Delhi High Court
Astrazeneca Ab & Anr. vs Micro Labs Limited on 18 November, 2020
$~
* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Reserved on: 23rd, October, 2020
Decided on: 18th November, 2020
+ I.A. 6931/2020 (under Order XXXIX Rule 1 and 2 CPC)
in
CS(COMM) 323/2020
ASTRAZENECA AB & ANR. ..... Plaintiffs
Represented by: Mr.Pravin Anand, Ms.Vaishali Mittal,
Mr.Siddhant Chamola, Mr.Rohin
Koolwal, Ms.Devyani Nath,
Mr.Souradeep Mukhopadhyay,
Advocates.
versus
TORRENT PHARMACEUTICALS LTD. ...... Defendant
Represented by: Mr.Sandeep Sethi, Sr. Advocate
with Mr.S.Majumdar, Mrs.Suhrita
Majumdar, Mr.Dominic Alvares,
Mr.Afzal B. Khan and Mr.Samik
Mukherjee, Advocates.
+ I.A.7399/2020 (under Order XXXIX Rule 1 and 2 CPC)
I.A.9484/2020 (under Order XXXIX Rule 4 CPC-by defendant)
in
CS(COMM) 346/2020
ASTRAZENECA AB & ANR. ..... Plaintiffs
Represented by: Mr.Pravin Anand, Advocate with
Ms.Vaishali Mittal, Mr.Siddhant
Chamola, Mr.Rohin Koolwal,
Ms.Devyani Nath, Mr.Souradeep M.,
Advocates.
versus
MICRO LABS LIMITED. ..... Defendant
Represented by: Mr.C.S.Vaidyanathan, Sr.Advocate
Ms.Bitika Sharma, Mr.Adarsh
Ms.Namrita Kochar, Ms.Nitya Sharma,
Signature Not Verified
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Mr. Devanshu Khanna, Ms.Vrinda
Pathak, Mr.Akshay Nagarajan,
Advocates.
Mr.J.Sai Deepak, Advocate
+ I.A. 8940/2020 (under Order XXXIX Rule 1 and 2 CPC)
in
CS(COMM) 414/2020
ASTRAZENECA AB & ANR. ..... Plaintiffs
Represented by: Mr.C.Aryama Sundaram, Sr.Advocate
with Mr.Pravin Anand, Ms.Vaishali
Mittal, Mr.Siddhant Chamola,
Mr.Rohin Koolwal, Ms.Devyani Nath
and Mr.Souradeep Mukhopadhyay,
Advocates.
versus
ZYDUS HEALTHCARE LTD. & ANR. .... Defendants
Represented by: Mr.C.S.Vaidyanathan, Sr.Advocate
with Ms.Bitika Sharma, Mr.Adarsh
Ramanujjan, Ms. Namrita Kochhar,
Ms.Vrinda Pathak, Mr.Lakshay
Kaushik and Ms.Nitya Sharma,
Advocates.
+ I.A. 8991/2020 (under Order XXXIX Rule 1 and 2 CPC)
in
CS(COMM) 418/2020
ASTRAZENECA AB & ANR. ..... Plaintiffs
Represented by: Mr.Pravin Anand, Ms.Vaishali Mittal,
Mr.Siddhant Chamola, Mr.Rohin
Koolwal, Ms.Devyani Nath,
Mr.Souradeep Mukhopadhyay,
Advocates.
versus
ERIS LIFESCIENCES LTD. .... Defendant
Represented by: Mr.C.S.Vaidyanathan, Sr.Advocate
with Ms.Rajeshwari H., Mr.Tahir
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A.J., and Mr.Praveen Singh,
Advocates.
+ I.A. 8997/2020 (under Order XXXIX Rule 1 and 2 CPC)
in
CS(COMM) 419/2020
ASTRAZENECA AB & ANR. ..... Plaintiffs
Represented by: Mr.Pravin Anand, Ms.Vaishali Mittal,
Mr.Siddhant Chamola, Mr.Rohin
Koolwal, Ms.Devyani Nath,
Mr.Souradeep Mukhopadhyay,
Advocates.
versus
USV PVT. LTD. .... Defendant
Represented by: Mr.C.S.Vaidyanathan, Sr.Advocate
with Mr.J.Sai Deepak, Mr.G.Natrajan
and Mr.Avinash Sharma, Advocates.
+ I.A. 9075/2020 (under Order XXXIX Rule 1 and 2 CPC)
I.A.9316/2020 (under Order XXXIX Rule 4 CPC-by defendant)
in
CS(COMM) 426/2020
ASTRAZENECA AB & ANR. ..... Plaintiffs
Represented by: Mr.Sudhir Chandra, Sr. Advocate with
Mr.Pravin Anand, Ms.Vaishali Mittal,
Mr.Siddhant Chamola, Mr.Rohin
Koolwal, Ms.Devyani Nath and
Mr.Souradeep Mukhopadhyay,
Advocates.
versus
MSN LABORATORIES PVT. LTD. .... Defendant
Represented by: Mr.J. Sai Deepak, Mr.G.Natarajan and
Mr.Avinash Sharma, Advocates.
Signature Not Verified
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% Reserved on: 6th November, 2020
Decided on: 18th November, 2020
+ I.A.10168/2020 (Under Order XXXIX Rule 4 CPC-by defendant)
in
CS(COMM) 323/2020
ASTRAZENECA AB & ANR. ..... Plaintiffs
Represented by: Mr. Pravin Anand and Mr.Siddhant
Chamola, Advocates.
versus
TORRENT PHARMACEUTICALS LTD. ...... Defendant
Represented by: Mr. Afzal B. Khan, Advocate with
Mr. Samik Mukherjee, Advocate for
applicant.
CORAM:
HON'BLE MS. JUSTICE MUKTA GUPTA
Brief Facts of the Plaintiffs:
1.1 By the present suits, the plaintiffs have sought decree of permanent
injunction against the defendants and their employees and agents including
third parties, for restraining them from manufacturing, selling, online
retailing of the products comprising of the compound Dapagliflozin thereby
infringing the patent owned by the plaintiffs being IN 235625 (in short, IN
625) besides damages and rendition of accounts in respect of the
infringement of the patents IN 205147 (in short, IN 147) and IN 625.
1.2 By the present applications, the plaintiffs seek a temporary injunction
restraining the defendants from manufacturing, selling, retailing etc. the
compound Dapagliflozin thereby infringing the plaintiffs‟ patent IN 625,
rendition of accounts and an ex parte relief in terms thereof. Since interim
injunctions were granted in CS(COMM) 323/2020, CS(COMM)
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CS(COMM) 426/2020 and CS(COMM) 346/2020, applications under Order
XXXIX Rule 4 CPC have been filed therein.
1.3 The defendants in the present suits are Torrent Pharmaceuticals Ltd.
(in short 'Torrent'), Micro Labs Limited (in short ''Micro Labs'), Zydus
Healthcare Ltd.(in short 'Zydus'), ERIS Lifesciences Ltd. (in short 'ERIS'),
USV Pvt. Ltd. (in short 'USV') and MSN Laboratories Pvt. Ltd. (in short
'MSN').
1.4 Plaintiff No.1 Astrazeneca AB is a company organized and existing
under the laws of Sweeden operating as a subsidiary of Astrazeneca PLC.
Plaintiff No.2 Astrazeneca Pharma India Limited is a company incorporated
under the laws of India and an Indian subsidiary of Astrazeneca marketing
pharmaceutical products in the domestic market. By the suit patent IN
235625 (in short IN „625) which is the species patent of IN 205147 the
genus patent, plaintiffs claim to have invented the pharmaceutical
composition i.e. Dapagliflozin which is a molecule having the chemical
formula (2S, 3R, 4R, 5S, 6R) -2-[4-Chloro-3-(4-ethoxybenzyl)phenyl]-6-
(hydroxymethyl)tetrahdro-2H-Pyran-3,4,5-triol.
1.5 According to the plaintiff Dapagliflozin has proven to be an effective
Sodium-Glucose co-Transporter 2 (in short SGLT2) inhibitor indicated for
managing diabetes mellitus type 2. SGLT2 protein is a transporter protein
majorly responsible for the reuptake of the glucose in the proximal tubule,
thus playing a crucial role in maintaining a balance between the levels of
glucose excretion as well as plasma glucose level by modulating what
proportion of sugar filtered by the kidneys gets reabsorbed in the blood
plasma. In view of Dapagliflozin working in reduction in re-absorption of
the glucose, the same has turned out to be very effective in control of
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diabetes and diabetic complication such as retinopathy, neuropathy,
nephropathy, wound healing and related diseases. The plaintiff‟s distributor
in India, namely Sun Pharma Laboratories Limited and Abbott Healthcare
Private Limited make drugs comprising of Dapagliflozin, such as OXRA,
OXAMET, OXMET IR, OXRAMET XR and GLEDEPA, GLEDEPA MET
IR and GLEDEPA MET XR.
1.6 Plaintiff No.1 is the registered holder of the patent IN '147 having the
title 'A C-ARYL GLUCOSIDE' wherein the plaintiffs claimed the Markush
structure which covered numerous compounds and based on various
permutations and combination, quadrillion compounds could be prepared.
The relevant bibliographic chart of the genus patent is as under:-
Application IN/PCT/2002/00433/MUM
Number
Applicant AstraZeneca AB
Name
PCT October 02, 2000 Genus Patent
International
Filing Date
Priority date October 12,1999
S.11A March 18, 2005
Publication
Date
Date of Grant March 15, 2007
Date of Patent October 02, 2020
Expiry
1.7 Plaintiff No.1 is also the registered holder of species patent IN '625 "A
COMPOUND (2S, 3R, 4R,5S,6R)-2(4-CHLORO-3(4-ETHOXYBENZYL)
PHENYL)-6 (HYDROXYMETHL) TETRAHYDRO-2H-PYRAN-3, 4, 5-
TRIOL AND COMPOSITION COMPRISING THE SAME", which was
prepared after further research and development and received on assignment
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from Bristol Myers Squibb Company. The bibliographic details thereof are
as under:-
Application 3573/DELNP/2004
Number
Applicant AstraZeneca AB
Name
Date of Filing November 16, 2004 Species patent
PCT May 15, 2003
International
Filing Date
Priority Date May 20, 2002
Publication April 01, 2005
Date (u/s 11A)
Date of Grant July 09, 2009
Date of Patent May 15, 2023
Expiry
1.8 According to the plaintiff the suit patent is valid in approximately 60
countries worldwide. It is the case of the plaintiff that IN „625 is a valid and
subsisting patent and neither any pre-grant nor post-grant opposition was
filed thereto except a post-grant opposition copy received by the plaintiff on
16th May, 2020 filed by the defendant/ TORRENT seeking revocation of the
patent almost 11 years of the grant of the patent.
1.9 Since the defendants challenged the validity of the suit patent, learned
counsels for the defendants addressed the arguments at length in the first
instance which was replied by the learned counsels for the plaintiffs.
Arguments on behalf of the parties were addressed on number of dates on
day to day basis.
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Contentions of Mr.C.S.Vaidynathan, Sr.Counsel on behalf of
ZIDUS, ERIS and USV:-
2.1 Contention of Mr. C.S. Vaidyanathan, learned Senior Counsel for the
defendants is that contrary to the claim of the plaintiffs, a prima facie case
showing invalidity of the suit patent IN 625 is made out in favour of the
defendants, the balance of convenience also lies in favour of the defendants.
In case, an injunction is granted, the defendants would suffer an irreparable
loss and that public interest also demands that no injunction be granted.
According to the learned Senior counsel for the defendants, the plaintiffs
could not have been granted the suit patent IN '625 as a specie patent but
could have been granted as a patent of addition only. In the pleadings
plaintiffs claim that IN '625 is covered under the genus patent IN '147 i.e.
under its Markush Structure but IN '625 which claims Dapagliflozin was
not disclosed in IN '147. This argument of the plaintiffs cannot be accepted
as claim cannot be larger than the disclosure. This finding has already been
returned by the Supreme Court in the decision reported as (2013) 6 SCC 1
Novartis AG Vs. Union of India and Ors. Further, this argument of the
plaintiffs is hit by Section 10 of the Patents Act. Even as per the definitions
under Sections 2(j) and 2(1)(ja) of the Patents Act, the species patent cannot
be held to be an invention or an inventive step involving technical
advancement. Further, the defendants have placed on record affidavits of
expert and at this stage, the defendants are not relying upon the affidavit of
Dr. Sanjay Desai, who is an employee of the defendants but on the affidavit
of Dr. Bipin Pandey, an independent witness who is Ph.D. in Organic
Chemistry from IIT Kanpur. In his affidavit, Dr. Bipin Pandey has stated
that on going through examples of IN '147, it is clear from Example 11, 12,
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70, 71 and 72 that halogen, preferably chlorine atom is a preferred
substituent for R1 and for R4, O-lower alkyl is a preferred compound. Thus,
the selection of R4 as ethoxy (-OEt group) will not be an undue burden to a
skilled person. As per this affidavit, the compound Dapagliflozin is
disclosed and claimed in IN 147 and preparation of compound as per
example 12 can be considered to be the closest analog to Dapagliflozin, the
only difference between the two being an-OEt (Et = ethyl groups, a lower
alkyl) in Dapagliflozin instead of an -OMe (Me=methyl group, a lower
alkyl) in example 12.
2.2 Learned Senior counsel for the defendants further contends that
though no affidavit of an expert was filed with the plaint, plaintiffs have
filed the affidavit of Mr.William N. Washburn, who is the co-author and
inventor of Dapagliflozin as an additional document filed on 6th October,
2020. However, the said witness deals with the objections of Natco Pharma
Limited only i.e. Dapagliflozin does not demonstrate increased efficacy and
the compound is obvious and anticipated. Hence, the affidavit by this
witness is of no use as it does not deal with the issue that the specie patent is
already disclosed in the genus patent.
2.3 Learned Senior counsel for the defendants further states that the suit
patent is also invalid for non-compliance of Section 8 as neither before the
Indian Patent Office while seeking the patent IN 625 nor before this Court,
the plaintiffs have disclosed that in the corresponding US patent, an
objection was raised by the US Patent Office on 25 th July 2002 stating that
the claims 1 to 17 of the corresponding US patents were rejected under the
judicially created Doctrine of Double Patenting unless a timely terminal
disclaimer was filed to overcome an actual or provisional rejection. In
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response to this objection by the US Patent Office, the plaintiffs filed their
terminal disclaimer on 14th August, 2002, therefore accepting that any patent
granted on the said application shall be enforceable only for enduring such
period as that of the prior genus patent US No. 6, 414, 126 (in short US
'126). Based on the terminal disclosure application plaintiffs were granted
the species patent US '6515117 (in short US '117) equivalent to IN '625. In
view of concealment of this document before the Indian Patent Office, the
Indian Patent Office did not have the complete record to form an opinion
thereon and hence, the suit patent IN 625 is invalid. Therefore, the
defendants have raised a credible defence of invalidity under Section 64 of
the Patents Act and not merely a triable issue, hence, there is no prima facie
case made out in favour of the plaintiff.
2.4 Further, the plaintiffs are bound by the admissions made in respect of
the claims made in the Orange Book and Form 27 besides the admission
before the US Patent Office while seeking terminal disclaimer.
2.5 It is further contended that the balance of convenience also lies in
favour of the defendants and in case, an injunction is granted, the defendants
would suffer an irreparable loss. It is stated that as per the pleadings the
only grievance of the plaintiffs is that the defendants have not taken a
licence. Thus, the ultimate claim of the plaintiffs is by way of royalty. The
plaintiffs are selling the drug with the compound Dapagliflozin by importing
the same and has given licence to two companies i.e. Sun Pharmaceuticals
and Abbot India Ltd. A perusal of the sales figures of the plaintiffs in para
68 of the plaint would show that half of the sales of the plaintiffs are through
import and half through licences. Thus, even if the plaintiffs succeed in the
suit, they would be entitled to the royalty and the defendants are ready and
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willing to submit their accounts before this Court. The defendants are
already selling the compound Dapagliflozin from 3rd October, 2020 and if
injuncted, would suffer an irreparable loss. The medicines sold by the
defendants is much cheaper in comparison to that of the plaintiffs and hence,
public interest also requires the drug being made available for Diabetic
patients, at lower prices.
2.6. Reliance of the learned counsel for the plaintiffs on the earlier interim
orders and decree passed by this Court is misconceived for the reason, in
none of those suits, challenge to the validity of the suit patent was argued
before this Court. Reliance is also placed on the decisions reported as
1994(56) DLT 673 Ravi Raj Gupta vs Acme Glass Mosaic Industries, AIR
1996 Cal 367 Hindustan Lever Limited v. Godrej Soaps Limited and Others,
2010 (167) DLT 6 Glaverbel S.A v. Dave Rose & Ors., 2014 (59) PTC 234
Sandeep Jaidka v Mukesh Mittal, 2010 FC 46 Biovail Corporation &
Depomed, Inc. & The Minister of Health & Apotex Inc. (Federal Court of
Canada), (1979) 2 SCC 511 Bishwanath Prasad Radhey Shyam v. Hindustan
Metal Industries, 2009 (110) DRJ 452 Hoffman La Roche v. Cipla (DB),
MIPR 2014 (3) 0004 3M Innovative Properties Company v. Venus Safety
Health Pvt. Ltd., [2005] UKHL 59 Synthon Case (decision of the House of
Lords in Synthon BV (Appellants) v. Smithkline Beecham plc (Respondents),
[1995] RPC 255 Glaverbel SA v. British Coal Corporation, , MIPR 2014 (3)
00043 M Innovative Properties Company v. Venus Safety Health Pvt. Ltd..
Contentions of Mr.Sandeep Sethi, Sr.Counsel on behalf of
TORRENT:-
3.1 In addition to the contentions in respect to the invalidity of the suit
patent on the ground of disclosure in the genus patent, admissions of
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plaintiffs in the pleadings, orange book and Form 27 filed by plaintiffs,
learned Senior counsel for the Torrent has taken two other substantial
objections one being the non-compliance of Section 8(1) and 8(2) of the
Patents Act and second being the fact that in view of the plaintiff not having
deposited its renewal fee the plaintiff‟s suit patent lapsed and in the absence
of the same being republished in the Gazette, the plaintiff as on date does
not have a valid and subsisting patent IN „625.
3.2 According to learned counsel for the defendant the basic requirements
under Section 8(1) of the Patents Act are that the applicant shall file along
with his application or subsequently within the period prescribed as referred
under Rule 12 of the Patents Rule, firstly, a statement setting details of any
application for patent being prosecuted in any country outside India in
respect of the same or substantially the same invention and secondly, an
undertaking that up to the date of grant of patent in India, the applicant
would keep the Controller informed in writing, from time to time of detailed
particulars as required under Section Clause 8 in respect of every other
application relating to the same or substantially the same invention filed in
any country outside India subsequently to the filing of the statement referred
to hereinabove. Thus under Section 8(1) the obligation on the applicant
does not depend upon any inquiry from the Controller but such an obligation
arises at the time of filing the patent application itself and continues till the
grant of the patent. Under Section 8(2) an obligation is cast on the applicant
from the time of filing the application till the grant or refusal of the patent
that if the Controller requires the applicant to furnish details, as may be
prescribed, relating to the processing of any application in any country
outside India, the applicant shall furnish to the Controller information
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available to him within such period as may be prescribed.
3.3 According to learned Senior counsel for the defendant, the plaintiff
has violated the mandate of both Section 8(1) and 8(2) of the Patents Act
inasmuch as the plaintiff filed an application as continuation in part-
application to the US genus patent US '126 which was granted as US '117
equivalent to the suit patent IN „625. The plaintiffs however did not file the
objection of the USPTO which rejected the claim of the plaintiff in
continuation in part-application, giving him an option for filing a terminal
disclaimer wherein the plaintiff opted to file an application for terminal
disclaimer. By merely giving the date and number of granted genus patent
and the species patent granted as a continuation in part, the plaintiff‟s
requirement of a complete disclosure before the Indian Patent Office in
respect of the disclosure of objections raised by the USPTO and the plaintiff
offering to convert the same to a terminal disclosure is not met. The
plaintiff was under an obligation to disclose these facts under Section 8(1)
and in any case on being required to furnish the details by the Controller
under Section 8(2) the relevant documents were required to be submitted
before the Indian Patents Office. Thus, the plaintiff consciously suppressed
the fact that the US equivalent of IN „625 was objected to on the ground of
double patenting, a concept equally prescribed under the Indian law.
Further, the plaintiff also did not disclose the rejection of the Columbian
equivalent of IN „147.
3.4 Reliance is placed on the Ayyangar Committee‟s report in respect of
the interpretation of Section 8 of the Act, particularly in respect of the patent
of addition. Reliance is also placed on the decision in
MANU/DE/1880/2009 Chemtura Corporation Vs. Union of India & Ors.;
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MANU/DE/2785/2014 Sukesh Behl v. Koninklijke Phillips Electronics;
(2015) SCConline Del 13619 F. Hoffmann-La Roche Ltd. v. Cipla Ltd.
3.5 The second objection of Torrent to the validity of the suit patent is in
respect of the suit patent having lapsed for want of paying the renewal fee.
It is stated that even if the renewal fee was paid belatedly, the suit patent
was required to be republished and could not have restored once it had
lapsed. According to the defendant suit patent was published on 31st July,
2009 and the date of recordal was 27th January, 2010. The plaintiff was
required to pay the accumulated renewal fee within three months i.e. 27 th
April, 2010, however, though due to the lapse of the patent office no
payment of renewal fee was made, the patent lapsed on 27th April, 2010. On
27th April, 2011 the plaintiff filed a petition under Rule 137 of the Patents
Rule 2003 to keep the patent alive which was allowed by the Patent Office
on 4th July, 2011. On 15th May, 2020 the defendant filed a representation
before the Patent office challenging the severe irregularity which
representation was dismissed on 13th July, 2020. The Patent office not only
noted that the renewal fees was not paid but also noted that the patent had
not been published in the post-grant journal and directed the publication
within 15 days. In this regard proceedings between the plaintiff and
defendant are pending in a writ petition, however for the purposes of the
present suit contention of the defendant is that the suit patent having lapsed
once, it could not have been restored without an application under Section
60/61 of the Patents Act read with Rule 84 to 86 of the Patents Rules and
without the patent being published. The suit patent according to the
defendant Torrent has thus lapsed and is invalid. Reliance is placed on the
decision in (2014) 15 SCC 360 Alloys Wobben & Anr. v. Yogesh Mehra &
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Ors.
Contentions of Mr.S.Majumdar, Counsel on behalf of TORRENT
4.1 Mr. S. Majumdar, learned counsel on behalf of Torrent further
submits that the suit patent IN „625 is hit by anticipation due to prior
claiming. He states that there is a distinction between anticipation by prior
claiming and anticipation by prior publication. For a suit patent to be
revoked under Section 64(1)(a) no prior publication is required. However, if
there is a prior patent for the same invention, no second patent can be
granted. Even the definition of invention under Section 2(1)(j) of the Act
provides that invention means a new product or process involving an
inventive step and capable of industrial application. Therefore, the
invention should be either a product or a process and consequently there is
bound to be a conflict.
4.2 A perusal of the specification of the species patent IN „625 as against
the genus patent IN „147 reveals that no disclosure at all which amounts to
added matter not disclosed in the genus patent with respect to the compound
Dapagliflozin exists. Further, mere details of synthesis being the process for
making Dapagliflozin does not show any advantage possessed by the
purported selected member of the species patent IN „625 over the genus
patent. A hindsight analysis may be impermissible in obviousness but is not
applicable to an objection of prior claiming and anticipation.
4.3 Relying upon the decision in (1970) R.P.C.; No.10 Ethyl Corporation
(Cook‟s) Patent, it is contended that just as in cases of anticipation and
obviousness, a claim is bad if it includes something within it which is shown
to be old or obvious, so also in prior claim by analogy if a latter claim
includes something already claimed in an earlier claim it is prima facie bad
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until amended. Based on the three typical instances of conflict between a
prior claim cited therein it is contended that a narrower latter claim which
falls wholly within the broader areas of the disclosure of an earlier published
prior document is hit by anticipation unless the patentee of the latter
invention can show that he has selected an area from the prior broad
disclosure which gives advantages beyond or different from those disclosed
by the prior document. It is thus contended that the concept of selection
patent necessitates that the advantage possessed by the selected member
must be clearly disclosed in the specification of the species patent.
4.4 Reliance is also placed on the decision in (2006) SCA 1194 Apotex
Vs. Sanofi wherein the established principle in the context of anticipation
were laid down in (930) 47 RPC 289 Re I.G. Farbenindustrie A.G. it is
contended that Dr. Washburn‟s affidavits cannot be treated as disclosure in
the specification and the said affidavit being an opinion of the inventor it
cannot be relied upon at this stage without the same being tested on the anvil
of cross-examination.
4.5 Relying upon the decision in Simpleair, Inc. Vs. Google LLC, it is
stated that a terminal disclaimer is a strong clue that a patent examiner and,
by concession, the applicant, through the claims in the continuation lacked a
patentable distinction over the parent. It is further stated that grant of a
patent does not lead to any presumption of validity as provided under
Section 13(4) of the Patents Act.
Contentions of Mr.J.Sai Deepak, Counsel on behalf of MSN and
USV
5.1 Though in the opening argument Mr.J. Sai Deepak, learned counsel
for the defendants MSN and USV took the plea of disclosure of the
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pharmaceutical composition Dapagliflozin in IN „147 i.e. Dapagliflozin was
disclosed prior to IN „625 the species patent and hence the same is invalid,
however in the rejoinder argument learned counsel for the defendant also
argued vulnerability of IN „625 on the ground of prior claiming in view
Section 13(1)(b) read with Section 64(1)(a) of the Patent Act, on the basis of
prior publication in terms of Section 13(2) read with Section 64(1)(e) of the
Act and obviousness under Section 64(1)(f) of the Patents Act.
5.2 It is contended that IN „625 is liable to be revoked under Section
64(1)(a) read with Section 13(1)(b) and Section 107 of the Act. Section
13(1)(b) requires the patent examiner to investigate the subject matter
claimed under examination in a patent application to see if any claim of
another complete specification filed in India, having a priority date earlier
than the filing date of complete specification in the subsequent application.
Since IN „147 has an earlier priority date than IN „625, therefore IN 625 is
anticipated by prior claiming within the meaning of Section 13(1)(b) to the
extent it too claims Dapaglifozin. The significance of Section 13(1)(b) read
with Section 64(1)(a) is that unlike other grounds of anticipation which
require prior publication of the document sought to be used as anticipatory
prior art, Section 13(1)(b) expressly permits the use of only an Indian Patent
application or Indian patent which was published subsequent to the priority
date of the challenged patent but has a priority date earlier than the
challenged patent. The object of the provision is to ensure that no patent
applicant takes the Patent Office for a ride by filing multiple patent
applications covering the same subject matter. Under Section 64(1)(a) read
with 13(1)(b) only coverage of the subject matter by a prior claim is required
and there is no requirement of disclosure whatsoever. Therefore, the plea of
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the plaintiffs that IN „147 only covers Dapagliflozin but does not expressly
disclose is of no help or consequence to the plaintiff and in view of the prior
claiming of Dapagliflozin in the claims of IN‟147 the consequences in terms
of Section 64(1)(a) must follow, whether or not Dapagliflozin is disclosed in
IN „147. This submission of the defendant is without prejudice to the
submission that Dapagliflozin is disclosed in IN „147.
5.3 The suit patent IN „625 is also liable to be revoked in terms of Section
13(2) read with Section 64(1)(e) of the Patent Act on the grounds of lack of
novelty due to prior publication of WO2001/27128 which is PCT equivalent
of the genus patent IN „147. WO2001/27128 was published on 19 th April,
2001 whereas the priority date of IN „625 is 20th May, 2002.
5.4 The detailed descriptions of IN ‟625 matches with the descriptions of
WO „128. WO „128 discloses C-aryl glucosides which are inhibitors of
Sodium dependent glucose transporters found in the intestine and kidney
(SGLT2). It is submitted that in Korea the concerned authority i.e. the
Korean IP Tribunal and Appellate Board invalidated KR 101021752,
equivalent to the species patent IN „625, based on WO „128 on the ground of
lack of novelty. Further, WO 128 is also relevant to challenge the alleged
inventive step of IN „625 i.e. IN „625 is obvious in the light of the claims
and disclosure of IN „147, based on the state of art on its priority date.
5.5 Leaned counsel reiterates the arguments in relation to concealment
under Section 8 of the Act and relies upon the decision in Chemtura
Corporation (supra) and Maj. (Retd.) Sukesh Behl & Anr. Vs. K. Philip
Electronics.
5.6 It is further contended that since the US species patent application
resulting in grant of US „117 was filed as a continuation-in-part application,
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which is akin to a patent of addition under Section 54 of the Patents Act, the
term of the two Indian patents i.e. IN „147 and IN „625 should also be the
same and IN „625 ought to be treated as a patent of addition and
consequently expired on 2nd October, 2020. Further, the plaintiffs also did
not submit before the Indian Patent Office, the rejection of the Colombian
equivalent of IN „147 and thus suppressed material facts.
5.7 According to Mr. Sai Deepak, learned Advocate appearing on behalf
of USV and MSN since the defendant launched its product after expiry of IN
„147 on 2nd October, 2020, the same did not amount to infringement and it
actually constitutes sufficient "clearing of the way". Since IN „147 claims
Dapagliflozin and its composition, on expiry of IN „147 the defendants
were entitled to use the information contained in such patent without legal
bar or hindrance and the same does not amount to infringement. Under
Section 13(4) of the Patents Act a patent enjoys no presumptive validity
despite having been granted as held in 1979 (2) SCC 511 Bishwanath
Prasad Radhey Shyam Vs. Hindustan Metal Industry. Since the defendant
has laid credible challenge to the validity of the suit patent and the challenge
being not vexatious as held by the Division Bench in F. Hoffman La Roche
& Anr. (supra) 2009 (110) DRJ 452 (DB), the plaintiff is not entitled to any
interim injunction.
5.8 According to the defendant as a matter of fact a case is made out for
summary dismissal of the suit under Order XIII-A CPC even without a trial
based on the documents of the plaintiff. In view of the own admission of the
plaintiffs on 2nd October, 2020 the plaint is required to be rejected under
Order VII Rule 11 CPC in terms of Section 53(4) of the Act. Further, while
the plaintiff filed along with the suit, the grant of Patent Term Extension
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(PTE) by the USPTO to US „117, they did not file the application for (PTE)
filed by the plaintiffs before USPTO in respect of US „126. Further,
pursuant to the final notice for election on 10th July, 2020 the plaintiffs
elected US „117 for grant of PTE, as a consequence of which only US „117
was granted the PTE. Also the plaintiff submitted before the USFDA that
US „126 which is equivalent to IN „147' covers Dapagliflozin. Moreover,
Dapagliflozin is covered at least by the claims, 1, 14, 15 & 26 of the genus
patent IN „147', as asserted by the plaintiffs in infringement proceedings
against the third parties in the US, in particular claim suit filed against
Zydus Pharmaceuticals (USA) Inc on 1st May, 2018. It is thus contended
that in view of the repeated admissions of the plaintiff that Dapagliflozin is
covered within the scope of the claims of the genus patent IN „147 the bar
under Section 53(4) of the Patents Act is triggered.
5.9 It is contended that not only have the defendants demolished the
plaintiff‟s claim of a prima facie case, even the balance of convenience and
irreparable harm lies in favour of the defendant because it would be both in
the interest of the public as also the rights of the defendants that no interim
injunction is granted and the interim injunction granted in the case of MSN
is vacated.
Contentions of Ms. Rajeshwari, Counsel on behalf of ERIS
6.1 Addressing further arguments Ms. Rajeshwari, Advocate, learned
counsel for ERIS contends that IN „625 is not a valid patent as the
compound Dapagliflozin is disclosed and thus anticipated by
WO2001/027128 (WO „128 which is the international publication of IN
„147). It is stated WO „128 is a prior art published prior to the priority date
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of IN „625. The contention of the plaintiff that IN „147 was published only
after 2005 and not a prior art is incorrect, since IN „147 was published as
WO „128 prior to the priority date of IN „625 and thus acts as prior art. It is
stated that WO „128 discloses several C-aryl glucoside compounds and also
provides a list of preferred compounds. Within the class of these preferred
compounds is one where R5a is lower alkyl; which could be thus methyl,
ethyl, propyl, etc. Further, R1 is a halogen preferably chlorine or fluorine.
Thus, Dapagliflozin is one of the compounds which is embraced within the
disclosure of WO „128.
6.2 Referring to the decision in re Petering (301 F.2d 676) it is contended
that even in case of markush, the publication would be deemed to describe
the individual compound even though it did not spell out the compounds
embraced by that markush. It is sufficient if a person of ordinary skill in the
art is able to arrive at the compound using the prior art specification and his
knowledge and there is no requirement under the Patents Act for the prior art
to disclose the claimed compound by structure and formula. Reliance is
placed on the decision in 1972 RPC 457 General Tire & Rubber Company
Vs. Firestone & Ors. to determine whether the claims at hand are disclosed
by prior art by using the infringement test.
6.3. Relying upon the admissions of the plaintiffs wherein the plaintiffs
claim infringement of IN „147 by the defendant by manufacturing and
selling Dapagliflozin, in the Orange Book plaintiffs list US „126 (equivalent
to IN „147) as one of the patents and notified the world at large that it would
be infringed if Dapagliflozin was made. Plaintiffs filed identical working
statements in Form-27 for IN „147 and IN „625 listing Dapagliflozin as the
compound which has worked. Plaintiffs also filed Patent Term Extension
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(PTE) in respect of US „126 claiming that Dapagliflozin is disclosed therein.
6.4 IN „625 has failed as a selection patent in terms of the principles
governing the grant of genus - species patents laid down in Re: I.G.
Farbenindustrie A.G. (1930) 47 RPC 289. It is submitted that therefore a
selection patent must demonstrate "substantial advantage" or "technical
advancement". Further, data in support of the "technical advancement"
must be present in the specification. In the present case IN „625 has
miserably failed to provide even a bare minimal statement of "substantial
advantage" or "technical advancement" with respect to the compound
Dapagliflozin and in comparison with the compounds of IN „147.
Therefore, IN 625 does not qualify as a selection patent or a species patent.
6.5 Plaintiff has relied upon the affidavit of Dr. Washburn, the inventor,
to wriggle out of the lack of novelty, however the specifications as
demonstrated in the affidavit cannot cure the defect of lack of proper
disclosure of inventive steps in the original patent application of IN „625.
6.6 Relying upon the decision in Astrazeneca AB Vs. TevaUK Limited it is
stated that "clear the way" doctrine is not applicable while granting or
refusing injunction. Thus the plaintiffs have not made out a prima facie case
in their favour. The balance of convenience also lies in favour of the
defendants and if an injunction is granted not only the defendants would
suffer an irreparable loss, public interest would also suffer.
Contentions of Mr.C.A. Sundaram, Sr.Counsel, Mr. Sudhir
Chandra, Sr.Counsel and Mr.Pravin Anand, Counsel on behalf of
the Plaintiffs-
7.1 In the initial arguments, case of the defendants was that Dapagliflozin
was disclosed in IN„147, thus invalid, however, in rebuttal arguments the
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defendants particularly, the defendants in MSN and USV also challenged the
validity of the suit patent due to anticipation, prior claiming and
obviousness. Learned counsels for the plaintiffs contend that infringement
of IN„625 is not the issue in the present suits for the reason the defendants
agree that in case this Court finds IN„625 to be valid, the product being
manufactured and sold by the defendants infringes the plaintiffs‟ suit patent.
As noted above in the initial arguments, as against the claim of the plaintiff
that genus patent IN „147 covers Dapagliflozin vide the species patent
IN„625 discloses the compound, the case of the defendants was that
Dapagliflozin was not only covered but disclosed in IN„147.
7.2 It is the case of the plaintiffs that IN„147 relates to a different
invention from that disclosed in IN‟625, the former is the base structure or
core, which can have variables at specific positions and the probable
permutations thereof can run into millions. The invention in IN„147 is a
Markush structure common to all compounds which it covers and they all
have common properties namely SGLT2 inhibition to prevent glucose re-
absorption in the kidneys. However, IN„625 discloses a specific compound
„Dapagliflozin‟ which has proved to be the winning candidate and a
successful drug for Diabetes Type-2 mellitus having regard to efficacy,
toxicity and other drug like properties. The defence of anticipation as taken
by defendants in MSN and USV is inapplicable since the genus patent
IN„147 has been cited as a prior art but the said patent does not disclose
Dapagliflozin by name or chemical formula or chemical structure. Out of
the 80 examples disclosed in IN„147, Dapagliflozin is not one of them.
7.3 It is contended that the defendants in their pleadings have clearly
admitted that Dapagliflozin was first disclosed in US„117, particularly, MSN
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while filing its applications for their respective patents in the year 2014 and
2018 as also Zydus Cadila that Dapagliflozin was first disclosed in US„117,
equivalent to IN „625, the suit patent. Disclosure is a question of fact and
disclosure of an invention in a prior art document alone destroys novelty of
the subsequent patent for the said invention making it vulnerable to
invalidity. Even in the decision in Novartis (supra) Supreme Court notes
that there is a distinction between disclosure and coverage however, it is
cautioned that the gap between the two should not be wide. Therefore,
coverage cannot be deemed to be disclosure. The so called admissions used
by the plaintiffs in Form-27 in India or the orange book or patent term
extension in US etc. nowhere states that Dapagliflozin was disclosed in
genus patents US„126 or IN„147.
7.4 Though none of the defendants have attacked the validity of IN„147
however, in rejoinder arguments, indirectly the validity of IN '147 is also
sought to be challenged on the basis of Markush formula by relying upon
passages in Novartis (supra). The importance of Markush Structure was
highlighted by the Division Bench of this Court in the decision reported as
2015 (63) PTC 257 (Del) Merck Sharp and Dohme Corporation & Ors. vs.
Glenmark Pharmaceuticals wherein the genus patent was noted to claim all
pharmaceutically acceptable salts of Sitaglptin as a Markush claim. Further
even in Novartis (supra) the Supreme Court did not disapprove of the
Markush structure of Zimmerman patent for Imatinib Mesylate. The Patent
Office Manual also recognizes the validity of Markush structures and states
that any species residing within the genus can be said to be anticipated only
if it is unambiguous and specifically disclosed in the genus. It is not only
the plaintiffs but the defendants and other similarly placed companies who
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have been applying and have been granted patents for the Markush claim.
IN„147 covers the basic core, structure, scaffold (pharmacophore) showing
three rings, one sugar and two phenyl, connected to each other in a certain
way, and having multiple variables on specific positions of the two phenyl
rings. If the total number of permutations are worked out, then several
millions of compounds are covered by this basic core. Out of this basic core
only 80 compounds were synthesized and identified in the genus patent
specification in IN„147, which can be treated as disclosed in IN„147. On the
expiry of the genus patent on 2nd October, 2020, only the inventive concept
of the basic, core structure and the disclosed 80 examples went into the
public domain and no further. In patent bargain in return for the disclosure
of certain invention, the inventor gets a period of monopoly. The
requirements of disclosure are provided under Sections 10(4) (b) read with
Sections 11(3), 11(3A), 11(4) of the Act and since Dapagliflozin was not
disclosed in IN„147 it cannot go into public domain. In Merck vs.
Glenmark, CS (OS) 586/2013, this Court has already held that multiple
patents can cover a single product as is also evident from Sections 19, 91(1)
and 141 (4) of the Patents Act. If a third party manufactures or sells the
product before the expiry of the patent, the same would amount to
infringement.
7.5 The decision in Novartis (supra) was based on the peculiar facts of
that case wherein a finding of fact had been arrived at by the US Board of
Appeals that Imatinib Mesylate was disclosed in Zimmerman patent. In the
present case, there is no such finding of any Board, Tribunal or Court.
Reliance is placed on the decision reported as 2013 FCA 214 Eli Lilly vs.
Apotex wherein it was held that disclosure of a chemical compound takes
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place when it is identified by reference to its chemical structure, name or
IUPAC name.
7.6 In Novartis (supra) Supreme Court was dealing with the question
whether the beta crystalline form of Imatinib Mesylate was an invention or
not. In the said case the claim of invention was in two steps i.e. Imatinib to
Imatinib Mesylate and Imatinib Mesylate to its beta-crystalline form. In
view of the clear disclosure of the compound methane sulphonic acid of
Imatinib in the Zimmerman patent and the claim expressly including
Imatinib and its pharmaceutically acceptable salts, including Imatinib
Mesylate Supreme Court held that since Imatinib Mesylate was disclosed in
the Zimmerman patent thus there was no error in declining grant of patent to
the beta crystalline form of Imatinib Mesylate.
7.7 Bar under Section 3(d) also does not apply to Dapagliflozin as it is
neither a salt, ether, esters or polymorph of the compounds in IN„147 unlike
in Novartis (supra) where the beta crystalline was hit by Section 3(d) being a
polymorph, thus requiring enhanced therapeutic efficacy. The therapeutic
efficacy of Dapagliflozin over example 12 of IN„147 has been duly
explained by Dr.Washburn, the inventor, in his affidavit, that is, the
enhanced ability of absorbtion of blood sugar 25%; plasma sugar 58%, 1.7
times selective of SGLT2 over SGLT1 Further, example 12 of In '147 never
became a drug and has no known efficacy as it was never tested in humans.
Dapagliflozin was synthesized in the year, 2001 after the priority date of
IN„625. All these factors clearly show that Dapagliflozin was not disclosed
in example 12 of IN„147.
7.8 Plea of the defendants in the rejoinder arguments that IN„625 is
invalid based on prior claiming under Section 64(1) (a) of the Indian Patents
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Act is also fallacious. This oral submission of the defendants is contrary to
the written pleadings of the defendants. Plaintiffs‟ response to the plea of
double patenting or prior claiming under Section 13 (1) (b) taken by the
defendants is that firstly there is no law in India on the question of double
patenting and secondly prior claiming under Section 13 (1) (b) read with
Section 64 (1) (a) requires that the invention as claimed in IN„625 should
have been claimed in a complete specification having a priority date earlier
to IN„625. The law of prior claiming requires two conditions; firstly that
only claims have to be compared and secondly that the invention in the two
claims is the same. Reliance is placed on the decisions reported as Daikin
Kogyo Co. Ltd. and application of Virgil W. Vogel
7.9 On the issue of obviousness, the plaintiffs have already filed the
affidavits of Dr. Washburn, the inventor and another affidavit of Dr.
Eswaran. Affidavit of Dr. Bipin Pandey has been filed by the defendants
which was relied upon by the defendants during the course of arguments,
besides the affidavit of Dr. Tiwary. As per the plaintiffs evidence, a person
of ordinary skill in the art on seeing IN„147 could not reach Dapagliflozin
unless he was motivated by hindsight. Plaintiff's affidavits explain that the
drilling down of 80 examples to a most preferred list by reference to
Formula-1B and by referring to the conspicuity of the explanations given for
Examples 1-15 and by reference to the fact that detailed manufacturing
processes appear to be appended only to Examples 1-15 is a faulty
methodology. Further, Formula-1B can have millions of possible
permutations and defendants armed with hindsight arguments urges the logic
to reach Dapagliflozin. As a matter of fact, the general knowledge prevalent
at the time actually taught away from the use of ethoxy and preferred
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methoxy as having superior qualities and thus the defendants cannot rely
upon Example 12.
7.10 Drug discovery is not a drawing of a molecular structure on a paper
but a complex task of pharmaceutical research involving synthesizing tens
of thousands of compounds, testing them for their physical, chemical and
biological properties, determining their best solubility, absorption through
most appropriate salts, determining the best processes, researching their
efficacy, safety and toxicity in vitro and then on animal models and once
they show promise, then clinical trials on phase-1, 2 and 3 to study the
pharmacokinetics and pharmacodynamics. Typically it takes ten years to
research and one or two USD billions.
7.11 Rebutting the arguments of learned counsel for the defendants that the
specifications in IN„625 are the same as IN„147 hence no technical
advancement is specified in IN„625, reply of the plaintiffs is that on the date
of priority even the inventor may not be fully aware of the advantages and
the properties of the invention. For example the instant drug Dapagliflozin
was brought as SGLT2 inhibitor and for diabetes type -2 mellitus but with
further treatments it has shown excellent properties for treatment of heart
failure as well. Thus there cannot be and there is no requirement of law that
all the properties, advantages and characteristics of the invention should be
stated on the filing date of the patent application. Further post filing data
with the inventor have also been held to be admissible in an attack on
infringement in a suit. Reliance is placed on the decision reported as 655 F
3rd 1291 (2011) Genetics Institute LLC vs. Novartis Vaccines and 367 F.3d
1381, 1385 Knoll Pharm Co. vs. Teva Pharms. USA, Inc. If the application
discloses the basic properties or utilities, the same satisfies the three
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elements of novelty, utility and non-obviousness as noted in Application of
Walter Lorenz and Gerhard Schrader, 333 F.2d 908 (C.C.P.A. 1964).
7.12 Under Section 10(4) Patents Act it is sufficient if the inventor
discloses the best method known to the inventor even though at that stage it
may not know all its advantages, benefits or special characteristics. Section
2(1) (ja) of the Patents Amendment Act, 2005 is unique to Indian law and
this requirement does not exist in other jurisdictions like USA etc. The
specifications of IN„625 clearly state that large population suffers from
Type-2 Diabetes which are expected to be solved by SGLT2 inhibition in
the kidneys, it being a novel, safe and orally active anti-diabetic agent with
less side effects, the known product was Phlorizin inhibited SGLT which
had adverse effects. Various prior art documents disclose compounds that
inhibit SGLT2 however, the specific compound of Formula-1 in IN„625
possesses SGLT2 activity and is useful for the treatment of diabetes.
7.13 Section 53(4) starts with 'Notwithstanding anything in any other law',
so it does not preclude other Sections of the Patents Act. Therefore, Section
53(4) relating to Term of Patent has to be reconciled with Sections 19(1),
88(3), 91 and 141 which relate to multiple patents covering a single product.
7.14 In respect of the application for terminal disclosure filed by the
plaintiff before the US Patent Office in its species patent US„117 though the
claim of the defendants is that the same amounts to an admission that the
patentee itself sought that the species patent was obvious and did not merit
separate protection beyond US„126, it is important to note the backdrop in
which terminal disclaimer was filed in USA which made no practical
difference to the plaintiff‟s right with respect to Dapagliflozin in USA. In
USA the plaintiff filed the species patent US„117 as a continuation in part
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application to the genus patent US„126 and as per the US law MPEP 201.08
the basic requirement of a continuation in part application filed during the
lifetime of an earlier non-provisional application is that it repeats substantial
portion or all of the earlier non-provisional application besides additional
matter not disclosed in the said earlier non-provisional application. Thus
disclosure of additional matter is a prerequisite to entertain a continuation in
part application. The moment, the US Patent Office accepted the application
of the plaintiff as a continuation in part application, it is deemed that in the
species patent there were further disclosures which were not there in the
genus patent. Since the priority dates of US„117 and US „126 were the same
and would have expired on the same date, hence filing of the terminal
disclaimer did not prejudice the plaintiffs. Further as held in 946 F2d 870
Quad Environmental Technologies Corporation vs. Union Sanitary District
Apt. that agreeing to a terminal disclaimer is not an admission or
acquiescence regarding invalidity on the ground of obviousness.
7.15 The plaintiffs have been able to clearly show compliance of Section
8(1) of the Patents Act when Form-3 was filled up along with necessary
requirements on 16th November, 2004, 10th January, 2005 and 1st January,
2009 followed by the documents on 17 th December, 2009. Specific
particulars of the corresponding patent registration in USA, i.e. US„117 were
provided by the patentee of its own volition. The first page of the complete
specification of the application for IN „625 before the Indian patent office
itself mentions that its corresponding patent in USA was filed as a
continuation in part application of the genus patent. In respect of non-
compliance under Section 8(2) of the Patents Act it is submitted that the test
is whether the examiner got full opportunity to examine the non-obviousness
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of IN„625. Since all material particulars in this regard were placed including
the plaintiffs arguments on non-obviousness made through responses dated
8th October, 2008 the examiner was duly satisfied. In any case, there has
been substantial compliance of requirement of Section 8(2) of the Patent
Act. Reliance is placed on Quad Environmental Technologies (supra) and
884 F.3d 1160 Simple Air vs. Google LLC and Patentee‟s response dated 8th
October, 2008.
7.16 The objection of the US patent office is not an order or a finding but a
mere objection. The decision to file a terminal disclaimer by the plaintiff
was not motivated by any acknowledgment or acceptance that US„117 was
obvious in the face of US„126 but only an obviation strategy which has been
clarified in the decision in Quad Environmental Technologies (supra).
Further even this Court in Sukesh Behl vs. Philips (supra) and Merck vs.
Glenmark (supra) held that the issue of Section 8 is not the be all and end all
of a temporary injunction claim, while adjudicating the issue of prima facie
case for infringement of patent and the Court is only required to look at the
issue broadly while deciding a temporary injunction claim.
7.17 Claim of the defendants that IN„625 ought to have been registered as
a patent of addition in view of the plaintiff having filed a continuation in
part application in respect of its species patent US„117 with the genus patent
US„126 so that both the patents co-terminated is fallacious for the reason it
is the choice of the applicant to trade off an inquiry as to obviousness with
co-terminus conditions under Sections 56 and 55 of the Patents Act and if
the applicant is confident in the case of new molecule that it would
withstand attack of obviousness, it need not seek a patent of addition. There
is a difference between a continuation in part application and patent of
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addition application for the reason the continuation in part application pre-
supposes an additional disclosure in the said application. Defendants‟
reliance on the decisions reported as 2018 EWCA Civ 671 Regeneron vs.
Kymab and 598 F.3d 1336 Ariad vs. Eli Lily is misconceived as Regeneron
had applied for patents covering hybrid structures known as Reverse
Chimeric Locus, which contained only a small part of human genetic
element, however it had actually patented mice regardless of the amount of
human genetic material. The Court held that the patent suffered from
insufficiency and therefore, was invalid. Similarly in Ariad (supra) it was a
biotechnology patent relating to methods only, not involving any Markush
formula, and it was held to suffer from a descriptiveness issue.
7.18 Contention of defendants relying upon Idenix Pharmaceuticals vs.
Gilead, 2018-1691 (CAFC) dated 30th October, 2019 citing the analogy with
blaze marks on tress to contend that IN 625 patent is invalid for want of
sufficiency also does not hold good in the facts of the present case as in
Gilead (supra) the defendant attacked the patent for lack of enablement and
failure to meet the written description requirement. There are no such flaws
in the suit patent claim. The plaintiffs having made out a prima facie case,
the balance of convenience also lies in favour of the plaintiff and the
plaintiffs will suffer an irreparable loss in case no injunction is granted to the
plaintiffs.
7.19 Adverting to facts relating to Zydus it is stated that Zydus
manufactured and launched the drug Dapagliflozin under the brand name
DAPAGLYN on 2nd October, 2020, released a large stock of Dapagliflozin
to various stockiest, distributors in different cities of Gujarat. The product
of Zydus reveals that it was manufactured in September, 2020. Zydus
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neither filed a pre-grant nor a post-grant revocation petition challenging the
suit patent. It is the case of the plaintiffs that the defendants were in clear
knowledge of the plaintiffs‟ right in the species patent IN„625 as in the year
2018 the plaintiffs instituted a suit in the US District Court, Delaware
against the defendants US company. Further Zydus in its own patent
application in India and USA has admitted that Dapagliflozin was disclosed
in the plaintiffs' species patent US„117 equivalent to IN„625. Even the
defendant‟s patent application in USA for amorphous form of Dapagliflozin
was rejected on the grounds of disclosure in US„117.
7.20 Qua the defendant MSN case of the plaintiffs is that on coming to
know that the defendants are manufacturing and launching Dapagliflozin,
plaintiff issued a legal notice on 6th October, 2020 and filed the instant suit.
MSN has neither filed a pre-grant nor a post-grant opposition till the filing
of the suit. In January, 2018 the defendant‟s US company submitted
multiple ANDA applications recognizing the plaintiffs‟ right in
Dapagliflozin and undertook that it will not launch any infringing generic
drug until the expiry of the plaintiff‟s US patents till 2025. Further the
defendant‟s own patent applications in India, in the years 2014 and 2015,
one application in European Union (EU) in October, 2016 and two
applications in USA one of which was filed on 28th November, 2018 as well
as its PCT application filed in 2015 states that Dapagliflozin and its process
for the preparation were first disclosed in US„117. The defendant‟s patent
applications in India, EP and USA have been rejected in view of US„117.
Though defendant MSN relies upon its 2016 application however, as noted
above in its application in the year 2018 before the USPTO defendant MSN
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again reaffirmed its position that Dapagliflozin was first disclosed in
US„117.
7.21 Defendant Eris is selling the pharmaceutical composition
Dapagliflozin manufactured by MSN who had made admissions over the
years that Dapagliflozin was first disclosed in US„117. On learning about
the defendants‟ action the plaintiffs issued a cease and desist letter on 3rd
October, 2020 which was replied by the defendant on the same day at 11.00
PM wherein the defendant confirmed that it has launched the drug with the
pharmaceutical composition Dapagliflozin under the brand name UDAPA.
Thereafter, the defendant hurriedly filed the revocation petition against the
plaintiffs‟ patent on 4th October, 2020 however, the said patent petition has
not been acted upon by the IPAB as yet and nor has the plaintiff received
any information in this regard.
7.22 Defendant Micro Labs applied for and was granted manufacturing
approval of Dapagliflozin from the Drugs Authority, Tamil Nadu and when
the plaintiffs learnt about the same they filed an application under Right to
Information Act, 2005 which was objected to by the defendant stating that
no such information should be provided. The defendant made an application
before the National Pharmaceutical Pricing Authority (NPPA) requesting to
fix the price for generic versions of Dapagliflozin as well as its combination
with Metformin, where the defendant stated that they would manufacture
and market the said drug. Initially this request was rejected by NPPA
however, in September, 2020 NPPA claimed that price fixation had no
linkage with the plaintiff. As per the plaintiff, the fixation of price does not
entitle the defendant to actually release the infringing product in the market
and violate the plaintiffs‟ right in the suit patent.
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7.23 Plaintiffs thus contend that from the facts as noted it is evident that
defendant MSN, Micro Labs, Eris, USV and Zydus have not cleared the way
before launching the drug.
7.24 In respect of Torrent, it may be noted that the defendant in its Form-
24 dated 17th June, 2020 filed before the patent office admitted having
acquired marketing approval for drug Dapagliflozin therefore the plaintiff
filed the suit wherein a statement was made on behalf of the defendant on
14th August, 2020 that the defendant would not commercialized the product
until 2nd October, 2020 and before the said undertaking expired, this Court
restrained the defendant from launching the drug by infringing the plaintiffs
product till the next date of hearing before this Court which order has
continued. The plaintiff and defendant Torrent are embroiled in multiple
litigations. Firstly the defendant filed a representation dated 15 th May, 2020
before the patent office challenging the species patent of the plaintiff which
was published in July, 2011 on the patent office website. This
representation was dismissed vide order dated 13th July, 2020 by the patent
office. From this application the plaintiff got to know that the defendant had
filed a revocation petition against IN 625 on 20 th February, 2020. Further
Torrent filed a post grant opposition before the patent office on 16th May,
2020, eleven years after the grant of the patent and atleast nine years since
the factum of grant of patent was published on the patent office website, the
defendant also filed a writ petition before W.P. (C) No.3470/2020 seeking
removal of IN 625 from the patent register on the grounds taken in the
revocation petition, the post grant opposition and the representation. The
writ petition was disposed of vide order dated 11 th June, 2020 whereafter
Torrent filed a further petition before the patent office in Form-24 on 17th
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June, 2020 followed by a second writ petition being W.P. (C) No.5187/2020
before this Court which is pending hearing. Plea of Torrent in the writ
petition is that no renewal fee having been deposited, the patent lapsed and
without fresh publication the patent could not have been revived.
ANALYSIS & REASONS:
Construction of claim & Disclosure of Dapagliflozin in IN '147
8.1 Main challenge to the validity of the suit patent IN '625 by all the
defendants is on the ground of prior disclosure and anticipation by prior
claiming in IN '147. These grounds would normally arise in most of the
cases of grant of genus patent and the species patent as substantial portion of
the claim/claims in a species patent are bound to be imbibed in the claims of
the genus patent. In India and abroad, grant of patents for Markush claim
and the selection claim i.e. the genus and species patents is legally
permissible. To ascertain whether IN '625 is disclosed or claimed in IN '147,
claims in the two patents are required to be compared.
8.2 Division Bench of this Court in the decision reported as 2015 (225)
DLT 391 F. Hoffman-La Roche vs. Cipla Ltd., dealing with the construction
of claim held:-
66. Before we apply the aforenoted legal position to the facts of
the instant case we need to discuss the legal position
concerning construction of claims. In the decision reported as
MANU/MH/0064/1969 : AIR 1969 Bombay 255 FH & B v.
Unichem Laboratories it was held that specifications end with
claims, delimiting the monopoly granted by the patent and that
the main function of a Court is to construe the claims without
reference to the specification; a reference to the specification
being as an exception if there was an ambiguity in the claim.
Claims must be read as ordinary English sentences without
incorporating into them extracts from body of specification or
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changing their meaning by reference to the language used in
the body of the specification. In a recent decision in FAO (OS)
No. 190/2013 Merck v. Glenmark the Division Bench held that
claim construction to determine the coverage in the suit patent
has to be determined objectively on its own terms with regard
to the words used by the inventor and the context of the
invention in terms of the knowledge existing in the industry.
Abandonment of an application cannot remove what is patented
earlier nor can it include something that was excluded earlier
and that a patent is construed by the terms used by the inventor
and not the inventors subjective intent as to what was meant to
be covered. Merely because an inventor applies for a latter
patent that is already objectively included in a prior patent, but
which inventor subjectively feels needs a separate patent
application, doesn't mean it is to be taken at face value and
therefore neither Section 3(d) or abandonment of subsequent
patent application can be used to read into terms of prior
application, which has to be construed on its own terms. In the
decision reported as 415 F. 3d 1303 Edward H. Phillips v.
AWH Corporation it was held that claims have to be given their
ordinary and general meaning and it would be unjust to the
public, as well as would be an evasion of the law, to construe a
claim in a manner different from plain import of the terms and
thus ordinary and customary meaning of the claim term is the
meaning of the term to a Person Of Ordinary Skill in the Art as
of effective date of filing of the patent application. In case of
any doubt as to what a claim means, resort can be had to the
specification which will aid in solving or ascertaining the true
intent and meaning of the language employed in the claims and
for which the court can consider patent prosecution history in
order to understand as to how the inventor or the patent
examiner understood the invention. The Court recognized that
since prosecution is an ongoing process, it often lacks clarity of
the specification and thus is less useful for claim construction.
The Court also recognizes that having regard to extrinsic
evidence such as inventor testimony, dictionaries and treaties
would be permissible but has to be resorted to with caution
because essentially extrinsic evidence is always treated as of
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lesser significance in comparison with intrinsic evidence. In the
decision reported as 457 F.3.1284 (United States) Pfizer v.
Ranbaxy the Court held that the statements made during
prosecution of foreign applications are irrelevant as they are in
response to unique patentability requirements overseas. The
Court also held that the statement made in later unrelated
applications cannot be used to interpret claims of prior patent.
In the decision reported as 1995 RPC 255 (UK) Glaverbel SA
v. British Coal Corp the Court held that a patent is construed
objectively, through the eyes of a skilled addressee. The Court
also held that the whole document must be read together, the
body of specification with the claims. But if claim is clear then
monopoly sought by patentee cannot be extended or cut down
by reference to the rest of the specification and the subsequent
conduct is not available to aid the interpretation of a written
document.
67. For the above conspectus, pithily put, principles of claim
construction could be summarized as under:--
"(i) Claims define the territory or scope of
protection (Section 10(4)(c) of the Patents Act,
1970.
(ii) There is no limit to the number of claims except
that after ten claims there is an additional fee per
claim (1st Schedule of the Act).
(iii) Claims can be independent or dependent.
(iv) The broad structure of set of claims is an
inverted pyramid with the broadest at the top and
the narrowest at the bottom (Manual of Patents
Office - Practice and procedure).
(v) Patent laws of various countries lay down rules
for drafting of claims and these rules are used by
Courts while interpreting claims.
(vi) One rule is that claims are a single sentence
defining an invention or an inventive concept.
(vii) Different claims define different embodiments
of same inventive concept.
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(viii) The first claim is a parent or mother claim
while remaining claims are referred to as
subsidiary claims.
(ix) If subsidiary claims contain an independent
inventive concept different from the main claim
then the Patent office will insist on the filing of a
divisional application.
(x) Subject matter of claims can be product,
substances, apparatus or articles; alternatively
methods or process for producing said products etc.
They may be formulations, mixtures of various
substance including recipes. Dosage regimes or in
some countries methods of use or treatment may
also be claimed.
(xi) Where claims are 'dependent' it incorporates by
reference 'everything in the parent claim, and adds
some further statement, limitations or restrictions'.
(Landis on Mechanics of Patent Claim Drafting).
(xii) Where claims are 'independent' although
relating to the same inventive concept this implies
that the 'independent claim stands alone, includes
all its necessary limitations, and is not dependent
upon and does not include limitations from any
other claim to make it complete.... An independent
Claim can be the broadest scope claim. It has fewer
limitations than any dependent claim which is
dependent upon it'. (Landis on Mechanics of Patent
Claim Drafting)
(xiii) For someone wishing to invalidate a patent
the said person must invalidate each claim
separately and independently as it is quite likely
that some claims may be valid even while some are
invalid.
(xiv) At the beginning of an infringement action the
Courts in the United States conduct what is known
as a 'Markman hearing' to define the scope of the
claims or to throw light on certain ambiguous
terms used in the claims. Although this is not
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technically done in India but functionally most
Judges will resort to a similar exercise in trying to
understand the scope and meaning of the claims
including its terms. "
In the case of (52 F.3d 967 also 517 US 370) Herbert Markman
v. Westview the Courts held that an infringement analysis
entails two steps:--
"(a) First step is to determine the meaning and scope of the
patent claims asserted to be infringed.
(b) Second step is to compare the properly construed claim with
the device accused of infringing.
(xv) The parts of the claim include its preamble, transition
phrase and the body. The 'transition phrase' includes terms
like:--
(a) Comprising;
(b) Consisting;
(c) Consisting essentially of;
(d) Having;
(e) Wherein;
(f) Characterised by;
Of these terms some are open ended, such as 'comprising'
which means that if the claim contains three elements 'A', 'B'
and 'C' it would still be an infringement for someone to add a
fourth element 'D'.
Further some terms are close ended such as 'consisting of, i.e.
in a claim of three elements, 'A', 'B' and 'C' a defendant would
infringe if he has all three elements. In case the defendant adds
a fourth element 'D' he would escape infringement.
(xvi) Each claim has a priority date so that in a group of claims
in a specification you could have multiple priority dates. This
only means that if a patent application with certain priority
date and claims was followed by another application with
different claims and different priority dates, then if they were
consolidated or cognate with another application, each claim
would retain the original priority date [Section 11(1)]."
8.3 Even at the stage of interim injunction, construction of the claim by
the Court, to verify its coverage is fundamental as held by the Division
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Bench of this Court in Merck Sharp and Dohme Corporation Vs. Glenmark
(supra). It was held that the coverage depends on the nature of the claims
made and enabling disclosures specified by the patentee in its "Complete
Specification" under Form 2 of the Act. The word used to describe the
claims - as read by a person of ordinary skill in the art - determine the
breadth of the monopoly granted by the patent, for which the substantive and
indeed substantial rights under Section 48 of the Act are triggered. Noting
the free base of Sitagliptin, the Division Bench observed that the patent was
"directed to pharmaceutical compositions comprising these compounds and
the use of these compounds and compositions". The issue required to be
decided by the Court was as to how far these compositions can be subsumed
with the "core" of the patent, without precise enabling disclosures; in other
words, how elastic can the Court read the claim to be.
8.4 The Division Bench held that the term "composition" used in the
specifications was intended to encompass a product comprising the specified
ingredients in the specified amount as well as any product which results,
directly or indirectly, from combination of the specific ingredients in the
specified amounts. Such a term in relation to pharmaceutical composition,
is intended to encompass a product comprising the active ingredients and the
inert ingredients that make up a carrier as well as any product which results,
directly or indirectly, from combination, complexation or aggregation of any
two or more ingredients or from disassociation. The Division Bench also
noted the limitations that the issues involved required a minute examination
of the patent claim and its disclosure, prior art, subsequent application and
the nature of Glenmark product which the Court cannot engage at the stage
of interim hearing and should be left to the stage of full trial with pleading
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and expert evidence, therefore, in determining whether a prima facie case
exists, a mini trial is not required to be resorted to. The Division Bench thus
noted that from the various examples which disclose the free base structure
of Sitagliptin besides several known compounds and several methods for
preparing the said compounds, the invention therein was that the compound
created through Schemes 1 to 5 are used in Scheme 6 to reach the Sitagliptin
free base, which is the essence of invention in the case. Case of Glenmark
was that the patent does not disclose the Sitagliptin free base but only the
Sitagliptin HCL salt.
8.5 The Division Bench in Merck Sharp and Dohme (supra) reiterated the
Wands test to determine sufficiency or enablement of disclosure which
provides: (1) the quantity of experimentation necessary (2) the amount of
direction or guidance presented. (3) the presence or absence of working
examples (4) the nature of the invention (5) the state of the prior art (6) the
relative skill of those in the art (7) the predictability or unpredictability of
the art, and (8) the breadth of the claims.
8.6 After applying the test laid down as noted above, the Division bench
came to the conclusion that Sitagliptin free base was disclosed in the suit
patent, as opposed to a salt form, whether phosphates, hydrochlorides or any
other. The Court also noted that Glenmark does not dispute that free base
was required to be transformed into a salt form before it could be
administered to the patients. Rejecting the arguments of Glenmark that no
free base was disclosed, this Court also noted that in each of the
specifications Sitagliptin is found as the free base without any attached form
and that the Court has to look to the invention in the case and read the claim
literally. The claims must not be imaginary and must not leave anything
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unarticulated that requires further research by those skilled in the art. Nor
was there any principle that patent specifications be interpreted in favour of
validity where an ambiguity exists. The Court noted that to constitute prior
disclosure of an invention, the matter relied upon as prior art must disclose
subject matter which, if performed, would necessarily result in infringement
of the patent. Noting Section 10(4)(b) of the Patents Act, the Division Bench
arrived at the conclusion that though Sitagliptin HCL salt was disclosed
specifically in Example 7, however the phosphate salt was not disclosed
leading to the clear inference that the specified salt was unknown to the
inventor at the time or perhaps even if known was not disclosed.
8.7 Dealing with a markush claim and a subsequent species claim, in
Model law of Patent, 2nd Edition, Consultant Editor -Judge Fysh, notes:
"A Markush group claim is used to define a family of
compounds by defining the structure that is common to the
whole family (the letter R being commonly used to represent the
alternatives). The advantage of such a claim is that it removes
the need to include a claim for each individual type of
compound and claims, the advantage given by the whole group.
The EPO has held by implication that a product can be defined
by a generic formula and that such a product will anticipate
products which are claimed in a more specific manner.
It has been stated that a class of compounds which is defined
only by a general structure, with at least two variable groups
does not anticipate each individual compound which would
result from the compound. This raises the issue of what happens
where the invention is a particular compound and the prior art
discloses a family of compounds, with a general formula
including the particular compound but not explicitly describing
it; in such a case the invention is novel. If the invention claimed
is a group of compounds (rather than a particular compound)
however; the invention lacks novelty."
(Emphasis supplied)
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8.8 In Re I.G. Farbenindustrie A.G. (supra) the principles governing
grant of genus and species patent were laid down as under:
"Three general propositions may, however, I think, be asserted
as true:- First, a selection patent to be valid must be based on
some substantial advantage to be secured by the use of the
selected members. (The phrase will be understood to include the
case of a substantial disadvantage to be thereby avoided.)
Secondly, the whole of the selected members must possess the
advantage in question. Thirdly, the selection must be respect of
a quality of a special character which can fairly be said to be
peculiar to be selected group. The first proposition is plain (see
the statement of Mr. Justice Parker in Clyde Nail Co. Ld. V.
Russell, (1916) 33 R..C. 291, at p. 306). I will add that this
condition must not be assimilated with the doctrine of utility as
applied to an originating patent. In such a patent there may
well be invention without utility. In a selection patent the
condition that there must be a substantial advantage
attributable to the use of the selected members in inherent in the
so-called invention...
... I must add a word on the subject of the drafting of the
specification of such inventive step, that it is necessary for the
patentee to define in clear terms the nature of the characteristic
which he alleges to be possessed by the selection for which he
claims a monopoly....
... I will summarise the conclusion at which I have arrived by
saying that in a selection patent the inventive step lies in the
selection for a useful and special property or characteristic
adequately defined; and this is the proposition which has to be
kept in mind in considering the application to amend and the
Petition for revocation"."
(Emphasis supplied)
8.9 Thus the principles which emerge from the decision in I.G.
Farbenindustrie A.G. (supra) for a selection patent to be valid are:
"(i) There must be a "substantial advantage" to be secured
or disadvantage to be avoided by the use of the selected
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members of the species patent as compared to the non-selected
members of the genus patent;
(ii) The whole of the selected members of the species patent
must possess the substantial advantage in question;
(iii) Selection must be in respect of a quality of a special
character peculiar to the selected members (i.e. as compared to
the non-selected members of the genus patent);
(iv) The patent specification qua the selection patent must
disclose the "substantial advantage" or "unexpected
advantage" possessed by the "selected members" and
compared to the non-selected members of the genus patent."
8.10 It is thus established that both a markush formula with number of
variables can be granted a valid patent besides a selection patent which
though covered under the markush formula is not disclosed clearly and
unambiguously in the markush formula. As noted above, one of the four
conditions laid down in I.G. Farbenindustrie A.G. case for the selection
patent to be valid are that the selection patent must show substantial
advantage or avoid disadvantage by use of the selected members of the
species patent as compared to the non-selected members of the genus patent.
It is the case of the plaintiffs that by the markush formula, the
pharmaceutical composition Dapagliflozin was not arrived at much less
manufactured or marketed. Thus the pharmaceutical composition
Dapagliflozin specifically disclosed in claim 1 and 2 of IN '625 clearly
shows a substantial advantage and hence it cannot be held that Dapagliflozin
is disclosed in IN '147. Further as noted in Merck Sharp and Dohme (supra),
a phosphate salt of Sitagliptin cannot be deemed to be disclosed in the
Sitagliptin free base or the HCL salt thereof, in the present case a compound
with ethoxy substitution instead of a methoxy as the lower alkyl group
cannot be interpreted to read disclosure of Dapagliflozin in IN '147.
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8.11 IN '147 seeks patent for a group of compounds as noted in the 26
claims with number of permutations and combinations of which claim 1 is
as under:
wherein R1, R2 and R2a are independently hydrogen, OH, OR5, alky1, CF3,
OCHF2, OCF3, SR5i or halogen, or two of R1, R2 and R2a together with the
carbons to which they are attached can form an anelated five, six or seven
membered carbocycle or heterocycle which may contain 1 to 4 heteroatoms
in the ring which are N, O, S, SO, and/or SO2; R3 and R4 are independently
hydrogen, OH, OR5a, OAryl, OCH2, Aryl, alkyl, cycloalkyl, CF3, -OCHF2,-
OCF3, halogen, -CN, -CO2R5b,-CO2H, COR6b, -CH (OH) R6c, -CH (OR5h)
R6d,- CONR6R6a, NHCOR5c, -NHSO2R5d, -NHSO2Aryl, Aryl, -SR5e, SOR5f,
-SO2R5g, -SO2Aryl, or a five, six or seven membered heterocycle which may
contain 1 to 4 heteroatoms in the ring which are N, O, S, SO, and/or SO 2, or
R3 and R4 together with the carbons to which they are attached form an
anelated five, six or seven membered carbocycle or heterocycle which may
contain 1 to 4 heteroatoms in the ring which are N, O, S, SO, and/or SO 2;
R5, R5a, R5b, R5c, R5d, R5e, R5f, R5g, R5h and R5i are independently alky; R6,
R6a, R6b, R6c and R6d are independently hydrogen, alkyl, aryl, alkyaryl or
cycloalkyl, or R6 and R6a together with the nitrogen to which they are
attached from an anelated five, six or seven membered heterocycle which
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may contain 1 to 4 heteroatoms in the ring which are N, O, S, SO, and/or
SO2, A is O, S, NH, or (CH2)n where n is O-e, or a pharmaceutically
acceptable salt, stereoisomer, or prodrug ester thereof; with the proviso that
where A is (CH2)n where n is O, 1, 2 or 3 or A is O, and at least one of R1,
R2, and R2a is OH or OR5, then at least one of R1, R2, and R2a is CF3, OCF3,-
CN, -CO2R5b, CH (OR5h) R6d, CH(OH) R6c, COR6b, -NHCOR5c, -NHSO2R5d,
-NHSO2Aryl, Aryl, -SR5e,-SOR5f, -SO2Aryl.
8.12 There are in total 26 claims in the application for which IN „147 was
granted. Claim No.1 is noted above. Claims-1 to 5 are further claims
wherein substitution of primarily „A‟ has been given with various
permutation and combinations. Claim-6 is a wide claim wherein not only
substitution of „A‟ has been provided but of R1, R2, R2a also with specified
claims thereof at Serial Nos.7, 8, and 9. Claim-10 gives certain specific
structure of claim-3 whereas claim-11 gives a specified structure of Claim-1,
wherein „A‟ is CH2 and various options for R1, R2, R2a and R3 have been
given. Claim-12, 13 and 14 give structures of claim-1. Claim-15, 16 and 17
provide for the pharmaceutical compositions of Claim-1 and Claim-16.
Claim-18 is a combination of Claim-17 with an antibiotic agent. Claim-19
provides the composition along with various anti diabetic agents such as
Metformin, Glytburide etc. Claim-20 gives weight ratio of the anti diabetic
agent as claimed in Claim-17 whereas Claim-21 describes the composition
in Claim-16 along with an anti obesity agent. Claim-22 describes the
various anti obesity agents in Claim-21. Claim-23 describes various lipid
lowering agents in Claim-16. Claim-24 also describes the various lipid
lowering agent in Claim-23. Claim-25 describes SGLT2 inhibitor weight
ratio to lipid lowering agent in Claim-23. Claim-26 describes the
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composition as claimed in any of the proceeding claims wherein SGLT2
inhibitors compound has a structure:
8.13 Claim of the plaintiff in patent IN '625 is as under:
(2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4ethoxybenzyl)phenyl)
(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol having
the structure
or a pharmaceutically acceptable salt, a stereoisomer thereof, or a prodrug
ester thereof. A pharmaceutical composition as and when prepared by using
the compound as defined in Claim 1 and a pharmaceutically acceptable
carrier of the kind such as herein described.
8.14 Case of the plaintiffs is that though IN „147 the genus patent covers
Dapagliflozin, however it nowhere discloses Dapagliflozin and the same is
specifically disclosed in the species patent IN „625. According to the
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plaintiff IN „147 discloses only 80 exemplified compounds and
Dapagliflozin is not one amongst these 80 compounds. Even claim 1 of IN
„147 i.e. markush structure has 22 variables and therefore markush structure
itself contains a large number of substituents.
8.15. According to the defendant example 12 of the IN„147 discloses the
compound claimed in IN„625. Example 12 of IN „147 gives five methods of
preparation of 5-Bromo-2-chloro-4‟-methoxydiphenylmethane. The five
methods of preparation of example 12 result in the following structure:
"Example 12
8.16 A reading of example 12 would indicate that out of the Halogens,
chorine has been identified as the preferred halogen however, in Example-12
all the procedures relate to methoxy substitution and not to ethoxy. In the
entire Example 12 of IN '147 there is no teaching in favour of ethoxy. Thus
based on the decisions noted above and reading of the claims in IN '147 and
IN '625 it is clear that IN '147 comprises of a group of claims belonging to a
family, and even the closest Example 12 in IN '147 discloses methoxy
benzophenone as the ingredient of the compound and there is no disclosure
of a compound with ethoxy group as in Dapagliflozin. Thus, as held by the
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Division Bench in Merck Sharp Dohme vs. Glenmark (supra) that though
Sitagliptin HCL salt was disclosed but not the phosphate salt in the present
case though the compound with methoxy salt was disclosed but not with
ethoxy. Further substantial improvement in IN '625 is attributable from the
fact that the drug Dapagliflozin came only under IN '625 and not under IN
'147 though it gave various options for SGLT2 inhibitors but not
Dapagliflozin. Also as per the tests laid down in I.G. Farbenindustrie A.G
(supra) Dapagliflozin the product of the claim in IN '625 shows a substantial
advantage over the claims in IN '147 as no viable drug could be
manufactured from the claims in IN '147, even though the compounds
thereof depicted SGLT2 properties.
Whether Admission of Coverage in IN '147 amounts to Disclosure
9.1 Case of the defendants is that since the plaintiffs have admitted in
their pleadings and applications that Dapagliflozin is covered by IN '147 and
there being no distinction between coverage and disclosure as per the
decision of the Supreme Court in Novartis (supra) the suit patent IN '625 is
invalid having been disclosed in IN '147.
9.2 In the case of Novartis, (supra) Novartis had filed an application
seeking patent for the beta crystaline form of Imatinib Mesylate. Though
the Zimmermann Patent was for Imatinib, however no patent for Imatinib
Mesylate was sought by Novartis and it sought patent only for the beta
crystaline form of Imatinib Mesylate. The grant of beta crystaline form of
Imatinib Mesylate to Novartis was rejected by the IPAB returning a clear
finding of fact that Imatinib Mesylate was disclosed in the Zimmermann
Patent for Imatinib.
9.2 Before proceeding to analyse the distinction between coverage and
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disclosure it would be appropriate to note the relevant paragraphs of the
decision in Novartis as under:
"105. From the above discussion it would be clear that the drug
Gleevec directly emanates from the Zimmermann Patent and
comes to the market for commercial sale. Since the grant of the
Zimmermann Patent, the appellant has maintained that Gleevec
(that is, Imatinib Mesylate) is part of the Zimmermann Patent. It
obtained drug approval for Gleevec on that basis. It claimed
extension of the term of the Zimmermann Patent for the period
of regulatory review for Gleevec, and it successfully
stopped NATCO Pharma Ltd. from marketing its drug in UK on
the basis of the Zimmermann Patent. Not only the appellant but
the US Board of Patent Appeals, in its judgment granting patent
for beta crystalline form of Imatinib Mesylate, proceeded on the
basis that though the beta crystalline form might not have been
covered by the Zimmermann Patent, the Zimmermann Patent
had the teaching for the making of Imatinib Mesylate from
Imatinib, and for its use in a pharmacological compositions for
treating tumours or in a method of treating warm-blooded
animals suffering from a tumoral disease. This finding was
recorded by the US Board of Patent Appeals, in the case of the
appellant itself, on the very same issue that is now under
consideration. The appellant is, therefore, fully bound by the
finding and cannot be heard to take any contrary plea.
xxx
112. That Imatinib Mesylate is fully part of the Zimmermann
Patent is also borne out from another circumstance. It may be
noted that after the Zimmermann Patent, the appellant applied
for, and in several cases obtained, patents in the US not only for
the beta and alpha crystalline forms of Imatinib Mesylate, but
also for Imatinib in a number of different forms. The appellant,
however, never asked for any patent for Imatinib Mesylate in
non-crystalline form, for the simple reason that it had always
maintained that Imatinib Mesylate is fully a part of the
Zimmermann Patent and does not call for any separate patent.
113. We thus find no force in the submission that the
development of Imatinib Mesylate from Imatinib is outside the
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Zimmermann Patent and constitutes an invention as understood
in the law of patent in India.
xxx
118. The submissions of Mr Andhyarujina and Mr
Subramanium are based on making a distinction between
the coverage or claim in a patent and the disclosure made
therein. The submissions on behalf of the appellant can be
summed up by saying that the boundary laid out by the claim
for coverage is permissible to be much wider than
the disclosure/enablement/teaching in a patent.
119. The dichotomy that is sought to be drawn
between coverage or claim on the one hand
and disclosure or enablement or teaching in a patent on the
other hand, seems to strike at the very root of the rationale of
the law of patent. Under the scheme of patent, a monopoly is
granted to a private individual in exchange of the invention
being made public so that, at the end of the patent term, the
invention may belong to the people at large who may be
benefited by it. To say that the coverage in a patent might go
much beyond the disclosure thus seem to negate the
fundamental rule underlying the grant of patents.
120. In India, Section 10(4) of the Patents Act, 1970
mandates:
"10.Contents of specifications.--(1)-(3) ***
(4) Every complete specification shall--
(a) fully and particularly describe the invention
and its operation or use and the method by
which it is to be performed;
(b) disclose the best method of performing the
invention which is known to the applicant
and for which he is entitled to claim
protection; and
(c) end with a claim or claims defining the
scope of the invention for which protection
is claimed;
(d) be accompanied by an abstract to provide
technical information on the invention:
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Provided that--
(i) the Controller may amend the abstract for
providing better information to third parties;
..."
And, Section 10(5) provides as under:
"10. (5) The claim or claims of a complete
specification shall relate to a single invention, or to
a group of inventions linked so as to form a single
inventive concept, shall be clear and succinct and
shall be fairly based on the matter disclosed in the
specification."
121. The UK Patents Act, 1977, in sub-sections (2), (3) and (5)
of Section 14, provides as under:
"14.Making of an application.--(1)-(1-A) ***
(2) Every application for a patent shall
contain--
(a) a request for the grant of a patent;
(b) a specification containing a
description of the invention, a claim or
claims and any drawing referred to in the
description or any claim; and
(c) an abstract,
but the foregoing provision shall not prevent
an application being initiated by documents
complying with Section 15(1) below.
(3) The specification of an application shall
disclose the invention in a manner which is clear enough
and complete enough for the invention to be performed by
a person skilled in the art.
***
(5) The claim or claims shall--
(a) define the matter for which the
applicant seeks protection;
(b) be clear and concise;
(c) be supported by the description; and
(d) relate to one invention or to a group
of inventions which are so linked as to form
a single inventive concept."
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122. Further, Section 112(a) of the Title 35 of the US Code
provides as under:
"35 U.S.C. § 112 [ Recall that it is on the basis of
this provision that the US Board of Patent Appeals had
held in the case regarding the appellant's claim for patent
for beta crystalline form of Imatinib Mesylate that "in
light of 35 U.S.C. § 282, therefore, we may presume that
the specification of the Zimmermann Patent teaches any
person skilled in the art how to use Imatinib, or a
pharmaceutically acceptable salt thereof,...".]
(a) In general.--The specification shall contain a
written description of the invention, and of the manner
and process of making and using it, in such full, clear,
concise, and exact terms as to enable any person skilled
in the art to which it pertains, or with which it is most
nearly connected, to make and use the same, and shall set
forth the best mode contemplated by the inventor or joint
inventor of carrying out the invention."
123. Terrell on Law of Patents (17th Edn., 2011) in Chapter
9: "Construction of the Specification and Claims", under the
heading "Principles equally applicable to infringement and
validity" states:
"9.05.--Section 125(1) defines an „invention‟ as
(unless the context otherwise requires) that specified in a
claim of the specification, and both validity (see Sections
1 to 4 and 72 of the Act) and infringement (see Section
60) are to be tested by reference to the „invention‟. It is,
of course, a fundamental principle that the construction
of a claim is the same whether validity or infringement is
to be considered; no patentee is entitled to the luxury of
an „elastic‟ claim which has a narrow meaning in the
former case but a wide meaning in the latter. Under
English procedure, infringement and validity are
normally litigated at the same time and therefore the
court is astute to avoid such a result. ..."
(emphasis supplied)
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124. Chisum on Patents: A Treatise on the Law of
Patentability, Validity, and Infringement (Vol. 3-6-2007) in
chapter "Adequate Disclosure" notes:
"§ 7.03. -- The enablement requirement
Since 1790, the patent laws have required that the
inventor set forth in a patent specification sufficient
information to enable a person skilled in the relevant art
to make and use the invention.
The „invention‟ that must be enabled is that defined
by the particular claim or claims of the patent or patent
application. This is consistent with the general principle
of patent law that the claim defines the invention for
purposes of both patentability and infringement."
125. Nevertheless, both Mr Andhyarujina and Mr
Subramanium strenuously argued that the coverage or the
claim, and the disclosure or the teaching, have different
parameters in a patent, and that the former may have an
extended boundary within which disclosure or teaching may be
confined to a narrower extent. In support of the submission, Mr
Andhyarujina relied upon a decision of the Court of Appeal
in A.C. Edwards Ltd. v. Acme Signs & Displays Ltd. [1992 RPC
131] and another of the High Court of Justice, Chancery
Division, Patent Court in Astellas Pharma Inc. v. Comptroller
General of Patents [2009 EWHC 1916 (Pat)] .
126. Mr Gopal Subramanium strongly relied upon the
decision of the United States Court of Customs and Patent
Appeals in Hogan, In re [Hogan, In re, 559 F 2d 595 (CCPA
1977)] in support of his contention.
xxx
132. It needs to be noted here that even in the
US, Hogan [Hogan, In re, 559 F 2d 595 (CCPA 1977)]
represents a decision given in the context of the special set of
facts and circumstances of the litigation over polypropylene. In
later decisions, the Federal Circuit appears to have drastically
narrowed Hogan case's [Hogan, In re, 559 F 2d 595 (CCPA
1977)] scope as a precedent. In Plant Genetic Systems,
N.V. v. DeKalb Genetics Corpn. [315 F 3d 1335, 1341 (Fed Cir
2003)] the effect of Hogan [Hogan, In re, 559 F 2d 595 (CCPA
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1977)] was considerably constricted and its effect is virtually
eliminated in Chiron Corpn. v. Genentech Inc. [363 F 3d 1247,
1257 (Fed Cir 2004)] Since Chiron [363 F 3d 1247, 1257 (Fed
Cir 2004)], the Federal Circuit has not referred
to Hogan [Hogan, In re, 559 F 2d 595 (CCPA 1977)] in any of
its cases that involved claims to a genus where a single species
was enabled.
xxx
134. However, before leaving Hogan [Hogan, In re, 559 F 2d
595 (CCPA 1977)] and proceeding further, we would like to say
that in this country the law of patent, after the introduction of
product patent for all kinds of substances in the patent regime,
is in its infancy. We certainly do not wish the law of patent in
this country to develop on lines where there may be a vast gap
between the coverage and the disclosure under the patent;
where the scope of the patent is determined not on the intrinsic
worth of the invention but by the artful drafting of its claims by
skilful lawyers, and where patents are traded as a commodity
not for production and marketing of the patented products but
to search for someone who may be sued for infringement of the
patent.
135. In light of the discussions made above, we firmly reject
the appellant's case that Imatinib Mesylate is a new product
and the outcome of an invention beyond the Zimmermann
Patent. We hold and find that Imatinib Mesylate is a known
substance from the Zimmermann Patent itself. Not only is
Imatinib Mesylate known as a substance in the Zimmermann
Patent, but its pharmacological properties are also known in
the Zimmermann Patent and in the article published in
the Cancer Research journal referred to above. The
consequential finding, therefore, is that Imatinib Mesylate does
not qualify the test of "invention" as laid down in Section
2(1)(j) and Section 2(1)(ja) of the Patents Act, 1970."
(Emphasis supplied)
9.3 Supreme Court in para 105 of the report noted that US Board of
Patents Appeal gave a clear finding that Imatinib Mesylate was disclosed as
a pharmaceutical preparation in the Zimmermann Patent for Imatinib and
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based on that finding of fact, Supreme Court held that Imatinib Mesylate
having been disclosed in the Zimmermann Patent, beta crystaline form of
Imatinib Mesylate could not have been granted a species patent. A finding of
fact that the Zimmerman Patent had the teachings for the making of Imatinib
Mesylate from Mesylate and for its use in a pharmacological compositions
for treating tumours was also noted by the Supreme Court. Further,
Novartis never sought any patent for Imatinib Mesylate though it sought for
its beta crystaline form and other forms of Imatinib. In view of these
findings of fact already arrived at by US Board of Patent Appeals, Supreme
Court rejected the claim that Imatinib Mesylate is a new product and
outcome of an invention beyond the Zimmermann Patent. However,
Supreme Court noted a caution saying that the law of patent in India is in its
infancy and it would not like the same to develop where there is a vast
difference between coverage and disclosure. This observation of the
Supreme Court clearly notes the distinction between coverage and
disclosure and thus it would have to be determined on the facts of each case
whether the species patent is merely covered by the Markush claim or is
disclosed in the same.
9.4 Both sides have filed the affidavits of the experts including the
plaintiff's inventor Dr.Washburn, however since these witnesses are yet to
be cross-examined, at this stage this Court can form no prima facie opinion
based on the affidavits of these experts as the averments in the respective
affidavits are diametrically opposite.
9.5 Applying the tests as noted in Novartis (supra) to the facts of the
present case and on claim construction it is evident that in the claim
specifications of IN '147 the composition of Dapagliflozin is not mentioned
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and the general properties of markush claim with various permutations and
combinations were mentioned. Further the plaintiffs did not apply for drug
approval based on IN '147 but based on IN '625, though plaintiffs' claim
infringement of IN '147 as well being the markush structure. Hence this
Court is of the prima facie opinion that Dapagliflozin is not disclosed in IN
'147, as further research and experimentation on IN '147 was required to
arrive at IN '625.
Anticipation by Prior Claiming:
10.1 Learned counsels for the defendants have challenged the validity of
the suit patent on the ground of anticipation by prior claiming even if not a
case of anticipation by prior publication. Section 10(4) of the Patents Act
provides for the complete specification of the claims which requires that the
specifications must fully and particularly describe the invention, its
operation or use and the method by which it has to be performed, disclose
the best method of performing the invention which is known to the applicant
and for which it is entitled to claim protection and end with a claim defining
the scope of invention for which protection is claimed. It is thus stated that
since DAPAGLIFLOZIN is claimed in IN„147, it is liable to be revoked
under the provisions of Section 64(1) (a) of the Patents Act.
10.2 Learned counsels for the defendants have relied upon the decision in
Ethyl Corporation (supra) to contend that if a later claim includes something
already claimed in an earlier claim, it is prima facie bad until amended. In
Ethyl Corporation (Supra) the Court considered three typical instances
where conflict in claims arises; firstly, where the earlier claim lies wholly
within the area of the later claim; secondly, where the areas of the earlier
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and later claims are not co-terminus but overlap; and thirdly, where the
earlier claim is broader than and includes within it the area covered by the
later claim. According to learned counsels for the defendants, the present
case falls in the third category. The test laid down to decipher prior
claiming in the third category, that is, in the case of a selection patent was
indicated as,
"This test is derived by analogy from the position of a so called
"selection" patent. In a "selection' case the position is that there
is a narrower later claim which falls wholly within the broader
area of the disclosure of an earlier published prior document.
In such case there will be anticipation unless the patentee of the
later invention can show that he has selected an area from the
prior broad disclosure which gives advantages beyond or
different from those disclosed by the prior document. Provided
the strict rules for validity laid down in I. G. Farbenindustrie's
Patents (1930) 47 R.P.C. 289, and other cases are observed,
there is no reason why the claim in the later selection patent
should not be valid."
10.3 In Apotx vs. Sanofi (supra) relied upon by the learned counsels for the
defendants, to overcome an objection of prior publication for a selection
patent, the tests as laid down in I.G. Farbenindustrie A.G. (supra) were
reiterated.
10.4 In Merck & Company (Macek‟s) patent, the Appeal Tribunal was
dealing with four claims of the later patent in the suit, that is, (1) A
composition having enhanced bactericidal activity comprising novobiocin in
combination with at least one other antibiotic selected from the following,
namely, penicillin, tetracycline, oxytetracycline, chlortetracycline,
streptomycin, chloramphenicol, bacitracin, neomycin, spiramycin,
streptothricin and grisein; (2) A composition as claimed in claim 1 in' which
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the antibiotics are incorporated in a solid carrier; (3) A composition as
claimed in claim 1 in which the antibiotics are incorporated in a parenteral
liquid. (4) A composition as claimed in claim 1 in which the antibiotics are
incorporated in an ointment vehicle. The Appeal Tribunal applying the
principle of law applicable in prior claiming cases noted that it was not in
dispute that the incorporation of antibiotics in carriers of the types specified
in claims 2 to 4 was so well known on the date of application so as not to
contribute an inventive merit. It was thus held that the claim inventions can
be regarded as covered by Claim-1 which was of a comprehensive type
permitting of alternative additions to novobiocin which alternative additions
consists of one or more of the named antibiotics. It is in relation to this
claim that the appeal tribunal held that the objection of prior claiming has
been established.
10.5 However, in Daikin Kogyo Co. Ltd. (supra) relied upon by learned
counsel for the plaintiffs, it was held that if an earlier claim is wider in its
scope than a later claim and there is no separate claim in the earlier
specification restricted to the subject matter of the later claim, the claimant
of the earlier claim cannot assert that he has made a prior claim to the
subject matter of the later claim. Daikin Kogyo Co. Ltd. (Supra) thus holds
that the later claim should not be subsumed in the earlier wider scope as a
separate claim. In Daikin Kogyo (Supra) the English Court of Appeal was
dealing with the grant of process patent wherein the specifications related to
a process for making tetrafluoroethylene [TFE] by pyrolysis of
chlorodifluoromethane [CDM] with water vapour. It was thus a case of
process patent and the Court concluded that the process claimed was
different in its features.
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10.6 Section 64 (1) (a) of the Patent Act provides that the patent may be
vulnerable to revocation due to prior claiming as under:
64 Revocation of patents. -
(1) Subject to the provisions contained in this Act, a patent,
whether granted before or after the commencement of this Act,
may, [be revoked on a petition of any person interested or of
the Central Government by the Appellate Board or on a
counter-claim in a suit for infringement of the patent by the
High Court] on any of the following grounds that is to say-
(a) that the invention, so far as claimed in any claim of the
complete specification, was claimed in a valid claim of earlier
priority date contained in the complete specification of another
patent granted in India;
10.7 Thus as per Section 64(1) (a) of the Patent Act if the subsequent claim
was claimed in a valid claim of earlier priority date contained in the
complete specification of another patent granted, the same would be
vulnerable to revocation. Thus the only issue to be determined is whether
the species claim of the complete specifications is contained in the complete
specifications of the earlier genus claim.
10.8 This Court while dealing with constructions of claims has already
held that though various SFLT2 inhibitors alongwith the properties of
SGLT2 inhibitors were disclosed and claimed in IN '147 but the specific
compound Dapagliflozin was neither claimed nor disclosed in IN '147 as
this compound with a ethoxy combination was revealed after further
research and development resulting in the claim in IN'625. Hence IN '625 is
prima facie not liable to be revoked on the ground of prior claiming.
Admissions by the Plaintiff in Form 27 and Orange Book
11.1 Case of the defendants is that the plaintiffs having admitted in their
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Form-27 in respect of IN „147 that it worked through the drug Forxiga, the
plaintiff cannot now turn around and take the plea that the pharmaceutical
composition dapagliflozin was not disclosed in IN „147.
11.2 It may be noted that till the year 2014 the plaintiff in respect of its
genus and species patent in the US and the genus and species patent in
India uniformly stated that the patent had not worked. Only after marketing
approvals of the drugs Forxiga that is pharmaceutical composition of
Dapagliflozin was granted to the plaintiff in Form-27 in respect of both the
genus and species patent, the plaintiff stated that the patent had worked
through the drug Forxiga. It is not the case of the plaintiffs that
Dapagliflozin is not covered by the genus patent and once plaintiff claimed
that Dapagliflozin is covered by the genus patent it was required to submit
Form 27 indicating that patent worked through the subsequent
pharmaceutical composition Dapagliflozin resulting in the drug Forxiga. The
admission of the plaintiff in the Orange Book also was after the drug
approval pursuant to IN '625 was granted.
11.3 Further, there are specific admissions of the defendants. Defendant in
CS(COMM) 426/2020 i.e. MSN Laboratories Private Limited which is also
the manufacturer for the defendants in CS(COMM) 418/2020 and
CS(COMM) 419/2020 in its application seeking registration of the patent in
respect of the crystalline/ amorphous form of Dapagliflozin in the years
2014 and 2018 categorically stated that Dapagliflozin was first disclosed in
US '117 i.e. IN „625, even though defendant MSN claims that in its 2016
application it stated that Dapagliflozin was disclosed in US '126. Further,
Cadila Zydus, which is the parent company of ZYDUS Healthcare, the
defendant in CS(COMM) 414/2020 also in its application seeking patent in
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respect of amorphous/ crystalline form pleaded that Dapagliflozin was first
disclosed in US „117 i.e. IN „625.
11.4 As noted above, there can be some gap between coverage and
disclosure and the extent of disclosure in the prior act is required to be
determined on the facts of each case, plaintiffs statements that the patent had
worked through Forxiga as against specific admissions of defendants that
Dapagliflozin was first disclosed in US '117 i.e. IN '625 cannot be read as
admissions of disclosure by plaintiff of Dapagliflozin in IN '147.
Obviousness:
12.1 Case of the defendants is that the claim in IN '625 is obvious to a
person with ordinary skill in the art whereas according to the plaintiffs there
was no motivation in Example 12 to proceed with the said example and then
substitute methyl to ethyl group and further convert it to ethoxy, from the 80
examples resulting in a number of permutations and combinations and thus
the claim in the suit patent is not obvious.
12.2 In the decision 2019 UKSC 15 Actavis Group PTC EHF and others
vs. ICOS Corporation and another, it was observed that even if prior art
comprises of an infinite number of starting point every prior art is deemed to
be suggestive to the person skilled in the art. The only exception being that
the identification/selection is based on an unknown technical effect and this
unknown technical effect must be justified by difference in structure
between the identified/selected compound and the rest of the molecules from
the prior art.
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12.3 Considering the legal effect of generic and specific descriptions of
isoalloxazine constructions in Karrer Patent, the Court in 301 F.2d 676 Re
Petering held as under:
"Next we consider the legal effect of the generic and
specific descriptions of isoalloxazine structures in the Karrer
patent. The generic formula of Karrer, "wherein X, Y, Z, P and
R' represent either hydrogen or alkyl radicals, R a side chain
containing an OH group," encompasses a vast number and
perhaps even an infinite number of compounds since there is no
express limit on the size of the alkyl group or the structure and
size of R. Even though appellants' claimed compounds are
encompassed by this broad generic disclosure, we do not think
this disclosure by itself describes appellants' invention, as
defined by them in any of the appealed claims, within the
meaning of 35 U.S.C. § 102(b). However, there is more than
this broad generic disclosure in Karrer. As set forth supra,
Karrer discloses certain specific preferences for X, Y, Z, P, R
and R' through his series of preferred R groups and his eight
specific isoalloxazines. Keeping in mind that the Karrer patent
is a publication addressed to those of ordinary skill in this art,
it is our opinion that the pattern of Karrer's specific preferences
in connection with his generic formula constitutes a description
of a definite and limited class of compounds which may be
defined with reference to the Karrer generic formula as
follows: where X, P and R' are hydrogen, where Y and Z may
be hydrogen or methyl, and where R is a member selected from
the group consisting of -CH2OH, -CH2CH(OH)CH2OH, -
CH2CH2OH -CH2(CHOH)3CH2OH and -CH2(CH OH)4CH2OH.
We think the Karrer patent, as a printed
publication, describes to one skilled in this art not only the
broad class but also this much more limited class within that
broad class, and we think it is immaterial that Karrer did not
expressly spell out the limited class as we have done here. It is
our opinion that one skilled in this art would, on reading the
Karrer patent, at once envisage each member of this limited
class, even though this skilled person might not at once define
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in his mind the formal boundaries of the class as we have done
here.
A simple calculation will show that, excluding isomerism
within certain of the R groups, the limited class we find in
Karrer contains only 20 compounds. However, we wish to point
out that it is not the mere number of compounds in this limited
class which is significant here but, rather, the total
circumstances involved, including such factors as the limited
number of variations for R, only two alternatives for Y and Z,
no alternatives for the other ring positions, and a large
unchanging parent structural nucleus. With these
circumstances in mind, it is our opinion that Karrer has
described to those with ordinary skill in this art each of the
various permutations here involved as fully as if he had drawn
each structural formula or had written each name. Although
isomerism within certain of the R groups will increase the total
number of compounds in this limited class, in our opinion, this
fact is immaterial in this case because we think that one with
ordinary skill in this art, with the 20 Karrer compounds before
him, would also have before him those subspecies which
involve standard well known isomerism within an R group. For
these reasons, we hold that each compound within the limited
class in Karrer, as defined supra, has been described in a
printed publication within the meaning of 35 U.S.C. § 102(b),
and that it is of no moment that each compound is not
specifically named or shown by structural formula in that
publication."
12.4 Division Bench of this Court in F. Hoffmann-La Roche Ltd. v. Cipla
Ltd. (supra) laid down the following steps to be conducted to determine
obviousness/lack of inventive,:
"Step No. 1 To identify an ordinary person skilled in the art,
Step No.2 To identify the inventive concept embodied in the
patent,
Step No.3 To impute to a normal skilled but unimaginative
ordinary person skilled in the art what was common general
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knowledge in the art at the priority date.
Step No.4 To identify the differences, if any, between the
matter cited and the alleged invention and ascertain whether
the differences are ordinary application of law or involve
various different steps requiring multiple, theoretical and
practical applications,
Step No.5 To decide whether those differences, viewed in the
knowledge of alleged invention, constituted steps which would
have been obvious to the ordinary person skilled in the art and
rule out a hide side approach."
12.5 This Court in CS(COMM) 27/2020 titled as "Bristol-Myers Squibb
Holdings Ireland Unlimited Company & Ors. Vs. BDR Pharmaceuticals
International Pvt. Ltd. & Anr." culled out the principles governing the field
to determine whether an invention is obvious or not as under:
"(i) A hindsight reconstruction by using the patent in question
as a guide through the maze of prior art references in the right
way so as to achieve the result of the claim in the suit, is
required to be avoided.
(ii) The patent challenger must demonstrate the selection of a
lead compound based on its promising useful properties and not
a hindsight driven search for structurally similar compounds.
(iii) There should be no teachings away from the patent in
question in the prior art.
(iv) Mere structural similarity cannot form the basis of
selection of lead compound in a prior art and the structural
similarity in the prior art document must give reason or
motivation to make the claim composition.
(v) Though mosaic of prior art documents may be done in
order to claim obviousness, however, in doing so, the party
claiming obviousness must be able to demonstrate not only the
prior art exists but how the person of ordinary skill in the art
would have been led to combine the relevant components from
the mosaic of prior art.
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(vi) It has to be borne in mind, small changes in structures
can have unpredictable pharmacological effects and thus,
structural similarity alone is not sufficient to motivate to
selection of the lead compound.
(vii) Though it would be tempting to put together a
combination of prior arts but this requires a significant degree
of hindsight, both in selection of relevant disclosures from these
documents and also in disregarding the irrelevant or unhelpful
teachings in them."
12.6 From the decisions as noted above, it is clear that there is a difference
between the subsequent claim being disclosed in the prior art and the
subsequent claim being obvious. For a claim to be obvious the person
skilled in the art has to move forward from the teachings of the prior art to
arrive at the subsequent claim, however, in the case of disclosure of the
subsequent claim in the prior art, the subsequent claim should be so
embedded in the prior art that it is evident to even a layman. Thus there is a
difference in the degree of teachings in the prior art to constitute disclosure
or obviousness in relation to the subsequent claim.
12.7 According to the plaintiff there is no motivation to look at Example
12 when 80 examples have been given of which Examples 1 and 2 were
synthesized on a large scale, there is no motivation to change methyl group,
there are no teachings towards substitution with ethoxy, efficacy data of
Example 12 was not known, the teaching of IN ‟147 were to have hydrogen
on central phenyl ring and no ethoxy on the distal phenyl in any of the 80
examples. As noted above, for preparation of the structure in Example 12,
four methods have been noted and in the said example though methoxy was
used and even though there was no teaching towards ethoxy, there were no
teachings even away from ethoxy. Both ethoxy and methoxy being lower
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alkyl, a person with ordinary skill in the art would have been motivated to
bring this single change of substitution of methoxy to ethoxy to find out if
predictable results ensue. Consequently, this Court is of the prima facie
opinion that the suit patent is vulnerable on the grounds of obviousness in
view of Example 12 of IN ‟147.
12.8 Undoubtedly, the objection of US Patent office is neither an order nor
a finding and the decision of the plaintiff to file a terminal disclaimer cannot
be treated as an admission that the later filed invention claim is obvious, as
held in Quad Environmental Technology (supra) In Simple Air Inc. Vs.
Google LNC the US Court of Appeal reiterated this proposition, however
held that the terminal disclaimer though not an admission of obviousness
would still be relevant to that enquiry and by filing a terminal disclaimer a
patent applicant waives potentially valuable right. It was held that a terminal
disclaimer is a strong clue that a patent examiner and, by concession, the
applicant, sought the claim in continuation lacked the patentable distinction
over the parents, however that strong clue does not give rise to a
presumption that a patent subject to a terminal disclosure is patentably
indistinct from its parents. Hence no presumption of lack of patentability is
available on filing of a terminal disclosure; the lack of patentability would
thus have to be decided on the facts of each case on the grounds of invalidity
available.
Section 8(1) and 8(2) of the Act:-
13.1 Mr. Sandeep Sethi, Learned Senior counsel appearing for the
defendant TORRENT claims that the suit patent is invalid in view of non-
compliance of Section 8. According to him Section 8(1) mandates that the
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plaintiff while filing his application must disclose details of all applications
filed by it either alone or jointly in India or outside in respect of the same or
substantially the same claim. According to the defendant since the plaintiff
did not file the details and documents relating to claiming a terminal
disclaimer in respect of US „147 before the US Patent Office, pursuant to the
Objection of double patenting raised by the USPTO thereby giving option to
the plaintiff of either rejection or to seek terminal disclaimer resulting in the
consequent terminal disclaimer dated 19th August, 2002, the suit patent is
invalid in view of non-compliance of the mandatory provisions of Section 8
of the Patents Act. According to the learned counsel, the plaintiffs not only
failed to comply with Section 8(1) of the Act but also Section 8(2) as the
Indian Patent Office specifically sought details regarding search and/or
examination report as referred to in Rule 12(3) in respect of same or
substantially the same invention filed in all the major patent offices such
USPTO, EPO, and JPO etc., however despite furnishing an undertaking the
plaintiffs only supplied the documents in relation to EPO and did not furnish
documents including the objection of double patenting raised by USPTO
and the consequential seeking of terminal disclaimer.
13.2 In response to the defendant‟s arguments learned counsel for the
plaintiffs submits that a bare reading of Section 8(1) discloses that only
applications which were being prosecuted are required to be filed and when
the application in respect of IN „625 was filed before the Indian patent
office, the US patent '117 had already been granted. Hence there is no non-
compliance of Section 8(1) of the Patents Act. It is further stated that along
with the application filed for grant of IN '625, plaintiffs gave the complete
list of its patents applied for and granted all over the world which amounted
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to sufficient compliance of Section 8 of the Patents Act.
13.3 Section 8 of the Patents Act reads as under:
"8. Information and undertaking regarding foreign
applications. -
(1) Where an applicant for a patent under this Act is
prosecuting either alone or jointly with any other person an
application for a patent in any country outside India in respect
of the same or substantially the same invention, or where to his
knowledge such an application is being prosecuted by some
person through whom he claims or by some person deriving
title from him, he shall file along with his application or
subsequently [within the prescribed period as the Controller
may allow]]-
(a) a statement setting out detailed particulars of such
application; and
(b) an undertaking that, 33 [upto the date of grant of
patent in India], he would keep the Controller
informed in writing, from time to time, of [detailed
particulars as required under] clause (a) in respect
of every other application relating to the same or
substantially the same invention, if any, filed in any
country outside India subsequently to the filing of
the statement referred to in the aforesaid clause,
within the prescribed time.
(2) At any time after an application for patent is filed in
India and till the grant of a patent or refusal to grant of a patent
made thereon, the Controller may also require the applicant to
furnish details, as may be prescribed, relating to the processing
of the application in a country outside India, and in that event
the applicant shall furnish to the Controller information
available to him within such period as may be prescribed."
13.4 Learned counsel for the defendant Torrent relies on the Ayyangar
Committee‟s Report pursuant whereof Section 8 was introduced in the
Patents Act. The relevant portion of the report reads as under:
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"350. In addition to the documents set out in Clause 7 (2) it
would be useful to require the applicant to furnish the following
further information. The majority of the applicants for patents
in India are foreign nationals and in several cases the
application in India is for the same or substantially the same
invention as that for which an application for patent has
already been made by them in other countries. It would be of
advantage therefore if the applicant is required to state whether
he has made any application for a patent for the same or
substantially the same invention as in India in any foreign
country or countries, the objections, if any, raised by the Patent
Offices of such countries on the ground of want of novelty or
unpatentability or otherwise and the amendments directed to be
made or actually made to the specification or claims in the
foreign country or countries upto the date of acceptance of the
application. This matter acquires added importance by reason
of the change which I have suggested in the content of the
publications which should constitute anticipation to deprive an
invention of novelty. As publication abroad before the relevant
date would also constitute anticipation, this information would
be of great use for a proper examination of the application.
351. I would further suggest a provision for ensuring that the
applicant keeps the Controller informed of any further foreign
applications made and of the orders made on such applications
after the date of the Indian application. Naturally this would
have to be in the form of an undertaking to be filed by the
applicant.
355. To secure compliance with this provision as to the
disclosure of information regarding foreign applications for the
same invention, I am adding to Clauses 21 and 37 words to
include failure to communicate information in possession of an
applicant, as constituting a ground of opposition and revocation
respectively.
13.5 In F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (supra), the Division
Bench of this Court dealing with Section 8 of the Patents Act held:
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"125. Thus though as a general rule if a consequence is
provided then the rule has to be interpreted as mandatory
however in the present case the consequence itself is not
mandatory because of use of the word „may‟ in Section 64(1).
This issue came up for consideration before Division Bench of
this Court in Maj.(Retd.) Sukesh Behl (supra) wherein this
Court held that though it is mandatory to comply with the
requirement under Section 8(1) of the Patents Act and non-
compliance of the same is one of the grounds for revocation of
the patent under Section 64(1)(m), however the use of the word
„may‟ in Section 64(1) itself indicates the intention of the
legislature that the power conferred thereunder is discretionary
and consequently it is necessary for the Court to consider the
question as to whether omission on the part of the applicant was
intentional or whether it was a mere clerical and bona-fide
error.
126. Having held that Section 64(1) is directory in nature and
thus non-compliance of Section 8 would not automatically
result in revocation of the patent, we need to note the further
distinction between a mandatory rule and a directory rule. In
the decision reported as (1980) 1 SCC 403 Sharif-Ud-
Din v. Abdul Gani Lone the Supreme Court noting the
distinction between a mandatory rule and the directory rule
held that while the former must be strictly observed, in the case
of the latter substantial compliance may be sufficient to achieve
the object regarding which the rule was enacted.
127. The doctrine of substantial compliance is a judicial
invention, equitable in nature, designed to avoid hardship in
cases where a party does all that can reasonably be expected of
it, but failed or faulted in some minor or inconsequent aspects
which cannot be described as the "essence" or the "substance"
of the requirements. Like the concept of "reasonableness", the
acceptance or otherwise of a plea of "substantial compliance"
depends on the facts and circumstances of each case and the
purpose and object to be achieved and the context of the
prerequisites which are essential to achieve the object and
purpose of the rule or the regulation. (See (2011) 1 SCC
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236 Commissioner of Central Excise, New Delhi v. Hari Chand
Shri Gopal)."
13.6 In Merck Sharp & Dohme (supra), the Division Bench of this Court in
relation to non-compliance of Section 8 in Paras 72, 73 and 76 noted
Glenmark‟s allegations that MSD did not comply with its obligation under
Section 8 of the Act to disclose patent application made for the "same or
substantially the same invention" or subsequent international application for
these compounds either. Referring to Section 64(1)(m) the Division Bench
noted that failure to comply with Section 8 is a ground for revocation of the
patent however reiterated the discretionary element consequent upon a
patent applicant‟s failure to comply with Section 8 as under:
""37. In the present case, it is no doubt true that it is
mandatory to comply with the requirements under Section
8(1) of the Patents Act and noncompliance of the same is one of
the grounds for revocation of the patents under Section
64(1)(m).
However, the fact that the word "may" is used in Section
64(1) itself indicates the intention of the legislature that the
power conferred thereunder is discretionary. The mere fact that
the requirement of furnishing information about the
corresponding foreign applications under Section 8(1) is
mandatory, in our opinion, is not the determinative factor of the
legislative intent of Section 64(1). We found that the language
of Section 64(1) is plain and unambiguous and it clearly confers
a discretion upon the authority/Court while exercising the
power of revocation. The interpretation of the FAO (OS)
190/2013 Page 64 provisions of Section 64(1) as discretionary,
in our considered opinion, does not result in absurdity nor in
any way effect the rigour of the mandatory requirements
under Section 8 of the Act.
38. Therefore, we are of the view that though any violation of
the requirement under Section 8 may attract Section
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64(1)(m) for revocation of the patent, such revocation is not
automatic."
An important element in this discussion is that at an
interlocutory stage, when the Court merely takes a broad look
at the prima facie nature of the case, rejection of the claim for
temporary injunction on the basis of such facial understanding
regarding non-disclosure of Section 8 would be drastic. The
possibility cannot be entirely ruled out, in cases where breach
of the provision is patent and manifest. In other cases, resting
the decision not to grant interlocutory relief (a powerful interim
order, given the length of a patent infringement trial) entirely
based on infraction of Section 8 can operate harshly - possibly
even cause irreparable harm in itself. The non- disclosure of
5948/DELNP/2005 (Sitagliptin Phosphate Monohydrate),
1130/DELNP/2006 (Sitagliptin Phosphate Anhydrate),
2710/DELNP/2008 (Sitagliptin plus Metformin) is thus prima
facie insufficient, in the opinion of this Court, for revocation
under Section 64(1)(m)."
13.7 In Chemtura Corporation Vs. Union of India & Ors.
MANU/DE/1880/2009 learned Single Judge of this Court dealing with
Section 8 held that in view of the facts of the case a credible challenge to
the validity of the suit patent was raised which was required to be examined
during the course of trial, thus the plaintiff was not entitled to the relief of
interim injunction. This Court held:
"18. It was pointed out that unaware of the serious objections
on the basis of cited prior arts raised by the US and European
Patent authorities, the Indian patent authority granted the
plaintiff the patent for the subject device with minimal
amendments. Claim No. 2 was merged in Claim No. 1 and the
subsequent claims were re-numbered by the plaintiff. The
Defendants point out that the First Examination Report (FER)
dated 20th October 2004 of the Controller of Patents in India
raised some insignificant objections without even citing a single
prior art whereas the US and European authorities had cited
several closely similar patents based on which the plaintiff was
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compelled to restrict its claims to the toroidal/torus shape of the
compression spring. In para 8 of the requirements
communicated with the PER the Controller sought information
on the details regarding the search and/or examination report
including claims of the applications allowed, as referred to in
Rule 12(3) of the Patents Rules 2003 (Rules.) in respect of same
or substantially same inventions filed in any one of the major
patent offices, such as USPTO, EPO and JPO etc., along with
appropriate translation where applicable. This had to be
furnished within a period of 30 days.
19. In response thereto, the plaintiff by its letter dated 14th
October 2005 did not specifically reply to para 8 of the
requirements while maintaining that all the remaining
requirements had been complied with. It appears that
telephonic discussions took place between the Patent Examiner
and the plaintiff's representative between 15th and 19th
October 2005. This resulted in a further letter dated October
19, 2005 by the plaintiff to the Patent Examiner. In the said
letter the plaintiff's attorneys stated that that there has been no
further development subsequent to the Form 3 which was filed
at the time of filing the application in India. The requirement in
this regard may be withdrawn. According to Defendants 2, 3
and 4 this statement was false since between 21st June 2001
when the Form 3 was filed and October 19, 2005 when the
aforementioned letter was written, the US Patent Authorities
had issued a rejection letter of 26th July 2001 stating that they
were not satisfied with the amendments made by the plaintiff to
its claims. By June 12, 2002 the claims were amended at least
five times because the plaintiff failed to overcome the closely
similar prior art citations of the US Patent Office. These facts
were withheld from the Controller of Patents in India. Likewise
the examination details of the applications before the European
Patent Office were also not brought to the notice of the
Controller of Patents in India.
24. It is pointed out by Mr. Shanti Bhushan that in terms of
the requirement under Section 8 of the Act read with Rules and
the corresponding Form 4 in force on the date of making the
patent application, the plaintiff had only to furnish information
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about the filing of patent applications elsewhere. Those details
were in fact furnished. With reference to the requirement of
furnishing the information as asked for by the Controller in
Clause 8 of the letter dated 20th October 2004, it is submitted
that only where a claim has been accepted and patent granted,
there would be a need for the plaintiff to furnish to the
Controller of Patents, the search and examination reports of the
corresponding authorities of the countries where the patent was
granted. However, as on that date i.e. 15th October 2005 no
grant of patent had been made by either the US Patent Office or
the European Patent Office. Therefore there was full
compliance with the requirement of Clause 8. It is stated that
there was no false information given or suppression of relevant
information by the plaintiff.
25. It is further pointed out by Mr. Shanti Bhushan that the
search report available at that point of time was the
international search report which was in fact furnished to the
Controller of Patents. The word status. in Form 3 only required
the plaintiff to indicate whether the application for patent in a
country outside India was pending, allowed or dismissed. If
every stage of the application in a country outside India has to
be disclosed to the Controller of Patents, it would make his task
impossible and cumbersome. Referring to a Wikipedia printout
on the PCT, Mr. Shanti Bhushan states that the filing of the
PCT application is to be construed as furnishing the details
relating to filing of application in each designated State.
Without prejudice to the above contentions Mr. Shanti Bhushan
submits that not every suppression of fact or false statement
would vitiate the grant of patent. What would have to be seen is
whether the suppression of fact had the potential of affecting the
grant of patent. In support of this submission, he refers to the
Halsbury's Laws of England (Vol.35 page 564) and the decision
in Valensi British Radio Corpn 1973 RPC 337.
37. The plaintiff submitted its National Phase Application for
grant of patent in respect of side bearing pad assembly
corresponding to the PCT Application dated 15th September
2000 to the Controller of Patents in Mumbai on 21st June 2001.
Among other documents, it enclosed with the said application
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the completed Form 3 and the international search report. That
search report merely indicated the filing of a patent action by
the plaintiff elsewhere. The International Application indicated
the US Application made in 1999 as the prior application. The
plaintiff may be right in contending that the Form 3 which was
prevalent at that point of time did not contain a column status.
and, therefore, all that it was required to inform the Patent
Controller was that it had made applications for patent for the
same invention in different countries. However, the requirement
of the law did not end there. While Section 8(1)(a) of the Act
required the applicant to furnish a statement on the applications
made in other countries, Section 8(1)(b) required the applicant
to give an undertaking that up to the date of grant of patent in
India (or as earlier worded up to the date of the acceptance of
his complete specification filed in India) the applicant would
keep the Controller informed in writing from time to time of
detailed particulars as required in Clause (a) in respect of
every other application relating to the same or substantially the
same invention if any filed in any country outside India
subsequent to the filing of the application referred to in the
abovesaid clause within the prescribed time. Even under the
Form 3 as was prevalent on the date of filing the application, an
undertaking had to be given to the effect that up to date of
acceptance of the complete specification filed in connection
with our abovementioned application, we would keep the
Controller informed in writing from time to time of the details
regarding the applications for patent filed outside India from
time to time for the same or substantially same invention within
three months from the date of filing such application. Therefore
this did not hinge on the Controller asking for particulars but
the applicant keeping the Controller informed from time to time.
The expression time to time meant a periodicity of furnishing
information akin to updating the Controller on the current
status of the applications filed in other countries. It is not, as
suggested by the learned Senior counsel for the plaintiff, a mere
furnishing of information whether the application is pending or
dismissed.
40. As far as Section 8(2) is concerned, the Controller on his
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own may also require the applicant to furnish details relating to
the processing of the application in a country outside India, and
in that event the applicant shall furnish to the Controller
information available to him within such period as may be
prescribed. That requirement is mandatory as has been further
emphasised by the wording of Section 64(1)(j) [that the
applicant has failed to disclose to the Controller the
information required by Section 8 or has furnished information
which in any manner was false to his knowledge] which
indicates the non- compliance with such directive of the
Controller as a ground for the revocation of the patent. The
obtaining of a patent, on a false suggestion or representation is
a further ground of revocation under Section 64(1)(m).
45. It is not possible to accept the submission, made by
referring to the Halsbury's Laws of England, that since the
omission to furnish particulars is not serious enough to affect
the grant of the patent, it did not impinge on its validity. Section
64(1) (j) and (m) indicate to the contrary. Further under Section
43(1)(b) a patent can be granted only when the application has
been found not to be contrary to any provision of the Act. It
cannot be said that the omission to comply with the requirement
of Section 8(2) was not serious enough to affect the decision of
the Controller to grant the patent to the plaintiff. The
information, if provided, would have enlightened the Controller
of the objections raised by the US patent office and the extent to
which the plaintiff had to limit its claims to the torus shape of
the compression spring, which was a key feature of the subject
device. Had the Controller been informed of the plaintiff's own
patent No. 3932005 dated 13th January 1976, he would have
been called upon to examine if that patent taught the use of a
toroidal shape of a compression member and whether therefore
the subject device was an inventive step within the meaning of
the Act."
13.8 Learned counsel for the plaintiff points out to the documents filed
wherein a tabulated chart has been filed in respect of the details of the
application along with the patents granted or not and the date if any in the
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various countries. Copy of the Form 3 filed while seeking the suit patent IN
„625 by the plaintiff is as under:
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13.9 Based on this document learned counsel for the defendant states that
the plaintiff was aware of the fact that not only the details of the application
for same or substantially the same patent which were being prosecuted were
required to be filed but details of the application for same or substantially
the same invention for which patents had been granted were also required to
be filed in Form 3, as is evident from the plaintiff's ANNEXURE filed with
Form 3 in the suit patent as noted above and thus the plea of the plaintiffs
that details of application being prosecuted only were required to be filed.
13.10 As per Section 8(1) of the Patents Act, the applicant is required to
furnish details of applications being prosecuted either jointly, separately or
individually, in respect of same or substantially the same invention in any
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country outside India and besides the detailed particulars, an undertaking is
also required to be furnished that the Controller will be kept informed in
writing, from time to time, of detailed particulars in respect of every other
application relating to the same or substantially the same invention, filed
subsequently to the filing of the statement within the prescribed time. Form
12 of the Patent Rules also reinforces the said requirement. In the present
case the objection of the US Patent Office seeking a terminal disclaimer by
the US Patent Office in relation to US '147 was prior to the plaintiff's filing
the application in respect of IN '625 in India and the details of the such
applications being PCT No.10/151436, alongwith the claim specifications,
applied and granted as a continuation in part application was duly informed
to the Indian Patent Office. As US '147 had been granted at the time of
filling the Indian PCT application No. 3573/DELNP/2004 resulting in IN
'625 and the particulars of the US '147 application alongwith the claim were
furnished, the same would amount to substantial compliance. Since details
of US PCT No.10/151436 were furnished alongwith the claim application
details and all further details were also available on the websites, thus
deemed to be within the knowledge of the Indian Patent Office, non-
furnishing of the objections raised by the USPTO at this stage cannot be
held as deliberate concealment and suppression under Section 8(1) of the
Act. Plea of Mr. Majumdar, Ld.Counsel for TORRENT that since the
computers of the Indian Patent Office were not working in the relevant
period, there was no compliance, cannot be attributed to the plaintiffs once
the plaintiffs had given the details of all the applications pending as well as
granted for same or substantially the same invention.
13.11 Plaintiffs have, however, failed to comply with Section 8(2) of the
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Patents Act wherein if the patent‟s office raises a query, the party is required
to mandatorily furnish the replies thereto as undertaken. The Indian Patent
Office required the plaintiff to file certain more documents and sought for
reply to the various objections and in this regard objection 12 and 13 are
relevant which read as under:
"12. Details regarding application for Patents which may be
filed outside India from time to time for the same or
substantially the same invention should be furnished within six
months from the date of filing of the said application under
Clause (b) of sub section (1) of section 8 and rule 12(1) of
Indian Patent Act.
13. Details regarding the search and/or examination report
including claims of the application allowed, as referred to in
Rule 12(3) of the Patent Rule, 2003, in respect of same or
substantially the same invention filed in all the major Patent
office such as USPTO, EPO and JPO etc., along with
appropriate translation where applicable, should be submitted
within a period of six months from the date of receipt of this
communication as provided under Section 8(2) of the Indian
Patents Act."
13.12 In reply to these including objection at serial No. 13 the plaintiff did
not submit any reply to objection No.12, and in response to objection No.13
the plaintiff furnished copies of the EPO decision of grant and the EP
granted patent only, which according to the plaintiff met the requirement of
Section 8(2) of the Act.
13.13 It is thus clear that despite the fact that the Patent office clearly sought
details regarding the search and/or examination report including claim of the
application allowed, as referred to in Rule 12(3) of the Patent Rule 2003 in
respect of the same or substantially the same invention filed in all major
Patent offices such as USPTO, EPO and JPO etc., the plaintiff only
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submitted the documents in relation to the EPO and not the USPTO where
on an objection being raised the plaintiff sought a terminal disclosure. The
plea of the plaintiffs that as in US '117 plaintiffs had filed a continuation in
part application, term whereof if granted was with the genus patent and
hence filing of a terminal disclaimer had no bearing deserves to be rejected.
The issue is not the term of the patent sought by the plaintiffs in US '117 but
the fact that an objection of double patenting was raised by US PTO for the
same invention, it was required to be brought to the notice of Indian Patent
Office, at least after the same was sought by the Indian Patent Office. Hence
the plaintiff's having not complied with Section 8(2), the validity of suit
patent is vulnerable for non-compliance of Section 8(2) of the Patents Act
Whether the Suit Patent Lapsed for non-filing the renewal fees in
time and non-publication thereafter?
14.1 Since the present application can be decided on the other issues raised
and in this respect writ petition is already pending consideration, this Court
is not dealing with this issue in the present applications.
Clearing the way:
15.1 In Bristol Myers Squibb company & Ors. Vs. J.D. Joshi & Anr. a
Single Judge of this Court held that old patents have a kind of presumption
of validity, and by filing a revocation petition just before expiry is not the
manner of clearing the way. Therefore if the party intends to launch the
drug in the market knowing fully well that the plaintiff has been granted a
suit patent, it must clear the way by filing a revocation petition well in
advance.
15.2 Further the Division Bench in Merck Sharp Dohme (supra) observed
that if a defendant is aware that there may be a possible challenge to its
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product, but still chooses to release the drug without first invoking
revocation proceedings or attempting to negotiate, that is surely a relevant
factor. The defendant's legal right to challenge the patent at any point in
time is intact, but that does not mean that this factor cannot determine the
interim arrangement.
15.3 In all these suits except TORRENT, none of the defendants filed any
revocation petition and straight away launched the drug Sitagliptin on expiry
of the validity of IN '147 on 2nd October, 2020. Even TORRENT filed the
revocation petition in February, 2020, nearly 15 years after the grant of the
patent. Thus the defendants have not cleared the way before launching the
drug.
Legal Principles on grant of refusal of injunction
16.1 As this Court is dealing with the applications for interim injunction, as
per the test laid down by the Division Bench of this Court in (2009) 40 PTC
125 F. Hoffman-La Roche vs. Cipla Ltd., this Court need not go into actual
invalidity of the suit patent but whether the suit patent is vulnerable based on
a credible challenge.
16.2 The Division Bench of this Court in the decision reported as Merck
Sharp and Dohme (supra) laid down the legal principles in respect of grant
or refusal of an interim injunction in a patent suit. It was held that the Court
cannot go into the issues of patent claim, its disclosure, prior art, subsequent
application and the nature of product, which require a minute examination of
the facts, which can be dealt after the Court has the benefit of the full trial
with pleadings and expert evidence, especially in matters as complicated as
pharmaceutical patents. However, since an interim injunction affects party‟s
legal right based on a necessarily incomplete legal finding that may possibly
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tilt the other way, so to speak, the other two factors - balance of
convenience and presence of an irreparable injury become all the more
important. In determining the balance of convenience between the parties
and whether an irreparable injury may result, the Division Bench made some
observations on the approach to be adopted by the Courts, however
cautioned that the equitable principles though guide the exercise of the
discretion, to which Courts must be alive, they not limit Judge‟s discretion
in tailoring the decision and the relief on the facts of each case.
16.3 In Merck Sharp and Dohme (supra) the Division Bench laid down six
equitable principles which are required to be considered; first of which being
that the Court must look at the public interest in granting an injunction. One
of the major criteria to determine public interest was price difference of the
drug and while comparing with, in Hoffman La Roche (supra) the price
difference was about 300%, in Merck Sharp and Dohme (supra), the price
difference was not so startling as to compel the Court to infer that allowing
Glenmark to sell the drug, at depressed prices would result in increased
access.
16.4 The second principle recognized by the Division Bench was that
where a strong case of infringement is established, there is an interest in
enforcing the Act. The Court also held that the argument that no injunction
should be granted since the patentee can be compensated monetarily by
damages from loss of sale, though appealing is to be rejected because a
closer look at the market forces reveal that the damages in some cases can
be irreparable.
16.5 The third principle recognized by the Division Bench was that where
an infringer is allowed to operate in the interim during the trial it may result
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in reduction in price by that infringer since it has no research and
development expenses to recoup and thus revenue received becomes profit.
However, the patentee can only do so at his peril and the victory for the
patentee therefore should not be pyrrhic but real. The Division Bench noted
that irreparable market effect in cases of sole supplier of a product has also
triggered the decision in SmithKline Beecham v. Generics, (2002) 25(1) IPD
25005, where in granting an interim injunction it was held that damages
would not be an adequate remedy for the plaintiff since it was the sole
supplier of the product, and the new entrants to the market were likely to
cause its prices to go into a downward spiral. On the facts of the case the
Division Bench noted that since the price differential between MSD‟s
product and the infringing products is 30%, a significant portion of which is
due to custom duty paid by MSD, the balance of convenience clearly was in
favour of MSD.
16.6 The Division Bench noted the fourth principle based on the
chronology of events and Glenmark‟s decision to release Zita without first
challenging Januvia or Janumet. It was noted that undoubtedly the Act
creates a right to oppose patents even after grant. However, if a defendant is
aware that there may be a possible challenge to its product but still chooses
to release the drug without first invoking revocation proceedings or
attempting to negotiate, that is surely a relevant factor. The defendant‟s
legal right to challenge the patent at any point in time is intact, but that does
not mean that this factor cannot determine the interim arrangement. Based
on the decision relied upon it was held that the fact that the patentee was
already dealing in the market on the basis of the patent weighed in as a
factor in granting the interim injunction and that the defendant has not
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cleared the way.
16.7 It was held that ultimately the Court must look at the combination of
three primary factors. A strong case can in some instances offset an equal
balance of conveniences between the parties and in the said case MSD
having established a prima facie case of infringement, an interim
arrangement which secures the interest of both the parties and maintains the
public interest involved is available, which also ensures that the possibility
of irreparable harm to the patentee is removed. The Division Bench thus set
aside the order of the learned Single Judge dismissing the application for
grant of an interim injunction and issued directions to MSD to file an
affidavit that in the event the suit is dismissed MSD would compensate
Glenmark for the damage or loss caused, including but not limited to loss of
earnings.
CONCLUSION:-
17.1 In view of the discussion aforesaid, since the defendants have prima
facie laid a credible challenge to the validity of suit patent on the ground of
obviousness and for non-compliance of Section 8(2) of the Act, this Court
finds that the plaintiffs have not made out a prima facie case for grant of
interim injunction which is declined. The balance of convenience and an
irreparable loss even though in favour of the plaintiffs as held in Merck
Sharp Dohme (supra), the prima facie vulnerability of the validity of the suit
patent outweighs these factors. The interim injunction granted in
CS(COMM) 323/2020, CS(COMM) 426/2020 and CS(COMM) 346/2020,
is vacated. During the pendency of the present suits, defendants are directed
to maintain complete accounts of the manufacture, sale and supply of the
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products and file in this Court on affidavits statements of such accounts on
quarterly basis, duly certified by their auditors with advance copies to the
plaintiffs. The Defendants will also file the annual statement of sales of the
products duly authenticated by their auditors. The defendants on affidavits
will also undertake to pay damages to the plaintiffs as and when directed by
the Court and file the list of their assets, both encumbered and
unencumbered alongwith their market value, within four weeks.
17.2 Accordingly, I.A. No. 6931/2020 (under Order XXXIX Rule 1 and 2
PC) in CS(COMM) 323/2020, I.A.7399/2020 (under Order XXXIX Rule 1 and 2
CPC) in CS(COMM) 346/2020, I.A. 8940/2020 (under Order XXXIX Rule 1
and 2 CPC) in CS(COMM) 414/2020, I.A. 8991/2020 (under Order XXXIX
Rule 1 and 2 CPC) in CS(COMM) 418/2020, I.A. 8997/2020 (under Order
XXXIX Rule 1 and 2 CPC) in CS(COMM) 419/2020 and I.A. 9075/2020
(under Order XXXIX Rule 1 and 2 CPC) in CS(COMM) 426/2020 are dismissed
and I.A.9484/2020 (under Order XXXIX Rule 4 CPC) in CS(COMM) 346/2020,
I.A.9316/2020 (under Order XXXIX Rule 4 CPC) in CS (COMM) 426/2020 and
I.A.10168/2020 (Under Order XXXIX Rule 4 CPC) in CS (COMM)
323/2020 are disposed of.
17.3 It is clarified that the observations made hereinabove while
ascertaining a prima facie case will have no bearing on the final decision
which would be decided after the full trial on its own merit.
(MUKTA GUPTA)
JUDGE
NOVEMBER 18, 2020
ga/akb/vn
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