still, I am inclined to deal with it. The provisions of Section 8
are already discussed at great length by the courts as such wherein
the Court may or may not revoke the patent depending upon the
nature of the information not supplied to the controller, relevance of
the information and the conduct of the patentee etc. This objection
under Section 8 has been discussed in the counter claim as well as in
the written submission which was not argued by the counsel orally
before the Court nor the relevance of such patents was brought to the
notice of the Court as to how the said patents could have effected or
impacted the validity of the suit patent. The mere stray references in
the written submissions by enlisting the number of the patents in an
itemised manner do not imply that there exists a violation of the
provisions of Section 8 of the Act which otherwise lies in the
discretion of the Court to accept such challenge or not in the end.
Therefore, for prima facie purposes, the said objection of the
defendant is also without any substance and is not considered to be
vital enough to doubt the validity of the patent. There is no positive
details produced by the defendants by raising such plea. The said
objection is afterthought. It was not raised in the first written
statement specifically.
Insufficiency
Likewise, in the same manner, the defendants counsel has also
enlisted the objections as to insufficiency of the patent in the written
submissions though no elaborate submissions were canvassed
across the bar to explain them. The same are:
It is submitted that the claims of the suit patent are very broad
and include thousands of compounds, if not millions.
The plaintiff has provided examples for preparation of around
500 compounds;
Undue experimentation required to test utility - hence patent
invalid for lack of sufficiency : There is nothing in the
specification to demonstrate whether all these compounds are
useful against all the diseases mentioned under the Section
"Utility" or whether some of the compounds are useful or not.
There is also no evidence in the specification for a person skilled
in the art to determine which compound is most effective as
compared to other compounds. Therefore, a person skilled in the
art would have to perform unduly large number of experiments to
ascertain which compound is useful for which disease condition.
No evidence as to which compound is superior - hence, patent
is a merely library of compounds, insufficient and vague : The
Markush clams is drawn to millions of compounds, if not billions.
Any person skilled in the art would require more than a life time
to actually prepare these compounds. Therefore, these are
theoretical compounds for which patent has been granted to the
plaintiff. Therefore, on this ground alone, the suit patent is
insufficient, vague and liable to be revoked.
In view of the above, the claims are overly broad, vague and
ambiguous rendering the entire patent void for such vagueness.
From the reading of the said objections as to insufficiency of
the patent, it can be said that the said objections are also the kinds of
the infirmities pointed out by the defendants. The said objections are
akin to the head of the utility as discussed above and raises the
several kinds of the concerns and questions, the answers to which
are required to be provided in the trial. The defendants are
themselves not sure while informing the court as to whether the
patent covers thousand compounds or millions as they take different
stands at different places and use these terms loosely. If the
objections of the defendants are not well founded or not properly laid
before the court, the defendants cannot expect the Court to rule on
such objections and the Court is left with no option but to reject them
as such. In case any such objection exists, the defendants are at
liberty to prove it at the time of the trial and final arguments.
Seeking Voluntary licence no bar to challenging the validity
On behalf of the defendants, it is argued that it is a settled
position of law that once a patent is granted, any person in the
market may seek voluntary licence. Making a request for voluntary
license is a bonafide act in everyday's business and such request for
license is without prejudice and not an admission of the validity of the
patent. In the present case, the communications regarding voluntary
license were "without prejudice" meaning thereby that they were
without prejudice to the rights and remedies that may be available to
the defendant but the plaintiff was not willing to grant any license and
therefore, the discussions did not succeed.
59. It is argued by the defendants that the filing of compulsory
license application or rejection thereof, was on the ground that
appropriate efforts for obtaining voluntary license was not made and
hence, the application for compulsory license was rejected. The
plaintiff was never willing to grant license and only kept asking for
unwanted information and derailed and frustrated the negotiation
process. As a result the application of the defendants came to be
rejected "for lack of efforts" The application was not rejected on
merits. Hence, this factor cannot be held against the defendants. The
plaintiffs cannot be allowed to take advantage of his own wrong.
60. I have gone through the submissions raised by the defendants
that seeking of the license is no bar to challenge the validity of the
patent. Once, I am deciding on the objections on the validity of the
patent by returning the prima facie opinion on the same, the said
question of seeking a license is no bar to challenge the validity is
purely academic in that sense. Therefore, I do not consider
necessary to venture into such exercise when the said question is of
less relevance in the facts of the present case.
Suppression of Material facts
61. It is submitted by the defendants that the plaintiffs have not
disclosed European Patent for Dasatinib for treatment of Chronic
Myeloid Leukaemia revoked in February 2013, much prior to the filing
of the suit. In the said patent, the use of Dasatinib for treatment of
Chronic Myeloid Leukaemia was claimed but such claim was
rejected.
62. It is further argued that the plaintiff has not disclosed that the
plaintiff's product in the market is a monohydrate. A separate
application No.4309/DELNP/2009 claiming such monohydrate was
filed. The same fact was not disclosed in CS (OS) No.679 of 2009.
The withdrawal of the Chinese patent was suppressed and not
disclosed to this Court. In view of such suppression, plaintiff is not
entitled to any injunction.
63. I have gone through these objections raised by the defendants
on the concealments taken by the defendants and prima facie found
no merit in any of them. This is due to the reason that the so far as
the revocation of the European patent is concerned, it is to be seen
what relevance the European patent would have on the Indian patent.
The patent law is always territorial in nature and the rejection,
acceptance of the patent depends on several factors which depends
on case to case basis. The defendants while raising these objections
that the plaintiffs European patent has been revoked and Chinese
patent has been withdrawn have not pointed out as to what bearing
these patents would have to the facts of the present case and how
the same could have the right and entitlement to the injunction of the
plaintiffs. Simply by raising the plea that there are patents which has
been revoked or withdrawn without discussing under what conditions
such happenings took place is totally out of place. Therefore, I do not
really find the said objections as concealments till the time it is shown
that the same are deliberate in nature and would otherwise if could
have shown or explained would be detrimental to the case of the
plaintiffs so far as the entitlement of the interim injunction is
concerned. Likewise, the plea that the product is monohydrate in
nature. Upon this fact being put to Mr. Anand, it has been
categorically stated that the salts of the compounds are covered
within the ambit of the claims of the patent which is as per claim no. 7
are covered. Monohydrate is one of the salts of the compound. In
such an event, the said alleged non disclosure as stated by the
defendants would also not disentitle the plaintiffs from the interim
injunction when the said product is prima facie appears to be covered
within the scope of the patent.
Non working of the patent
64. It is submitted by the defendants that "working" as envisaged
under Section 83 must be adequate so as to fulfil the requirement of
the public and not mere lipsake. A comparison of the import
data/sales in India (as in plaint), the working statement and the total
patient base would reveal that the supply of the product by the
plaintiff in India is highly inadequate. There is a great demand for the
product Dasatinib in the Country and the same can only be fulfilled if
there are more than one source of supply of the product. Working of
a patent in case of medicines and pharmaceutical products must be
interpreted as "local manufacture" keeping in view the "Make in India"
slogan of the Government of India. Without local working, it is
submitted that technology transfer would never occur. Mere
importation and sale of product in India would completely go against
the principle of "Make in India" adopted by the Government of India.
It is submitted that Non-working Patentee is not entitled to any
equitable relief such as injunction, the following decisions are
referred :
i) Franz Xaver Huemer v. New Yash Engineers, AIR 1997
Del 79, paras 16 - 21, 22
ii) Sandeep Jaidka v. Mukesh Mittal & Anr. (supra)
I have gone through the objection raised by the defendants
on working of the patent in India. I find that the said objection is
also without any substance in as much as it is the plaintiffs
position that the suit patent covers the salts of the compound
claimed therein and monohydrate product shall fall in the same
though the defendants states to the contrary. It is also known that
the plaintiffs have supplied the drugs of millions of rupees as
stated in the plaint in India as well. Thus, it really passes human
comprehension as to how this plea of the non working of the
Indian patent can be sustained at this stage when there is a
disputed question of fact which is yet to be determined as to
whether the suit patent covers the monohydrate version of the
compound or not. Prima facie on the fair reading of the
specification and the claim statement, it appears that the salts are
covered within the ambit of the suit patent. I find that the said
statement in the claims of the patent in this respect is enough for
the prima facie purposes to reject this plea of non-working of the
patent and rest is to be proved in trial. Lastly, so far as the non
fulfilment of demand and importation of the articles are concerned,
the aspects are more of a significance in the application seeking
compulsory licence as against in the infringement proceedings. I
have already discussed the difference between the scheme of the
Compulsory licensing, revocation on the ground of the non
working which is a distinct chapter providing independent grounds
than that of the infringement proceedings and defences available
as grounds of revocation which are altogether different from those
mentioned in the compulsory licensing. Therefore, the
considerations which are relevant for the compulsory licensing are
less of a significance in the defence to the infringement
proceedings. Thus, prima facie I do not find merit in the plea of the
defendants with respect to non working of the patent.
65. ON THE ISSUE OF PUBLIC INTEREST
It is stressed by the learned counsel for the defendants that the
product Dasatinib has now been recommended as first line treatment
for Chronic Myeloid Leukaemia therefore, all patients detected with
CML may be administered dasatinib 100 mg. People suffering from
Chronic Myeloid Leukaemia is more than 20,000 per year and the
patient base over the last 5 years may be more than 30-40,000
patients. Most CML patients are diagnosed at the chronic stage. A
perusal of the import data, the working statement and the total patient
base would show that there is a great demand for the product
dasatinib and over the last 5 years plaintiff's is able to fulfilment of
hardly 5% of the patient base. It shows that the product is not
available and beyond the reach of most of the population in the
country. The spread of the disease there is a compelling public
interest to make the drug available at reasonable cost, which is only
possible through generic competition. The price of plaintiff's product
and of defendants' proposed price are set out here below:
Strength of tablet Proposed Cost of BDR Cost of Plaintiff's
product [per month] product [per month]
100 mg Rs.8,100 Rs.1,67,000
66. The recommended dosage of the drug is 100 mg and average
cost of this therapy per month is about Rs.1,65,000/-. Even, if a drug
is, in fact, existing in the market but beyond the reach of the general
population, it would be deemed not 'available' to the public. While the
drugs Imatinib, Dasatinib and Nilotinib are used for treatment of CML,
only Dasatinib is a product that give a sustain long lasting relief to the
patient from CML. Imatinib as is known gives rise to resistance within
month and become useless thereafter. Nilotinib cannot be given to
patients with hyperglycaemia.
67. It is submitted by Ms.Rajeshwari, learned counsel for the
defendants that the plaintiff's charity program of a drug being out of
reach of common man and even an existence of the charity program
itself is an admission that the price of the plaintiff's product is too high
and beyond the reach of a common man in India. It is also an
admission that plaintiff is aware that their product is too expensive for
an average common man. Therefore, the public interest demands
that the injunction granted be vacated immediately.
68. Per contra, Mr. Anand, learned counsel for the plaintiff
submitted on the public interests plea by making suitable response to
the submissions of the defendants in the following manner:
69. As per the pleadings of the plaintiffs wherein it is stated that
ever since the launch of Dasatinib in India, the plaintiffs have
addressed the access and affordability needs of the patients by an
aggressive commercial Patient Access Program (PAP) through which
prices of the drug is reduced to a fraction of the MRP in order to
reduce the cost of drug to patients. BMS's Patient Access Program
(PAP) is publicized to all the oncologists of the Country through
regular advertisements in medical journals like India Journal of
Cancer. The PAP for Dasatinib is termed as the Sprycel Access
Programme as mentioned in the affidavit of Mr. Jitendra Tyagi dated
23rd April, 2015. The Sprycel Access Programme is made available
through a third party service provider for the self paying patients
prescribed Dasatinib by an Oncologist. It is alleged by the plaintiffs
that this programme is publicized to all the oncologists of the country
through leave behind literature/brochure as well regular
advertisements in medical journals like India Journal of Cancer and
banners in oncology conferences. The details or the same are filed
along with list of documents dated 24th March, 2015. It is the case of
the plaintiffs that the service provider, through a centralized call
center, delivers the drug to the patients at the door step anywhere in
India with no additional delivery cost. In its current form, the effective
cost for a months' therapy for the Indian patient is as follows:
a. 20mg- Rs. 7529 for a month's treatment
b. 50mg - Rs. 15062 for a month's treatment
c. 70mg- Rs. 16110 for a month's treatment
70. It is stated that in order to avail this service a patient is only
required to provide the following documents as mentioned in the
affidavit of Mr.Jitendra Tyagi, dated 23rd April, 2015 where the details
of declaration is shown:
a. A prescription for Dasatinib from an Oncologist.
b. Any identification to establish the nationality of the patient as
the program is available to only Indian nationals.
c. Declaration to the effect that patient is a self paying or that the
Patient's insurance would not cover the MRP of Dasatinib.
71. The details have been produced whereby the plaintiffs have
received tremendous appreciation from both patients and doctors for
their Patient Access Program. The plaintiffs have given the
justification about the current MRP for a month's treatment with 50mg
of Dasatinib is Rs.1,65,680/-. The MRP of the drug reflects the
investments made by BMS in the R&D; drug development; clinical
trials; pharmaco-vigilance and in addition to that, the MRP of the drug
cannot be reduced due to other factors inter alia efflux of parallel
exports to other jurisdictions including where governments provide
drug access to patients. The plaintiffs through their Sprycel Access
Programme have developed an effective mechanism to reduce the
price of the drug to 1/11th of the MRP for patients in India while
preserving the plaintiffs' right to recover investments in other
developed jurisdictions as alleged by them. It is the case of the
plaintiffs that Dasatinib is not the only treatment option available to
patients suffering from CML. In order to ascertain the demand for
Dasatinib, the plaintiffs had sent RTI Queries to 12 top Government
Cancer Hospitals across various regions in India enquiring about the
treatment protocols in respect of CML. Responses were received
from 9 hospitals. The answers to the RTI Applications clearly show
that (a) in 95-100% cases Imatinib is the first line treatment; and (b)
In the event of failure with Imatinib, the alternatives (without any
preference) are (i) Dasatinib; (ii) Nilotinib; (iii) Stem Cell Therapy; and
(iii) Bone Marrow Transplant. The RTI responses along with a
summary of the same from the 9 Cancer Hospitals have been filed in
the present proceedings. Assessing the demand of Dasatinib by
regularly filing RTI applications, conducting market surveys and
obtaining expert opinions, the plaintiffs are meeting such demands at
an affordable price. The opinion of an Oncologist in India Prof. Dr.
Purvish M. Parikh has been filed as Annexure D with the affidavit of
Mr. Jitendra Tyagi dated 23rd April 2015.
72. The following are the main reasons given by the plaintiffs to
provide the drug to the patients in reasonable price:-
(i) BMS, through its Patient Access Program, makes the product
available at reasonable prices to non-reimbursed self paying
patients. Through the program the product is available for a
monthly price of approximately Rs.15,000/- as opposed to
Rs.1,65,000/-. The PAP is transparent and easily accessible.
The said scheme has been appreciated by doctors and
patients.
(ii) CML itself is a very rare disorder and the first line treatment
option for this disease is Imatinib (several generic versions of
the same are available in the market). CML has in fact been
declared as an Orphan Disease and Dasatinib an Orphan
Drug considering minuscule population of patients which are
affected by this disease. Imatinib Mesylate continues to
remain the Gold Standard for first-line treatment of Chronic
Myeloid Leukemia;
(iii) Dasatinib is predominantly used as a second line of treatment
for a handful of patients who develop resistance to Imatinib.
There are other second line treatment options available for
patients and oncologists including Nilotinib, Bosutinib,
Ponatinib; and therapy including Bone Marrow Transplant
and Stem Cell Therapy as per Annexure A filed along with
the affidavit of Mr. Jitendra Tyagi dated 23rd April, 2015.
(iv) Dasatinib has been approved as a first line treatment only
recently and that too for patients who are resistant to Imatinib
in the first instance which is about 1% of the total population
suffering from CML as filed as Annexure D of affidavit of Mr.
Jitendra Tyagi dated 23rd April, 2015 which says as under:-
"First line therapy" is the treatment regimen or
regimens that are generally accepted by the medical
establishment for initial treatment of a given type and
stage of cancer. It is also called primary treatment or
therapy. "Second-line therapies" are those tried when
the first ones do not work adequately. The management
of a cancer case requires regular evaluation of treatment
to assess their success and adjust as needed."
73. I have gone through the submission of the defendants on the
public interest requiring the vacation of the injunction. I would say that
after examining the material available on record, again there exist the
rival stands of the parties in form of the contra material available on
record that the plaintiffs are adequately able to meet the demands of
the public. No conclusive opinion or prima facie opinion in favour of
the either side can be formed by appreciating the said material. At
this stage, it could be said that the credibility of the plea of the
defendants is yet to be tested in view of the fact that defendants
being a proposed competitor of the plaintiffs and is in desperately
attempting to launch the product under the same compound and
whether such plea of the serving the public interest is genuine or not.
In this connection, I have done detailed analysis in the judgment of
Novartis v. Cipla (supra) decided on 15th January, 2015 herein I
have discussed this plea of public interest often taken by the
defendants who intend to do private business by manufacturing the
products under the patents and affecting the statutory rights of the
patentees. The scheme of the patent Act allows the examination of
the plea of public interests towards allowance of the compulsory
licence under the distinct chapter of the compulsory licensing and
non working of the patent which is code in itself. The question of the
public interests for the purposes of the infringement proceedings in
the form of deciding the interim application has to be only seen from
the prima facie view of the credibility in the defence of the
defendants. I find that the plea of the defendants being non credible
in the present case and in case the defendants intend to have a
licence from the plaintiffs, the defendants need not inform the term of
2.7 % blanketly but should come out with concrete proposal which
should be discussed amongst the parties on the mutually agreed
terms or before the competent tribunal which is the compulsory
licensing tribunal as provided under the patents Act. This aspect has
been discussed by me in detail in Novartis case (supra) at great
length and is equally applicable to the facts of the present case.
Therefore, prima facie plea of the public interest or setting out the
terms of the royalty cannot be accepted at this stage. The defendants
are although free to approach the plaintiffs on any terms mutually
acceptable to the parties or before the compulsory licensing tribunal
in this respect.
Product not covered by the Patent claims
74. Learned counsel for the defendants has raised the plea that the
product which the plaintiff No.1 is using is the monohydrate version of
the Dasatinib which is not covered by the suit patent and is the matter
of the separate application. It has been argued that once the product
is not covered by the patent, thus, the proposed launch of the product
by the defendants would also not fall within the ambit of the suit
patent
75. In response thereto, plaintiffs submit that the plaintiff No.1 has
also filed applications including a divisional application for the
crystalline monohydrate form of Dasatinib and their intermediates
which are currently pending before the Patent Office. The chemical
structure for Dasatinib Monohydrate is as follows:
Monohydrate
Dasatinib
Carrier
Active compound
76. The active ingredient/molecule of the commercial product is
Dasatinib. It is the active ingredient which refers to the chemical that
results in the therapeutic effect. It is Dasatinib that has a medical
value in managing certain diseases and conditions. Monohydrate is
merely a carrier that has no therapeutic value. The Division Bench of
this Court in Merck v. Glenmark [FAO(OS) in 190/2013] observed
that:
"50. In this case, from known compounds, prima facie,
the Sitagliptin free base is disclosed. As it is a free base, a
pure form of an amine, as opposed to a salt form, this
naturally does not include particular salts, whether
phosphates, hydrochlorides or any other. The elements of
the free base - since many alternatives exist - are then
also detailed in the above table. Conspicuously - and this
is not denied by Glenmark- the free base must be
transformed into a salt form before it can be administrated
to patients (with the salt acting as the carrier).
Unsurprisingly the free base requires a further appropriate
reaction to create that salt. The argument that at no point is
the free base disclosed (and only salt forms, though still not
the phosphate salt form, SPM) lacks prima facie
substance. First, Scheme 6, read with the table above,
discloses the free base, which is claimed in Claim 1, and
specifically, Claim 19. In each of these specifications,
Sitagliptin is found as a free base, without any attached
salt. Two, the Court has to look to the invention in this
case, and not read the claims literally. The invention in this
case is a DPP inhibitor which assists control and
prevention of diabetes by regulating insulin production, and
specifically, inhibiting the DPP-IV enzyme activity. The
claims and disclosures made, should be seen in the light of
the invention underlying the patent and sought to be
disclosed. In this case, the active therapeutic component is
the Sitagliptin free base (which is delivered into the body
with an attached salt that wears away once in the system),
and not the attaching phosphate, Hcl or other carriers. No
doubt such carrier salts are needed to deliver the drug into
the body, and the salt must contain certain crucial
properties that allow for the drug to be administrated
properly (solubility, flow issues, propensity for adhesion,
poor filtration, drying etc.) This is recognized in the
statement of the inventor, Mr. Robert M. Wenslow FAO
(OS) 190/2013 Page 39 Jr, as well in determining the best
method for administration (on which Glenmark relies in its
written submissions); but there too, the active therapeutic
ingredient remains the Sitagliptin free base, and that
product is sufficiently disclosed in Form 2 filed by MSD. It
seems, that Sitagliptin free base's activity, prima facie, on
the DPP enzyme is not naturally affected by the attached
salt; those properties remain, though the efficacy of
administration is dependent in part upon the carrier. The
Sitagliptin free base, previously unknown as a compound
that could affect the activity of the DPP enzyme is a new
and arguably, a novel addition. It is in that context - and in
the shoes of that notional addressee who is working in that
field of pharmaceuticals - that the technical contribution
has to be seen...
...
65. The description of industrial applicability is of the
"active ingredient", i.e. Sitagliptin, instead of any individual
compound, for example, a salt. It is contemplated that the
active ingredient - which refers to the chemical that results
in the therapeutic effect - will be combined with a carrier of
some form. The essential focus of the specification
therefore is the industrial application of the main
therapeutic agent, or simply, the invention. There is also an
implicit admission that while it is the active ingredient -
Sitagliptin free base - that has a medical value in managing
certain diseases and conditions, it will be accompanied by
a carrier that has no therapeutic value.
...
79.....a case for the infringement by Glenmark - through its
product Zita - is established since it uses the Sitagliptin
free base as the active component in its chemical
formulation. An argument was advanced by Glenmark
during the course of oral hearings that this is not the case
since Zita uses SPM, which is manufactured directly
without using the Sitagliptin free base. The Court is
unimpressed with this submission - not only was no
evidence or document adduced to support this plea, but
moreover, the written submission and counter-claim do not
in any meaningful manner disclose such a case. Indeed,
Zita - by account of all documents canvassed before the
Court - uses the Sitagliptin free base as the active
component i.e. the DPP inhibitor. Glenmark's explanation
that it uses a different process to produce the infringing
article is facially unconvincing. It appears to this court
that the production of Sitagliptin Phosphate would
precede use of MSD's patented article, which entails
infringement."
77. To this, the learned counsel for the defendants states that the
operation of the order passed by this Court has been stayed and
hence the Division Bench judgment cannot be relied upon by the
plaintiffs.
78. I do not agree with the counsel for the defendants as Supreme
Court in Glenmark v. Merck [SLP (Civil) No. 9220 of 2015] has
made the following observation with regard to the order passed by
this Court wherein it was held as under :
"...Going by the prima facie satisfaction recorded by the
High Court, we are of the view that the unfinished
formulation of Sitagliptin Phosphate Monohydrate which is
to be processed in the petitioner's factory/factories will not
be undertaken for the present and until the next date
fixed..."
79. Even otherwise, the Supreme Court in Shree Chamundi
Mopeds Ltd. Vs. Church of South India Trust Association [(1992)
3 SCC 1] has held:
"11. ...While considering the effect of an interim order
staying the operation of the order under-challenge, a
distinction has to be made between quashing of an order
and stay of operation of an order. Quashing of an order
results in the restoration of the position as it stood on the
date of the passing of the order which has been quashed.
The stay of operation of an order does not, however,
lead to such a result. It only means that the order
which has been stayed would not be operative from
the date of the passing of the stay order and it does
not mean that the said order has been wiped out from
existence. This means that if an order passed by the
Appellate Authority is quashed and the matter is remanded,
the result would be that the appeal which had been
disposed of by the said order of the Appellate Authority
would be restored and it can be said to be pending before
the Appellate Authority after the quashing of the order of
the Appellate Authority. The same cannot be said with
regard to an order staying the operation of the order of the
Appellate Authority because in spite of the said order,
the order of the Appellate Authority continues to exist
in law and so long as it exists, it cannot be said that the
appeal which has been disposed of by the said order has
not been disposed of and is still pending."
80. Relying on the above decision, the Calcutta High Court in
Pijush Kanti Chowdhury vs. State of West Bengal and Ors.
[(2007) 2 CALLT] has held:
"13. Therefore, the effect of the order of stay in a
pending appeal before the Apex Court does not amount to
'any declaration of law' but is only binding upon the parties
to the said proceedings and at the same time, such interim
order does not destroy the binding effect of the judgment of
the High Court as a precedent because while granting the
interim order, the Apex Court had no occasion to lay down
any proposition of law inconsistent with the one declared
by the High Court which is impugned."
81. In any case, the sum and substance of the plea raised by the
defendants when they state that the plaintiff No.1 has filed another
patent for the monohydrate form of Dasatinib is that the monohydrate
form of the compound is not covered in the suit patent and the
product which is the reproduction of the monohydrate form of
DASATINIB would not be infringing the patent. On the contrary, Mr.
Anand states and urges that the said monohydrate form contains the
essentially the same compounds with some treatment but not able to
explain the filing of the separate patent if it is essentially covered in
the first one as a broad based claim. This question of the scope and
ambit of the monohydrate version Dasatinib is relevant and
necessarily required to be adjudicated once the defendants point out
elaborately the differences claimed in the subsequent patent filed by
the plaintiffs as claims relating monohydrate form of DASATINIB and
relate it with the claims of the suit patent and how they are different
from each other and relate all these with alterations in the
consequential products and its working. At this stage, where the
defendants are yet to launch the product containing DASATINIB in
either form after obtaining the license to manufacture the same, the
question of distinction of monohydrate form or otherwise lends no
support to the plea of the defendants that there lies difference in the
nature of the products and their workings and they are not covered
with in the ambit of the suit patent. After all, it is the defendants who
are raising the plea that the suit patent does not cover the
monohydrate version of DASATINIB, therefore, in order to set up this
plea, the onus lies upon the defendants to explain the differences by
carving out the two patents filed by the plaintiffs and thereafter
relating with the products which are available in the market whether
of the defendants or other parties in either of the forms suggested by
the defendants. It is only then, the onus shall shift to the plaintiffs who
shall be called upon to explain the difference in the patents filed by
them, the respective forms and the difference in their workings. This
requires further fact finding and elaboration that of merely raising the
plea. Without the existence of the product, a plea which has been
inadequately set up by the defendants purely on academic basis lying
a distinction between amorphous and monohydrate nature of
DASATINIB is merely a bald defence which is required to be
substantiated during the course of the trial. There exists a distinction
between the credible nature of the defence affecting the validity of the
patent vis-a-vis a bald defence of non infringing product to the claim
of infringement. The later form is not the question affecting the
validity of the patent and thus doubts of the invalidity in such a case
cannot be inferred on the suit patent. It is only to escape the charge
of the infringement, such a defence is raised. Therefore, the mere
fact that the defence as to non infringement is deferred to the trial for
further substantiation of facts does not warrant the variation of the
interim order till the time the defence raised by the defendants are
fully substantiated. At this prima facie stage, I find that in case the
defendants maintains the position is that the monohydrate version of
the DASATINIB product is not covered in the suit patent and the
defendants' product is monohydrate version of the DASATINIB which
is yet to be launched, then there was no occasion for the defendants
to contest the suit patent so vehemently or challenging its validity on
several scores though it is the statutory right of the defendants to
challenge the validity. On the contrary, the defendants are doing so
which means that there is some more facts which are to be brought
into light and the defendants are also unsure as to whether the suit
patent covers all forms of the DASATINIB or not. In such event, I
would refrain from upsetting the status quo in the form of ad interim
injunction which has already been operating merely on the ground
that the proposed product to be launched by the defendants which is
yet to the see the light of the day is the form of the DASATINIB drug
is not covered by the suit patent. If that is so, the status quo as on
date does not harm the defendants, but this Court would refrain from
commenting anything on the same till the facts are completely
brought into light during the voyage of the trial.
82. In view of the above discussion, it is seen that the defences
raised by the defendants are prima facie not credible but vague or
bald which require more factual foundation. The patent No. IN
203937 is an old patent and has been on the register for 15 years. It
is settled law that in the case of old patents there is a kind of
presumption of validity in the form of the continuance and perpetuity
arises unless controverted with the strong evidence to the contrary.
There has been no pre-grant or post-grant opposition or a
revocation that has been filed against IN 203937.
83. This Court in Strix Limited v. Maharaja Appliances Limited
[MIPR 2010(1) 0181] has held that:
"22. ..... In order to raise a credible challenge to the
validity of a patent, even at an interlocutory stage, the
Defendant will have to place on record some acceptable
scientific material, supported or explained by the evidence
of an expert, that the Plaintiff's patent is prima facie
vulnerable to revocation. The burden on the Defendant
here is greater on account of the fact that there was no
opposition, pre-grant or post-grant, to the Plaintiff's
patent."
84. The Division Bench of this Court in the case of Telemecanique
& Controls (I) Limited vs. Schneider Electric Industries SA, 2002
(24) PTC 632 (Del) (DB), in paras 28, 30 and 31 held as under :
"28. A further aspect which has to be analysed arose from
the subsequent application filed by the appellant IA
6504/2000 alleging that the patents of the respondent had
not been worked and since they were not being
commercially exploited, no injunction could be granted in
favor of the respondent. This plea is sought to be again
forcefully contended before us by counsel for the appellant.
The Division Bench judgment of this court in Franz Cavern
Huemer v. New Yash Engineers 1996 PTC (16) 232 has
been considered by the learned Single Judge. There can
be no doubt about the proposition that since the patents
create a monopoly, they must be commercially exploited
and the parties are not to only register a patent and sit tight
over it. However, Mr. Rohatgi, learned senior counsel for
the respondent sought to rely on the statement of working
of patents filed in the year 1998-99 to contend that the
patents are being exploited and thus the present case
would not fall within the parameters laid down in Franz
Xaver's case (supra) to categories the patents in the
present case as one which are not commercially exploited
and thus leading to a conclusion that public was being
denied the benefit of such patents by its lack of user. The
learned Single Judge accepting this contention concluded
that he was not satisfied at this stage that the five patents
are not being worked by the respondent in view of the
statement produced by the respondent for the year 1998-
99.
30. It has to be appreciated that undoubtedly patent
creates a statutory monopoly protecting the patentee
against any unlicensed user of the patented device. Thus
once a violation is established in case of a registered
patent, subject of course, to the patent being used, it will
not be permissible to contend that the said patentee is not
entitled to an injunction. A monopoly of the patent is the
reward of the inventor. It is also to be appreciated that law
of the patent is slightly different from the law of copyright
and trademark as the patent is granted only for a period of
14 years. It is also relevant to note that in the agreement of
technical services dated 28.11.94 there is no mandate for
the appellant to provide technical information to the
appellant in respect of the manufacture of any other items
but the only requirement is that the same can be done if
terms and conditions are agreed upon between the parties.
If the respondent would have provided D2 range of
products to the appellant it would have been entitled to
royalty in terms of Clause 6.4 of the said agreement. It is
thus difficult to believe, as stated above, that there could be
a license to copy and that is a major factor which has
weighed with us in deciding the present appeal. It may also
be added that Section 83 of the Patent Act, 1970 falls
under Chapter XVI dealing with the working of patents,
compulsory licenses, licenses of right and revocation.
Section 83 by its wording refers to the exercise of powers
conferred by the said Chapter and thus in view of their
being exploitation of the patent in the country by sale of
product by the respondent, the public is getting the product
and is not deprived of its benefit.
31. We would also like to note that while making
submissions in rejoinder Mr. Arun Kathpalia, learned
counsel for the appellant, sought to make submissions that
in view of Section 83 read with Section 90(d) of the Patents
Act, 1970 the patent has to be worked out in India by
manufacture and not by import. Mr. Kathpalia sought to rely
on the commentary of Terrel on the Law of Patent, 13th
edition chapter X para 10.07, 10.09, 10.10, 10.13, 10.14
and 10.17. Mr. Kathpalia submitted that same principles
would apply in respect of the Indian law and thus in the
absence of definition of commercial scale, natural and
ordinary meaning should be given to the expression. He
submitted that in terms of the said treaties the general
principles set out are that a patentee must manufacture the
product in that country and it should not also be mere
improvements. We have, however, considered this aspect
aforesaid and have come to the conclusion that there is no
force in the submission of the appellant."
Quia Timet Action
85. As far as law with regard to Quia Timet Action is concerned, it
is settled law that such action is maintainable. If a party fears or
apprehends, who may obtain injunction to prevent some threatened
act being done which if done, would cause him substantial damage
and which money would not be an adequate or sufficient remedy. In
a quia timet action, in the absence of evidence if a strong case is
made out against the defendants, after valid justification, the interim
order may be passed by the Court. Reliance is placed on the
following decisions:-
i) Kuldip Singh versus Subhash Chander Jain & Ors., AIR
2000 SC 1410
"A qui timet action is a bill in equity. It is an action
preventive in nature and a specie 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 " (Para 7)
ii) Rohtas Industries Limited v. IHP.Co.Ltd., AIR 1954 PATNA
"Even proof of an intention to infringe, apart from actual
infringement, may justify an injunction to restrain the
infringement provided it is established to the satisfaction
of the court that the alleged infringer, dealing with what
he is doing as a matter of substance, is taking the
invention claimed by the patent." (Para 16)
86. Therefore, the suit for quia timet action is maintainable. No
further discussions are necessary on this issue.
87. It was observed in the judgment of Roche vs. Cipla (supra)
cited by the defendants, that the plaintiffs failed to establish prima
facie case of infringement and on the contrary, defendant
successfully raised credible challenge to the validity of the patent and
the Courts have accepted the plea of the defendants in that case on
the basis of defence raised. However, such circumstances are
missing in the present case.
88. Prima facie, it appears that the plaintiffs have got the valid
patent and the defences raised by the defendants do not enable the
court to find out any apparent concerns which can doubt the validity
of the patent but are those which require more fact finding and
substantiation prior to arriving to any such contrary view. In such
event, the plaintiffs have a prima facie case of the valid patent and
the alleged apprehension of the infringement where the defendants
have already taken the preparatory steps towards the manufacturing
of the products by obtaining the license etc.
Irreparable Harm
89. The defendants have not launched the product in the market,
no loss or irreparable harm will be caused to BDR if they are
restrained from doing activities that they have not yet commenced.
On the other hand, grave prejudice will be caused to the plaintiffs if
the defendants are allowed to manufacture and market generic
Dasatinib in which the patentee has the exclusive rights in IN 203937
under Section 48(a) of the Patents Act, 1970 especially at the time
when the defences raised by the defendants are prima facie less
credible and does not warrant any alteration of the already existing
status quo in the form of the interim injunction.
90. There are cases pending against three other generic
companies which have been filed by the plaintiffs for the infringement
of IN 203937. Injunctions are operating in two matters.
91. Even otherwise, where the Central Government is of the
opinion that a patent granted, which is exercised, is mischievous to
the State or generally prejudicial to the public after giving the notice
to the patentee, make a declaration under Section 66 of the Patents
Act, 1978 to the effect that the patent shall be deemed to be
removed. In the present case, no doubt, the defendants have taken
the plea of non-availability of product to all patents in India, as the
product in question is of first line product which is highly expensive
and the issue of public interest. The grounds which are available for
the person interested while seeking an application for the compulsory
licensing or revocation of the patent on the ground of non working of
the patent could be urged before the relevant authority which will
consider the matter and cannot be imported as a matter of defence to
the suit for infringement as the civil court hearing the suit for
infringement cannot transgress within the domain of the authority/
controller/Central Government which are distinct functionaries having
their powers and considerations specifically defined under the
specific provisions of the Act. Even under the World Trade
Organization Trip Agreement, Compulsory Licenses are recognized
in order to overcome barriers in accessing affordable medicines and
on other ground of non-workable of suit patent as per conditions
prescribed under Sections 83 and 84 of the Act.
92. Hence, if the patent is valid and the defendant has not been
able to establish prima-facie credible defence, the case of
infringement is made out. Under the said circumstances, public
interest is an exception to the patent, otherwise the rights granted
under Section 48 by the Sovereign towards monopoly would be
undermined. The plea of public interest may be invoked once the
Court would find that prima-facie the case of credible defence is
made out. In the present case, the defendants have not made any
representation to the Central Government by raising the plea of
public interest, expensive drug and fully non-availability of the drug in
question to the patients, nor has the Government exercised its
discretion under Section 66 of the Act.
93. The ad-interim injunction has been operating against the
defendants since 4th December 2009. It is an admitted position that
the defendants have not yet launched the generic version of
Dasatinib commercially in the market. No application for vacation has
been filed by the defendants for the last more than five years. No
request was made by the defendants to the Court during this period
to know their interest or intent to launch the product. Proxy war in the
Court at this stage cannot be permitted to allow. The conduct of the
parties is obviously paramount. Thus, the balance of convenience
tilts in favour of the plaintiffs otherwise.
94. The object of the injunction in patent matters is to protect the
patentee against the injury by violation of right for which he could not
be adequately compensated in damages recoverable in the action if
ultimately a decree for damages is passed. There is no rule in the
patent matters that a plaintiff must make out a prima-facie case. No
doubt, the Court must be satisfied that the claim(s) is not frivolous or
vexatious. An interim injunction may be granted if the defendant has
applied for a compulsory licence but he infringes the patent. The
interim injunction may also be passed in respect of single claim which
is valid even though other claims in the specific actions are not prima
facie valid.
95. The patent law in India is governed by Patents Act, 1970 as
amended in the year 2005. What constitutes infringement of a patent
is not denied in the Act. Thus, one has to gather the meaning of
infringement from the scope of the monopoly rights conferred on the
patentee for infringement is the violation of those rights. Section 48
confers on the patentee, his agents and licensees the exclusive rights
to make, use, exercise or distribute invention in India. The rights of
the patentee are infringed if anyone makes and supplies or
commercially uses and the patentee may be granted interim order,
subject to the condition if the patent is valid. It is not incumbent upon
the plaintiff in case of infringement to show that the plaintiff has
suffered commercial loss.
96. In the present case, as per the conduct of the defendants,
prima-facie no credible challenge has been made, rather they have
admitted infringement in their pleadings. The defendants in both the
matters are connected with others, hence it is immaterial if two
companies are different entity. Their main intent is to manufacture
and sell the product in question.
97. In view of the above said reasons if defendants would be
allowed to commence the infringement in full knowledge of the
patentee invention, the plaintiffs would suffer injury and irreparable
harm.
98. On the balance of convenience in a quia timet action the House
of Lords, in American Cyanamid Company v. Ethicon Limited
[1975 FSR (1) 101], held that:
"Where other factors appear to be evenly balanced it is a
counsel of prudence to take such measures as are
calculated to preserve the status quo. If the defendant is
enjoined temporarily from doing something that he has
not done before, the only effect of the interlocutory
injunction in the event of his succeeding at the trial is to
postpone the date at which he is able to embark upon a
course of action which he has not previously found it
necessary to undertake ; whereas to interrupt him in the
conduct of an established enter- prise would cause much
greater inconvenience to him since he would have to start
again to establish it in the event of his succeeding at the
trial."
A similar approach has been taken by the Supreme Court in
India in the cases of Wander Ltd. & Anr. V. Antox India P. Ltd.
[(1990) Supp.SCC 727] and Colgate Palmolive (India) Ltd. v.
Hindustan Lever Ltd. [(1999) 7 SCC 1].
99. For the aforesaid reasons and in view of the facts and
circumstances, the interim order passed on 4th December, 2009 in
CS(OS) No.2303 of 2009 shall continue during the trial and the same
shall also apply to the parties in CS(OS) No.679 of 2013. The
prayers in both the applications are allowed by disposing of I.A.
Nos.15720/2009 and 5910/2013.
100. However, it is made clear that the defendants no doubt are at
liberty to move the fresh application for compulsory license with the
Controller of Patents or voluntary license with the plaintiffs as per law
as the defendants earlier application was rejected due to non
compliance but the liberty granted to the defendants does not
tantamount to allow or disallow such application(s) as the defendants
have to comply with the due process. Such petition(s)/application(s)
cannot be decided as per demand or as per defendants' whims and
fancy. The same has to be considered on merit and if so filed it
would be decided without any influence of the order passed in these
applications. Even otherwise, the findings are tentative and shall
have no bearing when the suit would be finally decided by the Court
after recording the evidence.
(MANMOHAN SINGH)
JUDGE
JUNE 29, 2015
