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Delhi High Court
F- Hoffmann -La Roche Ag & Anr vs Zydus Lifesciences Limited on 23 July, 2025
Author: Amit Bansal
Bench: Amit Bansal
* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Judgment Reserved on: 27.03.2025
Judgment pronounced on: 23.07.2025
+ CS(COMM) 159/2024 with I.A. 4196/2024, I.A. 4198/2024,
I.A. 5827/2024, I.A. 33509/2024 and I.A. 36101/2024
F- HOFFMANN -LA ROCHE AG & ANR. .....Plaintiffs
Through: Mr. Arvind Nigam and Mr. Sandeep
Sethi, Senior Advocates with Mr.
Pravin Anand, Mr. Shrawan Chopra,
Ms. Prachi Agarwal, Mr. Achyut
Tewari, Mr. Aayush Maheshwari, Ms.
Krisha Baweja and Mr. Sumer Seth,
Advocates.
versus
ZYDUS LIFESCIENCES LIMITED, .....Defendant
Through: Mr. Dushyant Dave and Mr.
Rajshekhar Rao, Senior Advocates
with Mr. Adarsh Ramanujan, Ms.
Bitika Sharma, Ms. Vrinda Pathak,
Ms. Sandhya Kukreti, Mr. Rajnish
Singh and Ms. S. L. Sojanya,
Advocates.
CORAM:
HON'BLE MR. JUSTICE AMIT BANSAL
JUDGMENT
AMIT BANSAL, J.
I.A. 5827/2024 (seeking constitution of a confidentiality club)
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1. The present suit has been filed inter alia seeking relief of permanent
injunction restraining infringement of the following two Indian patents
(hereinafter collectively referred to as the ‘suit patents’):
a. Indian patent no. IN 268632 titled as ‘PHARMACEUTICAL
FORMULATION COMPRISING HER2 ANTIBODY’ (hereinafter
‘IN’632’) is a product patent which relates to an aqueous
pharmaceutical formulation comprising Pertuzumab and excipients
such as sucrose, histidine acetate buffer, polysorbate such that the pH
of the said formulation is between 5.5-6.5.
b. Indian patent no. IN 464646 titled as ‘PERTUZUMAB VARIANTS AND
EVALUATION THEREOF’ (hereinafter ‘IN’646’) is a process patent
which relates to the method for making a composition comprising
Pertuzumab and one or more variants.
CASE SET UP IN THE PLAINT
2. The case set up by the plaintiffs in the plaint is as follows:
2.1 The plaintiff no.1, a Switzerland based company founded in 1896, is
one of the world’s leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. The plaintiff no.2, an American corporation
founded in 1976, is the world’s first biotechnology company, which was
acquired by the plaintiff no.1 in March 2009 as its wholly owned independent
subsidiary. The plaintiffs no.1 and 2 are hereinafter collectively referred to as
the ‘plaintiffs’.
2.2 As of 2023, the Roche Group, of which the plaintiffs are a part, has a
presence in over 100 countries. The Roche Group has invested significantly
in the field of research and development and one of the major areas of focus
and investment for the Group is treatment of cancer.
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2.3 Human epidermal growth factor receptor (HER) are important
mediators of cell growth, differentiation and survival and include four distinct
members, i.e., HER1, HER2, HER3 and HER4. The overexpression of HER2
gene is a primary cause for breast cancer tumours which is one of the most
aggressive forms of cancer.
2.4 Both the suit patents pertain to Pertuzumab, which is a monoclonal
antibody (MAb) biologic used to inhibit the dimerization of HER2 cells with
other HER receptors, and thus inhibits tumour growth. Pertuzumab is a
prescription medicine for treating patients with early-stage breast cancer and
metastatic breast cancer and has been approved by regulatory authorities in
several countries across the world.
2.5 The bibliographic details of the suit patents are set out below:
a. Suit Patent IN'632
Title PHARMACEUTICAL
FORMULATION COMPRISING
HER2 ANTIBODY
Patentee Plaintiff No. 2
Application No. 1730/DELNP/2007
Patent No. 268632
Priority Date 20.10.2004
National Phase entry-filing 05.03.2007
date in India
Date of Publication u/s 24.08.2007
11 A
PCT International PCT/US2005/037471
Application Number
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PCT International Filing 19.10.2005
date (Date of patent)
FER Issue Date 26.08.2010
FER Response Date 18.05.2011
Date of Grant 09.09.2015
Date of expiry 19.10.2025
b. Suit Patent IN'646
Title PERTUZUMAB VARIANTS
AND EVALUATION THEREOF
Patentee Plaintiff No. 1
Application No. 6979/CHENP/2015
Patent No. 464646
Priority Date 16.04.2013
PCT International Filing 15.04.2014
date (Date of patent)
PCT International PCT/US2014/034200
Application Number
National Phase entry-filing 12.11.2015
date in India
Date of Publication u/s 01.07.2016
l1A
FER Issue Date 30.12.2019
FER Response Date 30.06.2020
Pre-grant opposition date 12.10.2020
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Pre-grant order date 31.10.2023
finding the application in
order for grant
Date of Grant 01.11.2023
Date of expiry 15.04.2034
2.6. IN’632 has 4 claims which are set out in paragraph no.28 of the plaint.
IN’646 has 8 claims which are set out in paragraph no.15 of the plaint.
2.7. The inventiveness of IN’646 resides in the method of making a
composition having Pertuzumab and its variant(s) comprising unpaired
cysteine variants, low-molecular-weight-species (LMWS), high-molecular
weight-species (HMWS), afucoslated variant, Pertuzumab Peak 1, and
Pertuzumab Peak 2 and quantifying the said variants within the range
disclosed and claimed in IN’646.
2.8. The plaintiffs’ product Pertuzumab, which is sold under the brand name
Perjeta, is covered within the scope of the claims of the suit patents. Perjeta
(Pertuzumab) Concentrate for Solution for Infusion 420 mg/ 14 ml vials have
been granted approval on 8th June 2012 by the US FDA and on 29th December
2014 in India. The import and sale of the plaintiffs’ product Perjeta amounts
to working of both the suit patents in India.
2.9. The suit patents, granted after examination, are currently valid and
subsisting. Patents corresponding to the suit patents have also been granted in
several other countries.
2.10. During the term of the suit patents, the plaintiffs, being the rightful
owners/ exclusive licensees, have the exclusive right under Section 48 of the
Patents Act, 1970 (hereinafter ‘Act’/ ‘Patents Act‘) to prevent unauthorized
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third-parties from making, using, offering for sale, selling or importing any
product which fall within the scope of the claims of either of the suit patents.
2.11. The defendant is an Indian pharmaceutical company and is engaged in
the manufacturing and sale of drugs, active pharmaceutical ingredients, etc.
2.12. The plaintiffs, in February 2024, came across the recommendations of
the Subject Expert Committee (hereinafter ‘SEC’) (Oncology) of the Central
Drugs Standard Control Organization (hereinafter ‘CDSCO’), which were
made in the SEC meetings held on 23rd January 2024 and 24th January 2024.
As per the information available from the aforesaid SEC meetings, the
defendant filed an application for grant of permission to manufacture a new
drug formulation for sale and distribution of Pertuzumab as per the New
Drugs and Clinical Trials Rules, 2019. The SEC recommended for grant of
permission to manufacture and market Pertuzumab 30 mg/ ml concentrate
solution for infusion (420 mg/ 14 ml single-dose vial) to the defendant.
2.13. Previously, in January 2023, the defendant had procured 480 vials of
the original innovator biologic reference product Pertuzumab (Perjeta) from
the plaintiff no.1’s affiliate. Thereafter, the plaintiff no.1’s affiliate
representatives came across a document uploaded on the website of Clinical
Trial Registry of India (hereinafter ‘CTRI’) which detailed that the defendant
was undertaking clinical trials for a similar biologic/ biosimilar of the
plaintiffs’ Pertuzumab for its product under the nomenclature ZRC-3277. In
the said document, the defendant had mentioned the plaintiffs’ product
Pertuzumab (Perjeta®, Genentech Inc.) as the reference product.
2.14. Upon further verification, the plaintiffs also came across the
defendant’s application dated 9th September 2021 filed with the CDSCO
seeking permission to conduct clinical trials for its aforesaid similar biologic
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ZRC-3277 under the provisions of the New Drugs and Clinical Trial Rules,
2019 with the reference drug being Pertuzumab (Perjeta®, Genentech Inc.),
which is covered within the scope of the claims of the suit patents.
2.15. The defendant has also filed applications for registering its patents
relating to formulations of Pertuzumab including patent applications no.
WO/2020/084503 (international filing date – 23rd October 2019) and
WO/2021/079337 (international filing date – 23rd October 2020), which are
currently pending.
2.16. In view of the aforesaid SEC recommendation dated 24th January 2024,
there is an imminent threat that the defendant is attempting to manufacture,
launch and otherwise deal in Pertuzumab 30 mg/ ml concentrate solution for
infusion (420 mg/ 14 ml single-dose vial) during the term of the suit patents
without the plaintiffs’ authorization.
2.17. As the defendant had claimed its product to be a similar biologic of the
plaintiffs’ product covered by the suit patents, the present suit has been filed
as a quia timet action in view of the apprehension that the defendant would
launch its product.
CASE SET UP IN THE WRITTEN STATEMENT
3. The broad defences taken up by the defendant in the written statement
are as follows:
3.1. None of the suit patents covers the active ingredient Pertuzumab per se
and the same is evident from the titles of the suit patents. In fact, there cannot
be a patent for Pertuzumab per se in India because Pertuzumab was
admittedly first disclosed on 4th January 2001 in WO/2001/00245
(international filing date 23rd June 2000) for which no corresponding patent
was filed in India.
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3.2. The active ingredient Pertuzumab and the process of making it are
publici juris and several publications since 1986 have been cited to
substantiate the same (refer paragraph 11 of the written statement). Notably,
the product claim for Pertuzumab was deleted by the plaintiffs by way of an
amendment in the course of prosecuting IN’632, which amounts to a clear
acknowledgement by the plaintiffs that Pertuzumab and its variants were
known.
3.3. There is no explanation provided by the plaintiffs about the grounds to
allege that the formulation/ process employed by the defendant is covered
within the scope of the suit patents. The plaintiffs are only attempting to show
its similarity to Pertuzumab, which is already in the public domain.
3.4. As per the claim mapping of IN’632 with claim 1 of the defendant’s
patent application, the defendant’s formulation is entirely different from the
formulation claimed by the plaintiffs.
3.5. With regards IN’646, the following defences have been taken:
a. The plaintiffs have not satisfied the conditions to invoke Section 104A
of the Act in the present case.
b. The plaintiffs’ claim is solely on the basis of the defendant’s application
filed with the CDSCO for obtaining approval of its similar biologic.
c. IN’646 is liable to be invalidated on account of various grounds under
Section 64 of the Act.
d. The process adopted by the defendant does not infringe the plaintiffs’
process patent IN’646.
RELEVANT PROCEEDINGS IN THE SUIT
4. Summons in the present suit and notice in I.A. 4196/2024, the
application for interim injunction, were issued, and accepted on behalf of the
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defendant on 23rd February 2024. On the same day, after noting the
contentions of the parties, the Court passed a detailed order. Some of the
relevant extracts from the said order for the purposes of adjudicating the
present application are set out below:
“19. This lawsuit concerns allegations of patent infringement, specifically
targeting the ‘formulation’ and ‘process’ associated with an innovator
‘Reference Biologic Product’. The Plaintiffs contend that their Suit Patents
are on the verge of being infringed upon by a competing entity (the
Defendant) through development of a ‘Similar Biologic product’. Thus,
this case delves into the complexities inherent in the intersection of
biotechnological innovation and intellectual property law. At issue is the
precise determination of whether the Similar Biologic’s development
encroaches upon the intellectual proprietary rights encapsulated within
the patents of its Reference counterpart. Thus, the Court is called upon to
not only navigate the intricacies of patent law, but also scientific principles
that are foundational for the biologic and its biosimilar contender.
*** *** ***
25. Thus, in view of the aforenoted responses by Dr. Singhvi, and given the
fact that the reference biologic is protected under the Suit Patent IN’632
and the Defendant’s similar biologic is encapsulated by Claim 1 in their
patent application No. 2021079337, we must begin with the process of
claim mapping. The Court will have to discern whether the formulation
disclosed in Claim 1 of patent application No. 2021079337 is a variant of
Pertuzumab, different from the Plaintiffs’ formulation patent which is also
“pharmaceutical formulation comprising Pertuzumab”. However, the
absence of such claim mapping substantially restricts the Court from fully
assessing the infringement allegations. In the Court’s opinion, the
Plaintiffs ought to have carried out this claim mapping, as this
procedural step is essential not only for clarifying the contours of the
controversy but also for enabling the Court to make an informed
decision on the matter. Accordingly, they must now do so expeditiously
and present the same to the Court. The Defendant is also permitted to do
the claim mapping, in case they so desire.
*** *** ***
28. Given the above-discussed contest of similar and reference biologics
in this case, the Court, drawing upon the aforementioned provision,
deems it appropriate for the Defendant to reveal the process employed by
them to develop the formulation for which drug approval/ licensing has
been sought. However, as the issue of whether the Defendant’s biologic
formulation is identical to the Plaintiff’s remains to be thoroughly
examined, it is directed that the Defendant shall submit the
aforementioned information in a sealed envelope with the Court. ThisSignature Not Verified
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measure, in the Court’s opinion, would ensure the preservation of
sensitive information pending further deliberations. The Court will
subsequently also assess the need for establishing a confidentiality club
to manage the disclosed information, to ensure that access to such
information is appropriately controlled and limited to authorized
individuals.”
[emphasis supplied]
5. Following the aforesaid order, the plaintiffs filed the present application
on 11th March 2024 seeking constitution of a confidentiality club. By way of
the present application, the plaintiffs seek access to the information filed by
the defendant under a sealed cover by the members of the confidentiality club
for effectively mapping the defendant’s formulation(s) as well as process(es).
6. Notice in the present application was issued and accepted on behalf of
the defendant on 13th March 2024.
7. Pursuant to the aforesaid, the defendant, on 22nd March 2024, filed its
manufacturing process in a sealed cover.
8. Amidst the ongoing deliberations on the grant of an interim injunction,
the defendant launched a product, namely, ‘Sigrima’, a similar biologic of the
plaintiffs’ Perjeta, which comprises Pertuzumab. The plaintiffs therefore filed
another application under Order XXXIX Rules 1 and 2 of the Code of Civil
Procedure, 1908 (hereinafter ‘CPC‘), being I.A. 33509/2024, seeking interim
injunction restraining the sale and distribution of the aforesaid product.
9. On 9th July 2024, an ad interim injunction was passed by the
predecessor bench against the defendant in the following terms:
“10. In light of these considerations – fairness, equity, and the balance of
convenience – the Court finds compelling reasons to issue an injunction.
Accordingly, till the next date of hearing, the Defendants are restrained
from marketing / selling their product “Sigrima”, which is a biological
similar of Plaintiffs’ “Perjeta®”/ “Pertuzumab”.”
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10. Vide judgment dated 9th October 2024, the predecessor bench of this
Court dismissed I.A. 33509/2024. The aforesaid judgment was taken in appeal
by the plaintiffs and the said judgment was set aside by the division bench on
16th October 2024, and the matter was remanded back before this Court.
11. On 5th November 2024, senior counsel appearing on behalf of the
defendant requested that the hearing in the applications for interim injunction
be deferred on the ground that the defendant has filed a Special Leave Petition
(hereinafter ‘SLP’) before the Supreme Court against the aforesaid order
dated 16th October 2024 passed by the division bench. The Court ordered that
the ad interim injunction granted on 9th July 2024 shall continue in the
interregnum.
12. On 18th November 2024, the Supreme Court disposed of the aforesaid
SLP with a request that I.A. 4196/2024 and I.A. 33509/2024 in the present
suit be decided expeditiously by this Court.
13. The defendant also filed an appeal against the Order dated 5th
November 2024 before the division bench, and the same was set aside vide
order dated 21st November 2024 insofar as it extended the ad interim
injunction dated 9th July 2024.
14. As a result, there is no interim injunction in favour of the plaintiffs as
on date. However, at this stage, counsel for the plaintiffs does not wish to
press I.A. 4196/2024 and I.A. 33509/2024, the applications for interim
injunction. Instead, counsel for the plaintiffs presses the present application,
I.A. 5827/2024, seeking disclosure of the defendant’s manufacturing process
to the members of the confidentiality club.
15. Submissions on behalf of counsel for the parties were heard on 2 nd
December 2024, 7th January 2025, 14th January 2025, 14th February 2025 and
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4th March 2025 and the judgment was reserved on 27th March 2025. Both the
parties have filed their respective written submissions.
SUBMISSIONS ON BEHALF OF THE PLAINTIFFS
16. Mr. Arvind Nigam and Mr. Sandeep Sethi, learned senior counsel
appearing on behalf of the plaintiffs, have made the following submissions:
16.1. Pertuzumab is commercialized by the plaintiffs under the trade mark
Perjeta which, as is currently sold by the plaintiffs, uses both the suit patents.
The process covered by IN’646 is for making Pertuzumab and its variants,
(commercially known as Perjeta). This specific and precise manufacturing
process determines the quality of the composition comprising Pertuzumab
and its variants.
16.2. Section 104A of the Act is concerned with the burden of proof and not
with discovery. The said burden has to be established during the course of trial
and not at an interim stage wherein discovery of the defendant’s process is
sought by the plaintiffs. Thus, Section 104A of the Act may be invoked only
at the stage of final arguments and not at this stage.
16.3. The defendant’s argument that the pre-requisite of Section 104A of the
Act has not been satisfied as it requires the products of the parties to be
identical whereas the defendant’s product is only a similar biologic of the
plaintiffs’ product is a complete red herring. If such an argument made on
behalf of the defendant is accepted, there can never be a process patent
infringement of a biologic drug.
16.4. Unlike the case with chemical compounds, a similar biologic can never
be an exact replica of the innovator reference biologic, given the intrinsic
nature of the biologic product. Nonetheless, a similar biologic is nearly
identical to its reference biologic and the same is evident from the Guidelines
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on Similar Biologics, 2016 issued by the Department of Biotechnology
(Ministry of Science and Technology) and CDSCO (Ministry of Health and
Family Welfare), Government of India.
16.5. Considering that the defendant has claimed its product to be a similar
biologic of the plaintiffs’ Pertuzumab (Perjeta®, Genentech Inc.) and has used
the same as the reference drug in its application for clinical trials before the
CDSCO, the defendant admits that it is manufacturing a similar biologic of
the plaintiffs’ reference biologic Pertuzumab, which covers the formulation
claims of IN’632 as well as the process claims of IN’646. Further, since no
methodology for production of the defendant’s similar biologic has been
disclosed, the plaintiffs apprehend that the process employed by the defendant
is identical to that of Perjeta, and thus infringes the registered patent IN’646.
16.6. As regards the defendant’s formulation, the plaintiffs filed a claim
mapping with their rejoinder to the defendant’s reply to I.A. 4196/2024, which
establishes infringement of IN’632.
16.7. The defendant’s process of manufacturing the similar biologic of the
plaintiffs’ product Pertuzumab (Perjeta) is within the special knowledge of
the defendant only. Considering the defendant’s use of the plaintiffs’ product
Pertuzumab (Perjeta®, Genentech Inc.) as a reference drug/ comparator in its
application filed with the CDSCO, it is imperative that the defendant discloses
its process to the members of the confidentiality club set up by this Court.
16.8. Discovery/ disclosure of the defendant’s process also ought to be
granted under the provisions of Order XI Rules 1(7), 1(12) and 5 of the CPC
as amended by the Commercial Courts Act, 2015. No prima facie case is
required to be established by the plaintiffs for being permitted discovery of
the defendant’s manufacturing process. In this regard, the plaintiffs place
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reliance on the judgment of this bench in F-Hoffmann-La Roche v. Drugs
Controller General of India1.
16.9. Mere filing of the manufacturing process by the defendant in a sealed
cover will serve no purpose, as the question whether the process employed by
the defendant for making its similar biologic is identical to the plaintiffs’
process cannot be ascertained until the defendant’s process is disclosed to the
plaintiffs.
16.10. No prejudice would be caused to the defendant if the present
application is allowed and disclosure of the defendant’s process is permitted.
SUBMISSIONS ON BEHALF OF THE DEFENDANT
17. Mr. Dushyant Dave and Mr. Rajshekhar Rao, learned senior counsel
appearing on behalf of the defendant, have made the following submissions:
17.1. The present application does not make out any ground for disclosure
and is only an afterthought and a backhanded attempt to seek access to the
defendant’s proprietary process, as the plaintiffs failed to establish a prima
facie case of infringement of patent against the defendant.
17.2. The only ground for seeking constitution of a confidentiality club in the
pleadings of the present application is that the proprietary process of the
defendant is needed to conduct ‘claim mapping’ of the process patent IN’646
as directed by this Court vide order dated 23rd February 2024. However, the
said averment is false and misleading as the aforesaid order directed the
plaintiffs to conduct claim mapping only of the product patent IN’632 with
the defendant’s patent application, which was already in the public domain
and was filed with the suit.
1
2025 SCC OnLine Del 934
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17.3. The plaintiffs, in I.A. 4196/2024 and their rejoinder to the defendant’s
reply to I.A. 4196/2024, baldly asserted that the grounds for invoking Section
104A of the Act are satisfied. However, during the oral arguments, the
plaintiffs altered their stance, arguing that Section 104A is not attracted at the
stage of constitution of the confidentiality club and is only relevant at the final
adjudication stage. The plaintiffs’ aforesaid stance is contrary to the statute as
well as their own pleaded case.
17.4. The satisfaction of the pre-requisites prescribed under Section 104A of
the Act is mandatory prior to directing the defendant to disclose its process to
the members of the confidentiality club. The purpose of invoking Section
104A is to seek disclosure from the defendant in a proceeding where a plaintiff
has discharged its initial onus. Thus, Section 104A cannot be ignored at the
time of seeking disclosures from the defendant.
17.5. The plaintiffs’ reliance on Order XI of the CPC as amended by the
Commercial Courts Act, 2015 and the argument that its provisions will prevail
over the specific requirements under a sector-specific law is erroneous and
does not inure to their benefit. It is a settled position of law that the Patents
Act is a self-contained code and the pre-requisites of Section 104A cannot be
diluted by the introduction of the Commercial Courts Act, 2015.
17.6. The plaintiffs’ product obtained from IN’646 for the purpose of Section
104A of the Act is admittedly not Pertuzumab (Perjeta) but Pertuzumab
(Perjeta) + variants, wherein the variants have been specifically claimed to be
a product feature. Pertinently, the said variants are the basis on which the prior
art has been sought to be distinguished in IN’646. Therefore, the products of
the parties have not proven to be identical, as the defendant has only sought
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to make a similar biologic of Pertuzumab (Perjeta) and not Pertuzumab
(Perjeta) + variants.
17.7. Even assuming that the plaintiffs’ product obtained from IN’646 is
Pertuzumab (Perjeta) per se, it cannot be said that the products are identical
only on the basis that the defendant’s product is similar biologic of the
plaintiffs’ reference biologic Pertuzumab. Similar biologics, as per the
Guidelines on Similar Biologics, 2016, only refers to similarity in terms of
‘safety’, ‘efficacy’ and ‘quality’ of the product and does not mean that their
formulation is identical. The aforesaid Guidelines makes no reference to
patent infringement.
17.8. Thus, the pre-requisites under Section 104A of the Act have not been
satisfied in the present case.
ANALYSIS AND FINDINGS
18. I have heard counsel for the parties and examined the materials on
record.
19. The present application concerns enabling the confidentiality club and
permitting the members of the confidentiality club to access the process used
by the defendant for manufacturing its product ‘Sigrima’, which has been
filed by the defendant on 22nd March 2024 in a sealed cover.
20. Since the present application is concerned with the infringement of the
plaintiffs’ process patent and both sides have made submissions with regard
to the applicability of Section 104A of the Act, one of the key issues in
deciding the present application would be to determine the scope and
interpretation of Section 104A of the Act. Section 104A was inserted in the
Act in the year 2002 in compliance with India’s obligations under the
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Agreement on Trade-related Aspects of Intellectual Property Rights2
(hereinafter ‘TRIPS Agreement’).
Scope and ambit of Section 104A of the Act
21. For the sake of convenience, Section 104A of the Act is set out below:
“104A. Burden of proof in case of suits concerning infringement. -(1)
In any suit for infringement of a patent, where the subject matter of patent
is a process for obtaining a product, the court may direct the defendant to
prove that the process used by him to obtain the product, identical to the
product of the patented process, is different from the patented process if,-
(a) the subject matter of the patent is a process for obtaining a new
product; or
(b) there is a substantial likelihood that the identical product is made by
the process, and the patentee or a person deriving title or interest in the
patent from him, has been unable through reasonable efforts to determine
the process actually used:
Provided that the patentee or a person deriving title or interest in
the patent from him first proves that the product is identical to the
product directly obtained by the patented process.
(2) In considering whether a party has discharged the burden imposed
upon him by sub-section (1), the court shall not require him to disclose
any manufacturing or commercial secrets, if it appears to the court that
it would be unreasonable to do so.”
[emphasis supplied]
2
Article 34 – Process Patents: Burden of Proof – 1. For the purposes of civil proceedings in respect of the
infringement of the rights of the owner referred to in paragraph 1(b) of Article 28, if the subject matter of
a patent is a process for obtaining a product, the judicial authorities shall have the authority to order
the defendant to prove that the process to obtain an identical product is different from the patented
process. Therefore, Members shall provide, in at least one of the following circumstances, that any identical
product when produced without the consent of the patent owner shall, in the absence of proof to the contrary,
be deemed to have been obtained by the patented process:
(a) If the product obtained by the patented process is new;
(b) If there is a substantial likelihood that the identical product was made by the process and the owner
of the patent has been unable through reasonable efforts to determine the process actually used.
2. Any Member shall be free to provide that the burden of proof indicated in paragraph 1 shall be on the
alleged infringer only if the condition referred to in subparagraph (a) is fulfilled or only if the condition
referred to in subparagraph (b) is fulfilled.
3. In the adduction of proof to the contrary, the legitimate interests of defendants in protecting their
manufacturing and business secrets shall be taken into account.
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22. Section 104A of the Act represents a calibrated departure from the
general evidentiary principle that the burden of proof lies upon the party
asserting a fact. It carves out a statutory exception only in suits involving
infringement of process patents, where the patentee is often handicapped in
proving the infringing process due to its inherently concealed nature.
However, this exception is neither automatic nor routine. Section 104A
applies only when the plaintiff discharges the following threshold
requirements:
a. The defendant’s product is identical to the product directly obtained by
the patented process; and
b. The subject matter of the process patent is for obtaining a new product
or there is a substantial likelihood that the identical product is made by
the said process, and it is difficult for the plaintiff to determine the
process used by the defendant.
23. If the plaintiff is able to satisfy both the aforesaid conditions, the Court
has the discretion to direct the defendant to prove that the process adopted by
it to obtain its product is different from the patented process.
24. In order to protect the legitimate commercial interests of the defendant,
sub-section (2) of Section 104A of the Act provides that a defendant would
not be required to disclose any manufacturing or commercial secrets if it
appears to the Court that the same is unreasonable to do so.
25. Section 104A of the Act came up for consideration before the High
Court of Karnataka in Natural Remedies Pvt. Ltd. v. Indian Herbs Research
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and Supply Co. Ltd.3. The observations of the Court with regard to scope and
ambit of Section 104A of the Act are set out below:
“69. Now by amended Act and by virtue of introduction of Section 104-
A of the Act, the burden is sought to be shifted on the defendant. That is the
purpose and object of insertion of Section 104-A of the Act. A reading of
the aforesaid provisions makes it very clear that, in a suit for
infringement of a process, if the patentee proves that the product of the
defendant is identical to the product of the patented process, then the
burden of proving that the process used by the defendant in obtaining
his product is different from the patented process lies on the defendants.
Therefore, the condition precedent for application of the provisions is
that the product of the plaintiff and defendant should be identical. If the
products are not identical, a suit for infringement of a patent of the
process would not lie and Section 104-A of the Act is not [] attracted.
Once the plaintiff proves that his product and the product of the defendant
are identical, then, the Court may direct the defendant to prove that the
process used by the defendant to obtain the product is different from the
patented process. Therefore, in the event of the product of both the plaintiff
and the defendant being identical, the burden shifts on the defendant to
prove that the process adopted by him to obtain the product is totally
different from the process adopted by the plaintiff in obtaining his product.
The word used is identical and not similar. The definition of ‘identical’
in Oxford Dictionary is, similar in every detail exactly alike. Therefore,
the meaning of the word ‘identical’ means being the same, exactly equal
and alike having such a close similarity or resemblance as to be
essentially equal or interchangeable. Matching, equal, twin, equivalent,
synonymous, coinciding exactly when superimposed. Two things are
identical if one can be substituted for the other without affecting the
truth. However, the definition of similar in Oxford Dictionary means,
having a resemblance in appearance, character, or quantity, without being
identical. Showing resemblance in qualities, characteristics, or
appearance; alike but not identical. Resembling or similar; having the
same or some of the same characteristics often used in combination
expressing closely related meanings. Meaning the same or nearly the
same.
70. Therefore, from the aforesaid meaning attributed to these two
words, similar is not identical. The word used in Section 104-A is
identical and not similar. Therefore, unless the two products are
identical, Section 104-A is not attracted. The products being identical is
sine qua non for applicability of Section 104-A of the Act.
3
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71. Insofar as Section 104-A is concerned, it is not a weapon in the
hand of the plaintiff. It is a shield in the hand of the defendant. The
question of the defendant disclosing the process by which his product is
manufactured in defence to a claim for infringement for a patent would
not arise either at the stage of pleadings or at the stage of evidence. It
arises only when this Court holds the patent is valid and consequently it
comes to the conclusion that there is an identical product manufactured
by the defendant similar to that of the plaintiff and then the Court can
call upon the defendant to produce the particulars of the process by
which his product is manufactured. It is only then, if the defendant refuses
to furnish the particulars of the process, the Court may draw adverse
inference and invoke Section 104(a). If the Court comes to the conclusion
that the plaintiffs patent is valid and the product of the defendant is
identical with that of the plaintiff the Court may call upon the defendant
to disclose the process by which his, product is manufactured and the
defendant may be ready and willing to place the process, before the Court
subject to the Court protecting the trade secret of the defendants. The
trade secrets in India are protected under the, common law. There is no
statute as such, protecting that right. In either case, if the defendant has to
disclose either in the written statement or by way of evidence through trial,
the process by which he manufactures his product that would violate the
protection, which is given to the defendant, under the common law and,
therefore, any interpretation to be given by this Court, should bear in mind,
that when the plaintiffs interest is protected under the statute and the
defendant interest is also protected by common law. These two have to be
harmoniously interpreted so that either of the, parties are not put to
disadvantage. Other wise the protection given to the defendant under
common law is completely taken away. It is in this background the
amendment to Section 104(a) which overrides the provisions of the []
Indian Evidence Act contained in Sections 100 to 104 of the Evidence
Act is to be understood and construed.”
[emphasis supplied]
26. The aforesaid judgment was followed by the High Court of Andhra
Pradesh in Bristol-Myers Squibb Holdings Ireland v. Mylan Laboratories
Limited4. The observations of the Court with regard to interpretation of
Section 104A of the Act are set out below:
“21. A reading of Section 104-A of the Act of 1970 makes it clear that in
a suit for infringement of a process, if the patentee proves that the
product of the respondent is identical to the product of the patented4
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process, then the burden of proving that the process used by the
respondent in obtaining his product is different from the patented
process lies on the respondent. Therefore, the condition precedent for
application of the provisions is that the product of the appellant and
respondent should be identical and if the products are not identical, a
suit for infringement of a patent of the process would not lie and Section
104-A of the Act of 1970 is not attracted. Once the plaintiff proves that his
product and the product of the defendant are identical, then the Court may
direct the defendant to prove that the process used by the defendant to
obtain the product is different from the patented process. Therefore, in the
event of the product of both the plaintiff and the defendant being identical,
the burden shifts on the defendant to prove that the process adopted by him
to obtain the product is totally different from the process adopted by the
plaintiff in obtaining his product. The word used is identical and not
similar. The definition of ‘identical’ in Oxford Dictionary is, similar in
every detail ‘exactly alike’. Therefore, the meaning of the word ‘identical’
means being the same, exactly equal and alike having such a close
similarity or resemblance as to be essentially equal or interchangeable,
matching, equal, twin, equivalent, synonymous, coinciding, exactly when
superimposed. Two things are identical if one can be substituted for the
other without affecting the truth. However, the definition of ‘similar’ in
Oxford Dictionary means, having a resemblance in appearance, character,
or quantity, without being identical. Showing resemblance in qualities,
characteristics or appearance; alike but not identical. Resembling or
similar, having the same or some of the same characteristics often used in
combination, expressing closely related meanings. Meaning the same or
nearly the same. Therefore, the word used in Section104-A is identical
and not similar and that unless the two products are identical, Section
104-A is not attracted. The products being identical is sine quo non for
applicability of Section 104-A of the Act. Only when the court comes to
the conclusion that there is an identical product manufactured by the
defendant similar to that of the plaintiff, then the Court can call upon
the defendant to produce the particulars of the process by which his
product is manufactured. It is only then, if the defendant refuses to
furnish the particulars of the process, the Court may draw adverse
inference and invoke Section 104-A. If the Court comes to the conclusion
that the plaintiff’s patent is valid and the product of the defendant is
identical with that of the plaintiff the Court may call upon the defendant to
disclose the process by which his product is manufactured and the
defendant must be ready and willing to place the process before the Court
subject to the Court protecting the trade secret of the defendant. [Judgment
of Karnataka High Court in Natural Remedies Private Limited v. Indian
Herbs Research & Supply Co. Ltd., in O.S. No. 1 of 2004, dated
09.12.2011].”
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[emphasis supplied]
27. From a reading of the aforesaid judgments, the following legal
principles emerge with regard to the scope and ambit of Section 104A of the
Act:
a. Only when the plaintiff proves that the plaintiff’s product and the
defendant’s product are identical, the Court may direct the defendant to
disclose its process to show that the same is different from the patented
process.
b. The products of the plaintiff and the defendant being identical is a sine
qua non for the applicability of Section 104A of the Act. Mere
similarity between the two products would not suffice.
c. While directing the defendant to disclose its process, the Court would
protect the trade and commercial secrets of the defendant.
d. Where the products are found to be identical and the defendant
nonetheless refuses to furnish the particulars of its process, the Court
may draw adverse inference and invoke Section 104A of the Act.
28. I am in respectful agreement with the position of law elucidated by the
aforesaid judgments. The intent behind Section 104A of the Act is to shift the
onus of proof from the plaintiff to the defendant in cases involving
infringement of process patents. This is premised on the fact that the process
adopted by a defendant in manufacturing its product would only be known to
the defendant and would be difficult for the plaintiff to determine. However,
this is subject to certain pre-conditions, one of which is that the plaintiff has
to show that the product of the defendant is identical to the product that is
directly obtained from the process patent of the plaintiff.
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29. In Centrient Pharmaceuticals v. Dalas Biotech5, a coordinate bench
of this Court was deciding an application filed on behalf of the plaintiffs
seeking discovery by interrogatories. While discussing the plaintiffs’ burden
of proving infringement of a process patent by the defendant, the Court noted
that under Section 104A of the Act, the plaintiffs must first establish that the
defendant’s product is identical to the product obtained by the patented
process. The Court dismissed the aforesaid application and held that by way
of the said application, the plaintiffs were attempting a fishing and roving
inquiry, under the guise of interrogatories, which is impermissible. The
relevant extracts of the said decision are set out below:
“25. Insofar as the plea that written statement is vague, it was the
submission of Mr. Kohli that the written statement filed by the defendant
explain its position that the process does not infringe the patent of the
plaintiffs. In other words, the written statement filed by the defendant is
not vague. Mr. Kohli has primarily stated that since the regulatory
approvals procured by the defendant for manufacturing of Amoxicilin
Trihydrate is not the subject matter of the present suit, such an information
cannot be sought for, by the plaintiffs. Though, the plea of Mr. Kohli is not
appealing, what is important is, there is a burden on the plaintiffs to
prove that the patent infringement lies on the plaintiffs by first proving
that the product obtained by the defendant is identical to the product
obtained by the patented process.
26. It was submitted by Mr. Kohli that the plaintiffs have filed a
manipulated test report to discharge its burden, which is challenged by the
defendant. That apart, I find, the attempt of the plaintiffs is to discover
the fact, what constitute the exclusive evidence of the opponent’s case.
Further, the attempt is also for doing a roving and fishing inquiry, which
cannot be allowed through the process of interrogatories.
27. The plea of Mr. Lall that the defendant has added optionality to the
process to contend that the patent has not been infringed, can be taken
care of by the plaintiffs through the process of cross examination of the
defendant’s witness to test the credibility of the stand of the defendant. In
other words, interrogatories by the plaintiffs to extract something, which
it could do so in the course of cross examination, cannot be allowed.
5
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28. Under such circumstances, this Court is of the view that the application
filed by the plaintiffs calling upon the defendant to file response to the
interrogatories cannot be allowed. I do not see any merit in the
application. The same is dismissed.”
[emphasis supplied]
Whether Section 104A of the Act can be invoked at the present stage of the
suit
30. The plaintiffs have argued that Section 104A of the Act cannot be
invoked by the defendant at this stage of the suit and the same comes into play
only at the stage of final adjudication of the suit. The plaintiffs have also
sought to distinguish the decision in Natural Remedies (supra) on the ground
that the same was given at the stage of final hearing of the suit and not at the
interim stage.
31. From a plain reading of Section 104A of the Act, there is nothing to
suggest that Section 104A cannot be invoked at an earlier stage, particularly
when the plaintiffs are seeking disclosure of the defendant’s process by way
of an interlocutory application.
32. In Natural Remedies (supra), the High Court of Karnataka, at the final
adjudication of the suit, held that the defendant cannot be called upon to
disclose its process without fulfilling the requirement of Section 104A of the
Act. If the Court can refuse disclosure at the final stage relying upon Section
104A of the Act, it can surely refuse to direct the defendant to disclose its
process at an earlier stage if the conditions of Section 104A of the Act are not
met.
33. The decision in the Natural Remedies (supra) was followed in Bristol-
Myers (supra) which was in the context of an appeal against an order passed
by the Trial Court refusing to grant an ad interim injunction in favour of the
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plaintiff (appellant). Clearly, the said judgement was not at the stage of final
disposal of the suit and yet, the Court invoked Section 104A of the Act.
34. It has been pointed out on behalf of the defendant that the plaintiffs
have themselves admitted to the applicability of Section 104A of the Act. In
I.A. 4196/2024 filed on behalf of the plaintiffs seeking relief of interim
injunction, the plaintiffs have specifically stated that they have discharged
their onus under Section 104A of the Act by proving that the products of the
plaintiffs and the defendant are identical based on the defendant’s citation of
Perjeta as a reference drug before the CDSCO and the burden of proof now
rests with the defendant (refer paragraphs 27 and 28 of I.A. 4196/2024 and
paragraph 5 of rejoinder to the defendant’s reply to I.A. 4196/2024). The
aforesaid stand of the plaintiffs was also reiterated in their rejoinder to the
defendant’s reply to the present application (refer paragraphs 4 and 8 of
rejoinder to the defendant’s reply to I.A. 5827/2024). It is only at the stage of
oral arguments that the plaintiffs have taken a contrary stand that Section
104A of the Act is not applicable at the present stage of the suit. Clearly, a
party cannot be permitted to take contrary stands at different point of time as
per its own convenience.
35. The predecessor bench, in the order dated 23rd February 2024, observed
that Section 104A of the Act would be applicable insofar as the process patent
IN’646 is concerned. The relevant observations of the predecessor bench in
the aforesaid order are set out below:
“27. The Plaintiffs have a process patent IN’646, as discussed above.
Thus, to determine the allegations of process infringement, the Court
intends to invoke Section 104A of the Patents Act. Under this provision,
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to certain pre-requisites. This shift in the burden of proof is predicated on
the novelty of the product and the patentee’s disclosure of the process in
the patent document in a sufficiently detailed manner for replication by a
person skilled in the art.”
[emphasis supplied]
36. The aforesaid observation was also reiterated in the order dated 13th
March 2024, the relevant extracts of which are set out below:
“5. The previous order is clear as to the court’s observations regarding
the creation of confidentiality club and section 104A of the Patent Act,
1970 and thus no further observations are necessary. Right now, the
Court is simply setting up the confidentiality framework; precise terms
of access to sensitive process information aren’t yet under deliberation.
Creating the confidentiality club now would save crucial time without
prejudicing either party. This proactive step would only ensure that upon
the Court’s eventual decision, the confidentiality club can be enabled to
immediately access relevant information, if so required. Therefore, the
instant application must be viewed in this context.”
[emphasis supplied]
37. Neither of these orders were challenged by the plaintiffs. Therefore, the
plaintiffs at this stage cannot be permitted to submit that Section 104A of the
Act has no applicability at the present stage of the suit.
38. For all the aforesaid reasons, I am unable to accept the submission of
the plaintiffs that Section 104A of the Act would not be applicable at the
present stage of the suit.
Whether Section 104A of the Act would apply to ‘disclosure’ of the process
adopted by the defendant
39. Section 104A of the Act provides that the burden of proof to show that
the process adopted by the defendant is different from that of the plaintiff, can
be shifted to the defendant.
40. The main requirement for discharging the aforesaid burden of proof by
the defendant would be the disclosure of its process of manufacturing. Once
the defendant is directed to disclose its manufacturing process, the Court only
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has to compare/ map the same with the process claimed in the process patent
to see if they are identical/ similar. Therefore, disclosure of its manufacturing
process by the defendant is the key mandate under Section 104A of the Act.
This is also borne out from the language of sub-section (2) of Section 104A
of the Act, which specifically uses the term ‘disclose’ in relation to the
confidential aspects of the defendant’s process.
41. Therefore, in my considered view, the aspect of disclosure of the
defendant’s process to the plaintiffs is covered within the scope of Section
104A of the Act and accordingly, I am not inclined to accept the plaintiffs’
submission that Section 104A of the Act would have no application in cases
where the plaintiff seeks disclosure/ discovery.
Whether Section 104A of the Act would prevail over the discovery provisions
under CPC as amended by the Commercial Courts Act, 2015
42. Counsel for the plaintiffs has placed reliance on the provisions of Order
XI Rules 1(7), 1(12) and 5 of the CPC as amended by the Commercial Courts
Act, 2015 to submit that discovery/ disclosure of the defendant’s process
ought to be allowed. Counsel for the plaintiffs submits that the two judgments
cited by the defendant, i.e., Natural Remedies (supra) and Bristol-Myers
(supra) were delivered prior to the coming into force of the Commercial
Courts Act, 2015, which has liberal provisions for allowing discovery of
documents. Therefore, the provisions relating to discovery under Order XI
Rules 1(7), 1(12) and 5 of the CPC as amended by the Commercial Courts
Act, 2015 should prevail over the provisions of the Patents Act.
43. The Patents Act is a specialized legislation dealing with cases relating
to patents including patent infringement cases, whereas the Commercial
Courts Act, 2015 is a general legislation dealing with all commercial disputes.
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It is a settled position of law that provisions of a special statute would always
prevail over the provisions of general law. Therefore, Section 104A of the Act
would prevail over the discovery provisions under the CPC as amended by
the Commercial Courts Act, 2015. This issue was extensively discussed in
Telefonaktiebolaget LM Ericsson (PUBL) v. Competition Commission of
India6, where a division bench of this Court examined whether the provisions
of the Competition Act, 2002 would prevail over the provisions of the Patents
Act. The division bench held that a general law such as the Competition Act,
2002 cannot override a special law like the Patents Act. In this regard, the
relevant extract from the aforesaid judgement is reproduced below:
“55. Therefore, when assessed, by the maxim generalia specialibus non
derogant [General law will not override special law] or by the maxim lex
posterior derogat priori, the Patents Act must prevail over the Competition
Act on the issue of exercise of rights by a patentee under the Patents Act.
Even assessed by the rigours of Ashoka Mktg. Ltd. case [ASHOKA Mktg.
Ltd. v. Punjab National Bank, (1990) 4 SCC 406], which require the
conflict to be resolved by reference to the purpose and policy underlying
the two enactments and the clear intendment conveyed by the language
of the relevant provisions therein, the Patents Act must necessarily
prevail over that of the Competition Act.”
[emphasis supplied]
44. Reference may also be made to a judgement of this bench in
Telefonaktiebolaget LM Ericsson (PUBL) v. Lava International7. It was
reiterated that the provisions of the Patents Act, being a specialized
legislation, would prevail over the general law of limitation. The relevant
observations in the aforesaid judgment are set out below:
“816. Section 11A (7) of the Patents Act categorically states that the rights
of a patentee originate from the date of publication of the patent
application. First proviso to Section 11(A)7 provides that the suit for
infringement cannot be instituted before the date of grant of patent. Section6
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45 of the Patents Act provides that the suit can only be filed in respect of
an infringement that took place after the date of publication of the patent
application. Therefore, the position that emerges is that a suit for
infringement can only be filed after the grant of the patent. However, the
damages can be claimed from the date of publication of the patent
application. The rationale behind this appears to be that the grant of
patent may take considerable time and the patentee should not be denied
his right to claim damages, in respect of infringement that occurs post
publication of the patent. Thus, the period of limitation as prescribed under
Article 88 of the Schedule of Limitation Act, 1963 will not be applicable in
the present case. In any event, it is a settled position of law that the
provisions of special law, i.e., Patents Act would prevail over the
provisions of general law, i.e., Limitation Act, 1963.”
[emphasis supplied]
45. The plaintiffs have placed reliance in this regard on the judgment of
this bench dated 18th February 2025 in their own case, i.e., F-Hoffmann-La
Roche v. Drugs Controller General of India (supra). In the said judgment,
the application seeking discovery was allowed relying upon various
provisions of the CPC as amended by the Commercial Courts Act, 2015.
However, it was specifically noted in the said judgment that Section 104A of
the Act would have no relevance in the said case as the patents in question
had already expired. The relevant observations of the Court in F-Hoffmann-
La Roche (supra) are set out below:
“56. Another submission by the defendants was that the current
application for the discovery of documents cannot be allowed unless the
plaintiffs have fulfilled the requirement contained in Section 104A of the
Patents Act. As the language of Section 104A of the Patents Act itself
suggests, the section comes into play only in respect of the process patent
infringement suits. In the present suits, the patents had already expired
and hence, have not been asserted in the suits. Therefore, Section 104A
of the Patents Act has no relevance for the purposes of the present suit.”
[emphasis supplied]
46. Therefore, the observations made in the aforesaid decision would have
no bearing in the present suit.
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47. In light of the above discussion, in my considered view, Section 104A
of the Act would prevail over the discovery provisions under the CPC as
amended by the Commercial Courts Act, 2015.
Whether Section 104A of the Act would apply in respect of biological drugs?
48. Another contention of the plaintiffs is that Section 104A of the Act will
have no application in respect of biological drugs, as two different biological
drugs, by their very nature, cannot be identical to each other. In this regard,
reliance is placed on the observations made in the judgment of a coordinate
bench of this Court in Roche Products v. Drugs Controller General of India8.
Paragraphs 180 and 184 of the aforesaid judgment are set out below:
“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.
*** *** ***
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.”
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49. There is nothing in the language of Section 104A of the Act to suggest
that it would not apply in cases pertaining to infringement of biological drugs.
In Roche Products (supra), the applicability of Section 104A of the Act was
not an issue before the Court and hence, no observation was made with regard
to Section 104A of the Act.
50. While the Biosimilar Guidelines use the term ‘similar’ as sufficient for
regulatory approval, the legal burden under Section 104A remains one of
proving identity in substance and composition, as held in Natural Remedies
(supra). This threshold cannot be diluted in biologic cases merely because
absolute replication is scientifically difficult. The statutory use of the term
‘identical’ reflects the legislature’s conscious choice, and to read the same in
a lower threshold would amount to judicial dilution of the requirement.
51. Therefore, the plaintiffs’ contention with respect to inapplicability of
Section 104A of the Act in cases involving biological drugs is devoid of
merits.
Whether the plaintiffs have fulfilled the requirements of Section 104A of
the Act?
52. Now, I proceed to examine whether the plaintiffs have satisfied the
requirements of Section 104A of the Act and made out a case for the defendant
to disclose its manufacturing process. The plaintiffs contend that the
defendant’s product is identical to the plaintiffs’ product as the defendant itself
has used the plaintiffs’ product, i.e, Perjeta as a reference biologic in its
application before the CDSCO for approval of a similar biologic (refer
paragraph 54 of the plaint). In the said application, the defendant has admitted
that it is manufacturing a drug which is similar biologic of the plaintiffs’
aforesaid product.
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53. The predecessor bench, in the order dated 23rd February 2024, has
discussed the scope and relevance of the Guidelines on Similar Biologics,
2016. Relevant paragraphs from the aforesaid order are set out below:
“20. A biologic pharmaceutical, often simply called a ‘biologic’, is a type
of medication derived from living organisms or their cells. The inherent
complexity of biologics stems from their molecular size, structure, and the
intricacies of their development process. Unlike traditional
pharmaceuticals, which are typically synthesized through chemical
processes to create small molecule drugs, biologics are produced using
biotechnological methods involving recombinant DNA technology,
controlled gene expression, and antibody production. Biologic medicines
represent a paradigm shift from traditional small molecule
pharmaceuticals, introducing a new spectrum of challenges for the
intellectual property architecture designed to safeguard them.
21. …There are no clinically meaningful differences between a Similar
Biologic and an approved reference biological product. Similar Biologics
can only be developed against the Reference Biologic that has been
approved using a complete data package in India. A product can only be
considered as a Similar Biologic if it is proven to be Similar using extensive
quality characterization against the Reference Biologic and further
product development should only be considered once the Similar Biologic
is demonstrated to be similar in quality to a Reference Biologic…
*** *** ***
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, 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.”
[emphasis supplied]
54. To appreciate the aforesaid submission made on behalf of the plaintiffs,
a reference may be made to the Guidelines on Similar Biologics, 2016 issued
by CDSCO and the Department of Biotechnology (hereinafter ‘Biosimilar
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Guidelines’). The term ‘reference biologic’ has been defined in the glossary
of the Biosimilar Guidelines in the following manner:
“j. Reference Biologic
A Reference Biologic is used as a comparator for comparability studies
with the Similar Biologic in order to show Similarity in terms of safety,
efficacy and quality. The Reference Biologic should be licensed / approved
in India or ICH countries and should be the innovator’s product. The
Reference Biologic should be licensed based on a full safety, efficacy and
quality data. Therefore another Similar Biologic cannot be considered as
a choice for Reference Biologic.”
[emphasis supplied]
55. Similarly, the term ‘similar biologic’ has been defined in the glossary
of the Biosimilar Guidelines in the following manner:
“l. Similar Biologic
A Similar Biologic product is that which is similar in terms of quality,
safety and efficacy to an approved Reference Biologic product based on
comparability.”
[emphasis supplied]
56. Other relevant extracts from the Biosimilar Guidelines are set out
below:
“5. Scope
…
Any product can be considered as a Similar Biologic, only if it is proven to
be Similar using extensive quality characterization against the Reference
Biologic. Further product development should only be considered once the
similarity of the Similar Biologic is demonstrated in quality to a Reference
Biologic.
…
6. Principles for Development of Similar Biologics
…
Although the extent of preclinical and clinical evaluation of the Similar
Biologic is likely to be less than that required for the Reference Biologic,
it is essential that the testing of the Similar Biologic be sufficient to
ensure that the product meets acceptable levels of safety, efficacy and
quality to ensure public health in accordance with international guidelines
(WHO 2013).
…
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Identification of any significant differences in safety, efficacy and quality
studies would mean the need for a more extensive preclinical evaluation
and the product will not qualify as a Similar Biologic.
…
6.1 Selection of Reference Biologic
…
The Reference Biologic has to be used in all the comparability exercises
with respect to quality, preclinical and clinical considerations. The
following factors should be considered for selection of the Reference
Biologic:
• The Reference Biologic should be licensed / approved in India or ICH
countries and should be the innovator’s product. The Reference Biologic
should be licensed based on a full safety, efficacy and quality data.
Therefore another Similar Biologic cannot be considered as a choice for
Reference Biologic.
• In case the Reference Biologic is not marketed in India, the Reference
Biologic should have been licensed in any ICH countries. The Reference
Biologic product can be imported for developing the Similar Biologic for
quality, pre-clinical and clinical comparability.
• The same Reference Biologic should be used throughout the studies
supporting the safety, efficacy and quality of the product (i.e. in the
development Programme for the Similar Biologic).
• The dosage form, strength and route of administration of the Similar
Biologic should be the same as that of the Reference Biologic.
• The active drug substance (active ingredient) of the reference biologic
and that of Similar Biologic must shown to be similar.
…
6.2 Manufacturing Process
The Similar Biologics manufacturer should develop the manufacturing
process to yield a comparable quality product in terms of identity, purity
and potency to the Reference Biologic. The manufacturing process for
Similar Biologics should be validated and demonstrated to be highly
consistent and robust. If the host cell line used for the production of
Reference Biologic is disclosed, it is desired to use the same host cell line
for manufacturing Similar Biologics. Alternatively any cell line that is
adequately characterized and appropriate for intended use can be used
to develop a Similar Biologic, with appropriate justification in order to
minimize the potential for significant changes in quality attributes (QAs)
of the product and to avoid introduction of certain types of process
related impurities that could impact clinical outcomes and
immunogenicity…
The data requirements for review of manufacturing process at preclinical
submission stage include a complete description of the manufacturing
process from development and characterization of cell banks, stability of
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clone, cell culture/ fermentation, harvest, excipients, formulation,
purification, primary packaging interactions (if different from Reference
Biologic), etc…”
[emphasis supplied]
57. It is discernible from the above extracts of the Biosimilar Guidelines
that for a similar biologic to be approved by the CDSCO, there is no
requirement for the similar biologic to be identical to the reference biologic.
The requirement is that the active ingredient used in similar biologic should
be similar and the dosage form, strength and route of administration of the
similar biologic should be same as that of the reference biologic. Regarding
the process used for manufacturing a similar biologic, the Biosimilar
Guidelines only require the process to yield a comparable quality product in
terms of identity, purity and potency to the reference biologic. It is, however,
open for a similar biologic manufacturer to come up with alternative
manufacturing processes without compromising the safety, efficacy and
quality of its product.
58. The phrase ‘if different from Reference Biologic’ in the extract above
suggests that the manufacturing process of a similar biologic developed by its
manufacturer could be entirely different from that of the reference biologic.
This aspect was also noted by the predecessor bench in the order dated 23rd
February 2024 (refer paragraphs 24 and 26 of the order dated 23rd February
2024). Therefore, even if a drug is stated to be the similar biologic of a
reference biologic, it does not naturally follow that the process of
manufacturing the same is identical to that of the reference biologic.
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59. In this regard, a reference may be made to the judgment of the Federal
Court of Australia in Pfizer Ireland Pharmaceuticals v. Samsung Bioepis9,
where it was observed that merely because the product is a similar biologic
would not automatically lead to the conclusion that it was the outcome of the
same process as that of the patented process. In other words, merely because
the end products are similar, it does not lead to the conclusion that both were
derived from the same process. The relevant extracts from the aforesaid
judgement are reproduced hereinbelow:
“97. Ultimately, Dr Ibarra’s evidence in this respect does not rise above
speculation (Pfizer refers to it as an inference) that the similarities
observed might mean that the BRENZYS Process is similar to the Pfizer
Process. That speculation, in my view, clings tenuously to the coincidences
identified in Cho. These coincidences are cogently explained by a far
more available inference; that the end products are biosimilar. That fact
does not suggest similarity of process.”
[emphasis supplied]
60. Therefore, the filing of the aforesaid application dated 9th September
2021 by the defendant with the CDSCO by itself would not fulfil the
requirement of Section 104A of the Act that the defendant’s product is
identical to that of the plaintiffs. It also does not indicate that the defendant
has used the plaintiffs’ patented process.
61. There is another aspect of the matter to be considered. The defendant
contends that the product in its application dated 9th September 2021 filed
with the CDSCO refers to Pertuzumab (Perjeta®, Genentech Inc.), which is
in public domain and is different from the product obtained from the process
patent of the plaintiffs, i.e., a composition comprising Pertuzumab and one or
more variants.
9
MANU/AUFC/0847/2017
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62. The plaintiffs have averred in the plaint that Pertuzumab is sold under
the brand name Perjeta (refer paragraph 42 of the plaint). At several other
places in the plaint, the plaintiffs have interchangeably used the terms
Pertuzumab and Perjeta (refer paragraphs 11 and 41 of the plaint).
63. However, a perusal of the plaint would also show that the product that
is manufactured using the process patent IN’646 is not Pertuzumab per se but
Pertuzumab along with variants. A reference in this regard may again be made
to paragraph 11 read with paragraph 12 of the plaint, which are set out below:
“11. The present suit inter alia pertains to Indian Patent No. IN 464646
titled as “PERTUZUMAB VARIANTS AND EVALUATION
THEREOF” (also known as “suit patent IN’646”). The said patent
IN’646 relates to the method for making a composition comprising
Pertuzumab and one or more variants. Pertuzumab (commercially
known as (Perjeta®) is a monoclonal antibody (MAb) biologic and is the
first of its class in a line of agents called “HER Dimerization Inhibitors”.
Pertuzumab, by binding to HER2 cells, inhibits the dimerization of HER2
cells with other HER receptors and thus inhibits tumour growth.
12. The inventiveness of IN’646 resides in the method of making a
composition having Pertuzumab and its variant(s) comprising unpaired
cysteine variants, low-molecular-weight-species (LMWS), high-
molecular weight-species (HMWS), afucoslated variant, Pertuzumab
Peak l, and Pertuzumab Peak 2 and quantifying the said variants within
the range disclosed and claimed by IN’646, resulting in a much safer and
efficacious drug and further also has a positive impact on the anti-
proliferative qualities. This specific and precise manufacturing process
determines the quality of the composition comprising Pertuzumab and its
variants.”
[emphasis supplied]
64. Similar averments have been made by the plaintiffs in their rejoinder to
the defendant’s reply to I.A. 4196/2024, paragraph 8 of which is set out below:
“8. It is stated that none of the cited prior arts relied on by the Defendant
in paragraph 11 of their reply (item no. 1 to 7 and 9) are relevant. The
Defendant’s argument that Pertuzumab and its process are publici juris is
completely baseless and legally untenable, at the outset. The invention of
the suit patents relates to Pertuzumab and its variants thereof. However,
there has been no disclosure of the variants manufactured, identified, andSignature Not Verified
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characterized in the suit patent, IN’646, in any of the prior arts cited by
the Defendant.”
[emphasis supplied]
65. This is also evident from the background and summary of the invention
and claims of the complete specification of IN’646 wherein Pertuzumab
(Perjeta) has been identified as the prior art and it is stated that the invention
is in respect of “a method for making a composition comprising Pertuzumab
and one or more variants wherein the Pertuzumab and variant(s) each
comprise the variable light and variable heavy amino acid sequences in SEQ
ID NOs. 7 and 8”.
66. Therefore, it can be inferred that Pertuzumab (Perjeta) was already
known in the prior art and the end product of the process patent IN’646 is a
distinct composition comprising Pertuzumab and one or more variants.
67. Based on the aforesaid discussion, it cannot be said that the reference
made by the defendant in its aforesaid application filed with the CDSCO is to
the product obtained from the patented process IN’646. Therefore, on the said
basis, the plaintiffs cannot argue that the defendant’s product is identical to
the plaintiffs’ product directly obtained from the patented process, as
mandated under Section 104A of the Act.
68. Besides placing reliance on the aforesaid application of the defendant
referring to Pertuzumab (Perjeta®, Genentech Inc.) as the reference drug, the
plaintiffs have not filed any other documents to demonstrate that the product
manufactured by the defendant is identical to the product of the plaintiffs
covered under IN’646.
Claim mapping filed by the plaintiffs
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69. As the defendant’s product was not launched at the time of filing of the
present suit and the present suit was filed as a quia timet action, the
predecessor bench, on 23rd February 2024, directed the plaintiffs to do the
claim mapping in respect of IN’632, the product patent, with claims of the
defendant’s patent application no. 2021079337. Admittedly, the product of the
defendant was launched in the market in June 2024. Yet the plaintiffs have not
conducted any analytical characterisation or a reverse engineering of the
defendant’s product to show that the defendant’s product is identical, or even
similar, to the plaintiffs’ product manufactured using the process patent, which
is a statutory requirement under section 104A of the Act.
70. The claim mapping filed on behalf of the plaintiffs pertains to a product
patent and claims of the defendant’s patent application, and is therefore not
directly relevant to the adjudication of the present application which, as noted
above, concerns the process patent.
71. Even otherwise, upon examination of the claim mapping of IN’632 in
comparison with the claims of the defendant’s patent application, it is evident
that the defendant’s product relates to a composition comprising Pertuzumab
and excipients, specifically an arginine citrate buffer. In contrast, the
plaintiffs’ product employs a histidine acetate buffer.
72. Therefore, even in terms of the claim mapping filed on behalf of the
plaintiffs, it cannot be concluded that the composition described in the
plaintiffs’ product patent and the defendant’s patent application are identical.
Conclusion
73. Based on the aforesaid discussion, in my considered view, the plaintiffs
have failed to fulfil the mandatory requirements of Section 104A of the Act.
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Therefore, no direction can be issued to the defendant to disclose its
manufacturing process filed in a sealed cover.
74. Hence, I do not see any merit in the present application and the same is
dismissed.
75. Needless to state, any observations made in this judgment are only for
the purposes of deciding the present application and would have no bearing
on the final adjudication of the suit.
CS(COMM) 159/2024
76. List before the Joint Registrar on 23rd September 2025, the date already
fixed.
AMIT BANSAL
(JUDGE)
JULY 22, 2025
Vivek/-/ds/at/Rzu
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