Delhi High Court
E. R. Squibb And Sons, Llc & Ors vs Zydus Lifesciences Limited on 18 July, 2025
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* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ CS(COMM) 376/2024 & I.A. 10533/2024
E. R. SQUIBB AND SONS, LLC & ORS. .....Plaintiffs
Through: Mr. Sandeep Sethi, Sr. Advocate, Mr.
P.S. Raman, Sr. Advocate, Mr. Amit
Sibal, Sr. Advocate with Mr. Pravin
Anand, Ms. Archana Shanker, Ms.
Prachi Agarwal, Mr. Devinder Rawat,
Ms. Elisha Sinha and Mr. Manan
Mondal, Advocates
versus
ZYDUS LIFESCIENCES LIMITED .....Defendant
Through: Mr. Harish Salve, Sr. Advocate, Mr.
Dushyant Dave, Sr. Advocate, Mr.
Rajiv Nayar, Sr. Advocate, Mr.
Dayan Krishnan, Sr. Advocate with
Mr. Adarsh Ramanujan, Ms. Bitika
Sharma, Ms. Vrinda Pathak, Ms.
Sandhya Kukreti, Mr. Rajnish Kumar,
Ms. S.L. Soujanya, Mr. Parth Singh
and Mr. Manjunathan P.S., Advocates
CORAM:
HON'BLE MS. JUSTICE MINI PUSHKARNA
JUDGMENT
% 18.07.2025
MINI PUSHKARNA, J:
I.A. 10533/2024 (Application under Order XXXIX Rules 1 and 2, read
with Section 151 of the Code of Civil Procedure, 1908 for injunction)
Introduction:
1. By way of the present judgment, this Court shall decide the
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application of the plaintiffs for injunction, being I.A. 10533/2024.
2. The present suit has been filed seeking permanent injunction for
restraining infringement of Indian Patent No. IN 340060 (“IN „060”), which
is titled as, ―Human Monoclonal Antibodies to Programmed Death 1 (PD-1)
for use in treating Cancer‖ (“suit patent”). The suit patent is registered in
the name of the plaintiffs and is currently valid and subsisting.
3. The suit patent covers and claims a monoclonal antibody, also known
as „Nivolumab‟ or „5C4‟, in the complete specification of IN „060.
Nivolumab is a therapeutic antibody used in the treatment of various forms
of cancer. PD-1 is a protein found on T-cells, which are a type of immune
cell, that help to keep the body‟s immune responses in check. Monoclonal
antibodies are laboratory-produced engineered bio-molecules that can
restore, enhance, modify or mimic the immune system‟s attack on cells that
are not wanted, such as cancer cells.
4. The suit patent has a term of 20 years, starting from 02nd May, 2006,
which expires on 02nd May, 2026. The suit patent was granted after
adjudication of four pre-grant oppositions, contested under Section 25(1) of
the Patents Act, 1970 (“Patents Act“). Furthermore, a post-grant opposition
under Section 25(2) of the Patents Act, filed by Zydus Healthcare Limited, a
sister concern of the defendant, challenging the grant of the suit patent, is
currently pending.
Factual Matrix:
5. An Application no. 5057/CHENP/2007 was filed as a National Phase
Entry of International (PCT) Application no. PCT/JP2006/309606, filed on
02nd May, 2006, and published as International Publication no.
WO2006/121168 A1 on 16th November, 2006. This application claims
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priority to U.S. Provisional Application nos. 60/679,466 filed on 09th May,
2005; 60/738,434 filed on 21st November, 2005 and 60/748,919 filed on 08th
December, 2005.
6. The pharmaceutical product, Nivolumab is sold under the brand name
Opdivo® outside India, whereas, in India, Nivolumab is imported and
marketed by plaintiff no. 3 as Opdyta®.
7. As noted above, four pre-grant oppositions were filed during the suit
patent‟s prosecution history, which were rejected by the Controller of
Patents vide order dated 30th June, 2020, subsequent to which, the suit patent
was granted on 01st July, 2020. The four pre-grant oppositions were filed by
Indian Pharmaceutical Alliance (“IPA”), Mumbai; Pankaj Kumar Singh,
Delhi; Restech Pharmaceuticals, Ahmedabad and Dr. Reddy‟s Laboratories,
Hyderabad, respectively.
8. Subsequent to the grant of the suit patent on 01 st July, 2020, a post-
grant opposition under Section 25(2) of the Patents Act was filed against it
by Zydus Healthcare Limited, a sister concern of the defendant, on 01st July,
2021, which is currently pending before the Controller of Patents. The
Opposition Board Recommendation (“OBR”) dated 31st January, 2023,
opining that IN „060 is invalid and liable to be revoked, was set aside by the
High Court of Madras vide its order dated 15th March, 2024 in W.P. No.
8451/2023, filed by plaintiff nos. 1 and 2 herein. Thereafter, an appeal, i.e.,
W.A. No. 1697/2024 was preferred by the defendant herein against the order
dated 15th March, 2024, wherein, vide order dated 13th June, 2024, the
Division Bench of High Court of Madras held that the order dated 15th
March, 2024, passed by the Single Judge, shall be kept in abeyance.
9. Subsequently, vide order dated 10th January, 2025, the appeal, W.A.
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No. 1697/2024, was disposed of by way of a consent order, wherein, the
order dated 15th March, 2024, passed by the Single Judge was quashed and
set aside and the matter was remanded back to the Single Judge for
disposing of the writ petition expeditiously.
10. Plaintiffs, sometime in April, 2022, became aware that the defendant
(former name, Cadila Healthcare Ltd.), had applied for clinical trial approval
of Nivolumab before the Central Drugs Standard Control Organisation
(“CDSCO”). Thereafter, a letter was issued on behalf of the plaintiffs to the
defendant on 06th May, 2022, calling upon the defendant to cease-and-desist
from making or using Nivolumab, until the expiry of the term of IN „060.
The defendant issued a response dated 17th May, 2022, stating that seeking
approvals from the Directorate General of Commercial Intelligence and
Statistics (“DCGI”) for conducting clinical trials was within the scope of the
Patents Act and did not amount to infringement of the suit patent. As per the
plaintiffs‟ case, pursuant to the defendant‟s reply indicating that no
unauthorized activities were being carried out, the plaintiffs did not
apprehend any immediate threat at that stage, since clinical trials were under
progress.
11. However, further investigation by the plaintiffs revealed that the
defendant had registered a clinical trial for its bio-similar ZRC-3276 with
the Clinical Trial Registry of India (“CTRI”). In the said registration before
the CTRI, the defendant had mentioned plaintiffs‟ product Nivolumab,
identifying Opdivo®, as the reference product. The plaintiffs also came
across the permission granted by the CDSCO in September, 2022 to the
defendant to manufacture and import new drugs for clinical trials under the
provisions of New Drugs and Clinical Trials Rules, 2019 for its similar
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biologic/bio-similar, ZRC-3276, with the reference drug being Nivolumab,
i.e., Opdivo®.
12. Thereafter, in April, 2024, the plaintiffs, through plaintiff no. 3‟s
healthcare professional and later from their distribution network discovered
that the defendant might be planning to launch a bio-similar version of
Nivolumab, during the term of the suit patent, since several inquiries were
received regarding the defendant‟s product by the plaintiffs. It was also
revealed that the defendant had applied for regulatory approval from the
CDSCO/DCGI, for marketing the said bio-similar version of Nivolumab.
13. As per the plaintiffs, there existed a real, credible and reasonable
apprehension that the defendant intended to manufacture, launch and
otherwise deal in Nivolumab during the term of the suit patent without the
plaintiffs‟ authorisation, and thus, the present suit came to be filed as a quia
timet action. I.A. No. 10533/2024 has been filed along with the present suit
seeking interim relief, which is subject matter of adjudication herein.
14. It is noted that this Court, vide order dated 08th May, 2024, restrained
the defendant from placing its products in the market without prior
permission of the Court. The said order is continuing till date.
Submissions on Behalf of the Plaintiffs:
15. On behalf of the plaintiffs, it is submitted as follows:
15.1 A prima facie case of infringement has clearly been established by the
plaintiffs in view of the fact that the suit patent is valid and subsisting.
Further, the defendant has clearly admitted that only their activities of
carrying out research are exempt from patent infringement under Section
107A of the Patents Act, and commercial use. Moreover, if an ad interim
injunction is not granted, irreparable loss and harm will be caused to the
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plaintiffs, which cannot be compensated in monetary terms, particularly in
the present quia timet action.
15.2 There has been no delay in filing the present suit. The plaintiffs,
around April, 2022 became aware that the defendant had applied for a
clinical trial approval of Nivolumab before the CDSCO. Moreover, since
April, 2022, the plaintiffs continued to receive credible information in
relation to defendant‟s proposed launch of infringing products till 04th May,
2024, at which stage the plaintiff no.3‟s representative received emails
enquiring about the defendant‟s launch of a bio-similar Opdivo® without the
authorization of the plaintiffs. Thus, on account of apprehension of
commercial launch of product by the defendant, the present suit came to be
filed.
15.3 The defendant never made any official request from the plaintiffs
seeking to procure Nivolumab (Opdivo®) vials, nor have the plaintiffs
supplied any Nivolumab to the defendant. The affidavit of the independent
investigator has the records of imports of Nivolumab by the defendant, as
per which, the defendant had on multiple occasions, imported Nivolumab
(Opdivo®) in the years 2018 (4 instances), 2019 (6 instances), 2020 (2
instances), 2022 (6 instances), 2023 (2 instances), 2024 (1 instances) and
some of these imports were allegedly for test/research purposes. Further, the
defendant had also exported 1 glass bottle containing Nivolumab (bulk) in
the year 2024.
15.4 The plaintiffs, on account of the reply dated 17th May, 2022 by the
defendant, to the cease-and-desist letter issued by the plaintiffs on 06th May,
2022, did not apprehend any immediate threat at that stage. Since clinical
trials were in progress, the outcome of which was uncertain, the plaintiffs
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did not take any action.
15.5 The defendant is well aware of the rights of the plaintiffs in the suit
patent as its sister concern, Zydus Healthcare Limited, filed a post-grant
opposition against the grant of the suit patent, and was also served with a
cease-and-desist letter in May, 2022, to which they had categorically
responded. The defendant‟s disregard towards the plaintiffs‟ statutory rights
in the suit patent, is wilful. Additionally, one of the pre-grant oppositions
was filed by an organisation, IPA, of which the defendant is a member.
15.6 Furthermore, on 12th May, 2020, the Defendant has also filed a Patent
Application no. 202021019976 before the Indian Patent Office in respect of
―PROCESS OF PURIFYING ANTI-PD-1 ANTIBODY‖, wherein, the
preferred anti-PD-1 is Nivolumab, and the application is still pending.
15.7 Nivolumab is covered and claimed by the suit patent through Claims
1 and 3 of the suit patent, as Nivolumab contains the six Complementary
Determining Regions (“CDRs”) as claimed in granted Claim 1 and the
Heavy Chain Variable (VH) domain and Light Chain Variable (VL) domain
sequences as claimed in granted Claim 3. Further, the Claim 7 of the suit
patent also claims Nivolumab as a composition with a pharmaceutically
acceptable carrier.
15.8 IN „060 is a valid and subsisting patent in India, and the term of IN
„060 expires on 02nd May, 2026. Since the plaintiffs are the rightful owners
of IN „060 under Section 48 of the Patents Act, the plaintiffs have the
exclusive right to prevent third parties, who, without the plaintiffs‟
authorization, cannot perform in India, the act of making, using, offering for
sale, selling, exporting or importing the product(s) that fall within the scope
of the claims of the suit patent till 02nd May, 2026.
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15.9 The suit patent has been granted after thorough scrutiny and it is in its
20th year, and despite the four pre-grant oppositions and one post-grant
opposition, the suit patent has not been revoked. Moreover, the plaintiffs‟
patent has been granted in more than 50 countries, without being revoked in
any of the jurisdictions.
15.10 The challenge in post-grant opposition by the defendant‟s sister
concern has not attained finality. Therefore, the defendant should have
waited for the outcome of the said opposition.
15.11 The prior art document, i.e., EP1537878 B1 (“EP „878”)
(corresponding patent WO 2004/004771) on the basis of which the OBR
recommended that the suit patent is not novel and valid, has already been
dealt with by the plaintiffs in the pre-grant opposition proceedings, wherein,
it has been noted that the said prior art document does not disclose the
isolated monoclonal antibody or antigen binding portion that specifically
binds to human Programmed Death.
15.12 The OBR is not binding upon the Controller of Patents in deciding the
post-grant opposition, and has only a recommendary value, therefore, the
reliance of the defendant on the OBR is misplaced. Moreover, the validity of
the OBR is under challenge before the High Court of Madras, wherein, vide
order dated 10th January, 2025 in W.A. No. 1697/2024, the matter in relation
thereof, was remanded back to the Single Judge, which is currently pending
adjudication.
15.13 The defendant, at the interlocutory stage, is required to place on
record scientific material supported by expert evidence to discharge the
burden of proving invalidity of the suit patent, in relation to the foreign
patents.
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15.14 The plaintiffs have mapped Sequence Identifier ID (“SEQ ID”)
defined by Opdivo®/Opdyta® (Nivolumab), including the six CDR sequences
in figure 4A and figure 4B of suit patent and SEQ 4 and SEQ 11 with that of
the International Non-Proprietary Name (“INN”), clearly in the plaint.
Therefore, the defendant claiming its product to be bio-similar to Nivolumab
can only do so, if the said bio-similar version has six CDR sequences of
Claim 1, or the VH/VL region amino acid sequence of Claim 3.
15.15 There existed no commercial product of the defendant against which
claim mapping could be done. Therefore, the plaintiffs have mapped with
the Nivolumab INN, which is used as a reference product by the defendant
for development of its bio-similar product, ZRC-3276. By virtue of the said
claim mapping, Nivolumab INN is equivalent to Claims 1 and 3 of the suit
patent. Therefore, any reference to Nivolumab by the defendant would
constitute infringement of the suit patent.
15.16 The submission of the defendant that Nivolumab is not an anti-PD-1
antibody, as it binds to other cell surface receptors of the CD-28 family and
therefore is not covered by the suit patent, is incorrect. Further, the plaintiffs
have placed reliance on paragraphs 8 and 9 of the affidavit dated 15th
August, 2022 of Dr. Brian T. Fife, wherein at page 18 of the said affidavit,
he has confirmed that the claims of the suit patent are for Nivolumab.
15.17 The defendant has evaluated the binding specificity of the plaintiffs‟
product titled “Evaluation of the binding specificity of Opdivo® with human
PD1 and other proteins of CD28 family, i.e. ICOS, CTLA-4, and CD28 by
using ELISA method‖, through conducting the tests done by its own research
centre and through Sardar Patel University. Additionally, the defendant has
also evaluated the binding specificity of the defendant‟s product, i.e. ZRC-
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3276. The results of the said experiments of the defendant further
demonstrate infringement, as they establish the following:
―(i) Opdivo® is an anti-PD-1 antibody and is Nivolumab;
(ii) ZRC-3276 is also an anti-PD-1 antibody having the same claimed
sequences of the suit patent which is admittedly Nivolumab;
(iii) The difference in the binding affinity is common and is known as
―standard variations‖ in the art.‖15.18 Therefore, it is evident that the defendant‟s product is admittedly
Nivolumab. Additionally, since Nivolumab is claimed and covered under the
suit patent, the defendant‟s product is also covered within the scope of the
claims of the suit patent. Thus, both products fall under the claims of the suit
patent, and therefore, on basis of the admissions by the defendant, it has
admitted to infringement.
15.19 The word, „specifically‟ in the claims of the suit patent does not mean
„exclusively‟ or „only‟. The suit patent nowhere mentions that it only binds
to PD-1 nor does it state that there is no binding to other CD-28 receptors.
Further, the reliance on the usage of the term „isolated‟ is misplaced, as the
same is defined in the complete specification, wherein, it is noted that the
isolated antibody may have cross-reactivity with other antigens.
15.20 None of the prior art documents cited by the defendant from any
jurisdiction disclose any amino acid sequence, let alone the sequence of
Nivolumab as claimed in the suit patent. Further, if any sequence from a
prior art does not exactly match with the claimed sequence, the subject
matter of such claims cannot be said to be anticipated by the prior art
sequence, in terms of the Guidelines for Examination of Biotechnology
Applications for Patent, 2013.
15.21 At the stage of interim injunction, it is the onus of the defendant to
show a credible challenge to the validity of the suit patent, and the same is
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raised only based on the report from experts of Opposition Board, analysis
of independent expert and independent analysis of prior art by the defendant.
15.22 The defendant already has the requisites for manufacturing the drug
substance and drug product, i.e., Active Pharmaceutical Ingredient (“API”)
and finished formulation of Nivolumab. Additionally, the defendant also has
the requisite approval to import new drugs or an investigational new drug
for the purpose of clinical trials. Therefore, the plaintiffs have approached
this Court before the commercial sale/launch of the drug by the defendant.
Moreover, the defendant will not suffer any prejudice by the grant of an
interim injunction. However, the plaintiffs will suffer an irreparable injury.
15.23 The defendant‟s acts would cause huge damage to the plaintiffs‟
business/public interest and reputation, which cannot be accounted for in
monetary terms. The plaintiffs would also lose substantial sales if the
defendant is permitted to manufacture a similar biologic/bio-similar version
of Nivolumab or a generic product in India in contravention of plaintiff nos.
1 and 2‟s patent rights. The balance of convenience lies in favour of the
plaintiffs as the patent term expires within a year and thereafter the
defendant would be free to launch its product.
Submissions on Behalf of the Defendant:
16. On behalf of the defendant, it is submitted as follows:
16.1 The inventive feature in the suit patent is claimed to have specific
binding affinity to PD-1, while the defendant‟s product also binds to other
members of the CD-28 family, which shows that the defendant‟s product is
outside the purview of the suit patent. Moreover, the plaintiffs‟ Nivolumab
also falls outside the scope of suit patent as even plaintiffs‟ Nivolumab
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plaintiffs cannot seek protection of a product which itself is not protected
within the claims of the suit patent.
16.2 The defendant‟s product, ZRC-3276 is bio-similar to plaintiffs‟
Nivolumab. However, bio-similarity by itself does not substantiate
infringement as it is based upon product-to-product comparison, whereas,
infringement requires claim to product mapping. However, the exercise of
mapping undertaken by the plaintiffs is incorrect and incomplete, as the
plaintiff‟s focus is the reference to Nivolumab. However, the term
„Nivolumab‟ is assigned by World Health Organisation (“WHO”), and the
term cannot be exclusive to any one person. Further, as per WHO
description for Nivolumab, even non-isolated antibodies that do not bind
specifically to PD-1 can be termed as „Nivolumab‟, as long as they have the
sequences as mentioned in the WHO drug information document.
16.3 It is the plaintiffs‟ case that the claim scope of the suit patent is
limited to only those antibodies which bind to PD-1 with no binding or
statistically insignificant binding with other receptors in the CD-28 family.
The defendant‟s product does not fulfil this limitation and thus, is not
infringing the suit patent. Further, in the defendant‟s product there is
statistically significant binding, therefore, the defendant is following the
prior art.
16.4 The Subject Expert Committee under the „Guidelines on Similar
Biologics, 2016‟ (“Similar Biologics Guidelines”), found that the
defendant‟s product is similar to plaintiffs‟ Nivolumab, in terms of efficacy,
safety and quality. Thus, the lack of infringement does not affect the status
of the plaintiffs‟ product as bio-similar.
16.5 The defendant has raised the grounds inter alia, that the suit patent
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lacks novelty (Section 64(1)(e)), lacks inventive step (Section 64(1)(f)) and
is non-patentable (Section 64(1)(k)). Further, the suit patent is invalid on the
grounds, that, Nivolumab was already claimed in the patent WO
2004/004771; that the process for making Nivolumab is known in the art
before the priority date of the patent. Further, the monoclonal antibody used
in the suit patent is a natural phenomenon which is produced from
transgenic mice and does not involve any substantive human intervention.
The inventors of the current Indian patent have used hybridoma technology,
which is a well-known art. The suit patent is ostensibly drafted as a product
patent of Nivolumab and the claims are merely directed to the identification
of SEQ IDs, without providing any corresponding disclosure as to how the
present patent is different from the patent WO 2004/004771, which is also
the plaintiffs‟ patent.
16.6 The factors of balance of convenience and irreparable injury both are in
favour of the defendant, as the defendant‟s application for approval for a
similar biologic/bio-similar product was in the knowledge of the plaintiffs
since April 2022. Further, the plaintiffs, to plead a fresh cause of action and
overcome the arguments of delay, have relied on a self-serving email sent by
an unknown party.
16.7 The plaintiffs are attempting to increase the monopoly of Nivolumab,
and thus, the suit patent is prima facie vulnerable to challenge. Further, the
contention of invalidity of the suit patent, and vulnerability at the interim
stage, raised by the defendant is based inter alia on the basis of prior arts
D1-D3, wherein, the prior art D3 belongs to the plaintiffs themselves.
16.8 The plaintiffs, in a suit patent of D3 patent family, in the U.S., have
admitted that they have developed Nivolumab antibody by practising the
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invention mentioned in the U.S. patents (US 8728474, US 9073994 and US
9067999), with a priority of year 2002, which also are from the same patent
family of D3, having the same priority particulars as the Japanese patents,
i.e., JP 2002194491 dated 03rd July, 2002 and JP 2003029846 dated 06th
February, 2003.
16.9 The Patent Term Extension (“PTE”) for Opdivo® (Nivolumab)
product has been approved to plaintiff no. 2 and Mr. Tasuku Honjo in Japan
for the Japanese patent JP4409430 in 2015. The Japanese patent is a member
of the patent family of D3 which has a priority of 2002. Therefore, the
plaintiffs have sought extension of member D3 patent for Opdivo®
(Nivolumab), which evidences the admission that patent D3 is for
Nivolumab.
16.10 The plaintiffs, in submissions before the European Patent Office
(“EPO”) dated 28th August, 2008, have submitted „example 18‟ of pending
WO2006/121168 A1 that is corresponding to the suit patent, IN „060, as
additional data during examination to demonstrate the inventiveness of the
invention claimed in prior patent application D3, during the prosecution of
D3. Therefore, it is clear that the product Opdivo® (Nivolumab) which is
claimed in suit to be the subject matter of IN „060, was already a subject
matter of D3.
16.11 It is plaintiffs‟ own admission that Opdivo®/Nivolumab is part of prior
patent D3 and not a product arising from the suit patent IN „060. The
plaintiffs‟ only case of infringement is premised on the fact that the
defendant was developing a bio-similar Opdivo® containing Nivolumab,
thus, by plaintiffs‟ own admission, Opdivo/Nivolumab is part of the prior art
D3 and not a product of the suit patent.
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16.12 The defendants undertook a study of Opdivo® for which tests were
conducted both by the defendant at Zydus Research Centre and by an
independent entity, i.e., Sardar Patel University, which follow the protocol
disclosed in Example 3 of the complete specification of IN „060. The
defendant submits that both tests conclude that the binding of Opdivo ® is to
human PD-1 as well as other CD-28 family proteins (ICOS, CD-28 and
CTLA4). Therefore, it is evident that Opdivo®, the product of the plaintiffs,
arises out of prior art D3 and not from the suit patent IN „060.
16.13 The in-house experiment reports conducted by the defendant and the
report of an independent university, i.e., Sardar Patel University, show the
binding affinity of the defendant‟s product to other members of the CD-28
family. Therefore, defendant‟s product does not infringe the suit patent.
16.14 The Similar Biologics Guidelines, assess „similarity‟ in terms of
„safety, efficacy and quality‟, and does not make reference to patent
infringement. Additionally, the said Guidelines provide a caveat stating that
they are not meant to substitute/rephrase the Drugs and Cosmetics Act, 1940
or Rules made thereunder.
16.15 Preparation of anti-PD1 antibody by using transgenic mice is already
known and in the public domain, and the present invention is merely
preparing an antibody and therefore, is not new.
16.16 Process steps were already known from the prior art. There were
several techniques for the preparation of human anti-PD1 antibodies, which
were well-known on the priority date of the suit patent.
16.17 The post-grant opposition that was filed by Zydus Healthcare Limited,
led to the recommendation for revocation of the suit patent by the
Opposition Board, and the said recommendation clearly shows that such a
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method is commonly employed to produce antibodies.
Findings and Analysis:
17. Before adverting to the discussion in relation to the merits of the case,
this Court deems it appropriate to address the contention on behalf of the
defendant that there is a delay in filing of the present suit. This Court notes
that it is the submission of the plaintiffs that around April, 2022 they became
aware that the defendant had applied for a clinical trial approval of a drug,
with the suit patent, Nivolumab, as the reference drug, before the CDSCO.
Consequently, on 06th May, 2022, plaintiff nos. 1 and 2 issued a cease-and-
desist letter to the defendant with regard to using Nivolumab until the expiry
of the suit patent. However, the defendant, in its response dated 17 th May,
2022, had stated that the defendant was only conducting clinical trials and
took up the defence of Bolar Exemption under Section 107A of the Patents
Act. On account of the same, the plaintiffs took no further action.
Subsequently, upon receipt of certain information in April/May, 2024 by the
plaintiffs, with regard to the defendant‟s proposed commercial launch of
bio-similar of Nivolumab, the plaintiffs filed the present suit.
18. It is noted that in May, 2022, on account of the Bolar Exemption
under Section 107A of the Patents Act being invoked by the defendant, the
plaintiffs did not initiate any action, as the said exemption is an exception to
patent infringement. Furthermore, receipt of information by the plaintiffs in
April/May, 2024 regarding possibility of the defendant launching an
infringing product commercially, gives rise to a cause of action in favour of
the plaintiffs to initiate legal proceedings, as the present one, against the
defendant. Further, nothing has been brought before this Court by the
defendant to show that the plaintiffs had any knowledge of the proposed
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commercial launch of defendant‟s product, ZRC-3276, prior to the timeline
averred by the plaintiffs before this Court.
19. Thus, this Court agrees with the submission of the plaintiffs that cause
of action for initiating legal proceedings against the defendant arose only in
the year 2024, when the knowledge with regards to the commercial launch
of defendant‟s product was received by the plaintiffs in April/May, 2024.
Therefore, this Court rejects the contention on behalf of the defendant that
there is a delay in filing of the present suit.
20. The present suit concerns the infringement of Indian Patent No. IN
340060, i.e., IN „060, which is titled as, ―Human Monoclonal Antibodies to
Programmed Death 1 (PD-1) for use in treating Cancer‖. The bibliographic
details of the suit patent are as under:
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21. The suit patent, i.e., IN „060 is a therapeutic antibody used in
treatment of various forms of cancer, such as non-small cell lung cancer,
kidney cancer, head and neck cancer, melanoma and Hodgkin lymphoma.
The antibody in the suit patent is defined by Claims 1 and 3 of IN „060 and
is called Nivolumab (5C4) monoclonal anti-PD-1 antibody, which is used in
treatment of cancer. Nivolumab is the INN originally assigned by the WHO
in the year 2013.
22. For the purposes of better understanding the present matter, this Court
finds it apposite to bring forth the technical/scientific discipline involved in
the suit patent.
23. The white blood cells (“WBCs”) in our blood are divided into five
types, one of them being, lymphocytes. Lymphocytes are immune cells
which are prepared in our bone marrow, and are found in the blood and
lymph tissue. Lymphocytes further consist of B-lymphocytes (B-cells) and
T-lymphocytes (T-cells).
24. B-cells are the ones responsible for producing antibodies. Antibodies
are Y-shaped proteins that protect us when an unwanted foreign substance
enters our body. They are produced by our immune systems to neutralise
pathogens such as bacteria, virus, etc. In the event that such a pathogen
enters our body, it stimulates our immune system to produce antibodies that
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bind with a unique molecule of the pathogen, called an antigen.
25. The „Y‟-shaped structure of an antibody contains two „Heavy‟ and
two „Light‟ chains. The variable region in each heavy and light chain,
responsible for generating antigen-binding site of the antibody, are termed
Complementarity Determining Regions – CDRs, which are immunoglobulin
(Ig) hypervariable domains. Thus, the CDRs are responsible for binding to
the target antigen. The variable regions of both the heavy chain and the light
chain have three CDRs each and these CDRs are specific to an antibody for
binding to an antigen. General structure of an antibody, is represented in the
following manner:
26. The antibodies present in our body are basically proteins. Proteins in
turn are made up of amino acids which are small molecules that are the
building blocks of proteins. There are 20 amino acids commonly found in
the protein present in our body. The amino acids present in our body are
represented by standard codes. The unique arrangement of amino acids is
called an amino acid sequence.
27. Further, the T-cells in our WBCs are responsible for the identification
and destruction of abnormal/infected cells. They have CD-28 proteins,
which signal the immune system if a cell is normal or abnormal. When T-
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cells receive this signal, the immune system attacks the abnormal cells. One
important CD-28 protein on T-cells is called Programmed Death 1, i.e., PD-
1, which helps in identification of abnormal cells.
28. PD-1 has two ligands, i.e., PD-L1 (Programmed Death-Ligand 1) and
PD-L2 (Programmed Death-Ligand 2). PD-L1 and PD-L2 are proteins
which are located on the surface of normal cells. In a healthy human body,
once PD-1 binds with either of its ligands, it essentially signals to the T-cell
to tolerate those normal cells, and not attack them. Thus, engagement of PD-
1 with either of its two ligands suppresses immune system responses in case
of healthy normal cells.
29. However, cancer cells also have PD-L1 on their surface and have the
potential to impair PD-1‟s ability to send signals to the T-cell. Therefore,
when PD-1 on our T-cell binds to the PD-L1 ligand on a cancerous cell, it
deactivates the PD-1 on the T-cell. When PD-1 is inactive, T-cells do not
attack the cancer cells.
30. Thus, to prevent this binding between PD-1 and PD-L1 on a cancer
cell, monoclonal antibodies have been developed in order to allow the
immune system to recognise and destroy cancer cells. Monoclonal
antibodies are man-made antibodies which are created artificially in
laboratories and are designed to act like human antibodies for specific
purposes. As the name suggests, they are a single kind of antibody that bind
to a single target receptor/antigen or ligand.
31. The suit patent, i.e., Nivolumab, is one such monoclonal antibody,
which is an anti-PD-1 antibody, also called „5C4‟ antibody. In other words,
Nivolumab binds with the PD-1 protein on our T-cell, which prevents PD-1
from binding itself with PD-L1 ligand on a cancer cell. This ensures that our
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T-cells are not rendered inactive and the immune system is able to identify
the cancer cell and act accordingly.
32. For the purpose of adjudicating the various issues raised before this
Court pertaining to infringement of the suit patent, it would be imperative to
construct the Claims 1, 3 and 7 of the suit patent, which are material to the
issues at hand. Emphasizing that claim construction is generally the first and
foremost exercise carried out in adjudicating patent infringement, this Court
in the case of Jay Switches India Pvt. Ltd. Versus Sandhar Technologies
Ltd. and Others, 2024 SCC OnLine Del 8434, noted as follows:
―xxx xxx xxx
23. One of the most significant issues that arise for consideration
while deciding a patent infringement suit relates to the construction of
the claims. According to section 10(4)(c) of the Patents Act 1970, the
claims define the scope of the invention. However, claims have to be
read along with the Complete Specification. In this regard, a
reference may be made to the observations made by the coordinate
bench in the recent judgment Guala Closures SPA v. Agi Greenpac
Ltd., which are set out below:
“40. Claim construction is generally the first and foremost
exercise carried out in adjudicating patent infringement suits,
especially when confronted with products like tamper-evident
closures which are based on mechanical features. The same
has also been highlighted in „Chapter 9: Construction of the
Specification and Claims‟, in Terrell on the Law of Patents,
Eighteenth Edition. As per Terrell, determination of the actual
scope of the Claims of a complete specification, is one of the
most significant issues, in litigation involving patents. Once
the scope of the claims is clarified, questions regarding
infringement and invalidity often find swift resolution.
Therefore, it has been highlighted that patentees must navigate
a delicate balance, as they have to assert their claim in such a
way that the Claim is broad enough to cover infringement while
not excessively broad to avoid coverage by prior art. On the
contrary, it has been highlighted that Defendants, employ a
‗squeeze’ argument, often claiming that if a claim encompasses
their activities, it must also encompass prior art. This
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infringement and assessing patent validity. The relevant
extract from Terrell is set out below:
―Determination of the true construction of the claims
of a patent specification, which are to be read in the context
of the specification, is commonly one of the most significant
issues, if not the single most significant issue, in litigation
involving patents.‖‖
xxx xxx xxx‖
(Emphasis Supplied)
33. The Supreme Court in the case of Bishwanath Prasad Radhey Shyam
Versus Hindustan Metal Industries, (1979) 2 SCC 511, emphasised that in
order to understand the scope of an invention, it would be imperative to refer
to the description of the invention before referring to the claims. The
relevant portion of the said judgement is as follows:
―xxx xxx xxx
43. As pointed out in Arnold v. Bradbury the proper way to construe
a specification is not to read the claims first and then see what the
full description of the invention is, but first to read the description of
the invention, in order that the mind may be prepared for what it is,
that the invention is to be claimed, for the patentee cannot claim
more than he desires to patent. In Parkinson v. Simon Lord Esher M.
R. enunciated that as far as possible the claims must be so construed
as to give an effective meaning to each of them, but the specification
and the claims must be looked at and construed together.
xxx xxx xxx‖
(Emphasis Supplied)
34. Therefore, to understand the actual scope of the claims, reference to
the specifications of the suit patent is imperative.
35. To better understand the purpose and scope of the patented invention,
reference may be made to the ‗Technical Field’ of invention given in the
Complete Specification of the suit patent. The Technical Field of the
invention, as given in the suit patent, is reproduced as follows:
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36. Apart from the use of anti-PD-1 antibodies, the present invention is
also related to the use of combination immunotherapy, including, the anti-
PD-1 combination with CTLA-4 to treat cancer, as well as to address the
severity of adverse events associated with the treatment with these
antibodies individually. In this regard, the ‗Disclosure of the Invention’,
which is part of the Complete Specification of suit patent, is reproduced as
under:
37. Thus, this Court notes that the ‗Disclosure of the Invention’ in the
Complete Specification describes that the claimed isolated monoclonal
antibody exhibits numerous properties, such as high binding affinity to
human PD-1, but lacks substantial cross-reactivity with human CD-28,
CTLA-4 or ICOS. However, the binding affinity with other proteins, such as
human CD-28, is not completely absent.
38. Thus, from reading of the specification of the suit patent it is manifest
that PD-1 is a protein found on T-cells that assists in maintaining the body‟s
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immune responses. These monoclonal antibodies are laboratory-produced
engineered bio-molecules that can restore, enhance, modify, mimic or
behave like the immune system‟s attack on unwanted cells, such as cancer
cells. In the suit patent, Nivolumab is claimed under Claims 1, 3 and 7.
39. The Claims 1, 3 and 7 of the suit patent, which are relevant for the
present case, are reproduced as under:
―1. An isolated monoclonal antibody or an antigen-binding
portion thereof that binds specifically to human Programmed
Death (PD-1), comprising:
a) a heavy chain CDR1 consisting of the amino acid
sequence set forth in SEQ ID NO: 18;
b) a heavy chain CDR2 consisting of the amino acid
sequence set forth in SEQ ID NO: 25;
c) a heavy chain CDR3 consisting of the amino acid
sequence set forth in SEQ ID NO: 32;
d) a light chain CDR1 consisting of the amino acid sequence
set forth in SEQ ID NO: 39;
e) a light chain CDR2 consisting of the amino acid sequence
set forth in SEQ ID NO: 46; and
f) a light chain CDR3 consisting of the amino acid sequence
set forth in SEQ ID NO: 53.
xxx xxx xxx
3. The monoclonal antibody or antigen-binding portion thereof,
as claimed in claim 1, which comprises:
a) a heavy chain variable region comprising the amino acid
sequence set forth in SEQ ID NO: 4; and
b) a light chain variable region comprising the amino acid
sequence set forth in SEQ ID NO: 11.
xxx xxx xxx
7. A composition comprising the monoclonal antibody or
antigen-binding portion thereof as claimed in any one claims 1-6
and a pharmaceutically acceptable carrier.
xxx xxx xxx‖
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40. The sequence of 5C4 antibody, i.e., Nivolumab, showing the same as
artificially created antibody, is reproduced as under:
xxx xxx xxx
41. As noted by this Court hereinabove, amino acids are organic
compounds that are the building blocks of proteins. Every protein has a
unique amino acid arrangement which is called an amino acid sequence. In
the present case, the plaintiffs have made changes in the sequencing of
amino acids.
42. As noted above, antibodies are proteins that protect us when an
unwanted substance enters the body. All antibodies are constructed in the
same way. As per the suit patent, Nivolumab is a PD-1 blocking antibody
for treatment of cancer. It has specific amino acid sequences of heavy and
light chains of an antibody termed as the „5C4 antibody‟, which contains six
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CDRs. Changes have been made in the amino acid sequencing, which has
resulted in creation of the suit patent, Nivolumab, i.e., monoclonal anti-PD-1
antibody for treatment of cancer. Three changes have been made in the
sequencing of amino acid in the heavy chain variable and three changes
have been made in the sequencing of amino acid in the light chain variable,
totalling to six changes.
43. The changes, as made by the plaintiffs, in the amino acid sequencing
in the heavy chain variable region and light chain variable region, which is
reflected in red colour, is reproduced as under:
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b. SEQ ID No. 11 (light chain variable region)
44. The six separate changes in the amino acid sequencing, as done by the
plaintiffs, are reproduced as under:
―27. … … …
a. SEQ ID No. 18 (heavy chain CDR1)
b. SEQ ID No. 25 (heavy chain CDR2)
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c. SEQ ID No. 32 (heavy chain CDR3)d. SEQ ID No. 39 (light chain CDR1)
e. SEQ ID No. 46 (light chain CDR2)
f. SEQ ID No. 53 (light chain CDR3)
45. On account of the aforesaid changes made by the plaintiffs in the
amino acid sequencing, a new protein, i.e., suit patent antibody 5C4 has
been created by the plaintiffs, which has the assigned INN Nivolumab.
46. When cancer cells develop in human body, they attach/lock with the
immunity cells present in our body, on account of which the body immunity
is suppressed. The suit patent, Nivolumab, provides a solution to this
situation, by preventing attachment/locking of the immunity cell (T-cell) in
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the blood to the cancer cell ligand (PD-L1/PD-L2). The graphic
representation of the working of Nivolumab, in preventing the
locking/attachment of the T-cell, is reproduced as under:
47. The two issues that arise for consideration before this Court are as to
whether the defendant is infringing the suit patent in developing a bio-
similar version of Nivolumab; and the issue as regards the invalidity of the
suit patent, as raised by the defendant. The defence taken by the defendant in
the present case is two folds, firstly, invalidity of the suit patent, and
secondly, non-infringement by defendant‟s bio-similar product.
48. This Court takes note of the contentions of the defendant that the suit
patent is invalid on the grounds that there are already existing prior arts to
the suit patent, which envisage the claims in the suit patent, and therefore,
the process for making „Nivolumab‟ is a known art. Furthermore, it is the
defendant‟s case that the monoclonal antibody used in the suit patent is a
natural phenomenon, which on the face of it, is non-patentable. It is also the
ground of the defendant that the OBR which has been issued by an expert
body constituted in relation to the suit patent in the post-grant opposition,
has made recommendations to the effect that the suit patent is invalid. These
contentions raised by the defendant are dealt with hereinafter.
49. The defendant has challenged the validity of the suit patent on the
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ground that Nivolumab was already claimed by plaintiffs‟ own International
corresponding patent WO 2004/004771, D3, in the present case. It is the
case of the defendant that the process for making Nivolumab is known in the
art before the priority date of the suit patent. For this purpose, the defendant
has relied upon prior arts, D1-D3, i.e., WO 2001/014557, WO 2002/079499
and EP „878 (corresponding WO 2004/004771), respectively, to substantiate
the aspect of prior disclosure and in effect, the invalidity of the suit patent.
50. The defendant has specifically relied upon D3, which belongs to the
plaintiffs themselves. The prior art D3 is a European Patent Specification,
with International Publication No. WO 2004/004771. The description of
Technical Field in the said patent‟s specification, as per the record, is
extracted as below:
―xxx xxx xxx
TECHNICAL FIELD
[0001] The present invention relates to immunopotentiation characterized
by inhibiting immunosuppressive signals induced by PD-1, PD-L1 or PD-
L2, compositions for cancer or infection treatment, and therapies that use
them.
[0002] More specifically, the present invention relates to a use of an
anti-PD-1-antibody for the manufacture of a medicament for cancer
treatment.
xxx xxx xxx‖
(Emphasis Supplied)
51. The disclosure of the invention of the aforesaid prior art D3, is
extracted as below:
―xxx xxx xxx
[0011] A problem of the present invention is to provide compositions to
activate immunity by inhibiting the Inhibitory signals of PD-1, PD-L1 or
PD-L2 and compositions for cancer or infection treatment through this
mechanism.
[0012] The present inventors paid attention to PD-1, PD-L1, or PD-L2
as a new target in cancer or infection treatment and found thatSignature Not Verified
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substances that inhibit the inhibitory signals of PD-1, PD-L1 or PD-L2
inhibit cancer proliferation through the mechanism of the recovery and
activation of immune function. Further, they found that PD-1 signal,
concretely, an interaction of PD-1 and PD-L1 or PD-1 and PD-L2 took
part in the exclusion of infectious virus. According to those facts, they
found the substances that could inhibit the inhibitory signals of PD-1, PD-
L1 or PD-L2 having therapeutic potential for cancer or infection and
completed the present invention.
That is, the present invention relates to
1. Use of an anti-PD-1 antibody which inhibits the
immunosuppressive signal of PD-1 for the manufacture of a
medicament for cancer treatment.
2. The use according to item 1, wherein the anti-PD-1 antibody is
a human anti-PD-1 antibody.
xxx xxx xxx‖
(Emphasis Supplied)
52. Reference may also be made to the claims of the said prior art D3, i.e.,
EP „878, which are reproduced as under:
―xxx xxx xxx
Claims
1. Use of an anti-PD-1 antibody which inhibits the immunosuppressive
signal of PD-1 for the manufacture of a medi- cament for cancer
treatment.
2. The use according to claim 1, wherein the anti-PD-1 antibody is a
human anti-PD-1 antibody.
3. Anti-PD-1 antibody which inhibits the immunosuppressive signal of
PD-1 for the use in cancer treatment.
4. Anti-PD-1 antibody for the use according to claim 3, wherein the anti-
PD-1 antibody is a human anti-PD-1 antibody.
xxx xxx xxx‖
(Emphasis Supplied)
53. Perusal of the aforesaid disclosure and claims of the D3 prior art
document reveals that the said prior art document as cited by the defendant,
dealt with anti-PD-1 antibody for use in cancer treatment. However, the suit
patent on the other hand, invents the monoclonal antibody, i.e., Nivolumab.
Thus, while the prior art as cited, provided the target, the suit patent
provides the actual product.
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54. As noted above, the contention of invalidity of the suit patent and
vulnerability has been raised by the defendant inter alia on prior arts, D1-
D3, details of which, as given in the reply of the defendant, are as follows:
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55. In this regard, this Court notes that document B (D1) and C (D2) do
not provide sequence of any anti-PD-1 antibody. Furthermore, though D3
talks about anti-PD-1 antibody, however, prima facie, the same does not
disclose Nivolumab in any manner. It is apparent that while the prior art
documents pertain to process patents, the suit patent is a product patent.
56. Thus, the defendant has not been able to show that Nivolumab was
disclosed in the prior arts cited by the defendant. Nothing has been brought
before this Court to indicate that the documents WO2001/014557 (D1),
WO2002/079499 (D2) and EP „878 (D3) disclose the specific sequences of
the antibody, as claimed in the suit patent. The defendant has failed to show
that any feature of the plaintiffs‟ claimed invention is present in any of the
cited references.
57. Further, it is to be noted that D3, i.e., EP „878, is not directed to a
product like the suit patent, rather it is directed to the use of an anti-PD-1
antibody in the treatment of cancer. As noted by this Court, the defendant
has not pointed that D3 discloses the specific sequence of the antibodies as
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claimed in the suit patent.
58. In this regard, it would be fruitful to refer to the submissions of the
plaintiffs, in respect of the referred documents D1, D2 and D3 which have
been filed by the defendant. The said submissions are reproduced as below:
―xxx xxx xxx
51. The suit patent claims new and improved anti-PD-1 antibodies,
particularly monoclonal antibodies that specifically bind to human PD-1
with higher affinity and increased specificity relative to anti-PD-1
antibodies. The anti-PD- 1 antibodies disclosed in the suit patent can
modulate an immune response in a subject and can be used to treat
tumors. Anti-PD-1 antibodies comprising CDRs of the antibody referred
to as 5C4 in the specification of suit patent have exceptional properties
of treating tumors. The detailed submissions in respect of referred
documents WO2001/014557 (D1), WO2002/079499 (D2) & EP1537878
B1 (D3) filed by the Defendant as Document B, Document C and
Document D are as below:
a) WO 2001/014557 (D1): The referred document D1 does not
disclose the claimed sequence of the suit patent. WO ‗557 is
directed to the identification of B7-4 as a PD-L1. Further, it is
disclosed on page no. 56 of the documents filed by the Defendant
that anti-B7-4 or anti- PD-1 antibodies are obtainable by
techniques like hybridoma. D1 does not provide the sequence of
any anti-PD-1 antibody, and it does not provide any guidance
that would have led to the particular CDRs claimed in the suit
patent. Thus, WO2001/014557 (D1) does not disclose or suggest
creating an anti- PD-1 antibody comprising the six CDRs of the
5C4 antibody, as claimed in the suit patent.
b) WO2002/079499 (D2): D2 WO’ 499 discloses generation of
antibodies including humanized antibody, murine antibody, human
antibody, antigen-binding portions, and scFv, or any compound
which can bind to B7-4 or PD-1 to modulate signaling. Further,
WO’ 499 (D2) is a patent application that relates to ―[a]ssays for
identifying compounds which modulate signaling via PD-1.‖ One
of a wide range of possible methods in WO’ 499 (D2) discloses to
modulate PD-1 activity is using ―a blocking antibody that
recognizes PD-1. However, WO‟ 499 (D2) does not provide the
sequence of any anti-PD-1 antibody and does not provide any
guidance that would have led to the particular CDRs claimed in
the current application.
c) WO2004/004771 and its US/EP and JP family (D3): The
reliance on D3 by the Defendant is erroneous in view of theSignature Not Verified
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following:
(i) WO2004/004771 (WO ‗771 (D3) relates to
immunopotentiation characterized by inhibition of
immunosuppressive signals induced by PD-1, PD-L1, or
PDL2.
(ii) WO „771 claims use of an anti-PD-1 antibody for
manufacture of a medicament for treatment of cancer.
(iii) WO „771 discloses use of an anti-PD-1 antibody
which inhibits immunosuppressive signal of PD-1 for the
manufacture of a medicament for cancer treatment. It is
not directed to an anti-PD-1 antibody (i.e., is not directed
to a product), but is directed to the use of an anti-PD-1
antibody in the treatment of cancer.
(iv) On the other hand, the suit patent provides new and
improved anti-PD-1 antibodies (product), particularly
human monoclonal antibodies that specifically bind to
human PD-1 with higher affinity and increased specificity
relative to anti- PD-1 antibodies. The anti-PD-1 antibodies
disclosed in the suit patent can modulate an immune
response in a subject and can be used to treat tumors.
(v) Further, WO „771 does not disclose the specific
sequence of the antibodies as presently claimed
comprising the CDRs of the 5C4 antibody. Anti-PD-1
antibodies comprising CDRs of the 5C4 antibody are
claimed in the present patent and it has been demonstrated
that the said antibodies have exceptional properties for
treating tumors. Example 2 of WO ‗771 discloses mouse
antibody J110 (International trust number: FERM BP-
8392). Examples 12 and 13 also disclose J43, a hamster
antibody that binds to mouse PD-1 and another antimouse
antibody. There is no sequence for any antibody let alone
against human PD-1 disclosed in WO ‗771. As stated
above, J110 is a mouse monoclonal antibody and therefore
has low similarity to a human monoclonal antibody.
Similarly, J43 is a hamster antibody that binds to mouse
PD- 1 and has different CDRs with very low alignment to
the claimed antibodies. Each of the six CDRs of J43 has 0%
to 50% homology to the corresponding CDR of 5C4. Thus,
D3 does not disclose or teach or suggest an anti-PD-1
antibody or an antigen-binding portion thereof
comprising the six CDRs of the 5C4 antibody. Due to the
absolute lack of teaching or suggestion of the 5C4 CDR
sequences in the cited references, a person skilled in the
art would not have been motivated to start from the
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antibodies disclosed in the references and modify the
CDRs to arrive at the exact six CDRs of the 5C4 antibody.
xxx xxx xxx‖
(Emphasis Supplied)
59. Apart from prior arts D1-D3, the defendant has placed reliance on
other prior art documents as well which, as per the defendant, disclose key
aspects of the suit patent. Submissions of the defendant in this regard, in
their reply to the present application, are as under:
―xxx xxx xxx
a. WO 2004/056875 (D4 published on 08.07.2004, annexed as
DOCUMENT N) which describes manufacture of human anti-PD-1
antibodies PD-1-17, PD-1-28, PD-1-33, PD-1-35 and PD-1-F2 and
their characteristics;
b. Document D5, annexed as DOCUMENT O describes human anti-
PD- 1 antibodies PD-1-17 and PD-1-35 disclosed in D4 with their KD
values. (Page 713, left column, and 2nd paragraph);
c. Document D6, annexed as DOCUMENT P, describes generation of
mAbs against human PD-1 and provides experimental details of the
preparation of several anti-human PD-1 mAbs including J105, J108,
J110, J116 and J121 (Page 216, left-hand column, section 2.2);
d. Document D7, annexed as DOCUMENT Q, describes a rat anti-
mouse PD-1 mAb and related in vivo studies.
xxx xxx xxx‖
60. Perusal of the aforesaid description of the prior arts, D4 to D7, relied
upon by the defendant, has not been shown to include the same sequencing
as Nivolumab, i.e., the subject matter of the present suit. The defendant has
not prima facie brought before this Court that the prior arts D4-D7, disclose
in any manner, the specific amino acid sequencing of the „5C4‟ monoclonal
antibody of the plaintiffs.
61. Thus, it is evident that the prior arts cited by the defendant do not
disclose the specific sequences of the antibodies comprising the CDRs of the
5C4 antibody (“Nivolumab”), as claimed in the suit patent. There is no
enabling disclosure of the claimed 5C4 CDRs or an antibody comprising the
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same in any of the prior art documents cited.
62. Reference at this stage may also be made to the Guidelines for
Examination of Biotechnology Applications for Patent, 2013, issued by the
Office of the Controller General of Patents, Designs and Trade Marks,
wherein, it has been stated that if any sequence from a prior art does not
exactly match with the claimed sequence, then, the subject matter of such
claims cannot be said to be anticipated by the prior art sequence. The
relevant portion of the aforesaid Guidelines are extracted as under:
―xxx xxx xxx
7.2. SEQUENCE CLAIMS
A claim to a polynucleotide sequence that was available, e.g. as
part of a library before the priority date, lacks novelty, even if activity or
function of the said sequence of the polynucleotide has not been previously
determined. A claim to a specific fragment of polynucleotide may be
considered to be novel, but subject to fulfilment of the inventive step and
non-patentability under relevant clauses of Section 3 of the Act.
A prior disclosure of the same sequence as the claimed sequence,
even without any indication of its activity, would prima facie constitute
anticipation to the novelty of the claimed sequence. The reasoning is that
the earlier sequence inherently possesses the activity of the claimed
sequence. If any sequence of a polynucleotide/polypeptide from a prior
art does not exactly match with the claimed sequence of
polynucleotide/polypeptide, then the subject-matter of such claims
cannot be said to be anticipated by the prior art sequence. However, such
sequence of polynucleotide/polypeptide of the prior art would be relevant
for deciding inventive step or non-patentability under relevant clauses of
Section 3 of the Act.
xxx xxx xxx‖
(Emphasis Supplied)
63. Thus, the defendant, prima facie, has not been able to raise a credible
challenge with respect to the assertions made in relation to the prior arts, nor
have they been able to show, that the anti-PD-1 antibody, as disclosed in the
said prior arts, have the same amino acid sequence, as Nivolumab.
Therefore, the said issues as regards the averment of the defendant regarding
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cited prior arts disclosing anti-PD-1 antibody similar to plaintiffs‟
Nivolumab, would be subject matter of trial. Hence, all such factors would
be the subject matter of trial in order to arrive at any definite finding and
would not be delved into at this interim stage, in the absence of any prima
facie credible challenge being raised by the defendant.
64. Further, this Court takes note of the fact that the post-grant Opposition
proceedings, initiated by a sister concern of the defendant, are still pending.
Though the OBR contains a recommendation to the Controller of Patents
that the suit patent is invalid due to lack of novelty, inventive step, etc.,
however, proceedings pertaining thereto are pending before the learned
Single Judge of the High Court of Madras.
65. This Court notes that the said OBR was challenged by way of a writ
petition being W.P. No. 8451/2023, whereby, the OBR was set aside.
However, the matter travelled to the Division Bench, by way of an appeal
being W.A. No. 1697/2024, wherein, upon the consent of the parties, the
order of the learned Single Judge in W.P. No. 8451/2023 was quashed and
set aside and the question of validity of the OBR was remanded back to the
Single Bench.
66. Even otherwise, the OBR, as the name suggests, is a recommendation
given by the Opposition Board to the Controller which only has a persuasive
value and is not binding in nature. Reference in this regard may be made to
the judgment of this Court in the case of Novonordiskas Versus Union of
India and Others, 2022 SCC OnLine Del 1944, wherein, it has been held as
follows:
―xxx xxx xxx
24. It is also the settled legal position that the Opposition Board is to
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25(3) and 25(4) of the Act. The said recommendation has a
persuasive value but the ultimate decision is that of the Controller.
The recommendations of the Opposition Board are not binding on
the Controller. However, the recommendation of the Opposition
Board forms a crucial part of the material to be considered by the
Controller. The Supreme Court in Cipla (supra) has held as under:
―The aforesaid provisions indicate that the Opposition Board has
to conduct an examination of notice of opposition along with the
documents filed under Rules 57 to 60 and then to submit a report
with reasons on each ground taken in the notice of opposition.
The Opposition Board has, therefore, to make recommendation
with reasons after examining documents produced by the parties
as per Rules.
Section 25(4) of the Act says that on receipt of the
recommendation of the Opposition Board and after giving the
patentee and the opponent an opportunity of being heard, the
Controller shall order either to maintain or to amend or to revoke
the patent. The procedure to be followed by the Controller is
provided in Rule 62 of the Rules, which reads as follows:‖
xxx xxx xxx‖
(Emphasis Supplied)
67. This Court further notes that the prior art document, on the basis of
which the OBR has been made, is EP „878. The said prior art document has
been dealt with in pre-grant oppositions filed against the suit patent,
wherein, the Controller of Patents passed the decision dated 30th June, 2020
while dealing with the prior art document cited by the OBR, in the following
manner:
―xxx xxx xxx
The cited prior art document for lack of novelty in both the oppositions
PGO-3 and 4 is EP1537878 B1 [WO 2004004771] [referred as ‗878
herein after]. The prior art document cited ‗878 does not disclose the
isolated monoclonal antibody or antigen binding portion thereof that
specifically binds to human Programmed Death (PD-1), comprising
SEQ ID No. 18, 25, 32, 39, 46 and 53 as claimed in claim 1 of the
present invention, hence the product claimed in claim 1 of the present
invention is held new or novel over the cited prior art ‗878. The
opponents arguments based on the submissions of the applicant during the
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regulatory approval for Nivolumab from the US FDA are not tenable as
the opponent relied mainly on the prior document ‗878 and which never
discloses the monoclonal antibody as claimed in claim 1 with six CDR
sequences. The inherent anticipation by cited document ‗878 as argued by
the opponent along with the applicants’ assertion in complaints filed
before US courts is also cannot be forming basis for the lack of novelty in
the absence of disclosure of the monoclonal antibody as claimed in claim
1 with six CDR sequences in cited document ‗878. Therefore, the
antibody claimed in amended claim 1 is new or novel over the
disclosures of cited prior art „878. The amended claims 2 to 6 are
dependent claims on claim 1 and hence these claims are also said to be
new or novel over the disclosures of cited prior art ‗878.
xxx xxx xxx‖
(Emphasis Supplied)
68. Perusal of the aforesaid shows that in the said pre-grant opposition, a
categorical finding has been given that the prior art document, EP „878, does
not disclose the isolated monoclonal antibody that specifically binds to
human programmed death PD-1 comprising SEQ ID Nos. 18, 25, 32, 39, 46
and 53, as claimed in Claim 1 of the suit patent. Thus, the Controller held
that the product claimed in Claim 1 of the suit patent is new or novel over
the cited prior art.
69. Further, dealing with the various cited documents, the Assistant
Controller of Patents, in the aforenoted decision dated 30th June, 2020, while
rejecting all four pre-grant oppositions, has held as follows:
―xxx xxx xxx
On perusal of the disclosures and teachings in cited documents CD1 to
CD22 with the submissions by all the Opponents and applicant along with
all the affidavits submitted as expert evidences, case laws submitted and
also considering the arguments during the hearing by all the parties
attended hearing, it is clear that none of the cited documents CD1 to
CD22 either alone or in combination with each other make the isolated
monoclonal antibody or an antigen-binding portion thereof that binds
specifically to human Programmed Death (PD-1) claimed in amended
claim 1 of the ‗5057 is obvious to a person skilled in the art. The cited
prior art documents though they are disclosing the antibody against the
human PD-1 protein but there is no disclosure or teaching to achieve for
the human antibody having SIX specific CDR sequences of 5C4 asSignature Not Verified
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claimed in amended claim 1.
The opponents argument that the generation of monoclonal antibody
against PD-1 protein is known in the art by hybridoma technology in
transgenic mice and hence the monoclonal antibody claimed in claim 1 of
the present invention is obvious to a person skilled in the art is not tenable
as there are no specific disclosures or teachings in any of the cited
documents CD1 to CD22 for obtaining the specific monoclonal antibody
as claimed in amended claim 1 with SIX CDR sequences.
The opponents arguments for obviousness of the claimed antibody based
on the comparative data given by applicant and KD value are also not
proving the antibody claimed in amended claim 1 with SIX CDR
sequences is obvious to a person skilled in the art in view of the
disclosures in any of the cited documents CD1 to CD22.
xxx xxx xxx‖
(Emphasis Supplied)
70. Therefore, on the basis of aforenoted pendency of the proceedings in
relation to the OBR, the same being sub-judice before the High Court of
Madras, and in view of the pendency of the post-grant opposition
proceedings, and further, keeping in mind the categorical findings of the
Controller of Patents in its decision dated 30th June, 2020, while rejecting
the pre-grant oppositions, it cannot be said that a credible challenge has been
made by the defendant to the validity of the suit patent with regard to its
reliance on the OBR.
71. The defendant further seeks to highlight the lack of inventive step
involved in making of the suit patent by submitting that the use of transgenic
mice to produce monoclonal antibodies, including, against human PD-1, has
already been disclosed in the prior arts D1-D3. Though the prior arts cited
by the defendant disclose the use of transgenic mice to prepare monoclonal
antibodies, they do not disclose the claimed sequence of the suit patent.
72. It is evident from the analysis as aforesaid, the defendant has not been
able to show that in the cited prior arts, there is disclosure or teaching to
achieve the sequence for Nivolumab, as per the suit patent. Based on the
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documents on record, the averments made before this Court and the
discussion hereinabove, this Court is of the prima facie view that no specific
disclosures or teachings in the cited documents have been pointed out by the
defendant, wherein, the prior arts provide the sequence of any anti-PD-1
antibody, or any guidance that would have led to the particular CDRs claim
in the suit patent. As noted above, though the prior arts cited by the
defendant disclose the use of transgenic mice to prepare monoclonal
antibodies, they do not disclose the claimed sequence of the suit patent.
Therefore, the defendant has been unable to show as to how the prior arts, as
cited by it, disclose or suggest creating an anti-PD-1 antibody comprising
the six CDRs of the 5C4 antibody (Nivolumab), as claimed in the suit
patent.
73. The onus to show that the suit patent is invalid, or that there is
credible challenge to the validity of the patent, is on the person alleging the
same. To discharge this burden, the defendant is required to place on record
credible scientific material indicating that the plaintiffs‟ patent is prima facie
vulnerable to revocation. However, the same is not the position in the
present case. Reference in this regard may be made to the judgment in the
case of Strix Limited Versus Maharaja Appliances Limited, 2009 SCC
Online Del 2825, wherein, it has been held as follows:
―xxx xxx xxx
22. It was contended by learned counsel for the Defendant that at an
interlocutory stage, the Defendant should be held to have discharged
its burden of raising a „credible challenge‟ to the validity of the
Plaintiff’s patent by merely pointing out the existence of the
European Patent. This court is unable to agree. In order to raise a
credible challenge to the validity of a patent, even at an interlocutory
stage, the Defendant will have to place on record some acceptable
scientific material, supported or explained by the evidence of an
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revocation. The burden on the Defendant here is greater on account
of the fact that there was no opposition, pre-grant or post-grant, to the
Plaintiff’s patent. In Beecham Group Ltd. v. Bristol Laboratories Pty
Ltd., (1967-68) 118 CLR 618 and Australian Broadcasting
Corporation v. O’Neill, (2006) 229 ALR 457 it was held that the
defendant alleging invalidity bears the onus of establishing that
there is “a serious question” to be tried. In Hexal Australia Pty
Ltd. v. Roche Therapeutics Inc., 66 IPR 325 it was held that where
the validity of a patent is raised in interlocutory proceedings, “the
onus lies on the party asserting invalidity to show that want of
validity is a triable question.‖
xxx xxx xxx‖
(Emphasis Supplied)
74. It is pertinent to note that patents corresponding to IN „060 for
Nivolumab have been granted in more than fifty countries and the same
have not been revoked or invalidated in any jurisdiction. In fact, in the
European Union, the corresponding patent was granted after several
oppositions. This Court further notes that Nivolumab has also been granted
approvals by health regulatory authorities worldwide in over fifty countries,
including in India, the United States, Japan and countries in the European
Union.
75. This Court notes that the suit patent was filed in India in the year
2007, claiming priority since the year 2005, and was granted in the year
2020. Further, the grant of the suit patent was subject to four pre-grant
oppositions under Section 25(1) of the Patents Act, which were rejected by
the Controller of Patents, upholding the novelty of the suit patent.
76. As noted above, the suit patent is a product patent, while the other
cited prior arts, D1 to D3 are apparently process patents. The defendant has
failed to show that the amino acid sequencing in the suit patent was
disclosed in any prior art. It is prima facie apparent that the suit patent is a
monoclonal antibody, which is artificial and does not exist naturally.
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Accordingly, when the suit patent apparently pertains to an artificial
monoclonal antibody, with no prior existence, creation of the artificial
monoclonal antibody, i.e., Nivolumab, involves inventive step. Any
invention cannot be said to be patentable without an inventive step.
Therefore, the challenge of the defendant to the suit patent on the basis of
lack of inventive step, is not acceptable and accordingly, rejected.
77. Further, this Court notes that while rejecting the pre-grant
oppositions, the Controller of Patents, in the order dated 30th June, 2020, has
held that the suit patent meets the criteria of inventive step. The relevant
portion of the said order, is noted as follows:
―xxx xxx xxx
Therefore, in my opinion, the disclosures in these documents CD1 to
CD22 either alone or in combination do not make the claimed
antibody 5C4 in amended claim 1 in the ‗5057obvious to a person
skilled in the art and hence meets the criteria of the inventive step as
per the provisions of the section 2 (1) (ja) of the Patents Act, 1970. The
amended claims 2 to 6 are dependent claims on amended claim 1 and
hence they also involve inventive step as required under section 2 (1)
(ja) of the Patents Act, 1970.
The amended claim 7 is claiming for a composition comprising the
monoclonal antibody or antigen-binding portion thereof as claimed in
any one claims 1-6 and a pharmaceutically acceptable carrier. As the
composition is claimed with the novel and inventive antibody 5C4 of
claim 1 and hence this claim also involve inventive step as required
under section 2 (1) (ja) of the Patents Act, 1970.
The amended claim 8 is claiming for an isolated nucleic acid encoding
the monoclonal antibody or antigen-binding portion thereof as claimed
in any one claims 1- 7, wherein the nucleic acid sequence encoding the
heavy chain comprises sequence defined in Figure 4A and that encoding
the light chain comprises sequence defined in figure 4B. The isolated
nucleic acid claimed in claim 8 is encoding the novel and inventive
antibody 5C4 of claim 1 and hence this claim also involve inventive step
as required under section 2 (1) (ja) of the Patents Act, 1970.
Hence, the amended claims 1 to 8 are involving the inventive step as
required under section 2(1)(ja) of the Patents Act, 1970.Therefore, all
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the opponents clearly failed to establish this ground of opposition u/s
25 (1) (e) of the Patents Act, 1970.‖
(Emphasis Supplied)
78. Considering the detailed discussion hereinabove, prima facie, validity
of the suit patent is established. Thus, no credible challenge to the validity of
the suit patent can be said to have been raised by the defendant.
79. At this stage, this Court notes that the defendant has asserted the
claim of non-infringement on the grounds that despite their product being
bio-similar, regardless, the same does not constitute infringement of the
plaintiffs‟ drug, as firstly, it is essential to do product claim mapping in
cases of patent infringement. However, the defendant‟s product has not been
launched in the market, therefore, it is the defendant‟s case that the manner
in which claim mapping has been done by the plaintiffs, is incorrect.
Further, the defendant contends that the plaintiffs‟ scope of the suit patent
and claims thereof, themselves do not cover the claims as asserted by the
plaintiffs, and limits the patent to „specific‟ binding with only PD-1, and not
with other members of the CD-28 family. Lastly, it is asserted that the
balance of convenience lies in favour of the defendant and against the
plaintiffs. The aforenoted contentions of the defendant are dealt hereinafter.
80. Bio-similarity refers to the similarity of a biological medicine (bio-
similar) with its reference product, i.e., previously approved biological
medicine (biologic) in terms of safety, efficacy and quality. Essentially,
biological medicines are complex drugs which are produced using a living
system/organic life, such as a micro-organism, plant cell, or animal cell by
removing organic proteins or genetic materials from said cellular lifeforms
and reproducing or growing them in laboratories. Bio-similars are not exact
replicas of the reference biologics, however, they must demonstrate that
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there are no meaningful clinical differences in their purity, molecular
structure and bioactivity. The process of preparation of a biologic and bio-
similar may differ, however, the end result, i.e., the effect of the drugs must
be the same.
81. It is to be noted that all the studies for regulatory approvals are being
carried out by the defendant with respect to Opdivo®, i.e., Nivolumab, the
suit patent, which is the reference product for the bio-similar of the
defendant, i.e., ZRC-3276. As per the Similar Biologics Guidelines, issued
by the Department of Biotechnology, Government of India, „Similar
Biologic product‟ has been defined as follows:
―xxx xxx xxx
A Similar Biologic product is that which is similar in terms of quality,
safety and efficacy to an approved Reference Biological product based
on comparability.
xxx xxx xxx‖
(Emphasis Supplied)
82. As per the aforesaid Similar Biologics Guidelines, the following
attributes are to be established to show bio-similarity:
i. Bio-similarity is a concept that entitles subsequent companies to apply
for an abridged and shortened regulatory approval process based on
demonstration of similarity in the comparative assessment. This includes
ensuring comparable safety, efficacy and quality of a Similar Biologic to the
Reference Biologic.
ii. The demonstration of similarity depends upon detailed and
comprehensive product characterization, preclinical and clinical studies in
comparison with Reference Biologic.
iii. Any product can be considered as a Similar Biologic, only if it is
proven to be similar using extensive quality characterisation against theSignature Not Verified
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Reference Biologic.
iv. Similar Biologics are developed through a sequential process to
demonstrate the similarity by extensive characterization studies revealing
the molecular and quality attributes with regard to the Reference Biologic.
v. The dosage form, strength and route of administration of the Similar
Biologic should be the same as that of the Reference Biologic.
vi. The active drug substance (active ingredient) of the Reference
Biologic and that of the Similar Biologic must be shown to be similar.
vii. Similar Biologics manufacturers should develop the manufacturing
process to yield a comparable quality product in terms of identity, purity,
and potency to the Reference Biologic.
viii. The target amino acid sequence of the Similar Biologic should be
confirmed and is expected to be the same as for the Reference Biologic.
ix. The quality comparison between Similar Biologic and Reference
Biologic is essential for an abridged study.
83. Thus, it is clear that as per the aforesaid Similar Biologics Guidelines,
the target amino acid sequence of the similar biologic should be confirmed
and is expected to be the same for the reference biologic. The relevant
extract from the Similar Biologics Guidelines, is reproduced as under:
―xxx xxx xxx
6.3.2 Product Characterization
…….
i. Structural and Physicochemical Properties: The analysis of
physicochemical characteristic should include determination of primary
and higher order structure of the drug substance and the product along
with other significant physicochemical properties. The target amino acid
sequence of the Similar Biologic should be confirmed and is expected to
be the same as for the Reference Biologic. Analytical methods that are
used (including Biological and functional assays) should have
acceptable precision and accuracy. In cases, where post translational
modifications are taking place, these modifications need to be identified
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and quantified. In case any significant differences are found, these should
be scientifically justified and critically examined in preclinical studies and
clinical trials.
xxx xxx xxx‖
(Emphasis Supplied)
84. Thus, in bio-similar drugs, the efficacy and amino acid sequencing, is
also similar, however, chemically, the said drugs would be different.
85. In the present case, the defendant has specifically admitted that their
similar biologic product has the plaintiffs‟ product, Nivolumab, as the
reference biologic. Thus, the aforesaid attributes as per the Similar Biologic
Guidelines issued by the Government of India, would be available in the
product of the defendant, including, the sequence ID of the amino acid,
otherwise, the defendant could not have claimed their product as bio-similar
of Opdivo®. Further, this Court notes that it is not the case of the defendant
that the sequencing of their product is different from the suit patent.
86. On its claim of its product being bio-similar of Nivolumab, the
defendant in its note dated 17th February, 2025, has stated as follows:
―xxx xxx xxx
12. The Defendant‟s product can certainly be called a bio-similar of
“Nivolumab”. A product can be called “Nivolumab” so long as it
comprises the specific sequence of amino acids mentioned in the “WHO
Drug Information” document. However, claim 1 of the suit patent has an
added limitation over and above such sequences, i.e., the product having
such sequences must be isolated and bind specifically to PD-1.
Defendant’s product does not fulfill this additional requirement of claim 1
of the suit patent.
xxx xxx xxx‖
(Emphasis Supplied)
87. Further, in the same note dated 17th February, 2025, the defendant has
asserted as follows:
―xxx xxx xxx
18. ……
……
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c. Under the “WHO Drug Information” document, any product can be
called “Nivolumab” if it includes the sequences mentioned in that
document [Pg. 308, Document PF]. This list of sequences includes the
Complementarity-Defining Regions (CDRs).
Note: In simple terms, CDRs are the part of the monoclonal antibody that
binds with the target. It is the target binding site.
xxx xxx xxx‖
(Emphasis Supplied)
88. Perusal of the aforesaid, establishes the defendant‟s assertion that its
product is bio-similar of Nivolumab and that any product can be called
Nivolumab, if it includes the sequences mentioned in the WHO information
document. Thus, prima facie, similarity in the amino acid sequencing of
Nivolumab and the bio-similar product of the defendant, is established.
89. Reference may also be made to the clinical trial application filed by
the defendant before the CTRI, wherein, the defendant has categorically
named the comparator agent as Opdivo®, i.e., Nivolumab of the plaintiffs.
The comparator agent, as given in the clinical trial application of the
defendant, is reproduced as under:
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90. Further, as regards Nivolumab, the defendant in the brief summary of
the clinical trial application, has stated as follows:
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91. Thus, there is a categorical reference to Nivolumab, the plaintiffs‟
product, by the defendant in its clinical trial application, which is the
reference product for the bio-similar product of the defendant.
92. The defendant has further recognised Nivolumab being anti-PD-1
antibody with high affinity to PD-1 receptors. Figure from the Complete
Specification of the suit patent showing the binding specificity of
Nivolumab to PD-1 and other antibodies, is reproduced as under:
93. Further, the plaintiffs have done complete mapping of the suit patent
with Nivolumab as given in INN, which is reproduced as under:
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94. The aforesaid claim mapping with respect to Claims 1 and 3 of the
suit patent, IN „060 are shown to map to the International Non-Proprietary
Name -INN.
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95. The claim chart mapping the amino acid sequences as per Claims 1
and 3 of IN „060, vis-a-vis the Nivolumab INN, is as follows:
96. The structure/sequence of Nivolumab, the originally assigned INN by
the WHO in the year 2013, with an amendment in the description later in the
year 2014, as mentioned in the WHO recommended INN list, is reproduced
as under:
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97. Thus, it is evident that the amino acid sequencing is same in the suit
patent as well as Nivolumab INN. Therefore, Nivolumab INN is disclosed in
the suit patent.
98. The discussion as aforesaid discloses that Nivolumab is covered and
claimed in the suit patent by Claims 1, 3 and 7. The submission of the
plaintiffs in this regard, as encapsulated in their rejoinder, is reproduced as
under:
―xxx xxx xxx
16. Thus, IN „060 claims an isolated monoclonal antibody or an
antigen-binding portion thereof that binds specifically to human
Programmed Death (PD-1) comprising a heavy chain CDR1 consisting
of the amino acids sequence set forth in SEQ ID NO: 18, a heavy chain
CDR2 consisting of the amino acids sequence set forth in SEQ ID NO: 25,
and a heavy chain CDR3 consisting of the amino acids sequence set forth
in SEQ ID NO: 32, and a light chain CDR1 consisting of the amino acids
sequence set forth in SEQ ID NO: 39, a light chain CDR2 consisting of the
amino acids sequence set forth in SEQ ID NO: 46, and a light chain
CDR3 consisting of the amino acids sequence set forth in SEQ ID NO: 53
(Claim 1).
17. The six CDRs recited in claim 1 are the CDRs of an antibody termed
as the “5C4 antibody” embodied in the complete specification of IN
„060. Other than 5C4 antibody, IN „060 also discloses 6 other antibodies,
namely 17D8, 2D3, 4H1, 4A11, 7D3, 5F4. All these antibodies,
including 5C4, are not naturally occurring and are artificially produced.
18. The 5C4 antibody contains a heavy chain variable domain (VH) of
amino acid sequence set forth as SEQ ID NO: 4 (Claim 3), which contains
CDR’s of SEQ ID NOs: 18, 25, and 32, and a light chain variable domain
(VL) of amino acid sequence set forth as SEQ ID NO: 11 (Claim 3), which
contains CDR’s of SEQ ID NOs: 39, 46, and 53. The CDR‟s, heavy chain,
light chain sequences, and corresponding sequences of nucleic acids are
provided in the sequence listing which is part of the complete
specification of IN „060. The nucleic acid sequence encoding the VH and
VL domains are defined in Figure 4A and 4B, respectively of the complete
specification of IN ‗060 and the same are reproduced hereinbelow:
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xxx xxx xxx‖
(Emphasis Supplied)
99. In order to support their claim that the suit patent is for Nivolumab
and that Nivolumab is disclosed in the patent specification IN „060, the
plaintiffs have relied upon the affidavit of Dr. Brian T. Fife dated 15th
August, 2022, filed with the Patent Office, wherein, it has been stated as
follows:
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―xxx xxx xxx
8. As I explained in a previous Affidavit, nivolumab is disclosed by the
current specification. (See Annexure III). The entirety of SEQ ID NO: 4
aligns perfectly with the first 113 amino acids of nivolumab‟s heavy
chain sequence. (See Opposition, 112.5.3.) Because SEQ ID NO: 4
contains all of 5C4’s heavy chain CDRs, a person of ordinary skill in the
art would have understood that all of the antigen-binding regions of the
disclosed 5C4 heavy chain are the same as those in nivolumab. (See
Specification, pp. 10, 22 and Fig. 4A.) Similarly, a person of ordinary
skill in the art would have understood that all of the antigen-binding
regions of the disclosed 5C4 light chain variable region (i.e., SEQ IN
NO: 11) are the same as those in nivolumab. (See Specification, pp. 10,
22 and Fig. 48.) These disclosures are the critical aspects of disclosing
nivolumab, as the CDRs (i.e., complementarity determining regions)
have long been known as the regions that determine an antibody’s
specificity, with the surrounding variable region providing the
framework for presenting the CDRs.
xxx xxx xxx‖
(Emphasis Supplied)
100. The defendant claims to conform to the INN, Nivolumab. The
plaintiffs have mapped their suit patent, 5C4 antibody (Nivolumab) in order
to show that the suit patent conforms to INN, Nivolumab. Thus, it is clear
that when the suit patent of the plaintiffs conforms to INN Nivolumab and
the defendant has shown its product, ZRC-3276 to be conforming to INN
Nivolumab, the product of the defendant would have to have the same
sequencing as that of the plaintiffs‟ Nivolumab.
101. Defendant has nowhere stated that the sequencing of amino acids of
their product is different from the sequencing of amino acids of anti-PD-1
antibody of the suit patent. The defendant has conducted tests on both
Opdivo®, i.e., the product of the plaintiffs under which Nivolumab is sold,
and their own product, i.e., ZRC-3276. The drug of the defendant, i.e., ZRC-
3276, also has a high binding specificity to PD-1, as evidenced by the said
test results, as shown in the charts below. The relevant extract from the test
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report by Zydus as filed by the defendant with regard to evaluation of
binding specificity of defendant‟s product, i.e., ZRC-3276 with PD-1 and
other proteins of CD-28 family, is reproduced as under:
102. The defendant also tested the product of the plaintiffs, i.e., Opdivo® in
its in-house laboratory, the test results of which, as filed by the defendant,
are reproduced as under:
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103. The defendant also got its own product, ZRC-3276, tested from
Sardar Patel University, which showed the results as follows:
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104. The defendant also got the product of the plaintiff, i.e., Opdivo® tested
from Sardar Patel University, test results of which, as filed by the defendant,
are reproduced as under:
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105. Based on the results of the tests carried out by the defendant and by
Sardar Patel University with the product of the plaintiffs, the defendant
submits that both tests conclude that the binding of Opdivo® is to human
PD-1, as well as other CD-28 family proteins (ICOS, CD-28 and CTLA4)
and therefore, it is not Nivolumab. On the contrary, the results clearly show
that Opdivo® has higher binding affinity to human PD-1 receptor as
compared to other CD-28 family receptors, and therefore, it is an anti-PD-1
antibody, i.e., Nivolumab, as claimed in the suit patent. The ―Disclosure of
the Invention‖ is further evident by describing that the claimed isolated
monoclonal antibody binds to the PD-1 and exhibits numerous properties,
such as high affinity binding to human PD-1, but lacks substantial cross-
reactivity with either human CD-28, or CTLA-4 or ICOS.
106. The aforesaid test results to determine the binding specificity of
Opdivo®, the product of the plaintiffs, and ZRC-3276, the product of the
defendant, clearly demonstrate that both Opdivo ® and ZRC-3276, are anti-
PD-1 antibodies, that bind with PD-1 with high specificity than the other
CD-28 family receptors, and do not bind substantially with human CD-
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28/CTLA4 or ICOS receptors. The table summarising the test results of the
tests carried out at the behest of the defendant of the product of the plaintiffs
and defendant, is reproduced as under:
107. Considering the aforesaid test results filed by the defendant, it is
apparent that both the products, i.e., Opdivo® of the plaintiffs and ZRC-3276
of the defendant, fall within the scope of the claims of the suit patent. The
experiments and the technical reports of the defendant clearly demonstrate
that the product of the defendant, ZRC-3276, is a bio-similar of the
plaintiffs‟ product, i.e., Opdivo® and thus, ZRC-3276, the product of the
defendant, on account of being bio-similar, has the same claimed sequences
of the suit patent, which is admittedly Nivolumab.
108. As regards the difference in the binding affinity of Opdivo® and
ZRC-3276, which is demonstrated from the aforesaid test results filed by the
defendant, it is to be noted that the difference in the binding affinity is
common and is known as „Standard Variations in the Art‟. Thus, the
contention of the defendant that the product of the defendant is not an
„isolated monoclonal antibody that binds specifically to PD-1‟, as required
under Claim 1 of the suit patent, cannot be accepted. Therefore, the test
reports demonstrate that both Opdivo® and ZRC-3276 are anti-PD-1
antibodies as they both bind with PD-1 antibody with higher specificity than
the other CD-28 family receptors. This shows that both products fall within
the scope of the claims of the suit patent.
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109. It is undisputed that it is not possible to produce a biologic product,
i.e., protein, that has identical characteristics/properties as the original drug,
as similarity in properties is not dependent on the manufacturing process, the
conditions of manufacture, the cell system used to manufacture, etc.
However, what remains identical is the sequence of the claimed amino acid.
Reference in this regard may be made to the judgment in the case of Roche
Products (India) Pvt. Ltd. & Ors. Versus Drugs Controller General of
India and Ors., 2016 SCC OnLine Del 2358, wherein, it has been held as
follows:
―xxx xxx xxx
180. It is undisputed fact that biological drugs are synthesised by cells of
living organisms, as opposed to chemical drugs which are produced by
chemical synthesis. „Biosimilars‟ are biological drugs that are similar to
the innovator biological drug. Due to Owing to the complexity in the
molecular arrangement and manufacturing process of a biological drug,
it is not possible to replicate the structure and steps involved in the
manufacture of the innovator biological drug and to produce an
identical follow-on biological drug. Biosimilars, therefore, cannot be
generic equivalents of the innovator biological drug. The generic drugs
are characterised by their chemical and therapeutic equivalence to the
original, low molecular weight chemical drugs. These are identical to
the original product and are sold under the same chemical name.
xxx xxx xxx
184. In order to avoid any confusion, it is mentioned (as admitted by the
parties also) that the approval process for generic drugs is not the same
as the approval process for biosimilars. Biological drugs are synthesised
by cells of living organisms, as opposed to chemical drugs which are
produced by chemical synthesis. The „Biosimilars‟ are biological drugs
that are similar to the innovator biological drug. It is admitted by all
parties that it is not possible to replicate the structure and steps involved
in the manufacture of the innovator biological drug and to produce an
identical follow-on biological drug. Thus, biosimilars cannot be generic
equivalents of the innovator biological drug.
xxx xxx xxx‖
(Emphasis Supplied)
110. This Court also notes that the defendant has filed a patent application
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no. 202021019976 (“IN „976”) before the Indian Patent Office on 12 th May,
2020, in respect of ‗Process of Purifying anti-PD-1 Antibody’, wherein, the
preferred anti-PD-1 antibody, is Nivolumab and the same is pending. The
subject matter of IN „976 application of the defendant, is in relation to
purification of the anti-PD-1 antibody, in particular Nivolumab, for a
finished formulation. Thus, it is evident that the defendant is dealing in
Nivolumab, which is claimed in the suit patent, IN „060.
111. As per the defendant, patent infringement requires claim-to-product
mapping, which has not been done by the plaintiffs. However, it is to be
noted that the present suit is a quia timet action. By order dated 08th May,
2024, this Court had restrained the defendant from placing its product in the
market, without prior permission of the Court. Thus, there was no
commercial product of the defendant against which claim mapping could be
done.
112. The plaintiffs have done claim mapping with the Nivolumab INN
assigned by WHO, which is used as the reference product by the defendant
for the development of its bio-similar. The document pertaining to the claim
mapping of suit patent with the Nivolumab INN and documents of the
defendant, wherein, reference has been made to plaintiffs‟ product Opdivo ®,
i.e., Nivolumab, as a reference biologic, are on record before this Court.
113. Reference at this stage may be made to the judgment of this Court in
the case of Novartis AG and Another Versus Zydus Healthcare Limited
and Another, 2022 SCC OnLine Del 4373, wherein, it has been held that
the High Court of Delhi Rules Governing Patent Suits, 2022, dealing with
claim mapping use the word „to the extent possible‟ and questions the
applicability of the said Rules pertaining to claim mapping to a quia timet
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action. The relevant portions of the aforesaid judgment, are extracted as
below:
―xxx xxx xxx
59. All that Rule 3(A)(ix) and (x) of the Delhi High Court Patent Rules
require is that a plaint in a patent infringement action shall, to the
extent possible, include “precise claims v. product (or process) chart
mapping” and “infringement analysis explained with respect to the
granted claims in this specification”. The applicability of these
provisions, in the case of a quia timet action where the patent of the
defendant has yet to be granted, is itself questionable. That apart, the
Delhi High Court Patent Rules do not, at any point, indicate that, if these
formalities are not contained in a plaint alleging infringement of patent,
the plaint can be rejected. The various contents which a plaint in a patent
suit is required to contain, as envisaged by Rule 3(A) thereof are merely in
the nature of guidelines, intended at facilitating an expeditious resolution
of the dispute. Even if the plaint in a patent infringement suit does
not, stricto sensu, contain all the details envisaged in the various clauses
of Rule 3(A), in the manner as contemplated therein, the plaint would not
be liable to be rejected on that score.
60. The fact that the various clauses in the Rule 3(A) of the Delhi High
Court Patent Rules are not cast in iron is apparent even from the use of
the word “to the extent possible‖.
xxx xxx xxx
67. The use of the expression “to the extent possible” in Rule 3(A) of the
Delhi High Court Patent Rules, therefore, indicates that strict
compliance with the rigour of the various clauses of the said rule is not
mandatory and that a plaintiff is expected to comply therewith only to
the extent it is possible to do so. This reasoning would apply, mutatis
mutandis, to Rule 4(A) of the Delhi High Court Patent Rules as well,
which, too, requires the documents enumerated in the Rule to be filed
with the plaint “to the extent possible”.
xxx xxx xxx‖
(Emphasis Supplied)
114. In the present case, the drug under the suit patent is being sold under
the name Opdyta® (Nivolumab) in India. Since the product of the defendant
is not available commercially in the market, the plaintiffs have mapped their
suit patent to the Nivolumab INN. The defendant has already stated its
product to be bio-similar to Nivolumab. Such indirect method has been
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accepted by the Courts on various occasions. Thus, in the case of Intex
Technologies (India) Ltd. Versus Telefonaktiebolaget L.M. Ericsson
(Publ), 2023 SCC OnLine Del 1845, it has been held as follows:
―xxx xxx xxx
93. There is the direct test of infringement which is applied in all
standard patent cases. The other is the indirect method which involves
proving the following steps:
(i) Mapping patentee‟s patent to the standard to show that the patent
is a Standard Essential Patent.
(ii) Showing that the implementer‟s device also maps to the
standard.
xxx xxx xxx‖
(Emphasis Supplied)
115. The mapping done by the plaintiffs with that of Nivolumab sequence
clearly shows that the sequence ID of Nivolumab and the suit patent 5C4
antibody, is identical. Thus, any person who wishes to call their product as
bio-similar of Nivolumab, necessarily will have to have identical CDR
sequences and sequences of variable heavy chain and light chain. The
plaintiffs‟ product, Opdivo® is an anti-PD-1 antibody and is Nivolumab
(INN as declared by WHO) having the claimed sequences as that of the suit
patent. Furthermore, the product of the defendant, ZRC-3276 is also an anti-
PD-1 antibody like Opdivo®. Since the defendant claims its product as bio-
similar to Nivolumab, its product will essentially have the same claim
sequences of the suit patent, which is Nivolumab.
116. Thus, by virtue of the claim mapping done by the plaintiffs and the
discussion hereinabove, it is evident that Nivolumab INN is equivalent to
Claims 1 and 3 of the suit patent. Further, it is to be noted that defendant has
admitted that its product is a bio-similar of Nivolumab.
117. It is the contention of the defendant that there is no infringement
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because the suit patent only protects ‗Isolated’ monoclonal antibodies that
‗Specifically’ binds to human Programmed Death 1 (PD-1), whereas, the
defendant‟s product is not within the scope of the claims of the plaintiffs, as
the antibody of the defendant interacts with other proteins in the CD-28
family as well. In this regard, it is to be noted that Claim 1 of the suit patent
states that the suit patent is an isolated monoclonal antibody or an antigen
binding portion thereof, that binds specifically to PD-1. This Court takes
into account the submission made by the plaintiffs that „Specifically‟ does
not mean „exclusively‟ or „only‟. Furthermore, the claims of the suit patent
nowhere state that there is exclusive or only binding to PD-1.
118. As regards the rules of claim interpretation, a Division Bench of this
Court, in the case of F. Hoffman-La Roche Ltd. & Anr. Versus Cipla Ltd.,
2015 SCC OnLine Del 13619, has held as follows:
―xxx xxx xxx
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 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 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
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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 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 PatentsSignature Not Verified
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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.
(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 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.
xxx xxx xxx‖
(Emphasis Supplied)
119. Thus, it is evident upon perusal of the aforenoted judgment that
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claims have to be given their ordinary and general meaning, which is the
meaning of the term to a Person of Ordinary Skill in the Art. However, in
case of doubt as to the meaning and import of a term, resort can be made to
the specifications of a patent. Therefore, while the claims of the plaintiffs
nowhere state „exclusive‟ or „only binding‟ to PD-1, reliance can be placed
on the specification of the suit patent. The relevant extracts from the
complete specification of the claims of the suit patent, read as under:
―xxx xxx xxx
Disclosure of the Invention
xxx xxx xxx
In one aspect, the invention pertains to an isolated monoclonal antibody,
or an antigen- binding portion thereof, wherein the antibody exhibits at
least one of the following properties:
(a) binds to human PD-1 with a KD of 1 x 10-7 M or less;
(b) does not substantially bind to human CD28, CTLA-4 or ICOS;
(c) increases T-cell proliferation in an Mixed Lymphocyte Reaction (MLR)
assay;
(d) increases interferon-gamma production in an MLR assay;
(e) increases IL-2 secretion in an MLR assay;
(f) binds to human PD-1 and cynomolgus monkey PD-
(g) inhibits the binding of PD-L1 and/or PD-L2 to PD-1;
(h) stimulates antigen-specific memory responses;
(i) stimulates antibody responses;
(j) inhibits tumor cell growth in vivo
xxx xxx xxx
An ―isolated antibody‖, as used herein, is intended to refer to an antibody
that is substantially free of other antibodies having different antigenic
specificities (e.g., an isolated antibody that specifically binds PD-1 is
substantially free of antibodies that specifically bind antigens other than
PD-1). An isolated antibody that specifically binds PD-1 may, however,
have cross-reactivity to other antigens, such as PD-1 molecules from
other species. Moreover, an isolated antibody may be substantially free of
other cellular material and/or chemicals.
xxx xxx xxx
Anti-PD-1 Antibodies
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The antibodies of the invention are characterized by particular functional
features or properties of the antibodies. For example, the antibodies bind
specifically to PD-1 (e.g., bind to human PD-1 and may cross-react with
PD-1 from other species, such as cynomolgus monkey). Preferably, an
antibody of the invention binds to PD-1 with high affinity, for example
with a KD of 1×10-7 M or less. The anti-PD-1 antibodies of the invention
preferably exhibit one or more of the following characteristics:
(a) binds to human PD-1 with a KD of 1×10-7 M or less;
(b) does not substantially bind to human CD28, CTLA-4 or ICOS;
(c) increases T-cell proliferation in an Mixed Lymphocyte Reaction (MLR)
assay;
(d) increases interferon-gamma production in an MLR assay;
(e) increases IL-2 secretion in an MLR assay;
(f) binds to human PD-1 and cynomolgus monkey PD-1;
(g) inhibits the binding of PD-L1 and/or PD-L2 to PD-1;
(h) stimulates antigen-specific memory responses;
(i) stimulates antibody responses;
(j) inhibits tumor cell growth in vivo.
Preferably, the antibody binds to human PD-1 with a KD of 5×10-8 M or
less, binds to human PD-1 with a KD of 1×10-8 M or less, binds to human
PD-1 with a KD of 5×10-9 M or less, or binds to human PD-1 with a KD
of between 1×10-8 M and 1×10-10 M or less.
An antibody of the invention may exhibit any combination of the above-
listed features, such as two, three, four, five or more of the above-listed
features.
Standard assays to evaluate the binding ability of the antibodies toward
PD-1 are known in the art, including for example, ELISAS, Western blots
and RIAS. The binding kinetics (e.g., binding affinity) of the antibodies
also can be assessed by standard assays known in the art, such as by
Biacore analysis. Suitable assays for evaluating any of the above-
described characteristics are described in detail in the Examples.
xxx xxx xxx‖
(Emphasis Supplied)
120. The defendant has further relied upon example 3, figure 14 of
Complete Specification to argue that there is high binding affinity to PD-1,
but no binding affinity to other CD-28 receptors. However, perusal of the
specification, in particular to example 3, with reference to figure 14 shows
that it has nowhere been mentioned that the product of the plaintiffs has
exclusive binding with PD-1. It states regarding „High Specificity to PD-1‟.
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Relevant extract from example 3 of the Complete Specification, is
reproduced as under:
―xxx xxx xxx
Binding specificity by ELISA against other CD28 family members
A comparison of the binding of anti-PD-1 antibodies to CD28 family
members was performed by standard ELISA using four different CD28
family members to examine the specificity of binding for PD-1.
Fusion proteins of CD28 family members, ICOS, CTLA-4 and CD28
(R&D Biosystems) were tested for binding against the anti-PD-1 human
monoclonal antibodies 17D8, 2D3, 4H1, 5C4, and 4A11. Standard ELISA
procedures were performed. The anti-PD-1 human monoclonal antibodies
were added at a concentration of 20 ug/ml. Goat-anti-human IgG (kappa
chain-specific) polyclonal antibody conjugated with horseradish
peroxidase (HRP) was used as secondary antibody. The results are shown
in Figure 14. Each of the anti-PD-1 human monoclonal antibodies
17D8, 2D3, 4H1, 5C4, 4A11, 7D3 and 5F4 bound with high specificity to
PD-1, but not to the other CD28 family members.
xxx xxx xxx‖
(Emphasis Supplied)
121. Upon perusal of the above, it comes to the fore that Nivolumab has
been shown as an anti-PD-1 antibody, with high/substantial affinity to bind
to PD-1 receptors. Moreover, there is a clear mention that there is no
substantial binding to CD-28 receptors, which cannot be construed to mean
that there is no binding with the CD-28 receptors. The specification nowhere
states that there is no binding to other CD-28 receptors, thus, negating the
argument of the defendant.
122. Reference may also be made to the order dated 30 th June, 2020 passed
by the Controller of Patents in the pre-grant opposition proceedings,
wherein, with regard to high binding specificity of the antibody in the suit
patent to PD-1, it has been stated as follows:
―xxx xxx xxx
60. The 5C4 antibody also has a high binding specificity to PD-1.
Example 3 of the PCT specification (figure 14) teaches that the 5C4
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antibody bound to PD-1 with high specificity, but not to other CD28
family members (ICOS, CTLA-4, CD28).
61. In contrast, the PDI-17, PDI-28, PDI-33 and PDI-35 antibodies bind
to human PD- 1, but also bind to at least one of CTLAA. CD28 and I
COS. Sec fife Affidavit at Figure I and 10-17. As shown by Dr. Fife’s
af1idavit, the superior specificity of the 5C4 antibody to the reference
antibodies “would not have been expected.‖
xxx xxx xxx
64. The 5C4 antibody (nivolumab) is shown to have unexpectedly superior
therapeutic efficacy to standard chemotherapy. Dr. Feltquate has
explained the details in his evidence, a summary of which is also enclosed
herewith. In particular:
a. Nivolumab has repeatedly shown ―unprecedented‖ responses in
comparison to standard-of-care treatments and in various tumor types. As
evidence of the unprecedented response, Dr. Feltquate cites multiple
reports and scientific articles showing ―the transformative nature that
nivolumab [the 5C4 antibody] is expected to have on cancer treatments.‖
b. Dr. Feltquate quotes a statement of Professor Weber who conducted the
first phase Ill clinical trial of the 5C4 antibody indicating that ―the
impressive data on duration or response suggest that there will be
significant prolongation of progression-free and overall survival when the
analysis of those data is mature.‖
c. Nivolumab has been investigated in more than l 00 human clinical trials
both as a monotherapy and in combination with other therapies.
xxx xxx xxx‖
(Emphasis Supplied)
123. It is also to be noted that examples do not limit the scope of the
claims. While working examples are essential for demonstrating the
feasibility and workability of the invention, they do not define the patent‟s
scope. Thus, in the judgment dated 13th March, 2024, in the case of Bayer
Pharm Aktiengescllschaft Versus Controller General of Patents and
Designs, 2024 SCC OnLine Del 2044, it has been held as follows:
―xxx xxx xxx
9. Therefore, the Court finds merit in the contention of Mr. Banerjee that
mere recitations of the unit numbers of the components in claim 1 cannot
render it ineligible for patent protection under Section 3(i) of the Act.
Notably, in the said claim, as defined, there is neither any reference to a
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particular disease/ treatment, nor any reference regarding the modes/
manner of administration of the composition. In patent law, the claims of a
patent define the boundaries of the patent protection. That is, they set out
the legal limits of what the patent covers. The claims must be clear,
specific, and supported by the description within the patent application.
They are the most critical part of a patent application because they
determine the extent of protection granted by the patent. Working
examples, on the other hand, are provided in the subject application to
demonstrate the practical implementation of the invention. These
examples are intended to show that the invention is feasible and
workable and how it can be carried out in practice. They provide support
and understanding for the claimed invention, showing that it is not just
a theoretical concept, but has practical applicability. Thus, while
working examples are essential for demonstrating the feasibility and
workability of an invention, they do not define the patent‟s scope. The
scope is determined by the claims, which must be interpreted in light of
the description and any examples provided. The reasoning for applying
Section 3(i) of the Act to the subject application is therefore, misplaced.
Mr Banerjee also relies on the decision of this Court in Societe Des
Produits Nestle SA v. The Controller of Patents and Design and Anr.,
where, in a similar situation, the Court referenced the Manual of Patent
Office, Practice and Procedure, which gives the guidance for examination
with respect to exclusion of medical, surgical, curative, prophylactic,
diagnostic, therapeutic or other treatment, and held that the claims in
respect of the composition are patentable, and not hit by Section 3(i) of the
Act. In the present case as well, the claim 1, as defined, in the opinion of
the Court, does not render the application to be non-patentable.
xxx xxx xxx‖
(Emphasis Supplied)
124. Even otherwise, the test results filed by the defendant themselves
show high binding specificity of the product of the plaintiffs with PD-1.
Further, the test results of the defendant do not in any manner show that the
antibody, i.e., 5C4 (Nivolumab), does not bind to other CD-28 receptors.
125. This Court has already noted above that non-substantial binding
cannot be equated to no binding at all, therefore, even the test results of the
defendant which show that the product of the plaintiffs substantially does
not bind to CD-28, cannot be construed so as to mean that there exists no
binding with the CD-28 receptors. Therefore, to say that the suit patent
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exclusively binds to PD-1, is prima facie incorrect.
126. Further, it is to be noted that the defendant in its own application
before the CTRI has stated that Nivolumab is an anti-PD-1 antibody with
high binding affinity to PD-1 receptors. Therefore, even as per the
defendant, the suit patent discloses high affinity of Nivolumab with PD-1
receptors, in comparison to other receptors, such as that of CD-28 protein
family. Even the defendant does not state that Nivolumab exclusively and
only binds to PD-1. Further, high affinity of Nivolumab with PD-1 does not,
in any manner, exclude its binding with other receptors of CD-28, though it
does not have high specificity towards other CD-28 family members.
However, the same cannot be interpreted as claim of exclusive specificity to
PD-1.
127. As regards the expert evidence of Professor Ipshita Roy, filed on
behalf of the defendant, the same is a matter of trial and cannot be taken into
consideration at this interim stage, as the same would be subject to
examination and counter on part of the plaintiffs, who have the right to
ascertain the veracity of the claims made by the defendant‟s expert.
Moreover, the plaintiffs have placed on record the report of their own
expert, which is in contrast to the findings of the defendant‟s expert. Thus, it
is imperative that questions which are in dispute be a subject matter of trial.
128. Further, with regard to the defendant‟s claims that its product is bio-
similar to the product of the plaintiff, this Court agrees with the submission
of the plaintiffs that infringement may arise even where each and every
element of the patented claim is not identically found in the infringing
product, so long as the pith and marrow of the invention is taken under the
concept of Doctrine of Equivalence. Non-literal infringement is recognized
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where the substituted element performs substantially the same function in
substantially the same way to achieve substantially the same result. Thus, in
the case of SNPC Machines Private Limited and Others Versus Vishal
Choudhary, 2024 SCC OnLine Del 1681, it has been held as follows:
―xxx xxx xxx
35. The three decisions of this Court cited by plaintiffs and defendant,
of which relevant extracts have been reproduced above,
are Sotefin (supra) a decision of Single Judge of this Court of
February, 2022, FMC Corporation (supra) a decision of Division
Bench of December, 2022 and RxPrism (supra) a decision of Single
Judge of July, 2023. All these decisions have extensively relied upon
earlier decisions of the Indian Courts as well as Courts of foreign
jurisdictions. Our analysis is contoured on the test which needs to be
used for assessing a prima facie infringement of the suit patent. The
following principles can be culled out collectively from the aforenoted
decisions, since all of them rely upon the same previous sources while
articulating them from different perspectives:
A) Infringement is to be adjudged objectively and defendant’s
intention may not be material to determine this question; the
emphasis however has to be on mapping of „essential elements‟.
B) Whether elements which are missing in the defendant’s
products are so essential or substantial that the absence would
entitle the plaintiff to an injunction.
C) Patent infringement analysis, comparison of elements of the
suit patent’s claims is to be done with the elements/claims of the
infringing products.
D) There can be a case of non-literal infringement where each
and every component of patent specification is not found in the
infringing products i.e. all elements of a claim may not entirely
correspond with the infringing product, but it still can be a case
of infringement.
E) It is the pith and marrow of the invention claimed that is
required to be looked into. This test had been referred to
in Clark v. Adie, [L.R.] 2 App. Cas. 315 [House of Lords].
F) Non-essential or trifling variations or additions in the product
would not be germane, so long as substance of the invention is
found to be copied.
G) Pure literal construction is not to be adopted, rather doctrine of
purposive construction should be applied.
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H) Doctrine of equivalents is to be examined and applied if the
substituted element in the infringing product does the same work,
in substantially the same way, to accomplish substantially the
same result. The source of this doctrine traces its origin to an old
decision in Winans v. Denmead, 15 How. 330, 14 L.Ed. 717 which
was cited with approval in Graver Tank and Manufacturing
Co. v. Linde Air Products Co., 339 US 605 (1950) (Supreme Court
of United States).
I) The essential feature in an infringing article or process are of no
account. If the infringing goods are made with the same object in
view, which is attained by the patented product, then a minor
variation does not mean that there is no piracy. Some trifling or
unessential variation has to be ignored. This principle was cited by
the Division Bench of this Court in Raj Prakash v. Mangat
Ram, ILR (1977) 2 Del 412.
J) While product v. product comparison shall not to be
determinative of infringement as opposed to the granted
claim v. product comparison, an essential comparison between the
products of the plaintiffs and the defendants may be necessary.
K) The triple identity test is important – focusing on function, way
the elements serve the function and the result obtained is suitable
for analyzing mechanical device (cited in Warner-Jenkinson Co.
Inc. v. Hilton Davis Chemical Co., 520 US 17 (1997) (Supreme
Court of United States).
xxx xxx xxx‖
(Emphasis Supplied)
129. This Court also notes the judgment in the case of F-Hoffmann-La
Roche AG and Another Versus Zydus Lifesciences Limited, 2024 SCC
OnLine Del 7663, wherein, the Court held that if the bio-similar utilizes any
aspect which is patented by the reference biologic, then, there will be a case
of patent infringement. Thus, it was held as follows:
―xxx xxx xxx
24. Biosimilars are designed to be highly similar to the reference
product, but not identical. As discussed above, the Guidelines lay out
the pathway for approval of biosimilar, however, these focus on the
approval process and do not directly address patent issues. The
determination of infringement must begin with understanding the
scope of the patent(s) held by the reference biologic. We know that
Patents can cover a wide range of protectable subject matter,Signature Not Verified
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including the biologic’s molecular structure, the process by which it is
manufactured, formulations, methods of use, and more. If the
biosimilar or similar biologic utilizes or embodies any aspect that is
patented by the reference biologic, only then there could be a case
for patent infringement.
xxx xxx xxx‖
(Emphasis Supplied)
130. In view of the aforesaid detailed discussion, this Court is prima facie
of the view that in case the defendant launches its product commercially, the
same shall amount to infringement of the suit patent.
131. Further, the defendant has averred that there has been evergreening
and double patenting by the plaintiffs in view of the stand taken by the
plaintiffs in the prosecution history of other patents. However, the said
averment is found without any merit, in view of the discussion made
hereinafter.
132. It is the defendant‟s case that the plaintiffs have admitted in their
complaints against one Merck and Co. Inc. that they have developed
Nivolumab antibody by practising the US patents, US 87828474, US
9073994 and US 9067999. In this regard, it would be useful to refer to the
said patents.
133. The invention claimed in US 87828474, is as follows:
―xxx xxx xxx
The invention claimed is:
1. A method for treatment of a tumor in a patient, comprising
administering to the patient a pharmaceutically effective amount of an
anti-PD-I monoclonal antibody.
xxx xxx xxx‖
134. The invention claimed in US 9073994, is as follows:
―xxx xxx xxx
The invention claimed is:
1. A method of treating a metastatic melanoma comprising intravenously
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administering an effective amount of a composition comprising a human
or humanized anti-PD-I monoclonal antibody and a solubilizer in a
solution to a human with the metastatic melanoma, wherein the
administration of the composition treats the metastatic melanoma in the
human.
xxx xxx xxx‖
135. The invention claimed in US 9067999, is as follows:
―xxx xxx xxx
The invention claimed is:
1. A method of treating a lung cancer comprising administering a
composition comprising a human or humanized anti-PD-I monoclonal
antibody to a human with the lung cancer, wherein the administration of
the composition treats the lung cancer in the human.
xxx xxx xxx‖
136. Perusal of the aforesaid makes it apparent that the aforesaid patents
are method claims and none of them disclose the sequence of Nivolumab, as
claimed in the suit patent.
137. Even otherwise, it is to be noted that the subject matter of the US
patent cases was in relation to the first step of drug discovery, i.e., the
discovery that PD-1 receptor is a useful target in our body for treatment of
cancer. The entire document, i.e., the complaint filed by the plaintiffs
against Merck and Co. Inc. before the United States District Court, only
demonstrates that an antibody that is developed for PD-1 receptor will be
useful for treatment of cancer. Thus, it was the case of the plaintiffs that any
third party, who makes an anti-PD-1 antibody for treatment of cancer, will
infringe the US patents. The subject matter of the US complaints was the
use/method for treatment of cancer using an anti-PD-1 antibody
Pembrolizumab, which was developed by said Merck and Co., and has a
different sequence from that of Nivolumab, as per the case put forth by the
plaintiffs.
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138. Thus, as per the plaintiffs, the plaintiffs filed the US complaints in the
context that a third party who uses any anti-PD-1 human antibody for
treatment of cancer, will infringe D3‟s US equivalent. It is to be noted that
Merck was planning to make, use, sell, etc., an anti-PD-1 antibody,
Pembrolizumab for treatment of cancer, and not Nivolumab.
139. Relevant extract from the complaint filed by the plaintiffs against
Merck before the United States District Court, is reproduced as under:
―xxx xxx xxx
4. The invention at issue here covers using antibodies that bind to PD-1
(―anti-PD-1 antibodies‖) in a method for treating cancer. By binding to
PD-1 and blocking the PD-1 checkpoint pathway, the anti-PD-1
antibodies allow a patient’s immune system to resume its ability to
recognize, attack, and destroy cancer cells.
xxx xxx xxx
6. Merck is threatening to exploit that invention with a later-developed
anti-PD-1 antibody. As described below, Merck is preparing to infringe
plaintiffs‟ patent for methods of treating cancer with anti-PD-1
antibodies.
xxx xxx xxx
13. On May 20, 2014, the United States Patent & Trademark Office
(―USPTO‖) duly and legally issued United States Patent No. 8,728,474
(the ―474 patent‖ (Exhibit 1)) titled ―Immunopotentiative Composition.‖
The inventors of the 474 patent showed for the first time that anti-PD-1
antibodies were useful in methods to treat cancer. Ono is an assignee of
the 474 patent. BMS is an exclusive licensee of the 474 patent. The 474
patent claims methods for treating cancer with an antibody against PD-1.
14. Plaintiffs have put the invention of the 474 patent into practice by
developing the breakthrough biologic drug nivolumab. Nivolumab is a
monoclonal antibody that recognizes and binds to the PD-1 protein.
When nivolumab binds to the PD-1 protein, that PD-1 protein cannot
interact with its natural binding partners. Using nivolumab to block the
interaction between PD-1 and its binding partners allows a more robust
T cell response by the patient‟s own immune system.
xxx xxx xxx
18. Merck is planning to exploit the invention of the 474 patent with an
anti-PD-1 antibody called pembrolizumab. On information and belief,
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Merck started developing pembrolizumab after Plaintiffs had made and
started testing nivolumab, and Merck has since been engaged in efforts
to meet the FDA regulatory requirements for marketing, distributing,
offering for sale, and selling pembrolizumab for the treatment of cancer.
According to Merck, pembrolizumab is a PD-1 antibody that works by
blocking the PD-1 checkpoint to treat cancer.
19. On information and belief, Merck has known about the 474 patent and
has known that the use of pembrolizumab will infringe claims of the 474
patent since at least approximately May 20, 2014, when the 474 patent
was issued by the USPTO. In its August 7, 2014, 10-Q filing with the U.S.
Securities and Exchange Commission (―SEC‖), Merck acknowledged that
the USPTO had granted the 474 patent (Merck & Co., Inc. U.S. Securities
& Exchange Commission Form 10-Q at 22 (filed August 7, 2014)). In that
same SEC filing, Merck admits that the use of pembrolizumab to treat
cancer is covered by the European counterpart to the 474 patent (id. (―As
previously disclosed, Ono Pharmaceutical Co. (―Ono‖) has a European
patent (EP 1 537 878) (―’878‖) that broadly claims the use of an anti-PD-
1 antibody, such as the Company’s immunotherapy, pembrolizumab (MK-
3475), for the treatment of cancer.‖)).
xxx xxx xxx‖
(Emphasis Supplied)
140. Reading of the aforesaid clearly shows that the US patents are method
patents, while the suit patent is a product patent. As noted above, none of the
US patents disclose the sequence of Nivolumab. Furthermore, the complaint
filed in the US is a post published document, subsequent to the priority date
of the suit patent and does not assist the defendant in establishing that D3
discloses specific anti-PD-1 antibodies.
141. It is further to be noted that the plaintiffs had filed a suit against
Merck for infringement. This Court notes the submission made on behalf of
the plaintiffs that the said suit has since been settled between the plaintiffs
and Merck, and Merck is paying royalty to the plaintiffs.
142. Further, the defendant has relied upon Patent Term Extension-PTE by
plaintiffs for Japanese Patent being JP4409430. This Court notes the
submission of the plaintiffs that the Japanese Patent belongs to the same
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family as US 87828474, which claims the use of anti-PD-1 antibodies for
treatment of cancer. Further, the Japanese Patent is equivalent of EP „878.
The PTE was for the use of an anti-PD-1 antibody, i.e., Nivolumab for
treatment of cancer. Further, nothing has been brought before this Court that
there was disclosure of any sequence relating to Nivolumab in the Japanese
Patent. The Japanese Patent, which has been relied upon by the defendant,
covers the use of PD-1 antibodies for treatment. However, the sequence of
Nivolumab has not been disclosed in the Japanese Patent. The English
translation of the claims of the Japanese Patent, as filed by the plaintiffs, is
reproduced as under:
143. Similarly, the submissions made by the plaintiffs during the
prosecution of EP „878, again do not prima facie show the vulnerability of
the suit patent. The submissions of the plaintiffs were in response to the
post-grant opposition filed by Merck to D3. D3 showed that the inhibition of
PD-1 is effective in the treatment of cancer, to further show that any human
anti-PD-1 antibody, has been successful in the treatment of cancer. The
plaintiffs relied upon the data in the specification of the suit patent.
However, obviousness of the suit patent has not prima facie been established
by the defendant, and the same would be subject matter of trial.
144. Likewise, the supplementary patent protection sought in Europe does
not show that Nivolumab is the subject matter of EP „878. As noted earlier,
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EP „878 relied upon by the defendant, merely claims the use of an anti-PD-1
antibody and does not disclose the sequences of Nivolumab. Thus, reliance
on EP „878 is misplaced and does not raise a credible challenge to the
validity of the suit patent or come in aid to the defendant‟s defence with
respect to non-infringement of the suit patent.
145. This Court further takes note of the submission of the plaintiffs that
the monoclonal antibody of Nivolumab is a man-made antibody and is not
merely a discovery, i.e., human intervention is present in preparation of
Nivolumab. Therefore, Nivolumab cannot be said to be non-patentable
under Section 64(1)(k) of the Patents Act. The said submission, as
encapsulated in the plaintiffs‟ rejoinder, is reproduced as under:
―xxx xxx xxx
62. That the contents of paragraph nos. 21 & 22 under reply are denied
for being false and frivolous. It is submitted that the contents of paragraph
21 are generic statements wherein the Defendant attempts to suggest that
anti PD-1 antibody is known in the art and that the suit patent is a mere
preparation of an antibody against an alternate antigen. It is submitted
that for the first time PD-1 receptor was identified in 2002 as a target for
treatment of cancer as is evident from document WO2004/004771
(EP1537878). Further submissions are as below:
a) In response to the paragraph nos. 21 (a)-(e), it is submitted that the
suit patent is in relation to specific antibody which have been clearly
defined by the sequence ID. The process for preparing anti PD-1
antibody using hybridoma clones is well known technique to prepare
antibodies. By simply knowing the process, does not result in the
generation of novel and unknown antibodies. Recombinant human
antibodies can be generated in the laboratory by using two most
common method for antibody generation i.e. library-based method and
transgenic mouse-based methods. Notwithstanding the above, the
Plaintiffs‟ suit patent does not claim the process for preparing a known
antibody. The claims of the Defendant are completely flawed in as much
that each of the three documents referred i.e. WO2002/12500 (D23) and
WO2002/12502 (D24) have been granted patents in India as Indian Patent
No. 236195 and 225434 respectively. WO2001/014424D25 is directed to
novel human sequence antibodies against human CTLA-4 and methods of
treating human diseases, infections and other conditions using these
antibodies. None of the said documents referred to by the DefendantSignature Not Verified
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disclose 5C4 antibody. It is further denied that once the antigen is
injected, the antibody is automatically generated and therefore is an
essential biological process. This is also incorrect as each of the mAb
production requires human intervention and has to be generated
through recombinant and hybridoma technology.
b) Further, in response to the paragraph no, 21 (f), it is submitted that the
monoclonal antibody of Nivolumab is a manmade antibody and
therefore neither Section 3(j) nor Section 3(c) is attracted. An anti- PD-1
monoclonal antibody or an antigen-binding portion thereof in claim 1 or
any of the claims dependent thereon of the suit patent is not a discovery
or a product of nature for the reasons as follows:
Not a discovery: Oxford dictionary defines “discovery” as “the
action or an act of finding or becoming aware of for the first time, esp.,
the first bringing to light of a “scientific phenomenon”. The claimed
antibodies are novel because the claimed CDR sequences are not
disclosed in any of the prior art documents and were not known before
the priority date of the present invention, and are different from the
human germline sequences. Therefore, the claimed antibody of suit
patent cannot be considered, at the outset, as merely a discovery of a
natural or scientific phenomenon.
Not occurring in nature/not “product of nature”/made by human
intervention: The antibodies recited in the claims of suit patent are not
occurring in nature/not merely isolated from nature.
It is submitted that in the GUIDELINES FOR EXAMINATION OF
BIOTECHNOLOGY APPLICATIONS FOR PATENT issued by Office of
the Controller General of the Patents and Designs, issued in March 2013,
at page 11 for Section 3(c) it is mentioned that, ―products such as
microorganisms, nucleic acid sequences, proteins, enzymes, compounds,
etc., which are directly isolated from nature, are not patentable subject-
matter‖.
The Defendant has failed to point out any naturally occurring
anti- PD-1 antibody containing the six CDR sequences recited in the suit
patent‟s claims. No reference cited by the Defendant shows an antibody
or antigen-binding portion thereof that comprises the six CDRs recited
in the suit patent‟s claims.
Human PD-1 is a naturally occurring protein in the human
body. The claimed antibodies specifically bind human PD-1. A skilled
artisan would have known that a human would not naturally produce an
antibody against a self-antigen, PD-1. Said antibodies can only be
created in artificially with human intervention.
xxx xxx xxx‖
(Emphasis Supplied)
146. Thus, the statements of the plaintiffs made during the prosecution of
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foreign patent applications, as relied by the defendant, do not assist the
defendant in any manner, in the facts and circumstances of the present case.
147. This Court notes the submission of the plaintiffs that Nivolumab is a
blockbuster drug, since it has generated revenue of around 9.01 billion USD
in the year 2023 itself. In this regard, reference may be made to the
‗Statement Regarding the Working of Patented Invention(s) on a
Commercial Scale in India’ in Form 27, as submitted by the plaintiff no.1,
which is reproduced as under:
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148. Further, as noted hereinabove, Nivolumab has been granted approvals
in more than fifty countries, for more than twenty indications (Indication – a
specific use or application of an invention) worldwide and ninety indications
in India. It is also to be noted that the suit patent has been granted after
thorough scrutiny and after four pre-grant oppositions in India. Even
otherwise, the post-grant opposition filed by the defendant‟s sister concern is
still pending. Merely filing the challenge is not enough. The defendant was
aware of the litigation that would ensue if they sought for launch of their
product, indicative of the said knowledge are the multiple notices and the
post-grant opposition itself, as filed by defendant‟s sister concern. In this
regard reference may be made to the judgment in the case of Eisai Co. Ltd.
and Another Versus Satish Reddy and Another, 2019 SCC OnLine Del
8496, wherein, it has been held as follows:
―xxx xxx xxx
66. The balance of convenience for the grant of interim injunction lies
in favour of the plaintiffs as the defendants have evidently not “cleared
the way” before going ahead with obtaining a marketing approval for
launch of the infringing drug. The defendants were aware that there
may be a possible challenge to its product, but they chose to go ahead to
seek the marketing approvals without first invoking revocation
proceedings or attempting to obtain a license. Where litigation is bound
to ensue if the defendants introduce their product, the defendants could
have avoided the interlocutory injunction if they had cleared the way
first. Reference be made to Merck v. Glenmark; (2015) 63 PTC 257 [Del]
[DB].
xxx xxx xxx‖
(Emphasis Supplied)
149. Delving on the issue of „clearing the way‟, this Court in the case of
Novartis AG and Another Versus NATCO Pharma Limited, 2019 SCC
OnLine Del 12436, has held as follows:
―xxx xxx xxx
15. The Court has heard both sides on the grant of ad-interim relief. It is
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the admitted position that the post grant opposition is now pending
decision with the Patent Office and the question as to whether the patent is
to be maintained or not will be decided therein. Thus, in so far as the
validity of the patent itself is concerned, this court would not like to make
any observation at this stage, so as to ensure that the post grant
opposition is decided without being affected by any observation which
may be made by this court.
xxx xxx xxx
17. The actual commercial launch has also admittedly been done only on
20th March, 2019. Thus, during the period when the post-grant
opposition decision was yet to come, the Defendant has chosen to
commercially launch the product. While the Supreme Court in Aloys
Wobben (supra) held that the rights would be crystallized once the post
grant opposition is decided, launch of an allegedly infringing product,
prior to the said decision in the opposition by the entity opposing the
Patent, did not arise in the facts of the said case. Section 48 of the
Patents Act grants rights in favour of a patentee, which are not affected
during the pendency of a post-grant opposition. Section 48 provides as
under:
―48. Rights of patentees – Subject to other provisions
contained in this Act and the conditions specified in section
47, a patent granted under this Act shall confer upon the
patentee-
(a) where the subject matter of the patent is a product, the
exclusive right to prevent third parties, who do not have his
consent, from the act of making, using, offering for sale,
selling or importing for those purposes that product in
India
(b) where the subject matter of the patent is a process, the
exclusive right to prevent third parties, who do not have his
consent, from the act of using that process, and from the
act of using, offering for sale, selling or importing for those
purposes the product obtained directly by that process in
India‖
18. During the pendency of the post-grant opposition, the rights of a
patentee subsist – though they may be crystallized once the opposition is
actually decided. The Defendant ought to have awaited the decision in
the post grant opposition before launching its product. However, since it
chose to launch earlier, the Plaintiff has filed the present suit.
xxx xxx xxx‖
(Emphasis Supplied)
150. In the case of Smithkline Beecham Plc Versus Generics (UK) Ltd,
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2001 WL 1346930, the High Court of Justice Chancery Division discussed
the concept of „clearing the way‟ while granting an injunction, in the
following manner:
―xxx xxx xxx
As between the two, I will put it this way, the claimant’s damage is
more unquantifiable than that of the defendant’s but both are
unquantifiable. There are degrees (sic) of unquantifiability, just as
there are degrees of infinity. I turn to another factor which, to my
mind, indicates that the injunction should be granted. It is this. The
defendants have known for a long time about this patent. You would
have to be very naive in the pharmaceutical industry to think that
the patentee, with a product as important as this, would not, if it had
anything other than a frivolous chance of success, take action. So
the defendants knew, when they set out upon this project in 1997
that if the patentees would cause trouble they would.
The defendants could, so soon as they settled upon the product they
were intending to sell, have caused the litigation to start. They could
have done a number of things: First, they could have launched a
petition for the revocation of the patent and started a claim for a
declaration of non-infringement. Or, since there are certain
difficulties with the latter (for example onus of proof goes the other
way round), they could simply have said to the patentees, “We intend
(we are not saying when but it is a settled intention) to launch our
product within the next five years. If you intend to sue us, sue us
now”. If they had taken such a course, having settled upon the
product they intended to sell, the whole of this dispute would have
been got out of the way before their date of intended launch. Mr.
Arnold says, ―That is quite unfair. It puts the burden upon the
defendant. Why should there be any such burden to start litigation
when they are firmly of the opinion they do not infringe and‖ — as a
back-up opinion — ―the patent is no good?‖ The answer, to my mind,
is self-evident. They knew perfectly well the issue of infringement
was likely to arise. If they wanted to be sure of their position they
could and would have made sure that all their experimental data
was properly in place and vouched for by an independent scientist.
And they would have presented the evidence to the patentees.
xxx xxx xxx
I see no question of principle involved here of any sort. It is purely
commercial common sense. If there may be an obstacle in your way,
clear it out. To my mind, this is a case where the retention of the
status quo is a rational thing to do. It was something that could have
been avoided by the defendants; they chose not to do it.
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Other matters are prayed in aid by the defendants which I will
mention just briefly. They say they have taken a lot of orders. They did
so in the full knowledge of this patent action. I doubt, as they suggest,
that they will lose much face with their customers — they can and will
blame the patentees or this Court. Whether they do lose face or not, it
was a course which they invited.
Accordingly, I grant the injunction sought. I will hear submissions
as to directions for trial.
xxx xxx xxx‖
(Emphasis Supplied)
151. Thus, the defendant has failed to „clear the way‟ despite being aware
of the suit patent.
152. This Court also takes note of the submission made on behalf of the
plaintiffs that the plaintiffs run an affordable scheme for patients in India,
being Patient Assistant Programme (“PAP”). Under the PAP, patients have
to pay for upto first five paid doses that will be alternated with upto five free
doses. For the rest of the year, the patient will get the balance doses free of
cost. Further, the plaintiffs have categorically stated before this Court that
pricing in India is at a low end for the patented product of the plaintiffs.
153. The present suit was occasioned since the plaintiffs became aware that
the defendant, under its former name, Cadila Healthcare Ltd., had applied
for clinical trial approval of Nivolumab. Further, permissions were granted
to the defendant on 29th September, 2022 for the purposes of clinical trial for
its bio-similar drug, ZRC-3276.
154. Thus, as per the case put forward by the plaintiffs, the act of applying
for such approval reflects careful planning, intent and investment, which
points towards imminent infringement. In this regard, reference may be
made to the judgment in the case of Bristol Myers Squibb Company and
Anr. Versus V.C. Bhutada & Ors., 2013 SCC OnLine 4129, wherein, it has
been held as follows:
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―xxx xxx xxx
29. The above decisions are in line with the position in common law as
regards quia timet actions. Illustratively reference may be made to the
recent decision in Merck Sharp Dohme v. Teva Pharma B. V. (2012)
EWHC 627 (Pat). In the said case, the Defendant, Teva Pharma, obtained
the market authorization for a drug. It was held that while the obtaining
of such market authorization could not itself be constituted an
infringement, “application for a market authorization is not a trivial
matter and is the product of careful planning and work.” It was held
that such obtaining of market authorization provided “a concrete basis
for inference that TEVA threaten and intend to sell efavirenz
sometime.‖
xxx xxx xxx
31. It is not necessary at this stage, for the Plaintiff to name the particular
customers of Defendants 1 and 2 to whom the product is to be sold since
what is expressed is only an apprehension of ―offer for sale‖. At this
stage, the Plaintiff can at best refer to the fact that Defendant 2 supplies
oncology APIs to various generic companies and that the said APIs are
sold in Delhi. The apprehension that such oncology APIs may in the
near future include the infringing product which is also an oncology
API cannot, in the circumstances, be characterised as lacking credibility
and having been asserted merely to attract the jurisdiction of the Court.
The above averments in the present plaint, which is in a quia
timet action, are prima facie sufficient to show that Defendant No. 2
“carries on business” in Delhi and that the prima facie the cause of
action arises within the jurisdiction of this Court.
xxx xxx xxx‖
(Emphasis Supplied)
155. At this stage, reference may be made to Section 107A of the Patents
Act, which is also known as the Bolar Exemption that outlines specific acts
that are not considered patent infringement. Primarily, the said Section
allows the use of a patented product for research and development purposes,
as well as for submitting data to regulatory bodies for product approval,
without infringing the patent. Said Section 107A of the Patents Act, reads as
under:
―xxx xxx xxx
107A. Certain acts not to be considered as infringement.–For theSignature Not Verified
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purposes of this Act —
(a) any act of making, constructing, using, selling or importing a patented
invention solely for uses reasonably related to the development and
submission of information required under any law for the time being in
force, in India, or in a country other than India, that regulates the
manufacture, construction, use, sale or import of any product;
(b) importation of patented products by any person from a person who is
duly authorised under the law to produce and sell or distribute the
product,
shall not be considered as a infringement of patent rights.
xxx xxx xxx‖
156. Thus, Section 107A of the Patents Act provides a mechanism for
certain activities related to patented products, to be exempt from
infringement. However, manufacturing under the same is allowed only for
clinical trials, but not for commercial sale. Thus, Division Bench of this
Court, in the case of Bayer Corporation Versus Union of India and Others,
2019 SCC OnLine Del 8209, with regard to guidelines under Section 107A
of the Patents Act, has held as under:
―xxx xxx xxx
112. The approach of the learned single judge in permitting export,
without any inquiry and holding that export of 1000 or 2000 tablets
constituted reasonable use, in this case, cannot be countenanced. In
such case, upon the patent proprietor alleging the infringement was to
institute legal proceedings to injunct the alleged exporter or seller, it
is equally possible for the seller or exporter to seek a declaration or
appropriate relief (including in a suit for groundless threat, if such
action lies) that its overseas sales are for research and purposes
covered by Section 107A. This Court is of the opinion that the
inquiry and adjudication in such cases would be in regard to the
following:
(1) The patent granted;
(2) The nature of the product or elements sought to be exported;
(3) The details of the party or party importing the product,
(4) The quantity sought to be exportedSignature Not Verified
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(5) Other particulars with respect to the end use of the product, to
establish that it is solely for research and development of
information to regulatory authorities in the other country;
(6) All particulars regarding the relevant regulations, covering
the kind and scope of inquiry, including the quantities of the
product (i.e. the patented product or compound, API or fine
chemical needed). These details must be supplied by the
exporter/seller of the product to the overseas buyer. In case the
defendant is not the seller, it should disclose who had purchased
the product in the relevant quantities, to facilitate its impleadment
in the proceedings. In the event it cannot do so, the consequences
of such result ought to be considered by the court.
(7) If the regulations are in the language of that country, an
authentic English translation to facilitate a speedy resolution;
(8) Appropriate interim order, including undertaking by way of
affidavit to compensate the plaintiff, in the event the suit were to
be decreed and the extent of such monetary compensation. The
affidavit should be of an authorized personnel, and kept alive
during the pendency of litigation, duly authenticated by the board
of director or other controlling body of the defendant-and
whenever the company or entity undergoes amalgamation or
transfer, suitable undertaking from the successor organization;
(9) If necessary, verification through the Indian mission (and its
trade division) abroad regarding the authentication of the third
party and/or its facilities abroad.
(10) If it is held by the court that the exporter is not involved in
sale or export of any patented product, but a generic article,
unprotected by patent law, when denying relief, suitable
restitutionary relief should be awarded to the defendants in
monetary terms, to preclude litigation that prevents trade or
competition.
113. The above aspects are only indicative of the matters that need
examination, they are in no way exhaustive and the court may
consider any other matter relevant to the subject.
xxx xxx xxx‖
(Emphasis Supplied)
157. At this stage, reference may also be made to the reply dated 17 th May,
2022 issued on behalf of the defendant to the legal notice of the plaintiffs,
wherein, the defendant has categorically affirmed that it has only applied for
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clinical trial. The relevant portion of the said reply of the defendant, is
extracted as under:
―xxx xxx xxx
2. Your notice appears to be premised on the ground that our client has
applied for clinical trial approval for Nivolumab before the Drug
Controller General of India, Central Drugs Standard Control
Organization. In this regard, you would note that merely applying for a
clinical trial approval does not infract the rights of the patentee, under
Section 48. As you are aware, the Patents Act is a self-contained statute,
which contains the rights of the patentee, as well as those of the public.
Section 107A clearly stipulates that any act of making, constructing,
using, selling or importing a patented invention for uses related to the
development and submission of information required by law, is
permitted. It has also been clarified through judicial precedents that
through Section 107A, it was deemed necessary by the legislature to allow
the non-patentee to undertake experimentation and ready a product for its
availability for the general public and such preparation/experimentation
does not amount to infringement. In view of the same, seeking approvals
from the DCGI for conducting clinical trials is well within the purview of
the Patents Act, 1970, and does not amount to infringement of any patent
in any manner whatsoever.
xxx xxx xxx‖
(Emphasis Supplied)
158. Reference may also be made to the E-mail dated 04th May, 2024,
relied upon by the plaintiffs, wherein, a third party wrote to the plaintiffs
regarding the defendant launching the patented product of the plaintiffs, in
the following manner:
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159. This Court further notes that in an another suit, i.e., CS(COMM)
74/2024, titled as E R Squibb and Sons LLC and Ors. Versus Beacon
Pharmaceuticals Limited and Ors., vide order dated 25th January, 2024, an
ex-parte injunction has been granted in favour of the plaintiffs with regard to
the suit patent, wherein, the defendants therein have been restrained, in the
following manner:
―xxx xxx xxx
18. Accordingly, till the next date of hearing, the following directions are
issued:
(i) Defendant Nos. 1 and 2 or any other entity/person acting for and on
their behalf are restrained from using, making, manufacturing, selling,
distributing, advertising, exporting, offering for sale, importing in India or
in any other manner, directly or indirectly, dealing with generic
Nivolumab, under the brand Nivolunix or any other brand that infringes
the subject matter of the Suit Patent.
xxx xxx xxx‖
160. The aforesaid injunction in favour of the plaintiffs in the other suit is
still subsisting, as of date.
161. It is settled that in a quia timet action, where there is a reasonable
apprehension of imminent infringement likely to cause irreparable harm,
Courts are empowered to grant interim relief even before actual
infringement occurs, if a strong prima facie case is established. Thus, in the
case of Bristol-Myers Squibb Company and Ors. Versus Mr. J.D. Joshi
and Anr., 2015 SCC OnLine Del 10109, it was held as follows:
―xxx xxx xxx
85. As far as law with regard to Quia Timet Action is concerned, it is
settled law that such action is maintainable. If a party fears or
apprehends, who may obtain injunction to prevent some threatened act
being done which if done, would cause him substantial damage and
which money would not be an adequate or sufficient remedy. In a quia
timet action, in the absence of evidence if a strong case is made out
against the defendants, after valid justification, the interim order may be
passed by the Court. Reliance is placed on the following decisions: –
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i) Kuldip Singh v. Subhash Chander Jain, AIR 2000 SC 1410
―A qui timet action is a bill in equity. It is an action
preventive in nature and a specie of precautionary justice
intended to prevent apprehended wrong or anticipated
mischief and not to undo a wrong or mischief when it has
already been done. In such an action the Court, if
convinced, may interfere by appointment of receiver or by
directing security to be furnished or by issuing an
injunction or any other remedial process‖ (Para 7)
ii) Rohtas Industries Limited v. IHP. Co. Ltd., AIR 1954 PATNA 492
―Even proof of an intention to infringe, apart from actual
infringement, may justify an injunction to restrain the
infringement provided it is established to the satisfaction
of the court that the alleged infringer, dealing with what
he is doing as a matter of substance, is taking the
invention claimed by the patent.‖ (Para 16)
xxx xxx xxx‖
(Emphasis Supplied)
162. In the present case, the defendant has not been able to lay a credible
challenge to the validity of the suit patent. Further, the incidence of
infringement of the suit patent by the defendant also stands established in
view of the discussion hereinabove. Thus, holding that where a strong case
of infringement exists, Courts must be mindful of the interest in enforcing
patent rights, this Court, in the case of Merck Sharp and Dohme
Corporation and Anr. Versus Glenmark Pharmaceuticals, 2015 SCC
OnLine Del 8227, has held as follows:
―xxx xxx xxx
85. This leads us to the second principle, which is whether the Court can
overlook the public interest in maintaining the integrity of the patent
system itself, so that a legitimate monopoly is not distorted. As this Court
noted in Bayer Corporation v. Cipla, Union of India (UOI), 162 (2009)
DLT 371
―[i]f, after a patentee, rewarded for his toil – in the form of
protection against infringement – were to be informed that
someone, not holding a patent, would be reaping the fruitsSignature Not Verified
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of his efforts and investment, such a result would be
destructive of the objectives underlying the Patents Act.‖.
The Court must be mindful – especially in a case where a strong case of
infringement is established, as here – there is an interest in enforcing
the Act. It may be argued that despite this no injunction should be
granted since all damages from loss of sales can be compensated
monetarily ultimately if the patentee prevails. This argument though
appealing, is to be rejected because a closer look at the market forces
reveal that the damage can in some cases be irreparable. This in turn
leads to the third principle, which is where an infringer is allowed to
operate in the interim during the trial, it may result in a reduction in
price by that infringer since it has no research and development
expenses to recoup – most revenue becomes profit. The patentee
however can only do so at its peril. Importantly, prices may not recover
after the patentee ultimately prevails, even if it is able to survive the
financial setback (or ―hit‖) during the interim, which may take some
time. The victory for the patentee therefore should not be pyrrhic but
real. This irreparable market effect in cases of a sole supplier of a
product has also triggered the decisions in Smith Kline
Beecham v. Generics, (2002) 25(1) IPD 25005 and Smithkline Beecham
Plc (2) Glaxosmithkline UK Ltd. v. Apotex, [2003] EWCA Civ L37,
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. New entrants to the market would be likely to cause its
prices to go into a downward spiral, and Smith Kline’s prices may not
recover even if it wins eventually. Equally, granting the injunction would
not prejudice Glenmark to an equal extent since – if the suit is dismissed –
it may return to a market that is largely variable.
xxx xxx xxx
87. A related concern that this Court heeds – the fourth principle operative
in this case – is that of the chronology of events and Glenmark’s decision
to release Zita without first challenging Januvia or Janumet. Undoubtedly,
the Act creates a right to oppose patents even after grant. There is no
obligation to only utilize the pre or post grant opposition mechanisms.
Neither does a patent benefit from a presumption of validity if it is
challenged in the course of an infringement suit. 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. This is more so where Glenmark today argues that
MSD ought to have disclosed international patent applications for SPM
and Sitagliptin plus Metformin since they were the ―same or substantially
the same‖ as the suit patent under Section 8. That is Glenmark’s stated
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position. Such being the state of things, it is surely reasonable for
Glenmark to detect the possibility to challenge, when a US patent
application for SPM filed by it was opposed by MSD. Despite this,
Glenmark released the drug without initiating revocation proceedings
under the Act, which is also a right vested in Glenmark that would have
obviated the need for the interim arrangement we are today considering.
This does not mean that Glenmark’s right to question the validity of the
patent in an infringement is affected, but the manner of challenge is a
relevant factor against it at the interim stage. As Justice Jacob noted in
both Smithkline Beecham cases (supra):
―I remain of the same opinion that I was in the Generics
case. Where litigation is bound to ensue if the defendant
introduces his product he can avoid all the problems of an
interlocutory injunction if he clears the way first. That is
what the procedures for revocation and declaration of non-
infringement are for.‖
Similarly, in the Australian decision of Pharmacia Italia
S.p.A v. Interpharma Pty Ltd., [2005] FCA 1675, the Court noted the
fact that Inter-pharma had acted in full knowledge of Pharmacia’s
patent and the possible consequences flowing from that. This
consideration that the patentee is already in the market and has been
operating the patent has found favour in Indian Courts as well. In K.
Ramu v. Adayar Ananda Bhavan and Muthulakshmi Bhavan, 2007 (34)
PTC 689 (Mad), Bajaj Auto Ltd. v. TVS Motor Company Ltd., 2008 (36)
PTC 417 (Mad) and National Research Development Corporation of
India v. The Delhi Cloth and General Mills Co. Ltd., AIR 1980 Del 132,
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.
xxx xxx xxx‖
(Emphasis Supplied)
163. It is further to be noted that when patent is prima facie found to be
infringed and is being exploited without license, the balance of convenience
tilts in favour of restraining such infringement. Thus, in the case of
Pharmacyclics LLC and Another Versus Hetero Labs Limited and Others,
2023 SCC OnLine Del 8162, it has been held as follows:
―xxx xxx xxx
107. Where a granted patent is prima facie found to be infringed,
and is being exploited without a license from the patent holder, the
balance of convenience is always in favour of restraining further
infringement. I am aware that the drug in question is needed forSignature Not Verified
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treating various serious ailments, including cancer. That said, the
law sternly prohibits patent infringement, and it may not be possible
to argue that considerations of public interest should be allowed to
justify infringing drugs to circulate in the market.
xxx xxx xxx‖
(Emphasis Supplied)
164. This Court is further of the view that any infringing products
manufactured, offered for sale or sold, etc., during the life/term of the patent,
do not gain credibility. Thus, manufacture of infringing goods and
stockpiling them during the said period, so as to release it/flood the market,
would also amount to infringement. Hence, any use and sale of any products
manufactured during the said period, in violation of a patent, is also liable to
be restrained. Delving on this aspect, in the case of Sotefin SA Versus
Indraprastha Cancer Society and Research Centre and Others, 2022 SCC
OnLine Del 516, it has been held as follows:
―xxx xxx xxx
49. In the opinion of the court, if infringement has occurred during the
lifetime of the patent, the infringing goods would not become kosher on
expiry of the patent. Plaintiff would be entitled to seek restrain on Smart
Dollies which were made or imported at a time when the suit patent was
valid and subsisting. Therefore, irrespective of the fact that the patent is
to expire the next month, since the Smart Dollies are prima facie
infringing the suit patent as on the date of infringement, plaintiff can
insist on protection under Section 48 of the Act. On this aspect no case
law has been cited and Mr Lall has contended that there is no precedent of
an Indian court on this issue. In these circumstances, he has placed
reliance on judgments of USA and UK to argue that infringing articles
made during the term of patent would continue to be restrained, even
after expiry of the patent term.
xxx xxx xxx
54. Therefore, on a prima facie basis, this Court is in agreement with the
views expressed by the foreign courts, which suggest that any product
which is infringing, during the term of the patent, would continue to be
tainted. The infringement cannot get dissolved with the lapse of the
patent. Undoubtedly, the monopoly of the patentee would stand
extinguished with the expiry of the term, but the infringement that has
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occurred during the lifetime of the patent would not fade away. Hence
the use of the Smart Dollies, imported during the term of a subsisting
patent, in violation of the patentee’s exclusive rights, have to be
restrained:
Whether defendants are entitled to protection under Section 107-
A(b) of the Act?
xxx xxx xxx‖
(Emphasis Supplied)
165. It is to be seen that the patent expires in May, 2026. The defendant
will be free to launch its product thereafter. The patent in question is valid in
fifty countries across the world. The validity of the patent was challenged in
thirty countries and has successfully been sustained. Further, the plaintiffs
were granted the suit patent after fourteen years, thereby, shortening the
limited monopoly of the plaintiffs.
166. Furthermore, the defendant has already been suffering an injunction
since more than a year and did not get a manufacturing license till
December, 2024. It is also to be noted that one of the pre-grant oppositions
was filed by IPA, of which defendant is also a member. The said pre-grant
opposition filed by IPA was rejected along with other pre-grant oppositions,
leading to grant of the suit patent.
Conclusion
167. Thus, considering the detailed discussion hereinabove, the plaintiffs
have established a prima facie case in their favour. The balance of
convenience also lies in favour of the plaintiffs. The plaintiffs shall suffer
irreparable loss, in case interim relief as prayed for, is not granted.
Accordingly, the defendants, and all others acting on its behalf, are
restrained from manufacturing, using, selling, offering for sale, importing,
exporting, advertising or dealing in any bio-similar/similar biologic of
Nivolumab, the suit patent, during the pendency of the present suit.
Signature Not Verified
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168. Further, the defendant is also restrained from launching any
manufactured product, if any, manufactured during the pendency of the
patent of the plaintiffs, even upon expiry of the patent. The defendant is
accordingly directed to file an affidavit disclosing the quantity of its
manufactured bio-similar product of Nivolumab, within a period of four
weeks, from today.
169. It is clarified that the observations made hereinabove, are only prima
facie in nature for the purposes of deciding the application for interim
injunction. Nothing contained herein shall be construed as an expression on
the merits of the case, which shall be decided after trial, independent of any
observations made herein.
170. The present application being I.A. 10533/2024 is accordingly,
disposed of, with the aforesaid directions.
CS(COMM) 376/2024
171. List before the Roster Bench on 08th August, 2025.
(MINI PUSHKARNA)
JUDGE
JULY 18, 2025/AU/KR
Signature Not Verified
Digitally Signed CS(COMM) 376/2024 Page 101 of 101
By:HARIOM SHARMA
Signing Date:18.07.2025
20:46:14
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