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Fmc Corporation & Ors. Vs. Natco Pharma Limited

  Delhi High Court CS(COMM) 607/2024
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CS(COMM) 607/2024 Page 1 of 79

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* IN THE HIGH COURT OF DELHI AT NEW DELHI

CS(COMM) 607/2024 & I.A. 34151/2024

FMC CORPORATION & ORS. .....Plaintiffs

Through: Mr. Sandeep Sethi, Mr. Adarsh

Ramanujan, Ms. Bitika Sharma, Ms.

Aadya Chawla, Mr. George Vithayathil,

Ms. S. L. Soujanya Ms. Ahaana Singh

Rana, Ms. Mrinalini Goyat and Mr. Parth

Singh, Advs.

Mob: 8449336373

Email: ahaana@singhandsingh.com

versus

NATCO PHARMA LIMITED .....Defendant

Through: Mr. J. Sai Deepak, Sr. Adv. with Mr.

Sidhant Goel, Mr. Mohit Goel, Mr.

Aditya Goel, Mr. Deepankar Mishra, Mr.

Kartikeya Tandon and Mr. Avinash K.

Sharma, Advs.

Mob: 9716746496

Email: deepankar@simandsan.com

CORAM:

HON'BLE MS. JUSTICE MINI PUSHKARNA

JUDGEMENT

% 17.11.2025

I.A. 34151/2024 in CS(COMM) 607/2024

INTRODUCTION

1. By way of the present judgement, this Court shall decide the application

being I.A. 34151/2024, filed by the plaintiffs under Order XXXIX Rules 1 & 2

read with Section 151 of the Civil Procedure Code, 1908 (“CPC”), seeking an

interim injunction for restraining the infringement of the plaintiffs‟ patented

Compound of Formula 3 as claimed in Claim 12 of the Indian Patent No.

298645 (“IN’645 / suit patent”), titled as “Method For Preparing N-

CS(COMM) 607/2024 Page 2 of 79

Phenylpyrazole-1-Carboxamides”.

2. The suit has been filed by the plaintiffs as a quia timet action under

Section 48 read with Section 108 of the Patents Act, 1970 (“the Act”), seeking

permanent injunction, restraining the defendant from manufacturing/preparing

the product, „Cyantraniliprole 10.26% OD (Oil Dispersion)‟

(“infringing/impugned product”) and/or other admixture, combination,

formulation products containing Cyantraniliprole using the Compound of

Formula 3 as claimed in Claim 12 of the suit patent as a specific intermediate,

as the same allegedly infringes upon the plaintiffs‟ Claim 12 of the suit patent.

3. This Court notes that vide order dated 01

st

August, 2025, it was brought

forth that the defendant has launched its product. Upon the submissions of the

defendant that they had already ‗cleared the way‘ and the statement thereof, this

Court issued directions to the defendant to file details of the stock manufactured

and launched, in relation to its product, before this Court. The relevant portion

of the order dated 01

st

August, 2025, is reproduced as under:

―xxx xxx xxx

2. During the course of hearing, learned Senior Counsel appearing

for the plaintiffs has brought forth that the defendant has already

launched the product.

3. Learned Senior Counsel appearing for the defendant does not

dispute the same. He submits that the defendant has already cleared

the way, which is disputed by learned Senior Counsel appearing for

the plaintiffs.

4. Learned Senior Counsel appearing for the defendant submits that

in view of the fact that the defendant has already launched the

product, the defendant shall file all the details of the stock

manufactured, as well as launched by the defendant. Further, the

defendant shall also file the details of all the revenue earned by the

defendant, in a tabular form.

5. He further submits that the defendant shall also clearly state in

the affidavit as regards the various approvals obtained by the

defendant for the purposes of marketing the product.

6. The aforesaid statement is taken note of.

7. Let the needful be done by the defendant before the next date of

CS(COMM) 607/2024 Page 3 of 79

hearing.

xxx xxx xxx‖

(Emphasis Supplied)

4. Pursuant to the aforesaid order, the defendant has filed its affidavit dated

14

th

August, 2025, detailing the stocks manufactured, sold and revenue earned

by the defendant from the sale of its product up to 31

st

July, 2025.

FACTUAL MATRIX

5. Facts as relevant to the present case are as follows:

About the parties:

5.1 The plaintiffs in the present case are a group of companies under the

FMC group. Plaintiff no. 1 – FMC Corporation, is a company incorporated

under the laws of the State of Delaware, United States of America, and is a co-

patentee to the suit patent. Plaintiff no. 2 – FMC IP Technology GmbH is a

company registered under the laws of Switzerland and is a subsidiary of

plaintiff no. 1 corporation. Plaintiff no. 3 – FMC India Private Limited and

Cheminova India Ltd., are the local entities through which plaintiff nos. 1 and 2

conduct their agrochemical business in India.

5.2 The plaintiff no. 1 along with its subsidiary, i.e., FMC Agro Singapore

Pte. Ltd. were initially the co-patentees to the suit patent. The plaintiffs‟ group

of companies acquired the crop protection business of E.I. DU Pont De

Nemours and Company, inter alia, including the suit patent. By virtue of

Assignment Agreement dated 01

st

May, 2018, with effective date of 01

st

November, 2017, all rights, title and interest in the suit patent was transferred to

plaintiff no. 1 and its Singaporean subsidiary. Subsequently, the subsidiary of

plaintiff no. 1, FMC Agro Singapore Pte. Ltd., by way of Patent Assignment

Agreement dated 01

st

May, 2014, transferred its right as co-patentee in the suit

patent to plaintiff no. 2. Therefore, plaintiff no. 1 and plaintiff no. 2 are

currently the co-patentees to the suit patent.

CS(COMM) 607/2024 Page 4 of 79

5.3 The defendant – Natco Pharma Limited, in the present case is a company

incorporated under the Companies Act, 1956, and is involved in the business of

pharmaceuticals and agro-chemical solutions. Further, the defendant

manufactures crop protection chemicals such as pesticides, insecticides and

herbicides. The defendant is alleged to have infringed plaintiffs‟ patented

Compound of Formula 3 as claimed in Claim 12 of the suit patent, by way of its

impugned product, „Cyantraniliprole 10.26% OD‟, which is an insecticidal

composition.

Prior/Existing Lis and Applications:

5.4 Initially, the plaintiffs had filed the suit, i.e., C.S. (COMM) 611/2019,

titled as ―FMC Corporation & Anr. Versus Natco Pharma Limited‖, seeking to

restrain the defendant from infringing another set of plaintiffs‟ patents bearing

nos. IN 201307 (“IN’307”) and IN 213332 (“IN’332”).

5.5 Thereafter, the defendant on 06

th

May, 2022, filed a declaratory suit

before this Court bearing no. C.S. (COMM) 295/2022, titled as ―Natco Pharma

Ltd. Versus FMC Agro Singapore Pte. Ltd. & Ors.‖ under Section 105 of the

Act, seeking a prayer for declaration of non-infringement in respect of Claims 1

to 11 of the suit patent, relating to manufacture of another product, i.e.,

„Chlorantraniliprole‟.

5.6 Pursuant to the declaratory suit, the plaintiffs on 20

th

May, 2022, filed a

suit for infringement, i.e., C.S. (COMM) 349/2022, titled as ―FMC Corporation

& Others Versus Natco Pharma Limited‖, seeking injunction against the

defendant with respect to infringement of Claims 1, 5 to 8 and 11 of the suit

patent. In the said suit, the Co-ordinate Bench of this Court passed a judgement

dated 19

th

September, 2022, dismissing the application filed by the plaintiffs

seeking interim injunction against the defendant.

5.7 Subsequently, an appeal, i.e., FAO (OS)(COMM) 301/2022, was filed

CS(COMM) 607/2024 Page 5 of 79

against the judgement dated 19

th

September, 2022, wherein, the Division Bench

of this Court by way of order dated 05

th

December, 2022, dismissed the appeal

and affirmed the judgement dated 19

th

September, 2022.

5.8 The defendant in October, 2023, filed another suit for declaration, i.e.,

C.S. (COMM) 787/2023, titled as ―Natco Pharma Limited Versus FMC Agro

Singapore Pte. Ltd. & Ors.‖, seeking declaration of non-infringement in

relation to another one of plaintiffs‟ patent, i.e., IN 277358 (“IN’358”)

regarding the present impugned product, i.e., „Cyantraniliprole 10.26% OD‟.

5.9 The defendant thereafter filed a revocation petition, i.e., C.O. (COMM-

IPD-PAT) 7/2023. The defendant also filed an application for registration of

insecticides under Section 9(3) of the Insecticides Act, 1968, with the Central

Insecticide Board & Registration Committee, Directorate of Plant Protection

Quarantine and Storage, on 28

th

July, 2023, for manufacturing and

commercialising the insecticidal composition, „Cyantraniliprole 10.26% OD‟,

which is the impugned product in the present case. Further, the defendant has

obtained regulatory approval for technical indigenous manufacture of

Cyantraniliprole technical 93% as per the Minutes of the 453

rd

Central

Insecticides Board & Registration Committee (“CIBRC”) meeting held on 16

th

January, 2024.

5.10 Pursuant to the same, the plaintiffs filed three other suits, i.e., C.S.

11/2023, C.S. 2/2024 and C.S. 3/2024, against the defendant herein before the

District Court (Commercial) Chandigarh seeking to restrain the defendant from

infringing Claim 12 of the suit patent in relation to defendant‟s impugned

products therein, i.e., „NATGEN‟, „NATLIGO‟ and „NATVOL‟. The said suits

have been transferred to this Court by the Supreme Court by way of order dated

09

th

April, 2024, in Transfer Petition (Civil) Nos. 504, 488 and 513 of 2024. The

said suits were then renumbered as C.S. (COMM) 410/2024, 409/2024 and

CS(COMM) 607/2024 Page 6 of 79

408/2024 respectively, and are currently pending in this Court.

5.11 The defendant has also filed two patent applications, i.e.,

PCT/IN2019/050321, which shows the process of manufacturing of

Cyantraniliprole, and PCT/IN2023/051094, published on 06

th

June 2024, as

WO/2024/116197 A1, which claims to show an improved process for the

preparation of intermediate of Cyantraniliprole.

Suit Patent:

5.12 The suit patent was granted to plaintiffs‟ predecessor-in-interest, E.I. DU

Pont De Nemours and Company, a US-based company on 09

th

July, 2018, under

Section 43 of the Act. As noted above, the plaintiff nos. 1 and 2 are the current

co-patentees and the successors-in-interest to the suit patent, by way of the

aforementioned Assignment Agreements.

5.13 The suit patent, IN‟645 is set to expire on 06

th

December, 2025.

5.14 The plaintiffs have filed corresponding claims in the suit patent which are

patented by the plaintiffs in more than 20 countries/jurisdiction, other than

India, including, jurisdictions such as Europe, United States of America, Japan

and Republic of Korea. It has been disclosed by the plaintiffs that some of the

claims of the corresponding patent to the suit patent, have been invalidated in

China.

5.15 The plaintiffs in India have been granted four patents in relation to the

compound, „Cyantraniliprole‟, including the suit patent.

5.16 The suit patent, IN‟645 is granted, valid and subsisting in the Register of

Patents, whereby, a total of 12 claims have been granted in the suit patent. The

suit patent claims a process for the preparation of „Cyantraniliprole‟ in Claims 1

to 11 and Claim 12 is for a Compound of Formula 3, which is an intermediate

used in the said process.

5.17 As per the plaintiffs, the Compound of Formula 3 is qualified by provisos

CS(COMM) 607/2024 Page 7 of 79

(a) to (d), of which the proviso (d) of Claim 12 states „when R

1

is CH3 and R

2

is

CN, then R

3

is other than H‘.Therefore, as per proviso (d) of Claim 12 of the

suit patent, where R

1

is CH3 and R

2

is CN, then R

3

in the Compound of Formula

3 can be any of C1-C4 alkyl groups as limited by Claim 12. Further, when R

3

is

C1 alkyl, i.e., CH3, the Compound of Formula 3 becomes 2-amino-5-cyano-N,

3-dimethylbenzamide, which is the intermediate compound in question.The said

intermediate compound has also been specifically disclosed as „Example 6‟ in

the complete specification of the suit patent.

5.18 The intermediate compound in question, i.e., 2-amino-5-cyano-N, 3-

dimethylbenzamide, which is culled out of the proviso (d) of Claim 12 under the

suit patent, and is used to manufacture „Cyantraniliprole‟, is alleged to have

been infringed by the defendant, as the same is covered under the suit patent.

The depiction of 2-amino-5-cyano-N, 3-dimethylbenzamide, is as under:

5.19 As per the plaintiffs, Claim 12 of the suit patent is used for manufacturing

and launching a product of „Cyantraniliprole‟, which is manufactured using the

intermediaries claimed in Claim 12 of the suit patent.

5.20 Thus, the present suit has been filed by the plaintiffs seeking reliefs

against the defendant‟s usage of the intermediate compound in question in the

manufacturing of the impugned product, as the intermediate compound in

question is protected under Claim 12 of the suit patent. Therefore, the

application in question before this Court, seeks an interim injunction against the

defendant‟s usage of the intermediate compound in question, i.e., 2-amino-5-

cyano-N, 3-dimethylbenzamide, which is protected by Claim 12 of the suit

patent.

CS(COMM) 607/2024 Page 8 of 79

SUBMISSIONS OF PARTIES

Plaintiffs‟ Submissions:

6. On behalf of the plaintiffs, the following submissions are made:

6.1 The plaintiffs have been granted exclusive rights to prevent third parties

from making Compounds which are claimed under Claim 12 of the suit patent.

The defendant in their reply to the present application has admitted that they are

making and using the intermediate compound in question, 2-amino-5-cyano-N,

3-dimethylbenzamide, to make „Cyantraniliprole 10.26% OD‟. Therefore, by

virtue of the admission by the defendant, and the said intermediate compound in

question being protected under Claim 12 of the suit patent, the defendant‟s use

of the intermediate compound in question, amounts to infringement.

6.2 The defendant has admitted to using the intermediate compound in

question, and the only defence raised is the alleged invalidity of the suit patent.

The said admission has been made by the defendant in their reply to the present

application, wherein, they have categorically admitted to manufacturing and

using the intermediate compound under Claim 12 of the suit patent. Therefore,

based on the said admission, a prima facie case is made out for grant of interim

injunction.

6.3 The suit is not barred by Order II Rule 2 of the CPC, as the prior suit, i.e.,

C.S. (COMM) 349/2022, filed by the plaintiffs against the defendant was to

enforce the process patent covered by Claims 1, 5 to 8 and 11 of the suit patent,

and not for asserting rights under Claim 12 of the suit patent. Thus, the cause of

action of the present suit is distinct from the cause of action of the aforesaid

suit.

6.4 The revocation of the counterpart of the suit patent in China has been on

grounds other than prior claiming and novelty, which are the grounds invoked

by the defendant in the present case. Further, the grounds of

CS(COMM) 607/2024 Page 9 of 79

invalidity/patentability are different in China in comparison to India.

6.5 The onus is upon the defendant to establish invalidity of Claim 12 of the

suit patent, and mere filing of a revocation petition by itself, cannot amount to a

‗credible challenge‘ nor will it amount to ‗clearing the way‘.

6.6 The claim of the defendant that the plaintiffs are ‗serial litigants‘ and

have developed their group of patents around two products, i.e.,

„Cyantraniliprole‟ and „Chlorantraniliprole‟, in order to evergreen or re-

monopolise its products, is an attempt to prejudice and mislead the Court. The

formulation, molecule and the process to arrive at „Cyantraniliprole‟ and the

intermediates used in the said process are all separate inventions, meriting their

distinct patents. The intermediates to reach „Cyantraniliprole‟ are protected by

Claim 12 of the suit patent, and each of the claims/patents independently qualify

the patenting standards, even if they are not the final product, but because they

all have some commercial viability.

6.7 In contrast, the defendant is a ‗habitual infringer‘, which is indicated by

the table of injunction orders granted against the defendant in various

intellectual property suits.

6.8 The plaintiffs have a patent portfolio of approximately 700 global patents

that cover several aspects of their business. Moreover, the plaintiffs

continuously improve manufacturing processes and existing active ingredients

of the product portfolio through inventions.

6.9 The claim of the defendant that another one of plaintiffs‟ patent, i.e., IN

269104 (“IN’104”), is a prior art and anticipates the suit patent, therefore, the

suit patent is not novel, is meritless. To assess anticipation by prior publication

under Section 64 (1)(e) of the Act, the test is to see whether the prior art is

published before the priority date. In the present case, IN‟104 was published on

15

th

August, 2008, which is much later to the priority date of the suit patent, i.e.,

CS(COMM) 607/2024 Page 10 of 79

07

th

December, 2004, therefore, IN‟104 cannot be a prior art with respect to the

suit patent. Furthermore, Section 11 (8) of the Act prohibits use of any

document published later to attack the novelty and inventive step of a claimed

invention.

6.10 The contention of the defendant that it is the position of the plaintiffs that

the priority date of IN‟104 has shifted owing to its filing in 2008, is incorrect,

and IN‟104, being published after the priority date of the suit patent, is not a

prior art in respect of the suit patent.

6.11 Further, the contention of the defendant that the suit patent is invalid

since it is anticipated by the prior publication of WO 03/062226 (“WO’226”),

which is the international counterpart to IN‟104, is incorrect. The defendant, at

best, could have contended the aspect of novelty of the suit patent, citing the

international publication, WO‟226, which was published prior to the suit patent.

However, even WO‟226 does not anticipate Claim 12 of the suit patent, as it

neither discloses nor enables the Compounds claimed under Claim 12 of the suit

patent.

6.12 The defendant has argued that „Formula 6‟ as claimed in WO‟226,

discloses the Claim 12 of the suit patent. However, WO‟226 does not

specifically disclose or give an individualised description of the Compounds

protected by Claim 12 in proviso (d) or make any specific reference to the

intermediates protected by Claim 12 of the suit patent.

6.13 The claim of the defendant that three of the substituent combinations in

WO‟226, are the same as Claim 12 of the suit patent, is completely misleading

and misplaced as „Formula I‟ is an entirely different molecule, and is not an

intermediary, but rather an end product contemplated in WO‟226. Therefore,

the defendant cannot break down the end product and assert that the

Compounds constitute intermediaries, when the end products of WO‟226 and

CS(COMM) 607/2024 Page 11 of 79

the suit patent are distinct from one another. The defendant‟s claim is

unfounded and only seeks to cherry-pick one end-product out of the 2700 end

products that are suggested in WO‟226, reverse engineer the intermediary and

then come to a conclusion that Compounds in WO‟226, constitute

intermediaries in the suit patent.

6.14 The defendant could not overcome the onus that a ‗Person Skilled in the

Art‘, by reading WO‟226, can reach the Compounds as claimed in Claim 12 of

the suit patent. Furthermore, WO‟226 does not have an enabling disclosure to

arrive at the intermediate compound in question protected under proviso (d) of

Claim 12 of the suit patent, without undue experimentation, which is a matter of

trial, and the defendant has not led prima facie expert evidence to explain the

said disclosure. Moreover, WO‟226 being cited by the International Search

Authority as a category „A‟ prior art means that it is only „general background

art‟ and therefore, does not destroy the novelty/inventive step of the suit patent.

6.15 The Venn Diagram used by the defendant to try and show anticipation of

the suit patent by WO‟226, is a hindsight approach and used to mislead the

Court, as the size of the circles in the diagram are misleading, since the number

of compounds possible in Formula 6 of WO‟226 are massive, i.e., 115 billion

compounds, while possible compounds in Claim 12 of the suit patent are

relatively only a few, i.e., 40 compounds. Furthermore, the Venn Diagram does

not show the point in time for each disclosure, as the claims of IN‟104, did not

exist at the time Claim 12 of the suit patent was filed. Even if there was an

overlap of one of the compounds, Claim 12 of the suit patent is a distinct

invention as compared to Claim 1 of IN‟104 because the molecules of Claim 12

of the suit patent have a technical effect of resulting in a higher yield when used

as an intermediate, a property, which was unknown in IN‟104.

6.16 The defendant cannot use WO‟226 to contend that the suit patent is prior

CS(COMM) 607/2024 Page 12 of 79

claimed by IN‟104, as in a challenge under Section 64 (1)(a) of the Act, one can

only use a granted Indian patent, and WO‟226, not being an Indian patent,

cannot be used for the purposes of a challenge under Section 64 (1)(a) of the

Act. Furthermore, the defendant in its claim of invalidity based upon IN‟104,

has only done a verbal comparison of the claims with the suit patent, in order to

assert the anticipation by prior claiming. However, it is settled law that an

invention has to be seen in totality of the claims read with the specifications,

and in a case of the present nature, the defendant has to show that IN‟104

discloses the special advantages as mentioned in the suit patent, which the

defendant has failed to do.

6.17 The contention of the defendant that the plaintiffs‟ predecessor-in-interest

has allegedly admitted that the intermediate compound in question, patented in

Claim 12 of the suit patent, was already disclosed in IN‟104, is completely

misplaced. If indeed the alleged admission was made, the same would only be

relevant if IN‟104 was a prior art. However, the same being published much

after the priority date of the suit patent, cannot be a prior art. Moreover, the

complete specifications of IN‟104 and the suit patent are directed to different

inventions in substance, and the suit patent has a distinct lineage from IN‟104.

Thus, any statements made in the prosecution of IN‟104 form extrinsic

evidence, and are therefore of lesser significance in comparison to the intrinsic

evidence and should not be considered.

6.18 There are no admissions by the plaintiffs in the rejoinder to the interim

application, as usage of the words ―overlap‖ and ―discloses‖ does not imply

admission. Further, disclosure of „Formula 6‟ does not amount to admission of

disclosure of the specific substance of Claim 12 of the suit patent.

6.19 The suit patent is not liable to be revoked under Section 64 (1)(h) of the

Act, as the suit patent sufficiently and fairly describes the invention and its

CS(COMM) 607/2024 Page 13 of 79

operation, along with the best method by which it is to be performed. Further,

the plaintiffs have been granted corresponding patents in various foreign

jurisdictions, based on the same specifications/descriptions as the present suit

patent.

6.20 The suit patent is not liable to be revoked under Section 64 (1)(j) of the

Act, as the patent application for IN‟104 was filed 3.5 years after the priority

date of the suit patent. Further, the patent application WO‟226 was cited in the

International Search Report, therefore, the complete specification contained in

WO‟226 was never concealed or suppressed from the Patent Office.

6.21 The argument of the defendant that the present case is a case of reverse

genus v. species or „prior species‟ and „later genus‟, is misguided, as the said

concept is purely hypothetical. Even so, no species-genus relationship exists

between IN‟104 and the suit patent, as there is no common lineage between the

said patents, and there exists no hierarchy to enable one to learn the teachings

from the other. Furthermore, the scope and purpose of IN‟104 and the suit

patent are different, as IN‟104 is directed to the discovery of a class of new

compounds, whereas, the suit patent is directed to a novel chemical process to

make specific compounds and certain novel chemical intermediates for that

process.

6.22 The defendant has wrongly argued that IN‟104 came about as an

amendment and hence Section 59 of the Act would apply. However, IN‟104

was filed as a divisional application to IN 232417 (“IN’417”), therefore, the

same is not an amendment, and Section 59 of the Act would not apply.

6.23 The inventors in both patents are entirely different. Therefore, the concept

of ‗Person in the Know‘ is also defeated. Moreover, as there is no

enablement/disclosure in IN‟104 for the suit patent, a ‗Person Skilled in the

Art‘, cannot use disclosures contained in IN‟104 to arrive at the Compounds

CS(COMM) 607/2024 Page 14 of 79

claimed in Claim 12 of the suit patent or vice versa, without any undue

experimentations, and the same is without prejudice to the argument that IN‟104

is published after the suit patent.

6.24 No examination reports by the Patent Office for the suit patent have cited

IN‟104 or its parent application, i.e., IN‟417, as a prior art in India or abroad.

6.25 The book cited by the defendant to show automatic anticipation in

species-genus cases is incorrect, as there exists no disclosure in WO‟226 of the

species in question, nor any enabling disclosure. Therefore, when there is no

disclosure, the proposition of automatic anticipation does not apply.

6.26 The defendant has not successfully made out a case for Gillette Defence,

as there is no disclosure/enablement of any process to manufacture the

intermediate under the suit patent, in WO‟226. Further, the said defence does

not apply in the case of IN‟104, as the defence only applies to prior art, which

IN‟104, being published much after the suit patent, cannot be.

6.27 The contention of the defendant that the plaintiffs have not revealed the

prosecution history of IN‟104 is false. The plaintiffs have clearly stated that

they rely on their reply filed in the revocation petition, which adequately deals

with the objections in relation to IN‟104.

6.28 The case of the defendant that the plaintiffs have not responded to the

case set up by the defendant on science, is incorrect. The plaintiffs have

demonstrated their case with the science and law involved in respect of novelty,

prior claiming and validity of the suit patent. In contrast, the defendant has

failed to show as to how the complete specifications of WO‟226 demonstrates

any lack of novelty or inventive step in the suit patent or the same is anticipated

by WO‟226.

6.29 The plaintiffs seek a narrow scope for interim injunction as the only issue

is with regards to the defendant using the intermediate compound in question to

CS(COMM) 607/2024 Page 15 of 79

manufacture „Cyantraniliprole 10.26% OD‟, and if the same is not used, the

defendant is free to manufacture „Cyantraniliprole 10.26% OD‟.

6.30 The suit patent expires on 06

th

December, 2025. Thus, considering the

limited time left before patent expiry, this case falls under the category of

„bridgehead‟, wherein, balance of convenience is in favour of the plaintiffs.

Moreover, the suit patent stood the test of time as it was granted without any pre

or post-grant opposition, and only in its 18

th

year, it was challenged by way of

the revocation petition filed by the defendant, therefore, effect must be given to

the statutory grant. Further, irreparable harm will be caused to the plaintiffs if

the defendant is allowed to frustrate the plaintiffs‟ suit patent before its term

expires.

6.31 There exists a public interest in protecting patents, especially, when the

same is not even a pharmaceutical patent, where there are overriding public

concerns. Moreover, the defendant has malafidely launched the impugned

product during the course of argument of the present application, which is an

inequitable conduct and has impacted the balance of convenience, even more in

favour of the plaintiffs.

6.32 There is no delay in filing of the present suit as it is the admitted case of

the defendant that they are awaiting the regulatory approval for its infringing

formulation. Further, in the declaratory suit, i.e., C.S. (COMM) 787/2023, the

defendant only disclosed the process of making a formulation but not the

process of making the active ingredient, Cyantraniliprole. Therefore, there was

no indication that the defendant will be using the intermediate compound in

question claimed under Claim 12 of the suit patent.

6.33 The judgement of the Division Bench in the case of F. Hoffman La-

Roche AG Versus Natco Pharma, FAO (OS)(COMM) 43/2025, relates to a

genus-species relationship, which does not exist in the present matter.

CS(COMM) 607/2024 Page 16 of 79

Defendant‟s Submissions:

7. On behalf of the defendant, the following submissions are made:

7.1 Prior to the filing of the present suit by the plaintiffs, the defendant had

filed the revocation petition, i.e., C.O. (COMM.IPD-PAT) 7/2023, wherein, the

defendant had raised a substantial credible challenge to the validity of Claim 12

of the suit patent. Thus, if the defendant at the present prima facie stage

demonstrates a credible challenge, the interim injunction ought not to be

granted. Furthermore, the defendant has already ‗cleared the way‘ by filing the

revocation petition.

7.2 The defendant filed a suit for non-infringement, being C.S. (COMM)

295/2022, titled as ―Natco Pharma Limited Versus FMC Agro Singapore Pte

Ltd. & Ors.‖ on 06

th

May, 2022, seeking a declaration that the defendant‟s

process for manufacturing „Chlorantraniliprole‟ did not infringe the suit patent.

In response, the plaintiffs filed the suit being C.S. (COMM) 349/2022, titled as

―FMC Corporation & Ors. Versus Natco Pharma Limited‖, for infringement of

the suit patent, and also sought ad-interim injunction with respect to claims 1, 5

to 8, and 11 of the suit patent against the defendant. Vide judgment dated 19

th

September, 2022, this Court dismissed the plaintiff‟s application for interim

injunction on the ground that the defendant‟s process did not infringe Claims 1

to 11 of the suit patent. The appeal filed against the said judgment dated 19

th

September, 2022, was dismissed with costs, vide judgement dated 05

th

December, 2022, in FAO (OS)(COMM) 301/2022.

7.3 The plaintiffs claimed the ad-interim injunction against the defendant only

with respect to Claims 1, 5 to 8, and 11 of the suit patent, and therefore,

relinquished the relief of injunction with respect to Claim 12 of the suit patent

under Order II Rule 2 of the CPC.

7.4 In the alternative, even if it is assumed that the suit being C.S. (COMM)

CS(COMM) 607/2024 Page 17 of 79

349/2022, was filed only with respect to Claims 1 to 11 of the suit patent, and

not Claim 12 of the suit patent, then also the plaintiffs are barred from claiming

relief with respect to Claim 12 by way of a subsequent suit under Order II Rule

2 read with Rule 3 of the CPC.

7.5 The defendant had filed the revocation petition, i.e., C.O. (COMM.IPD –

PAT) 7/2023, for revocation of Claim 12 of the suit patent. Despite this, the

plaintiffs instituted three more suits namely, C.S. 11/2023 (renumbered as C.S.

(COMM) 410/2024), titled as ―FMC Corporation and Ors. Versus Natco

Pharma Limited‖, C.S. 2/2024 (renumbered as C.S. (COMM) 409/2024) titled

as ―FMC Corporation Versus Natco Pharma Limited‖ and C.S. 3/2024

(renumbered as C.S. (COMM) 408/2024) titled as ―FMC Corporation Versus

Natco Pharma Limited‖, before the District Court, Chandigarh, seeking relief in

respect of infringement of Claim 12 of the suit patent. The plaintiffs have,

therefore, filed multiple proceedings before the Court with respect to the suit

patent, and therefore, the present suit is an abuse of the process of the Court.

7.6 The plaintiffs have a strategy of using a thicket of more than 40 patents to

prevent third parties, such as the defendant, from launching the product

„Chlorantraniliprole‟ or products analogous thereto. The plaintiffs had filed the

suit being C.S. (COMM) 662/2022, titled as “FMC Corporation and Ors.

Versus GSP Crop Science Private Limited‖ for infringement of the suit patent

by a third party. By way of the judgment dated 14

th

November, 2022, this Court

observed that the long list of patents filed by the plaintiffs in respect of

„Chlorantraniliprole‟ and its various components points to an attempt for

evergreening „Chlorantraniliprole‟, even though the product patent for the same

has expired and therefore, fallen into the public domain.

7.7 The Claim 12 of the suit patent is liable to be revoked under Section 64

(1)(a) of the Act on the ground of anticipation by prior claiming, as IN‟104

CS(COMM) 607/2024 Page 18 of 79

retains its priority date of 22

nd

January, 2002, despite publication of its amended

form in the year 2008. In the present case, Claim 12 of the suit patent falls

within the scope of IN‟104.

7.8 The argument of the plaintiffs is that the Claim in IN‟104 were amended

and published in their current form only in the year 2008, however, the said

argument is incorrect. For the purpose of Section 64 (1)(a) of the Act in relation

to the present case, the relevant date for determining whether IN‟104 is a prior

art with respect to the suit patent, would be the priority date of IN‟104 and not

the date of publication. Furthermore, as per Section 13 (1)(b) of the Act, for

establishing prior claiming, only the priority date of the prior art is relevant, and

the date of publication of the prior art being after the priority date of the

impugned patent, would be immaterial.

7.9 The prior art, IN‟104 retains the priority date, i.e., 22

nd

January, 2002, of

the United States patent application being US 60/350,632. Therefore, the

amended claims of IN‟104 would be relevant for the ground of prior claiming of

Claim 12 of the suit patent.

7.10 The argument of the plaintiffs that the priority date of IN‟104 is pushed to

2008 due to the amendment of IN‟104, is not tenable. This is because the

priority date of IN‟104 from the records of the Indian Patent Office remains 22

nd

January, 2002. The plaintiffs in their reply dated 07

th

November, 2013, to the

examination report by way of amendments, stated that the amendments made to

the patent were within the scope of the original specifications. Therefore, it is

not open to the plaintiffs to now contend that the priority date of IN‟104 is in

2008 under Section 59 of the Act, and the principle of prosecution history

estoppel. Additionally, IN‟104 being a divisional application retains the priority

date of the parent application, as the subject matter of IN‟104 stood disclosed in

the parent application.

CS(COMM) 607/2024 Page 19 of 79

7.11 The Claim 1 of IN‟104 discloses three compounds, and all these three

embodiments have also been claimed in Claim 12 of the suit patent. The

intermediate compound in question, i.e., 2-amino-5-cyano-N, 3-

dimethylbenzamide under Claim 12 of the suit patent stands prior claimed, when

R

3

is methyl in Claim 1 of IN‟104. Thus, the specific compound for which the

plaintiffs assert their right, i.e., the intermediate compound in question, is

specifically claimed in IN‟104.

7.12 In relation to proviso (d) of Claim 12 of the suit patent, the same stands

prior claimed on another aspect such as when R

3

is isopropyl in Claim 1 of

IN‟104. Further, proviso (b) of Claim 12 of the suit patent also stands prior

claimed when R

3

is H in Claim 1 of IN‟104. Therefore, as all three compounds

as claimed in Claim 12 of the suit patent are prior claimed in IN‟104, it would

result in anticipation by prior claiming of Claim 12 in its entirety. Thus, the suit

patent is liable to revoked under Section 64 (1)(a) of the Act.

7.13 For the purposes of prior claiming, it is not essential that the claims are

identical or that the prior claim be an enabling document.

7.14 In the present case, the patent IN‟104 is a species patent, and the suit

patent is a genus patent. The Formula 6 of Claim 1 of IN‟104, being the species

patent, covers the broadly known Formula 3 of Claim 12 of the suit patent. A

generic claim cannot be allowed to the plaintiffs if the prior art discloses a

species falling within the subsequently claimed genus patent. Thus, the suit

patent, being a genus patent, is prior claimed by the species patent.

7.15 The plaintiffs have already enjoyed monopoly rights in the compounds of

Claim 1 of IN‟104 and are attempting to re-monopolize/evergreen the same

compounds through the suit patent.

7.16 The test of ‗person in the know‘ is applicable to the present matter given

the presence of common applicant between IN‟104 and the suit patent.

CS(COMM) 607/2024 Page 20 of 79

7.17 Alternatively, Claim 1 of IN‟104 covers the subject matter of the suit

patent, and such coverage is sufficient to prove anticipation of Claim 12 of the

suit patent by prior claiming.

7.18 The Claim 12 of the suit patent lacks novelty. The patent IN‟104 was

filed as a national phase application corresponding to PCT application dated

16

th

January, 2003 for WO‟226, which was published on 31

st

July, 2003, which

is prior to the priority date of the suit patent. Further, the Claims as granted in

IN‟104 were incorporated by way of an amendment from the original complete

specification filed in India, which is identical to WO‟226, and the same could

have only been done, if the amended claims in IN‟104 were within the scope of

WO‟226. Therefore, any statement to the contrary would statutorily nullify the

priority claim in respect of IN‟104, as IN‟104 cannot extend beyond the claims

made in the priority corresponding application WO‟226 and any amendments

made cannot be inconsistent with the earlier claims, and should fall within the

scope of the earlier claims.

7.19 In the present case, it is established that the Claim 12 of the suit patent

falls within the scope of the disclosure made in the IN‟104 and WO‟226.

Further, the Claim 12 of the suit patent is enabled by the disclosures made under

WO‟226. Claim 12 stands anticipated by the disclosures made in WO‟226.

7.20 The submission of the plaintiffs that WO‟226 only discloses the

preparation of Formula 1 is incorrect, as once the preparation and use of

Formula 6 is disclosed in enabling detail, Claim 12 of the suit patent will be

anticipated by WO‟226. Moreover, WO‟226 clearly discloses not only the end

products of Formula 1, but also the preparation of Formula 6, which are the

intermediates that are also claimed in Claim 12 of the suit patent.

7.21 IN‟104 explicitly deals with the process of manufacture of Compounds of

Formula 6 of Claim 1 of IN‟104, which are the class of Compounds that relate

CS(COMM) 607/2024 Page 21 of 79

to Formula 3 of Claim 12 of the suit patent. IN‟104 and its parent WO‟226

disclose the specific process of manufacture of bromo analogue of 2-

aminobenzamides, which is analogous to the Compound in Claim 12 of the suit

patent. The prior patent WO‟226 also states that by using the said procedure,

with methods known in the art, the compounds mentioned in Tables 1-10 can be

prepared. The Tables in the said specification provide for the manufacture of the

intermediate compound in question under Claim 12 of the suit patent. Thus,

IN‟104 and WO‟226 result in express disclosure of the intermediate compound

in question under Claim 12 of the suit patent. Thus, the argument of the

plaintiffs that the defendant is slicing the compound in IN‟104 is unfounded.

7.22 The plaintiffs admit that there is an overlap between Claim 12 of the suit

patent and Claim 1 of IN‟104, in the rejoinder to the reply of the present

application.

7.23 The plaintiffs have made clear admissions during the prosecution of

IN‟104, which shows that Claim 12 of the suit patent falls within the scope of

WO‟226. The plaintiffs in the First Examination Reports dated 18

th

January,

2013 and 13

th

December, 2013, Responses dated 07

th

November, 2013 and

10

th

January, 2014, to the First Examination Reports, and in their rejoinder to the

revocation petition, have made clear admissions to the said aspect. Further, the

Controller withdrew the objection under Section 10 (4)(a) of the Act solely on

the basis of the submissions that the claimed subject matter of the amended

claims of IN‟104 was already disclosed in WO‟226 and in the originally filed

version of IN‟104.

7.24 The plaintiffs in their reply to the revocation petition, have admitted to

the fact that the Claim 12 of IN‟645 is covered by IN‟104, and that the

Compounds claimed in Claim 12 of IN‟645, have been selected from the subject

matter of WO‟226. Therefore, the admissions made by the plaintiffs in their

CS(COMM) 607/2024 Page 22 of 79

reply, disentitles them from taking any defence to the injunction application, at

the least at the interim stage.

7.25 The defendant can invoke the Gillette Defence as the defendant does not

infringe the suit patent since the intermediate compound in question, being 2-

amino-5-cyano-N, 3-dimethylbenzamide, made by the defendant, is both

claimed and disclosed by IN‟104 and WO‟226, which have already expired.

Thus, the defendant is practising the prior art already in public domain, and

does not infringe the suit patent.

7.26 The Gillette Defence also results in the invalidity of the Claim 12 of the

suit patent as the same is anticipated by IN‟104 by prior claiming, and by

WO‟226 by prior publication. Additionally, the Compound in Formula 3 of

Claim 12 of the suit patent is a known substance, and the same cannot be a valid

patent under Section 3 (d) of the Act.

7.27 The Claim 12 of the suit patent lacks inventive step and is liable to be

revoked under Section 64 (1)(f) of the Act, as a ‗Person Skilled in the Art‘

would know the use of alternate halogen, pseudo halogen and bioisosteres, as

was done by the plaintiffs in the suit patent in comparison to the prior arts. The

same is supported by the statements made by the plaintiffs in their Response to

the Examination Reports in IN‟104, which shows that a ‗Person Skilled in the

Art‘ would already know Claim 12 of the suit patent.

7.28 The Claim 12 of the suit patent is also liable to be rejected under Section

64 (1)(k) of the Act, as the Compounds claimed in Claim 12 of the suit patent

are obvious variant and/or derivative of the already known prior art, and also

does not show any significant difference in efficacy between the known

Compounds in the prior art and the Compounds claimed in Claim 12 of the suit

patent. Further, the burden is on the plaintiffs to show that Claim 12 of the suit

patent shows significant efficacy to the prior art Compounds, which they have

CS(COMM) 607/2024 Page 23 of 79

failed to do so.

7.29 Claim 12 of the suit patent is also liable to be rejected under Sections 64

(1)(i) and Section 64 (1)(h) of the Act, on account of insufficient description of

the invention. Further, the complete specifications of the suit patent are not

complete or categorical in defining the best mode of working the invention.

Moreover, the plaintiffs have failed to disclose the scope of the said Claim 12 of

the suit patent, and use ambiguous terms such as “other than” in all of its

proviso, which is ambiguous and suggests that vast number of Compounds can

be claimed in Claim 12, which is against the settled principles of patent law.

7.30 Claim 12 of the suit patent is also liable to be rejected under Section 64

(1)(j) of the Act, as the plaintiffs materially suppressed that they were well

aware of the existence of IN‟104 and other prior art documents, and the

plaintiffs were under an obligation to disclose the filing of the same before the

Patent Office at the time of prosecuting the suit patent.

7.31 The balance of convenience lies in favour of the defendant and

irreparable loss would be caused to the defendant, as the defendant has prima

facie shown a credible challenge to the validity of Claim 12 of the suit patent,

and has already started the commercial production of Cyantraniliprole

compound since April, 2025. Therefore, the defendant has invested heavily

towards the same. In contrast, the plaintiffs can be compensated by damages in

the event they succeed in the suit as any injury that they may suffer would be

purely monetary, given that only three months are left for the suit patent to

expire.

7.32 The plaintiffs are disentitled to any relief on account of the delay in filing

the present suit, as the defendant had filed the revocation petition on 31

st

October, 2023, and the plaintiffs filed the present suit on 22

nd

July, 2024.

Further, in view of the earlier filed pending litigations between the parties, and

CS(COMM) 607/2024 Page 24 of 79

the disclosure made by the defendant in the said proceedings, the plaintiffs have

approached this Court with a substantial delay. Therefore, such delay disentitles

the plaintiffs from receiving any interim relief.

7.33 The plaintiffs despite there being several litigations between the parties,

has been unable to obtain any favourable orders from this Court, particularly,

when the defendant has already disclosed the use of the intermediate compound

in question, i.e., 2-amino-5-cyano-N, 3-dimethylbenzamide for the purpose of

manufacturing Cyantraniliprole. Therefore, in view of the conduct of the

plaintiffs in earlier proceedings, the plaintiffs are not entitled to any

equitable/interim relief.

7.34 The patent application, i.e., CN102285899B of the plaintiffs in China,

which corresponds to the suit patent, has already been revoked in China on the

ground, inter alia, of lack of inventive step.

7.35 The judgement of the Division Bench in the case of F. Hoffman La-Roche

AG Versus Natco Pharma, FAO (OS)(COMM) 43/2025, reaffirms Section 53

(4) of the Act and the test of ‗Person in the Know‘. Therefore, the defendant has

not infringed the rights of the plaintiffs by using the intermediate compound in

question claimed under Claim 12 of the suit patent.

FINDINGS AND ANALYSIS

8. The present suit has been filed by the plaintiffs as a quia timet action, on

the basis that the plaintiffs had a strong and credible apprehension that the

defendant was manufacturing/preparing the product covered by the suit patent,

i.e., „Cyantraniliprole 10.26% OD‟ and/or other ad-mixture, combination,

formulation products containing Cyantraniliprole (“CNTPR”) using the

Compound of Formula 3 as claimed in Claim 12 of the suit patent as a specific

intermediate.

9. In the present case, the plaintiffs assert their rights in the suit patent with

CS(COMM) 607/2024 Page 25 of 79

respect to Claim 12 of IN‟645 for manufacturing and launching a product

comprising CNTPR, manufactured using the claimed intermediates. Claim 12 of

the suit patent relates to intermediates that can be used in the manufacture of

CNTPR, carrying the structure and formula as mentioned in Claim 12.

10. The bibliographical details of the suit patent, IN‟645 which is set to

expire on 06

th

December, 2025, are detailed in the table reproduced as under:

CS(COMM) 607/2024 Page 26 of 79

11. The suit patent claims a process for the preparation of

„Cyantraniliprole/CNTPR‟ and a claim for intermediates which are utilised to

manufacture CNTPR. The Claim 12 under the suit patent, i.e., the claim in

dispute in the present case, is a product claim that claims a Compound of

Formula 3. The said Compound of Formula 3 under Claim 12, as per the suit

patent, is depicted as under:

CS(COMM) 607/2024 Page 27 of 79

12. The Compound of Formula 3 is qualified by provisos (a) to (d), of which

proviso (d) states ―when R

1

is CH3 and R

2

is CN, then R

3

is other than H‖.

Therefore, as per proviso (d) of Claim 12, where R

1

is CH3 and R

2

is CN, then R

3

in the Compound of Formula 3 can be any of C1-C4 alkyl group as limited by

Claim 12. Moreover, when R

3

is C1 alkyl, i.e., CH3, the Compound of Formula 3

becomes 2-amino-5-cyano-N, 3-dimethylbenzamide, which is the intermediate

compound in question. The said intermediate compound in question, as depicted

in the plaint, is reproduced as under:

13. Thus, the compound named as 2-amino-5-cyano-N, 3-dimethylbenzamide,

i.e., intermediate compound in question, has also been specifically disclosed as

CS(COMM) 607/2024 Page 28 of 79

Example 6 in the complete specification of the suit patent, as put forward by the

plaintiffs in the plaint.

14. On the basis of the submissions advanced on behalf of the counsels for

the parties, it is clear that the defendant‟s argument of non-infringement is

based on the ‗Gillette Defence‘, in that the defendant is practicing the prior arts,

i.e., IN‟104, and WO‟226, which have already expired and fallen in public

domain, and therefore, the defendant is not infringing Claim 12 of the suit

patent.

15. Furthermore, the defendant has challenged the validity of Claim 12 of the

suit patent under Section 107(1) of the Act, by raising grounds for revocation of

Claim 12 of the suit patent under Section 64 of the Act. From the defences taken

by the defendant under Section 64 of the Act, this Court is of the considered

opinion that the key questions which arise for consideration before this Court at

this stage are, as follows:

a. Whether the suit patent is anticipated by prior claiming by the plaintiffs in

IN‟104, in terms of Section 64 (1)(a) of the Act.

b. Whether the suit patent lacks novelty as it falls within the scope of

WO‟226 in terms of Section 64 (1)(e) of the Act.

16. Since the defendant is raising grounds of its non-infringement on the

basis of invalidity of Claim 12 of the suit patent, this Court notes that law is

well settled that grant of a patent does not guarantee the validity of a patent and

there is no presumption of validity. Reference may be made to Section 13 (4) of

the Act, which reads as under:

―xxx xxx xxx

13. Search for anticipation by previous publication and by prior

claim.

…….

(4) The examination and investigations required under section 12 and

CS(COMM) 607/2024 Page 29 of 79

this section shall not be deemed in any way to warrant the validity of

any patent, and no liability shall be incurred by the Central

Government or any officer thereof by reason of, or in connection with,

any such examination or investigation or any report or other

proceedings consequent thereon.

xxx xxx xxx‖

17. Thus, holding that grant of the patent does not guarantee the validity of

the patent, which can be challenged on various grounds of revocation, the

Supreme Court in the case of Bishwanath Prasad Radhey Shyam Versus

Hindustan Metal Industries

1

, has held as follows:

―xxx xxx xxx

32. It is noteworthy that the grant and sealing of the patent, or the

decision rendered by the Controller in the case of opposition, does

not guarantee the validity of the patent, which can be challenged

before the High Court on various grounds in revocation or

infringement proceedings. It is pertinent to note that this position

viz. the validity of a patent is not guaranteed by the grant, is now

expressly provided in Section 13(4) of the Patents Act. 1970. In the

light of this principle, Mr Mehta's argument that there is a

presumption in favour of the validity of the patent, cannot be

accepted.

xxx xxx xxx‖

(Emphasis Supplied)

18. Similarly, holding that registration of a patent per se does not entitle a

party to an injunction when a credible challenge has been raised to the patent,

and that there is no presumption of a validity of a patent, this Court in the case

of TenXC Wireless Inc. and Anr. Versus Mobi Antenna Technologies

(Shenzhen) Co. Ltd.

2

, has held as follows:

―xxx xxx xxx

7.10 The well settled principles for grant of interim injunction in

patent matters laid down by the Courts in the aforesaid judgments are

summarized as under:—

7.10.1 The registration of a patent per se does not entitle the plaintiffs

to an injunction. The certificate does not establish a conclusive right.

1

(1979) 2 SCC 511

2

2011 SCC OnLine Del 4648

CS(COMM) 607/2024 Page 30 of 79

7.10.2 There is no presumption of validity of a patent, which is

evident from the reading of Section 13(4) as well as Sections 64 and

107 of the Patents Act.

7.10.3 The claimed invention has to be tested and tried in the

laboratory of Courts.

7.10.4 The Courts lean against monopolies. The purpose of the legal

regime in the area is to ensure that the inventions should benefit the

public at large.

7.10.5 The plaintiff is not entitled to an injunction if the defendant

raises a credible challenge to the patent. Credible challenge means a

serious question to be tried. The defendant need not make out a case

of actual invalidity. Vulnerability is the issue at the preliminary

injunction stage whereas the validity is the issue at trial. The

showing of a substantial question as to invalidity thus requires less

proof than the clear and convincing showing necessary to establish

invalidity itself.

7.10.6 At this stage, the Court is not expected to examine the

challenge in detail and arrive at a definite finding on the question of

validity of the patent. That will have to await at the time of trial.

However, the Court has to be satisfied that a substantial, tenable and

credible challenge has been made.

xxx xxx xxx‖

(Emphasis Supplied)

19. Delving on the aspect of there being no presumption of validity of a

patent and that at the interim stage, the defendant is required only to raise a

credible challenge to the validity of a patent or show vulnerability to the said

patent, the Division Bench of this Court in the case of F. Hoffman-LA Roche

Ltd. & Anr. Versus Cipla Ltd.

3

, held as follows:

―xxx xxx xxx

53. The plea of the plaintiff that since there is a multi-layered,

multi-level examination of the opposition to the grant of patent it

should accorded the highest weightage, is not entirely correct. The

contention that there is a heavy burden on the defendant to discharge

since it has to establish that it has a stronger prima facie case of the

plaintiff is contra indicated of the decisions in the context of Section

13(4). Reference may be made to the decisions in Biswanath Prasad

3

2009 SCC OnLine Del 1074

CS(COMM) 607/2024 Page 31 of 79

Radhey Shyam v. Hindustan Metal Industries, AIR 1982 SC 1444 :

PTC (Suppl)(1) 731 (SC), Standipack Pvt. Ltd. v. Oswal Trading Co.

Ltd., AIR 2000 Del 23 : 1999 PTC (19) 479 (Del), Bilcare Ltd. v.

Amartara Pvt. Ltd., 2007 (34) PTC 419 (Del), Surendra Lal

Mahendra v. Jain Glazers, (1979) 11 SCC 511. In Beecham Group

Ltd. v. Bristol Laboratories Pty Ltd., (1967-1968) 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 on that

issue. In Hexal Australai 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.‖ In Abbot

Laboratories v. Andrx Pharmaceuticals Inc. (decision dated 22nd

June 2006 of the U.S. Court of Appeals for the Federal Circuit 05-

1433) the Court of Appeals followed its earlier ruling in Helifix Ltd. v.

Blok-Lok Ltd. 208 F.3d 1339 where it was held (at 1359): “In

resisting a preliminary injunction, however, one need not make out

a case of actual invalidity. Vulnerability is the issue at the

preliminary injunction stage, while validity is the issue at trial. The

showing of a substantial question as to invalidity thus requires less

proof than the clear and convincing showing necessary to establish

invalidity itself.” (emphasis supplied) In Erico Int'll Corprn v. Vutec

Corprn (U.S. Court of Appeals for the Federal Circuit, 2007-1168) it

was held that the ―defendant must put forth a substantial question of

invalidity to show that the claims at issue are vulnerable.‖

54. In the present case, the grant of a patent to the plaintiffs for

Erlotinib Hydrochloride as a mixture of Polymorphs A and B will not

ipso facto entitle them to an interim injunction if the defendant is able

to satisfy the court that there is a serious question to be tried as to the

validity of the patent. The use by the learned Single Judge of the

expressions ―strong credible challenge‖, ―arguable case‖ or that the

defendants claim being not unfounded, cannot be termed as vague and

inconsistent since they convey the same meaning in the context of the

strength of the defendant's challenge.

55. The question before this Court is when can it be said that the

defendant has raised a credible challenge to the validity of a patent

held by the plaintiff in an infringement action? During the course of

the argument it was suggested by counsel that the challenge had to

be both strong and credible. Also, the defendant resisting the grant

of injunction by challenging the validity of the patent is at this stage

required to show that the patent is “vulnerable” and that the

challenge raises a “serious substantial question” and a triable issue.

Without indulging in an exercise in semantics, the Court when faced

CS(COMM) 607/2024 Page 32 of 79

with a prayer for grant of injunction and a corresponding plea of the

defendant challenging the validity of the patent itself, must enquire

whether the defendant has raised a credible challenge. In other

words, that would in the context of pharmaceutical products, invite

scrutiny of the order granting patent in the light of Section 3(d) and

the grounds set out in Section 64 of the Patents Act 1970. At this stage

of course the Court is not expected to examine the challenge in any

great detail and arrive at a definite finding on the question of

validity. That will have to await the trial. At the present stage of

considering the grant of an interim injunction, the defendant has to

show that the patent that has been granted is vulnerable to

challenge. Consequently, this Court rejects the contentions of the

plaintiffs on this issue and affirms the impugned judgment of the

learned Single Judge.

xxx xxx xxx‖

(Emphasis Supplied)

20. It may be noted that prior to the present suit for infringement filed by the

plaintiffs, the defendant had filed a revocation petition, wherein, the defendant

had challenged the validity of Claim 12 of the suit patent. Thus, in consonance

with the principles as laid down in F. Hoffman-LA Roche Ltd. & Anr. Versus

Cipla Ltd.

4

, at this interim stage, this Court would adjudge whether the

defendant has prima facie demonstrated a vulnerability of Claim 12 of the suit

patent. If a prima facie case on invalidity of Claim 12 of the suit patent is

demonstrated by the defendant, then this Court would not grant any interim

injunction.

Challenge under Section 64 (1)(a) of the Act:

21. It is the case of the defendant that Claim 12 of the suit patent is liable to

be revoked under Section 64 (1)(a) of the Act on the ground that the said Claim

12 is prior claimed in IN‟104, i.e., another one of plaintiffs‟ patent, as it claims

and discloses the intermediate compounds claimed under Claim 12 of the suit

patent, and the priority date of IN‟104 is prior to that of the suit patent.

22. Before considering IN‟104 on the aspect whether it anticipates Claim 12

4

2009 SCC OnLine Del 1074

CS(COMM) 607/2024 Page 33 of 79

of the suit patent by prior claiming, it would have to be determined as to

whether IN‟104 can be considered to have a prior claim in relation to the suit

patent, i.e., IN‟645, in view of the various objections raised by the plaintiffs in

this regard. The plaintiffs have averred that considering that IN‟104 was

published under Section 11A of the Act on 15

th

August, 2008, much later to the

priority date of the suit patent, i.e., 07

th

December, 2004, the same is not prior

art.

Date of Publication or Date of Priority:

23. In the present case, the plaintiffs have relied on the aspect that when

ascertaining the claim of invalidity under Section 64 (1)(a) of the Act, it is the

‗date of publication‘ of the prior patent which has to be considered. In contrast,

the defendant propounds that it is the ‗priority date‘ of the patent, that is to be

considered in relation to Section 64 (1)(a) of the Act. Thus, it is for this Court to

consider, whether in the present case, it is the ‗date of publication‘ or ‗priority

date‘ which shall be the relevant date for the purposes of there being any

credible challenge raised under Section 64 (1)(a) of the Act.

24. Before adverting to the facts of the present case, it would be apposite to

discuss the law in relation to Section 64 (1)(a) of the Act, which lays down

factors that are to be considered for determining that an invention is claimed in

an earlier claim of the complete specification of another patent granted in India.

Section 64 (1)(a) of the Act reads as under:

―xxx xxx xxx

64. Revocation of patents – (1) Subject to the provisions contained in

this Act, a patent, whether granted before or after the commencement

of this Act, may, [be revoked on a petition of any person interested or

of the Central Government [* * *] or on a counter-claim in a suit for

infringement of the patent by the High Court] on any of the following

grounds, that is to say,—

(a) that the invention, so far as claimed in any claim of the

complete specification, was claimed in a valid claim of earlier

CS(COMM) 607/2024 Page 34 of 79

priority date contained in the complete specification of another

patent granted in India;

xxx xxx xxx‖

(Emphasis Supplied)

25. Anticipation by prior claiming has also been specifically discussed under

Section 13 (1)(b) of the Act. According to the said section, for the purpose of

ascertaining whether the invention as claimed in any claim of the complete

specification is anticipated by prior claiming, the priority date of the prior patent

shall be relevant, not the date of publication. Section 13 (1)(b) of the Act, reads

as under:

―xxx xxx xxx

13. Search for anticipation by previous publication and by prior

claim.—The examiner to whom an application for a patent is referred

under Section 12 shall make investigation for the purpose of

ascertaining whether the invention so far as claimed in any claim of

the complete specification—

(a) has been anticipated by publication before the date of filing

of the applicant's complete specification in any specification

filed in pursuance of an application for a patent made in India

and dated on or after the 1st day of January, 1912;

(b) is claimed in any claim of any other complete specification

published on or after the date of filing of the applicant's

complete specification, being a specification filed in pursuance

of an application for a patent made in India and dated before

or claiming the priority date earlier than that date.

xxx xxx xxx‖

(Emphasis Supplied)

26. Likewise, this Court in the case of Boehringer Ingelheim Pharma

GMBH & Co. KG Versus Vee Excel Drugs and Pharmaceuticals Private Ltd.

and Others

5

, has culled out factors that are to be considered in order for a patent

to be revoked under Section 64 (1)(a) of the Act. Thus, it was held as under:

―xxx xxx xxx

54. In order for a patent to be revoked under Section 64(1)(a) of the

Patents Act, the following factors have to be established:

5

2023 SCC OnLine Del 1889

CS(COMM) 607/2024 Page 35 of 79

i. The prior patent has to be the one granted in India.

ii. The said prior patent has to have an earlier priority date than the

latter patent application.

iii. The invention claimed in the latter patent was also claimed in the

earlier patent application.

iv. The date of publication of prior patent is irrelevant.

55. In the present case, it is undisputed that the genus patent, IN ‗719,

is an Indian patent having an earlier priority date than the species

patent, IN ‗301. Therefore, what has to be examined is whether what

has been claimed in the species patent, has been claimed in the genus

patent. The fact that in the present case, the publication date of the

genus patent was after the priority date of the species patent, would

not be relevant.

xxx xxx xxx‖

(Emphasis Supplied)

27. Thus, it is clear that it is the ‗date of priority‘, and not the ‗date of

publication‘ of the prior patent that is relevant for determining whether a patent

is a prior art under Section 64 (1)(a) of the Act, and the ‗date of publication‘ of

the prior art is irrelevant. Therefore, the test is to enquire whether subject matter

claimed in the patent under dispute has already been claimed in a patent which

has an earlier priority date.

28. This Court also notes that IN‟104 has been filed as a divisional patent of

IN‟417, which corresponds to the international counterpart being WO‟226.

29. It is settled law that the priority date of a divisional application is the date

of filing of that specification in which the matter was first disclosed. Law with

regard to division applications is encapsulated in Section 11 and Section 16 of

the Act, relevant portions of which are reproduced as under:

―xxx xxx xxx

11. Priority dates of claims of a complete specification.— (1) There

shall be a priority date for each claim of a complete specification.

……

(4) Where the complete specification has been filed in

pursuance of a further application made by virtue of sub-section (1)

of Section 16 and the claim is fairly based on the matter disclosed in

CS(COMM) 607/2024 Page 36 of 79

any of the earlier specifications, provisional or complete, as the case

may be, the priority date of that claim shall be the date of the filing

of that specification in which the matter was first disclosed.

xxx xxx xxx

16. Power of Controller to make orders respecting division of

application.—(1) A person who has made an application for a patent

under this Act may, at any time before the[grant of the patent], if he so

desires, or with a view to remedy the objection raised by the

Controller on the ground that the claims of the complete specification

relate to more than one invention, file a further application in respect

of an invention disclosed in the provisional or complete specification

already filed in respect of the first mentioned application.

(2) The further application under sub-section (1) shall be

accompanied by a complete specification, but such complete

specification shall not include any matter not in substance disclosed

in the complete specification filed in pursuance of the first

mentioned application.

xxx xxx xxx‖

(Emphasis Supplied)

30. In this regard, it would be useful to refer to the Patent Cooperation Treaty

(“PCT”), wherein, under Article 2, Clause (xi), „priority date‟ has been defined

as follows:

―xxx xxx xxx

(xi) “priority date,” for the purposes of computing time limits,

means:

(a) where the international application contains a priority claim

under Article 8, the filing date of the application whose priority is

so claimed;

(b) where the international application contains several priority

claims under Article 8, the filing date of the earliest application

whose priority is so claimed;

(c) where the international application does not contain any

priority claim under Article 8, the international filing date of such

application;

xxx xxx xxx‖

(Emphasis Supplied)

CS(COMM) 607/2024 Page 37 of 79

31. At this stage it would be relevant to note the bibliographic data of IN‟104,

which is extracted as below:

CS(COMM) 607/2024 Page 38 of 79

32. This Court notes that as per the bibliographic data of IN‟104, the priority

date of IN‟104 is 22

nd

January, 2002. Thus, from the documents on record, it

can be ascertained that WO‟226 has retained the priority date of the US phase

application, i.e., US60/350,632 which is 22

nd

January, 2002.

33. This Court further makes note of the admission on behalf of the plaintiffs

in their replication, wherein, it is stated that IN‟417 takes priority from

WO‟226, which in turn takes priority from the US60/350,632. The relevant

portion of the replication filed by the plaintiffs is reproduced as under:

―xxx xxx xxx

25. As mentioned hereinabove, IN'104 is a divisional of patent

application 1492/DELNP/2004, which in turn is the national phase

application of PCT/US2003/01482 (published as WO 03/062226A1)

which in turn takes priority from US60/350632. A reading of the

complete specifications of all these patent documents would inform

the person skilled in the art that the invention was actually directed to

a broad class of insecticides, having Formula I, as depicted

hereinbelow.

xxx xxx xxx‖

(Emphasis Supplied)

34. It is also noted that even the records maintained by the Indian Patent

Office for IN‟104 on their website reflects the priority date as 22

nd

January,

2002. The relevant portion of the Indian Patent Office website reflecting details

CS(COMM) 607/2024 Page 39 of 79

of IN‟104 is reproduced as under:

―xxx xxx xxx

xxx xxx xxx‖

35. Therefore, keeping in view of the aforesaid, the divisional patent, i.e.,

IN‟104 filed by the plaintiffs having retained its priority date, i.e., 22

nd

January,

2002, from IN‟417, will be relevant for the purposes of Section 64 (1)(a) of the

Act.

36. Thus, in effect, as the suit patent, IN‟645 has its date of priority as 07

th

December, 2004 and IN‟104 which, as noted above, retains date of priority of

IN‟417, i.e., 22

nd

January, 2002, will be a prior art to IN‟645. Therefore, the

contention of the plaintiffs that IN‟104, cannot be considered as a prior art for

assessing anticipation under Section 64 (1)(a) of the Act, is prima facie

untenable.

37. Therefore, keeping the above into consideration, if this Court arrives at

the conclusion that IN‟104 prior claims the Claim 12 of the suit patent, the same

would necessarily be vulnerable to invalidity.

CS(COMM) 607/2024 Page 40 of 79

Claim to Claim Comparison:

38. Thus, to examine whether Claim 12 of the suit patent is prior claimed in

Claim 1 of IN‟104, a comparison of Claim 12 of IN‟645 and Claim 1 of IN‟104,

is set out below:

Claim 12 of Suit patent along with

Example 6

Claim 1 of IN’104

12. A compound of Formula 3

wherein

R

1

is CH3 or Cl;

R

2

is Br, Cl, l or CN; and

R

3

is H or C1-C4 alkyl;

provided that

(a) when R

1

and R

2

are Cl, then R

3

is

other than H, CH 2CH3, or

CH(CH3)CH2CH3;

(b) when R

1

is CH3 and R

2

is Cl, Br

or CN, then R

3

is other than CH3 or

CH(CH3)2;

(c) when R

1

is Cl and R

2

is Cl or Br,

then R

3

is other than CH3 or

CH(CH3)2; and

(d) when R

1

is CH3 and R

2

is CN,

then R

3

is other than H.

1. 2-aminobenzamides compound of

Formula 6:

wherein

R

3

is H, methyl or isopropyl;

n is 2;

one R

4

group is attached to the

phenyl ring at the 2-position and said

R

4

is CH3; and a second R

4

is

attached to the phenyl ring at the 4-

position and said R

4

is CN.

Example 6:

Preparation of 2-amino-5-cyano-

N,3-dimethylbenzamide

CS(COMM) 607/2024 Page 41 of 79

39. From the aforesaid comparative table, it is manifest that Claim 12 of

IN‟645, the suit patent, directly claims the intermediate compound in question,

i.e., 2-amino-5-cyano-N, 3-dimethylbenzamide. In this regard, reference may be

made to proviso (d) in Claim 12 of IN‟645, the suit patent, wherein, R

1

is CH3,

R

2

is CN and R

3

is other than H. The Compound of Formula 3 in IN‟645, the

suit patent, itself stipulates as follows:

I. R

1

is CH3 or Cl;

II. R

2

is Br, Cl, 1 or CN; and

III. R

3

is H or C1-C4 alkyl

40. Thus, the Compound of Formula 3 in IN‟645, the suit patent, itself shows

that if R

3

is other than H, then it would be C1-C4 alkyl. Thus, in proviso (d),

when R

3

is C1 alkyl group or Methyl, i.e., CH3, then the said proviso (d) of

Claim 12 in IN‟645, the suit patent, claims the intermediate compound in

question, i.e., 2-amino-5-cyano-N, 3-dimethylbenzamide.

41. The intermediate compound in question as claimed in proviso (d) of

Claim 12, and as exemplified in Example 6 is specifically claiming „2-amino-5-

cyano-N, 3-dimethylbenzamide‘. This Compound is structurally represented as

below:

42. This compound has a benzene ring with –CONHCH₃ (benzamide with N-

methyl) at 1-position, –NH₂ (amino group) at 2-position, –CH₃ (ring methyl) at

CS(COMM) 607/2024 Page 42 of 79

3-position and –CN (cyano group) at 5-position.

43. Now coming to the prior patent, it is seen that IN‟104 claims the

Compound of Formula 6, i.e., 2-aminobenzamides. Further, from a reading of

Formula 6 of Claim 1 of IN‟104 from the point of view of a Person Skilled in

the Art, the following can be culled out:

i. There are three positions on the chemical structure namely, R

3

, first

R

4

attached to the phenyl ring at the 2-position, and the second R

4

attached to the phenyl ring at the 4-position.

ii. It is claimed that R

4

attached to the phenyl ring at the 2-position is

CH3, and the second R

4

attached to the phenyl ring at the 4-position

is CN, which does not vary in all the compounds claimed under

Claim 1 of IN‟104.

iii. It is claimed that R

3

position in the chemical structure has three

variables, namely, H, methyl or isopropyl.

iv. Thus, the only variable is R

3

, which has three variants namely H,

Methyl, or Isopropyl. All other aspects of Claim 1 of IN‟104 are

fixed.

44. From the above, prima facie, it is seen that there are three compounds

claimed in Claim 1 of IN‟104, as also asserted by the defendant, which position

the plaintiffs have been unable to controvert with any substantial argument.

Though the plaintiffs have argued that IN‟104 discloses a vast number of

compounds, the said argument was not substantiated or addressed in any

manner by demonstrating or bringing forth any other compound which could be

derived from Claim 1 of IN‟104. The three compounds which have been

claimed in Claim 1 in IN‟104 are as follows:

CS(COMM) 607/2024 Page 43 of 79

a) When R

3

is Isopropyl, the compound claimed in IN‟104 would be chemically

represented as follows:

b) When R

3

is Methyl, the compound claimed in IN‟104 would be chemically

represented as follows:

c) When R

3

is Hydrogen, the compound claimed in IN‟104 would be chemically

represented as follows:

45. Therefore, when comparing Claim 12 along with Example 6 of the suit

patent with the three compounds derivable from the Claim 1 of the prior patent,

i.e., IN‟104, it is to be seen as to whether the intermediate compound in

question of Claim 12 of the suit patent is already claimed as one of the

compounds in Claim 1 of the prior patent, IN‟104. Thus, the Compounds of

Formula 6 in Claim 1 of IN‟104, i.e., prior art, has to be perused alongside the

intermediate compound in question in Claim 12 of the suit patent.

CS(COMM) 607/2024 Page 44 of 79

46. This Court notes that when R

3

is methyl, i.e., CH3 , in Claim 1 of the

IN‟104, the prior art, the resultant compound is 2-amino-5-cyano-N, 3-

dimethylbenzamide. Thus, in both the compounds of Claim 1 of IN‟104, i.e.,

prior art, and C1 alkyl group variable in proviso (d) of Claim 12 of IN‟645, i.e.,

suit patent, in the said two patents, the resultant compound, i.e., 2-amino-5-

cyano-N, 3-dimethylbenzamide, is the same. This is diagrammatically shown

below:

COMPOUND IN PROVISO (D)

OF CLAIM 12 OF THE SUIT

PATENT, IN’645

COMPOUND IN CLAIM 1 OF

THE PRIOR ART, IN’104

WHEN R

3

IS METHYL (CH3)

47. From the above, it is manifest that the intermediate compound in question

which is being asserted for infringement by the plaintiffs is 2-amino-5-cyano-N,

3-dimethylbenzamide, which has been specifically claimed in IN‟104, the prior

art, as well. Thus, it is clear that the intermediate compound in question of

Claim 12 of suit patent alongwith Example 6 has already been claimed in Claim

1 of IN‟104, the prior art.

48. Even when seen from the perspective of a Person Skilled in the Art,

wherein, upon following the instructions in Claim 1 of IN‟104 without using

any inventive ingenuity, the Person Skilled in the Art would be able to form the

compound in IN‟104, the prior art, where R

3

is methyl, and it would be clear

that the compound would be 2-amino-5-cyano-N, 3-dimethylbenzamide, i.e., the

intermediate compound in question in the present suit. The Person Skilled in the

Art would further be guided to reach the other two compounds which are

CS(COMM) 607/2024 Page 45 of 79

claimed in Claim 1 of IN‟104. Since it has come to the fore that there are only

three compounds which can be claimed in Claim 1 of IN‟104, the intermediate

compound in question being one of them, it cannot be said that Person Skilled

in the Art would be cherry picking any one specification out of the multifarious

options, when only three compounds are claimed in the Claim 1 of prior art,

IN‟104.

49. In view of the above, it is apparent that the requirement of the

intermediate compound in question of Claim 12 of the suit patent, being prior

claimed in Claim 1 of IN‟104, i.e., prior art, under Section 64 (1)(a) of the Act,

stands satisfied.

Species v. Genus:

50. At this stage, this Court notes the submission made on behalf of the

defendant that besides the intermediate compound in question, the suit patent

claims the other two compounds of the prior art of Claim 1 of IN‟104, as well.

51. It is also the case of the defendant that the prior art, IN‟104 is a species

patent and the suit patent, IN‟645 is the genus patent, therefore, IN‟104

anticipates the suit patent, IN‟645 and there exists species-genus relationship

between the said patents. The defendant has further argued that if any

embodiment of Claim 12 of the suit patent stands anticipated by IN‟104, then it

would result in anticipation of the Claim 12 of the suit patent in its entirety. On

the other hand, the plaintiffs have argued that no species-genus relationship lies

between IN‟104 and suit patent, as the lineage, scope, purpose and inventors of

IN‟104 and the suit patent, are completely different. The plaintiffs have further

argued that no Person Skilled in the Art can use the disclosure in IN‟104 to

arrive at the impugned compound in question without undue experimentation.

52. In terms of patent law, there is no such definition that is enumerated by

the legislature in the Act with regards to a genus or species patent/claim.

CS(COMM) 607/2024 Page 46 of 79

However, the concept of genus and specie relationship often occurs, though not

necessarily, in cases that are related to chemical patents, wherein, the „Genus‟

refers to a larger set or a broader class of compounds, whereas, in the case of

„Specie‟, the reference is made to a more specific embodiment or a subset

therein, which are related to the same core structure.

Core Structure & Common Lineage:

53. At this stage, this Court takes note of the argument of the plaintiffs that

there exists no common lineage between IN‟104, i.e., the prior patent and

IN‟645, i.e., the suit patent, and thus, there exists no species-genus relationship

between the said patents. Hence, in order to adjudicate the issue as regards the

specie-genus relationship as raised by the defendant, it would be apposite to

consider the core structure of Claim 12 of the suit patent with Claim 1 of the

prior art. The Claim 12 of the suit patent and Claim 1 of the prior art, are

reproduced as follows:

CS(COMM) 607/2024 Page 47 of 79

54. A perusal of the Claim 1 of IN‟104 and Claim 12 of the IN‟645 reveals

that both are Markush Structures. In a Markush Structure the compounds

exemplified arise from a common core structure. The said compounds may have

multiple variations and combinations, however, when exemplified from a

Markush, the core structure remains the same. In a case, where even if one of

the variations arising from the core structure are known in a prior art, the same

would be susceptible to the challenge of not being novel under the Act.

Reference in this regard be made to Para 2-089 and 2-090, Chapter 2, Pratibha

M. Singh on Patent Law, First Edition, which reads as under:

―xxx xxx xxx

MARKUSH PATENTS

2-089 In the case of NCEs, it is seen that the general practice

that is adopted is to define and disclose a common core structure (a

'pharmacophore') of a class of compounds in the patent

specification and to exemplify certain possible compounds based on

CS(COMM) 607/2024 Page 48 of 79

the core structure by carrying out substitutions in the core structure.

Thereafter, if the compound is targeted towards medical use, the

possible ailments for which the said compounds can be used are

identified.

2-090 On this basis, patents are sought for novel core

structures, the plethora of compounds that could be prepared from

the core structure, various methods and processes of preparation of

the compounds, as also for the different forms in which the

compounds could exist. The range of molecules with the various

combinations of possible substitutions could run into millions,

billions, trillions and even quintillions. Such a structure is described

as a Markush formula. The said name is derived from the title of a

decision by the USPTO in Ex Parte Markush". For a Markush

structure, there are several challenges in establishing novelty. Since

the patent covers a broad spectrum of compounds and several forms

of the same compound, if even one of the permutations or

combinations arising from the core structure is known in prior art,

questions challenging novelty can be raised.

xxx xxx xxx‖

(Emphasis Supplied)

55. Comparison of the aforesaid structures of the Claim 12 of the suit patent

and Claim 1 of the prior art makes it apparent that both the structures have a

common benzene ring having common molecules at position 1 and 2, i.e.,

C(O)NH and NH2 respectively, in both the structures, in Claim 1 of the prior art

and Claim 12 of the suit patent. Further, it is apparent that Claim 1 of the

IN‟104, i.e., the prior art claims a 2-Aminobenzamides compound of Formula 6.

Thus, as both Claim 12 of the IN‟645, the suit patent, and Claim 1 of IN‟104,

the prior art, claim compounds of 2-Aminobenzamide, they have a common core

structure, and thus share a significant structural element. Therefore, Claim 1 of

IN‟104, the prior art and Claim 12 of IN‟645, the suit patent, are prima facie

related to each other, as they share a common core structure of 2-

aminobenzamides.

56. Further, it is also to be noted that the plaintiffs in their written

submissions have made a categorical admission towards the possibility of

CS(COMM) 607/2024 Page 49 of 79

overlap between the compounds of Claim 12 in IN‟645 and Claim 1 in IN‟104.

The relevant portion of the plaintiffs‟ written submissions are as under:

―xxx xxx xxx

xxx xxx xxx‖

57. Thus, in view of there being a prima facie finding of IN‟104, prior art and

the suit patent, IN‟645 having a common core structure, this Court is of the

view that there exists a common lineage between the said patents, and thus, the

argument of the plaintiffs on this aspect, cannot be accepted.

58. At this stage, it would be pertinent to see whether the other compounds in

Claim 12 of the suit patent are prior claimed by the compounds in Claim 1 of

IN‟104, prior art.

59. Thus, it is seen that the compound formed when R

3

is isopropyl under

Claim 1 of IN‟104, the prior art, is the exact same compound which is claimed

under proviso (d) of Claim 12 of IN‟645, the suit patent, when R

3

is C3 alkyl

group, i.e, isopropyl. This is diagrammatically shown below:

CS(COMM) 607/2024 Page 50 of 79

COMPOUND IN PROVISO (D) OF

CLAIM 12 OF THE SUIT PATENT,

IN’645

COMPOUND IN CLAIM 1 OF THE

PRIOR ART, IN’104 WHEN R

3

IS

ISOPROPYL (C3 ALKYL GROUP)

60. Similarly, it is seen that the compound formed when R

3

is H in Claim 1 of

IN‟104, and the other non-variables, i.e., R4 at 2-position and R4 at 4-position,

are CH3 and CN, is the exact same compound which is claimed under proviso

(b) of Claim 12 of IN‟645, the suit patent, when R

3

is H, R

1

is CH3 and R

2

is

CN. This is diagrammatically shown below:

COMPOUND IN PROVISO (B) OF

CLAIM 12 OF THE SUIT PATENT,

IN’645

COMPOUND IN CLAIM 1 OF THE

PRIOR ART, IN’104 WHEN R

3

IS

HYDROGEN (H)

61. A cumulative table comparing the compounds claimed in Claim 1 of

IN‟104, the prior art and Claim 12 of IN‟645, the suit patent, is reproduced as

CS(COMM) 607/2024 Page 51 of 79

below:

COMPOUNDS CLAIMED UNDER

CLAIM 12 OF IN’645

COMPOUNDS CLAIMED UNDER

CLAIM 1 OF IN’104

When R

3

is Hydrogen (H) (Proviso (b)

of Claim 12)

When R

3

is Hydrogen (H)

When R

3

is Methyl (CH3) (Proviso (d)

of Claim 12)

When R

3

is Methyl (CH3)

When R

3

is Isopropyl (Proviso (d) of

Claim 12)

When R

3

is Isopropyl

CS(COMM) 607/2024 Page 52 of 79

62. Thus, all three compounds as claimed in Formula 6 of Claim 1 of IN‟104

are claimed exactly in Formula 3 in provisos (b) and (d) of Claim 12 of the suit

patent, i.e., IN‟645. Therefore, as all compounds of Claim 1 of IN‟104 are

found in Claim 12 of IN‟645, it becomes apparent that Claim 1 of IN‟104 is the

specie claim in relation to Claim 12 of IN‟645, which is the genus claim that has

encompassed all the three claimed compounds of Claim 1 of IN‟104.

63. Furthermore, the compounds resulting from the claims as discussed

above, when placed in a side-to-side comparison, also show that the positioning

of the variable and non-variable molecules in Claim 12 of the suit patent and

Claim 1 of IN‟104 are the same, albeit with different terminology being used to

depict and describe the compound structure.

64. It is also noted that during the course of prosecution for IN‟104, the

predecessor-in-interest of the plaintiffs in their response dated 10

th

January,

2014 before the Indian Patent Office, has made a categorical admission that the

disclosures in Claim 1 of IN‟104 presents a general method for the synthesis of

compounds of Formula 6 and the procedures disclosed will enable a Person

Skilled in the Art to use the claimed compounds in Formula 6 of IN‟104. Thus,

when this Court has already held that the said compounds in IN‟104 are claimed

in IN‟645, the plaintiffs cannot argue that a Person Skilled in the Art will

require undue experimentation to come to the compounds as claimed in Claim

12 of IN‟645, using the disclosures made in IN‟104. The relevant portion of the

response dated 10

th

January, 2014, is reproduced as under:

CS(COMM) 607/2024 Page 53 of 79

―xxx xxx xxx

xxx xxx xxx‖

65. Moreover, the plaintiffs in their replication have reiterated the aspect of

the compounds in Formula 6 in Claim 1 of IN‟104 being disclosed in the

complete specification of IN‟104. Therefore, the disclosure itself would enable

a Person Skilled in the Art to arrive at the compounds in Claim 1 of IN‟104,

which are also the subject matter of compounds in Claim 12 of IN‟645,

including the impugned intermediate in question. The relevant portion of the

plaintiffs‟ replication is reproduced as under:

―xxx xxx xxx

21. Without prejudice, the complete specification of IN' 104, which

was filed as a divisional application by E.I. DuPont's Crop

Protection to the parent application bearing 1492/DELNP/2004, also

filed by E.I. DuPont's Crop Protection, merely discloses the said

Formula 6, on pages 22 and 23 of the complete specification, as an

intermediate used in the process of preparing certain variations of

Formula I therein. It is submitted that the complete specification of

TN' 104 neither discloses, teaches, instructs nor enables the technical

effect of using the intermediate depicted as Formula 6, nor the

advantages of using certain compounds of Formula 6.

xxx xxx xxx‖

(Emphasis Supplied)

66. At this stage, it would be appropriate to refer to the case of Boehringer

Ingelheim Pharma GMBH & Co. KG Versus Vee Excel Drugs and

CS(COMM) 607/2024 Page 54 of 79

Pharmaceuticals Private Ltd. and Others

6

, wherein, while holding that reliance

can be placed on the admissions made by the plaintiff in their pleadings, the

Court noted as follows:

―xxx xxx xxx

66. The principles of law that emerge from the judgment of the

Division Bench are as follows:—

i. Once a patentee claims infringement of an earlier genus patent in

respect of a product, it necessarily follows that the said product was

the subject matter of the earlier genus patent.

ii. Only one patent can be granted in respect of one inventive concept.

Therefore, a patentee cannot claim infringement of the two patents in

respect of the same inventive concept.

iii. The term of a patent is twenty years in terms of the Patents Act and

it cannot be granted successive protection by means of separate

patents.

iv. The Indian law permits grant of a Markush patent. However, if one

of the combinations in the Markush patent includes the product in

question, it would form part of the inventive concept of the earlier

patent and cannot again be claimed as an inventive concept of a

subsequent patent.

v. The pleadings made on behalf of the plaintiff in the suit can be

considered by the Court to determine the stand of the plaintiff vis-à-

vis the genus patent and the species patent.

xxx xxx xxx

100. It has been vehemently contended on behalf of the plaintiffs that

no reliance can be placed on any post grant admissions made by the

plaintiffs after the priority date of the suit patent. However, in the

judgments of the Supreme Court in Novartis (supra) as well as the

judgment of the Division Bench in Astra Zeneca (supra), the Court has

placed reliance on admissions made by the plaintiffs in the pleadings

that were filed much after the grant of the suit patent. Therefore,

there is no merit in the submission of the plaintiffs that reliance

cannot be placed on any admissions made by the plaintiffs after the

priority date or after the grant of the suit patent.

xxx xxx xxx

102. The pleadings/admissions made by the plaintiffs in the present

6

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case, when examined in light of the scheme of the Patents Act and

the principles of law laid down by the judgments above, leads me to

a prima facie view that Linagliptin was “disclosed”, “claimed” and

“covered” under the genus patent, IN „719 as well as the suit patent,

IN „301. Had Linagliptin not been disclosed or claimed in the genus

patent, the plaintiffs could not have made a claim for infringement of

the genus patent in CS(COMM) 239/2019 and CS(COMM) 240/2019.

Therefore, at an interlocutory stage at least, the requirements with

regard to prior claiming under Section 64(1)(a) of the Patents Act are

satisfied in the present case.

xxx xxx xxx‖

(Emphasis Supplied)

67. Thus, in view of the aforesaid detailed discussion, it is apparent that while

Claim 1 of IN‟104 is the prior species claim, the Claim 12 of the suit patent is a

subsequent genus claim. Thus, prima facie it is seen that there exists a species-

genus relationship between the said two patents, which in consequence would

lead to automatic anticipation of the genus by the species.

68. Thus, holding that a generic claim cannot be allowed to an applicant, if

the prior art disclosed is a species falling within the claimed genus, the United

States Court of Customs and Patent Appeals in the case of IN Re Slayter

7

, has

held as follows:

―xxx xxx xxx

Appellant seems to place great reliance on the contention that he has

a broad inventive concept involving the use of two classes of

materials, which concept is lacking in Smith. Assuming that to be true,

it would not justify allowance of claims which are readable on Smith's

disclosure, which we think is the case here. It is well settled that a

generic claim cannot be allowed to an applicant if the prior art

discloses a species falling within the claimed genus; in other words,

whatever would infringe if subsequent will anticipate if prior. Peters

v. Active Manufacturing Co., 129 U.S. 530, 537, 9 S.Ct. 389, 32 L.Ed.

738; Knapp v. Morss, 150 U.S. 221, 14 S.Ct. 81, 37 L.Ed. 1059;

Faries Mfg. Co. v. S. W. Farber Mfg. Co., 2 Cir., 47 F.2d 571, and

cases there cited.

xxx xxx xxx‖

(Emphasis Supplied)

7

276 F.2d 408

CS(COMM) 607/2024 Page 56 of 79

69. Likewise, holding that a later genus claim is not patentably distinct from

being anticipated by the earlier species claims and therefore, defeats the novelty

of a subsequent claim to the genus, US Court of Appeals, Federal Circuit, in the

case of Eli Lilly & Co. Versus Barr Laboratories

8

, has held as follows:

―xxx xxx xxx

The only other difference between claim 1 of the '213 patent and claim

7 of the '549 patent is that the former is directed to humans while the

latter is directed to animals. Humans are a species of the animal

genus. Our case law firmly establishes that a later genus claim

limitation is anticipated by, and therefore not patentably distinct

from, an earlier species claim. In re Berg, 140 F.3d at 1437, 46

USPQ2d at 1233 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046,

1053, 29 USPQ2d 2010, 2016 (Fed. Cir. 1993); In re Gosteli, 872

F.2d 1008, 1010, 10 USPQ2d 1614, 1616 (Fed. Cir. 1989); Titanium

Metals Corp. v. Banner, 778 F.2d 775, 782, 227 USPQ 773, 779 (Fed.

Cir. 1985); In re Van Ornum, 686 F.2d at 944, 214 USPQ at 767

(C.C.P.A. 1982).

xxx xxx xxx‖

(Emphasis Supplied)

70. Further, Chapter 9 of the Manual of Patent Office Practice and

Procedure, dated 26

th

November, 2019, published by the Office of Controller

General of Patents, Designs & Trademarks, states that while a generic

disclosure in the prior may not necessarily take away the novelty of a specific

disclosure, a specific disclosure in the prior art takes away the novelty of a

generic disclosure, in the following manner:

―xxx xxx xxx

8

251 F.3d 955

CS(COMM) 607/2024 Page 57 of 79

xxx xxx xxx‖

71. Likewise, the Manual of Patent Examining Procedure (MPEP), Ninth

Edition, Revision 01.2024, issued by the United States Patent and Trademark

Office, under Section 2131.02 states that a species will anticipate a claim to a

genus, in the following manner:

―xxx xxx xxx

xxx xxx xxx‖

72. The rationale behind a species automatically anticipating a genus, can be

understood by way of an analogy. If a patent is granted over a specific claim,

the same would enjoy a monopoly for 20 years. A subsequent patent sought for

CS(COMM) 607/2024 Page 58 of 79

the broader genus, would necessarily encompass the earlier specific species

within it, thereby granting another 20-year protection to the genus patent, which

would then mean, granting an extension beyond the term of 20 years to the

earlier specific species therein, leading to double patenting and re-

monopolization of the specific species.

73. Holding that patent with respect to the same invention cannot be granted

more than once successively in time, as the same will negate the legislative

intent of limiting the life of the patent, Division Bench of this Court in the case

of Astrazenca AB and Another Versus Intas Pharmaceuticals Ltd.

9

, held as

follows:

―xxx xxx xxx

31. The Patents Act, though protects the rights and interests of

inventors, but for a limited period, whereafter the monopoly of the

patentee ceases and comes to an end and the invention with respect to

which patent was granted, falls in public domain i.e. open for all to

practice and reap benefit of. A patent, vide Section 48 of the Act,

confers a right on the patentee of a product patent, as DAPA is, to,

during the life of the patent, prevent others from making, using,

offering for sale, selling or importing, the new product with respect

whereto patent is granted. The life of a patent is limited, whereafter,

notwithstanding the new product having been invented by the

patentee, patentee no longer has exclusive right to make, use or offer

for sale the same and anyone else interested can also make, use or

offer for sale the said new product invented by the patentee, without

any interference from the patentee. If patents with respect to the same

invention can be granted more than once, successively in time, the

same will negate the legislative intent of limiting the life of the

patent and enable the patentee to prevent others from making, using

or offering for sale, the new product invented by the patentee, till the

time patentee successively keeps on obtaining patent therefor.

xxx xxx xxx‖

(Emphasis Supplied)

74. Thus, in view of the above, the argument of the plaintiffs that there exists

no common lineage between Claim 1 of IN‟104 and Claim 12 of IN‟645 and

9

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there being no species-genus relationship between the said claims, cannot be

accepted.

75. For the purposes of the present interim application, and in view of the

discussion made as above, the defendant has been able to prima facie establish

its case that Formula 6 of Claim 1 of the IN‟104 claims the intermediate in

question known as 2-amino-5-cyano-N, 3-dimethylbenzamide, which is the

subject of Formula 3 of Claim 12 of the suit patent. The said intermediate in

question is prima facie one of the three intermediate compounds claimed in

Claim 1 of IN‟104, prior art, belonging to the plaintiffs, which has already

expired on 16

th

January, 2023. Moreover, it is further apparent that the other two

compounds under Claim 1 of IN‟104, the prior art, are also claimed in Claim 12

of the suit patent. Therefore, Claim 1 of IN‟104 is a species, while Claim 12 of

the IN‟645, the suit patent, is the genus. Consequently, a prima facie credible

challenge is made to the validity of Claim 12 of the suit patent, on this ground.

76. Thus, in view of the discussion hereinabove, the defendant has prima

facie raised a credible challenge under Section 64 (1)(a) of the Act in relation to

Claim 12 of the suit patent.

Challenge under Section 64 (1)(e) of the Act:

77. In relation to Section 64 (1)(e) of the Act, it is the case of the defendant

that Claim 12 of IN‟645, i.e., suit patent, stands anticipated by various

disclosures in WO‟226, in light of which , the defendant has raised a challenge

to the validity of Claim 12 of the suit patent under Section 64 (1)(e) as well.

78. Per contra, it is the case of the plaintiffs that WO‟226 does not disclose,

nor enable the group of compounds of Formula 3 under Claim 12 of the suit

patent, therefore, the challenge raised under Section 64 (1)(e) is not cogent.

79. It is to be noted that WO‟226 is the international counterpart of IN‟417

under which the division patent, i.e., IN‟104, the prior art in question for the

CS(COMM) 607/2024 Page 60 of 79

argument under Section 64 (1)(a), was granted. The defendant has asserted that

compounds of Formula 6 in Claim 1 of IN‟104 is disclosed in WO‟226,

therefore, in effect, WO‟226 will also disclose and thereby anticipate Claim 12

of IN‟645.

80. At this stage it would be pertinent to make reference to Section 64 (1)(e)

of the Act. The same is reproduced as under:

―xxx xxx xxx

64. Revocation of patents.—(1) Subject to the provisions contained in

this Act, a patent, whether granted before or after the commencement

of this Act, may, [be revoked on a petition of any person interested or

of the Central Government [* * *] or on a counter-claim in a suit for

infringement of the patent by the High Court] on any of the following

grounds, that is to say,—

xxx xxx xxx

(e) that the invention so far as claimed in any claim of the complete

specification is not new, having regard to what was publicly known

or publicly used in India before the priority date of the claim or to

what was published in India or elsewhere in any of the documents

referred to in Section 13;

xxx xxx xxx‖

(Emphasis Supplied)

81. From the above it can be culled out that the prior art under the ambit of

Section 64 (1)(e) of the Act can be any document, i.e., patent or non-patent

document, which was publicly known or used anywhere in the world before the

priority date of the patent under question. Therefore, WO‟226 despite being an

international patent, having its national phase patent, i.e., IN‟417 granted in

India, with divisional application, IN‟104, will be relevant for the purposes of

Section 64 (1)(e) of the Act, as it falls within the ambit of what was ―published

in India or elsewhere‖.

82. Further, under the said section for a prior art to anticipate a patent, it

should have been published prior to the priority date of the said patent. In the

CS(COMM) 607/2024 Page 61 of 79

present case, the date of publication of WO‟226 is 31

st

July, 2003, which is prior

to the priority date of the suit patent, IN‟645, i.e., 07

th

December, 2004.

Therefore, if this Court comes to the conclusion that WO‟226 anticipates the

intermediate compound in question in Claim 12 of IN‟645, i.e., the suit patent, it

would lead to a prima facie credible challenge being laid by the defendant to the

validity of Claim 12 of the suit patent under Section 64 (1)(e) of the Act.

83. The parameters for the assessment of novelty under the Act have been

elaborated under Section 09.03.02 of Manual of Patent Office Practice and

Procedure, dated 26

th

November 2019, published by the Indian Patent Office, in

the following manner:

―xxx xxx xxx

Novelty

1. An invention is considered as new(novel), if it is not anticipated by

prior publication in patent and non-patent literature, i.e., an

invention is novel if it has not been disclosed in the prior art, where

the prior art means everything that has been published, presented or

otherwise disclosed to the public before the date of filing/priority

date of complete specification.

2. An invention is considered as novel, if it has not been anticipated

by prior use or prior public knowledge in India.

3. For the purpose of determining novelty, an application for patent

filed at the Indian Patent Office before the date of filing of complete

specification of a later filed application, but published after the same,

is considered for the purposes of prior claiming.

4. While ascertaining novelty, the Examiner takes into consideration,

inter alia, the following documents:

- which have been published before the date of filing of the

application in any of the specifications filed in pursuance of

application for patent in India on or after 1

st

January, 1912.

- such Indian Patent Applications which have been filed before the

date of filing of complete specification and published on or after the

date of filing of the complete specification, but claims the same subject

matter.

5. The examiner shall make such investigation for purpose of

ascertaining whether the invention, so far as claimed in any claim of

the complete specification, has been anticipated by publication in

CS(COMM) 607/2024 Page 62 of 79

India or elsewhere in any document other than those mentioned in

section 13(1) before date of filing of the applicant‘s complete

specification.

6. A prior art is considered as anticipating novelty if all the features

of the invention under examination are present in the cited prior art

document.

7. The prior art should disclose the invention either in explicit or

implicit manner. Mosaicing of prior art documents is not allowed in

determination of novelty.

xxx xxx xxx‖

(Emphasis Supplied)

84. The test for determining anticipation under Section 64 (1)(e) of the Act

has been consolidated by the Court in the case of LAVA International Limited

Versus Telefonaktiebolaget LM Ericsson

10

, in the following manner:

―xxx xxx xxx

83. In my opinion, the seminal guidance on determination of novelty

has been provided in the decision of the House of Lords

in Hills v. Evans, wherein it has been concluded that the test of

novelty evaluates whether an invention is truly new by assessing if it

was previously disclosed in a manner that would allow a person

skilled in the art to reproduce the invention without additional

research or experimentation. The relevant extracts from the said

decision are set out below:

―I have therefore to consider, and to give my opinion upon, the

question that has been argued, namely, whether there be or be

not anything in these specifications which has rendered the

Plaintiff's invention matter of public knowledge, and therefore

matter of public property, anterior to the granting of the patent…

With regard to the specification of a prior patent it is not to be

distinguished in principle from any other publication. The only

peculiarity attending the specification of a prior patent is this, that

it must of necessity be considered as a publication. There has been

some doubt with regard to books and documents under particular

circumstances, whether they can be considered as amounting to a

publication. With regard to a specification there can be no doubt,

because the specification is that which the patentee gives to the

public and makes a matter publici juris in return for the privilege

which he receives. But upon all principle a specification is not to

be distinguished from any prior publication contained in a book

10

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published in the ordinary manner. The question then is, what must

be the nature of the antecedent statement? I apprehend that the

principle is correctly thus expressed-the antecedent statement must

be such that a person of ordinary knowledge of the subject would at

once perceive, understand, and be able practically to apply the

discovery without the necessity of making further experiments and

gaining further information before the invention can be made

useful. If something remains to be ascertained which is necessary

for the useful application of the discovery, that affords sufficient

room for another valid patent. By the words of the statute of

James, it is necessary for the validity of a patent that the invention

should not have been known or used at the time. These words are

held to mean ―not publicly known or publicly used.‖ What amounts

to public knowledge or public user is still to be ascertained. One of

the means of imparting knowledge to the public is the publication

of a book, or the recording of a specification of a patent. If,

therefore, in disproving that an allegation which is involved in

every patent, that the invention was not previously known, appeal

be made to an antecedently published book or specification, the

question is, what is the nature and extent of the information thus

acquired which is necessary to disprove the novelty of the

subsequent patent? There is not, I think, any other general answer

that can be given to this question than this: that the information as

to the alleged invention given by the prior publication must, for

the purposes of practical utility, be equal to that given by the

subsequent patent. The invention must be shown to have been

before made known. Whatever, therefore, is essential to the

invention must be read out of the prior publication. If specific

details are necessary for the practical working and real utility of

the alleged invention, they must be found substantially in the prior

publication.

Apparent generality, or a proposition not true to its full extent,

will not prejudice a subsequent statement which is limited and

accurate, and gives a specific rule of practical application.

The reason is manifest, because much further information, and

therefore much further discovery, are required before the real truth

can be extricated and embodied in a form to serve the use of

mankind. It is the difference between the ore and the refined and

pure metal which is extracted from it.

Again, it is not, in my opinion, true in these cases to say, that

knowledge, and the means of obtaining knowledge, are the same.

There is a great difference between them. To carry me to the place

at which I wish to arrive is very different from merely putting me

on the road that leads to it. There may be a latent truth in the

words of a former writer, not known even to the writer himself, and

it would be unreasonable to say that there is no merit in

discovering and unfolding it to the world.

CS(COMM) 607/2024 Page 64 of 79

Upon principle, therefore, I conclude that the prior knowledge of

an invention to avoid a patent must be knowledge equal to that

required to be given by a specification, namely, such knowledge

as will enable the public to perceive the very discovery, and to

carry the invention into practical use.‖

(Emphasis supplied)

84. In addition, in General Tires & Rubber Co. v. Firestone Tyre &

Rubber Co. Ltd., it has been held that even if not all details are

present in the earlier document cited as novelty destroying prior art, it

is possible that the prior art document and the patent in question

essentially convey the same message but in different terms. The key

question to resolve in such instances is whether the prior art

document provides clear and unmistakable instructions that, if

followed, would inevitably lead to a result that falls within the scope

of the patent's claims or inventive concept. The relevant extract from

the said decision is set out below:

―As to novelty, one must consider in relation to each of the

documents cited whether all the specific details are disclosed and if

not, whether the reader would assume from his ordinary knowledge

that he should carry out the steps in question and if so how. One

must also instruct oneself with the surrounding circumstances as

they exist; Hills v. Evans (supra). If one cannot find all the details

in the early document, it may still be possible that the prior

document and the patent-in-suit were really saying the same

thing in different words. The question to be answered in such a

case is; does the prior document give clear and unmistakeable

directions which when carried out will inevitably result in

something coming within the claims of the patent?‖

(Emphasis supplied)

85. The aforesaid decisions lay down the legal framework for

assessing the novelty of an invention, emphasising that for an

invention to be considered novel, it must not have been previously

disclosed in a manner that would enable a skilled person to

reproduce the invention without further experimentation. It has also

been specified that for prior knowledge or disclosure to challenge

the novelty of an invention, it must offer practical utility equivalent

to the invention. In addition, it has also been clarified that if

disclosures from prior art inevitably led to the invention, even

without explicit details, it can be said the novelty of an invention is

compromised.

xxx xxx xxx

88. When assessing the novelty of an invention, a Judge or even a

patent examiner ought to follow a systematic approach to ensure a

thorough and unbiased analysis of the invention claimed and the

CS(COMM) 607/2024 Page 65 of 79

prior art cited. Another important aspect of the test for assessment of

novelty in an invention is to maintain a distinction between the test

of novelty and test for inventive step or lack of obviousness. I am of

the view that the following steps, which may be referred to as the

„Seven Stambhas Approach‟ serve as guiding principles and provide

a clear framework for assessing novelty, reflecting the distinction

between novelty and non-obviousness:

(i) Understanding of the Claims of the Invention

• The determination of lack of novelty should begin with the

understanding of the Claims of the invention as it is the Claims that

define the boundaries of the invention and what the applicant

considers as their novel contribution.

(ii) Identify Relevant Prior Art

• Collecting the prior art, including any public disclosure,

publication, patent, or patent application that predates the filing date

of the patent application which is relevant to the Claims of the

patent.

(iii) Analyse the Prior Art

• Conducting a detailed analysis of the identified prior art to

ascertain its relevance to the Claims of the invention. This step

involves searching and documenting both the similarities and the

differences, if any, between the Claims of the invention and the text

of the prior art. This step requires comparing the technical details

and features of the prior art against those claimed in the invention.

(iv) Determine Explicit and Implicit Disclosures

• Examining whether the prior art explicitly or implicitly discloses

the same invention. Explicit disclosure means the prior art directly

describes the invention claimed. Implicit disclosure refers to whether

the prior art describes elements or aspects so similar to the claimed

invention that a direct link can be drawn.

(v) Assessment material differences while considering the entire

scope of the Claims

• Identifying the material differences between the claimed invention

and the prior art, if any, such that a material difference would

indicate that the claimed invention has not been disclosed in the

prior art and, therefore, the invention, is novel.

(vi) Verifying Novelty in light of Comprehensive Scope and Specific

Combination of Claimed Elements

• Evaluation of novelty of the invention is carried out in light of the

comprehensive scope of its claims, not just individual elements.

• The invention is novel only if the combination of claimed elements

as a whole has not been previously disclosed.

(vi) Documentation of the Analysis and Novelty Determination

CS(COMM) 607/2024 Page 66 of 79

• Specify the finding of the examination of novelty, while providing a

clear rationale for the said determination. The specific

documentation must include references to specific sections of the

prior art examined and a reasoning as to how the section affects the

novelty of the claims and the inventive concept of the invention.

• Based on the analysis, issue a formal decision, if the invention or

any of its claimed elements is found in the prior art, the invention is

not novel. Conversely, if the invention is not disclosed by the prior

art, it is considered novel.

xxx xxx xxx‖

(Emphasis Supplied)

85. It is the case of the defendant that the intermediate in question under

Claim 12 of the suit patent is already claimed and disclosed in IN‟104,

therefore, it will automatically be disclosed under WO‟226, as IN‟104 is the

divisional patent to the national phase patent, i.e., IN‟417, which relates to the

international counterpart, WO‟226.

86. As noted above, IN‟104 was a divisional patent of IN‟417 which is the

national phase patent for WO‟226. Therefore, the disclosure in the complete

specification of IN‟104, regardless, cannot be inconsistent or beyond the scope

of the disclosures made in the complete specification of the original application

granted as IN‟417, and in consequence with the international counterpart being

WO‟226. Thus, the disclosures made in the complete specification of IN‟104

would necessarily fall within the scope of the disclosures made in WO‟226.

87. It is noted that a divisional patent, IN‟104 cannot disclose anything which

is not in substance already disclosed under the original application, which in the

present case would be for the granted patent, IN‟417, i.e., national phase

application. The national phase application, IN‟417, takes its lineage from its

international counterpart, WO‟226. In effect, as per the operation of law, the

disclosure made under IN‟104, cannot extend beyond what has been in

substance disclosed under the complete specification of WO‟226. In this regard,

reference is made to Section 16 of the Act, which is reproduced as under:

CS(COMM) 607/2024 Page 67 of 79

―xxx xxx xxx

16. Power of Controller to make orders respecting division of

application.—(1) A person who has made an application for a patent

under this Act may, at any time before the [grant of the patent], if he

so desires, or with a view to remedy the objection raised by the

Controller on the ground that the claims of the complete specification

relate to more than one invention, file a further application in respect

of an invention disclosed in the provisional or complete specification

already filed in respect of the first mentioned application.

(2) The further application under sub-section (1) shall be

accompanied by a complete specification, but such complete

specification shall not include any matter not in substance disclosed

in the complete specification filed in pursuance of the first

mentioned application.

(3) The Controller may require such amendment of the complete

specification filed in pursuance of either the original or the further

application as may be necessary to ensure that neither of the said

complete specifications includes a claim for any matter claimed in the

other.

Explanation.—For the purposes of this Act, the further

application and the complete specification accompanying it shall be

deemed to have been filed on the date on which the first mentioned

application had been filed, and the further application shall be

proceeded with as a substantive application and be examined when

the request for examination is filed within the prescribed period.

xxx xxx xxx‖

(Emphasis Supplied)

88. Reading of the aforesaid section makes it clear that a division application

shall not include any matter which is not in substance disclosed in the complete

specification filed in pursuance to the original application.

89. A reference in this regard, may be made to the decision of this Court in

the case of Novartis AG Versus Controller of Patents & Designs

11

, wherein,

the Court held as follows:

―xxx xxx xxx

22. Thus, there are twin conditions under Section 16 of the Act for

filing of divisional application:

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1. The divisional application has to be in respect of an invention

disclosed in the provisional or complete specification already

filed in respect of the first mentioned application.

2. There cannot be duplication of claims in the two specifications i.e.

the parent specification and the divisional specification.

23. Therefore, as per Section 16 of the Act, the claims of the

divisional cannot be outside the scope of the claims of the parent

specification and at the same time there cannot be duplication of

claims. In the present case, it is not in dispute that the compound

being claimed in the divisional application is within the scope of the

parent application. The matter forming part of the divisional

application is also disclosed in the original parent specification as

well. The objection of the patent office is that the compound being

claimed in the divisional application is already covered by the granted

claims of the parent application and hence, there is duplication of

claims. The crux of the argument of the learned CGSC is that there

can only be one patent for one invention.

xxx xxx xxx‖

(Emphasis Supplied)

90. Further, the aforesaid aspect has been clarified by the Division Bench of

this Court in the case of Syngenta Limited Versus Controller of Patents and

Designs

12

, wherein, it has categorically been held that any further application

filed in respect of an invention under Section 16 (1) of the Act, must be

disclosed in the specifications contained in the earlier application. The relevant

portion of the said judgement is reproduced as under:

―xxx xxx xxx

18. We note that Section 16(1) in unambiguous terms enables the

filing of a further application in respect of an invention, provided it

is disclosed in the provisional or complete specification already filed.

As the learned Judge rightly observes there appears to be no

justification to restrict the filing of a Divisional Application only to a

situation where the plurality of inventions is found in the claims. The

significance of the provision using the expression “disclosed in the

provisional or complete specification” can neither be ignored nor

discarded. While it would have been open for the Legislature to

restrict the amplitude of that provision by stipulating that plural

inventions must be embodied or be identifiable from the claims as

originally filed, it has in unequivocal terms provisioned for the same

being discernible from the provisional or complete specification. The

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provision as structured neither leaves any space of ambiguity nor

does the language of the text warrant any doubt being harbored in

respect of the clear intent of the provision. We thus find ourselves

unable to concur with the interpretation placed upon that provision

in Boehringer Ingelheim.

xxx xxx xxx‖

(Emphasis Supplied)

91. Thus, as this Court has already come to a finding that the intermediate

compound in question under Claim 12 of the suit patent is claimed and

disclosed under IN‟104, and further this Court has noted that the disclosure

made under IN‟104 would in substance be already disclosed under WO‟226 as

per Section 16 of the Act, it would follow that the intermediate compound in

question under Claim 12 of the suit patent is also disclosed under WO‟226.

92. Further, this Court notes that the disclosure in the complete specification

of WO‟226 would necessarily have to be an enabling disclosure. The same is

obligatory to fulfil the tenor of Section 10 (1) and 10 (4) of the Act, which reads

as under:

―xxx xxx xxx

10. Contents of specifications.—(1) Every specification, whether

provisional or complete, shall describe the invention and shall begin

with a title sufficiently indicating the subject-matter to which the

invention relates.

xxx xxx xxx

(4) Every complete specification shall—

(a) fully and particularly describe the invention and its operation or

use and the method by which it is to be performed;

(b) disclose the best method of performing the invention which is

known to the applicant and for which he is entitled to claim

protection; and

(c) end with a claim or claims defining the scope of the invention for

which protection is claimed.

(d) be accompanied by an abstract to provide technical information

on the invention:

Provided that—

(i) the Controller may amend the abstract for providing better

information to third parties; and

CS(COMM) 607/2024 Page 70 of 79

(ii) if the applicant mentions a biological material in the specification

which may not be described in such a way as the satisfy clauses (a)

and (b), and if such material is not available to the public, the

application shall be completed by depositing the material to an

[international depository authority under the Budapest Treaty] and by

fulfilling the following conditions, namely:—

[(A) the deposit of the material shall be made not later than the date

of filing the patent application in India and a reference thereof shall

be made in the specification within the prescribed period;]

(B) all the available characteristics of the material required for it to

be correctly identified or indicated are included in the specification

including the name, address of the depository institution and the date

and number of the deposit of the material at the institution;

(C) access to the material is available in the depository institution

only after the date of the application for patent in India or if a priority

is claimed after the date of the priority;

(D) disclose the source and geographical origin of the biological

material in the specification, when used in an invention.]

xxx xxx xxx‖

(Emphasis Supplied)

93. Perusal of the above brings forth that any invention filed in India should

sufficiently and fairly describe the invention as per Section 10 (4) of the Act,

and the complete specification of a patent application should have a proper

description of the invention, which would enable a Person Skilled in the Art to

perform the invention.

94. Further, this Court notes that the international patent, WO‟226 has

entered India as a national phase application which was granted as an Indian

patent, i.e., IN‟417, which was later divided into two patents according to

Section 16 of the Act, one of which is IN‟104 and the other being IN‟417.

95. It is noted that any patent that enters into India, will be obligated to

sufficiently and fairly describe the invention as per Section 10 (4) of the Act,

and the complete specification of the same should have proper description of the

invention, which would enable a Person Skilled in the Art to understand and

work the invention. Thus, any international patent, when filed in national phase

under the contours of Section 10 (4) of the Act, would necessarily also be

CS(COMM) 607/2024 Page 71 of 79

required to provide disclosure which enables a Person Skilled in the Art, to

practice the invention without undue experimentation. Accordingly, as this

Court has already held that the intermediate compound in question under Claim

12 of IN‟645 is also claimed and disclosed in Claim 1 of IN‟104, therefore, at

prima facie stage for the purposes of deciding the present application, this Court

is of the considered view that WO‟226, which is the international counterpart

would also necessarily have an enabling disclosure to allow a Person Skilled in

the Art to come to the intermediate compound in question as claimed in Claim

12 of IN‟645.

96. Thus, this Court is of the prima facie view that the intermediate

compound in question under Claim 12 of the suit patent, IN‟645 will be

anticipated by WO‟226, and therefore, would be vulnerable to challenge on the

ground of Section 64 (1)(e) of the Act.

Gillette Defence:

97. The defendant has raised the ‗Gillette Defence‘ of non-infringement, i.e.,

that the defendant does not infringe the suit patent since it is practicing the

teachings of the earlier patent IN‟104. ‗Gillette Defence‘ is premised on the

principle that if the defendant‟s product or process is nothing more than what

was already disclosed in the prior art, then there can be no infringement of the

suit patent. In such a case, the defendant does not need to challenge the validity

of the suit patent itself. It is sufficient to demonstrate that its activities fall

entirely within the scope of prior disclosures, thereby avoiding infringement.

Thus, as per the case put forward by the defendant, since the specific compound

being practiced by the defendant, i.e., 2-amino-5-cyano-N, 3-

dimethylbenzamide, is also claimed and disclosed in IN‟104 and WO‟226, the

defendant has a right to practice this compound, once the period of protection of

IN‟104 has expired.

CS(COMM) 607/2024 Page 72 of 79

98. The ‗Gillette Defence‘, as raised by the defendant has its origin from the

decision of the House of Lords in the case of Gillette Safety Razor Versus

Anglo-American Trading

13

. The aspect of ‗Gillette Defence‘ has been

elucidated in Para 12-176, Chapter 12, Pratibha M. Singh on Patent Law,

First Edition, in the following manner:

―xxx xxx xxx

GILLETTE DEFENCE

12-176 Another defence which can be raised by the defendant is that

it is manufacturing its product as per the teachings in the prior art

to the plaintiff's patent. While raising such a defence, the defendant

argues that the plaintiff's patent is invalid due to lack of novelty and in

addition, is also not infringing the plaintiff's patent. This defence is

known as the Gillette defence having its origin from the decision of

the House of Lord. As per this defence, the defendant can rely upon

a prior art document that may also destroy the novelty of the

plaintiff's patent, and argue that the product or process being

manufactured or followed by the defendant is in line with the

disclosure made in the said prior art document. When the defendant

raises such a defence and relies on a specific prior art or a

publication, the Court would only consider the narrow issue raised

by the defendant and thus need not go into other issues of

infringement/invalidity. Such a defence has been recognised by

Indian courts.

xxx xxx xxx‖

(Emphasis Supplied)

99. This Court has made a categorical finding that the intermediate

compound in question in Claim 12 of IN‟645, suit patent is prior claimed by

Claim 1 of IN‟104, prior art. Therefore, since IN‟104 has already expired on

16

th

January, 2023, this Court is of the considered view that in the present case,

the defence as raised by the defendant on the aspect of ‗Gillette Defence‘ is

prima facie tenable.

100. Considering the pleadings/admissions made by the plaintiffs in the

present case and the detailed discussion hereinabove, this Court is of the view

that the defendant has, at this interim stage, set out a credible challenge to the

13

(1913) 30 RPC 465

CS(COMM) 607/2024 Page 73 of 79

validity of Claim 12 of IN‟645, by showing that Claim 12 of IN‟645, the suit

patent, is prima facie vulnerable to challenge. The requirements with regard to

prior claiming under Section 64 (1)(a) and Section 64 (1)(e) of the Act are

satisfied in the present case at the interlocutory stage. Thus, an interim

injunction cannot be granted in favour of the plaintiffs.

101. In view of the aforesaid findings, it would not be necessary to consider

the other grounds of revocation of the patent and dismissal of the suit, as raised

by the defendant, which shall be considered at the stage of the trial.

Balance of Convenience and Irreparable Harm:

102. This Court notes that during the course of pendency of the present suit,

the defendant has already launched the product. Thus, vide order dated 01

st

August, 2025, it was noted and directed as follows:

―I.A. 34151/2024 in CS(COMM) 607/2024

1. Learned Senior Counsel appearing for the plaintiffs has

commenced his rejoinder arguments

2. During the course of hearing, learned Senior Counsel appearing

for the plaintiffs has brought forth that the defendant has already

launched the product.

3. Learned Senior Counsel appearing for the defendant does not

dispute the same. He submits that the defendant has already cleared

the way, which is disputed by learned Senior Counsel appearing for

the plaintiffs.

4. Learned Senior Counsel appearing for the defendant submits that in

view of the fact that the defendant has already launched the product,

the defendant shall file all the details of the stock manufactured, as

well as launched by the defendant. Further, the defendant shall also

file the details of all the revenue earned by the defendant, in a tabular

form.

5. He further submits that the defendant shall also clearly state in the

affidavit as regards the various approvals obtained by the defendant

for the purposes of marketing the product.

6. The aforesaid statement is taken note of.

7. Let the needful be done by the defendant before the next date of

hearing.

8. Re-notify for hearing on 18

th

and 19

th

August, 2025 at 2:30 PM‖

103. As per the plea raised by the defendant, the defendant has already

CS(COMM) 607/2024 Page 74 of 79

‗cleared the way‘, before the commencement of the production and marketing

of the impugned product.

104. As per Terrell on the Law of Patents

14

, the defendant can avoid an

interlocutory injunction in situations where litigation is bound to ensue if the

defendant introduces his product, provided he clears the way first. This can be

achieved by using the procedures for revocation and declaration of non-

infringement.

105. The whole concept is resting on the aspect that the Courts shall avoid

multiplicity of litigation. If a party clears the way first, thereafter, the said party

need not face the rigors of an interim injunction. Furthermore, the legal

mechanism provides for direct approaches to ‗clear the way‘, for instance by

filing a suit for non-infringement.

106. The Single Bench in the case of Merck Sharp and Dohme Corporation

Versus Glenmark Pharmaceuticals

15

, while discussing the principle of the

‗clearing the way‘ held that it would be a relevant factor, if a party with

knowledge of forthcoming proceedings between the parties would launch its

product without filing a revocation petition. Further, the Division Bench relied

on the Smithkline Beecham Cases which first developed the concept of

„clearing the way‟, wherein it was observed that non-infringement and

revocation cases are the procedures to follow for ‗clearing the way‘. The

relevant portion of the judgement reads as under:

―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

14

See Terrell on the Law of Patents (19

th

ed) at paragraphs 19-245, 19-246

15

2015 SCC OnLine Del 8227

CS(COMM) 607/2024 Page 75 of 79

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 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 : (1950-2000) Supp 22(1) PTC 95 (Del), 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)

107. In the facts of the present case the defendant had filed a revocation

petition seeking invalidity of Claim 12 of the suit patent on 31

st

October, 2023.

CS(COMM) 607/2024 Page 76 of 79

Further, the defendant had first disclosed the impugned product, i.e.,

Cyantraniliprole 10.26% OD, in the suit for non-infringement filed by the

defendant on 30

th

October, 2023, with respect to another patent of the plaintiffs,

i.e., IN‟358.

108. This Court notes that the defendant has already commenced commercial

production of the impugned product using the intermediate compound in

question, and has been continuously marketing and selling the said product

since April, 2025. As noted above, the defendant has at this interim stage, prima

facie set out a credible challenge to the validity of Claim 12 of IN‟645 by

showing that the same is prima facie vulnerable to challenge. Thus, a credible

defence to the infringement action has been set up by the defendant. Thus, the

balance of convenience lies in favour of the defendant and against the plaintiffs.

109. This Court notes the submission made on behalf of the defendant that the

defendant has invested heavily in infrastructure, regulatory compliance and

commercial arrangements, with investments in its manufacturing facilities

amounting to several crores. Given that the patent is about to expire in less than

two months, any injury that may be caused to the plaintiffs are purely monetary

in nature and can be adequately compensated by damages. In this regard,

reference may be made to the judgment in the case of Astrazeneca AB and

Another Versus Intas Pharmaceutical Ltd.

16

, wherein, it has been held as

follows:

―xxx xxx xxx

130. Having considered the case from the point of view of facets

involving balance of convenience and irreparable harm, it has to be

stated that the fact that a challenge has been laid at the stage when

the plaintiffs seek to enforce their rights under the patents would not

propel the Court [as indicated above] to grant an injunction if the

challenge is credible.

16

2020 SCC OnLine Del 2765

CS(COMM) 607/2024 Page 77 of 79

131. The provisions of the Act do not provide any shield of

inviolability. This principle is true not only in India but jurisdictions

across the world. In no country, a mere grant of a patent by the patent

offices' guarantees their validity. It is important to remember that

grant of monopoly to the inventor, which is necessary for her/him to

recoup investments and/or derive profits from her/his inventions,

comes with a quid pro quo as noticed in paragraph 38 of Report on

the Revision of the Patents Law by Shri Justice N. Rajagopala

Ayyangar (September, 1959). Paragraph 38 reads thus:

―38. I have already set out the considerations which are said to

constitute the quid pro quo for the grant of the patent monopoly,

namely; (1) the working of the invention within the country so as

to result in the establishment in the country of a new industry or

an improvement of an existing industry which would profitably

employ the labour and capital of the country and thus increase

the national wealth, and (2) disclosure to the public of the

invention and the manner of its working so that on the expiry of

the life of the patent the public are enabled to work the invention

themselves and in competition with each other. Where the

patentee has no intention of working the invention in this country

either because he considers that this is not profitable or because he

prefers to expand the production in his home country so as to

achieve there greater efficiency and more production or is

otherwise not interested in working the invention in India, the grant

of the Indian patent might tend to improve the economy of the

patentee's home country but offers little advantage to us. Unless

therefore the law provides for measures to be taken to compel the

patentees to work the invention within the country, and these

measures are effective to achieve their purpose, the social cost

involved in the grant of the patent is not offset by any benefit to

the community. As regards the possible advantage which might

result by disclosure it should be noted that most of the inventions

patented by foreigners in this country are also patented abroad and

the theory therefore that but for patent protection the invention

would have been worked in secret and that the public would have

been deprived of the knowledge of the invention has no relevance

in the case of the large majority of patents granted in India. As

neither of the above considerations seems to be present in the case

of patents granted to foreign nationals which are not worked in this

country the cost to the community by the grant of the patents is

unrelieved by any positive advantage by way of an increase of

technical skill or of national wealth.‖

[Emphasis is mine]

xxx xxx xxx

CS(COMM) 607/2024 Page 78 of 79

135. What persuades me to decline injunction, in addition to what I

have stated above, is also the fact that in this case damages if proved

at trial, appear to be compensable. The defendants have averred that

the plaintiffs have, possibly, licensed their rights under the suit patents

to two entities i.e. Sun and Abbott. The packaging of the products of

the drug sold through these entities is indicative of this aspect. The

plaintiffs, however, for reasons best known to them have not placed on

record the agreements arrived at with these entities in support of their

plea. Therefore, it has to be inferred that the said entities are

licensees.

136. Besides this, the plaintiffs also aver that they are importing their

drug into the country. Therefore, the plaintiffs seek to monetize their

invention. Thus, at the end of the trial, if they were to succeed, they

could be granted damages, if proved, under the law. Thus, as long as

a mechanism can be put in place for securing the recovery of

damages by the plaintiffs, it would, at this stage balance the interest

of the parties. [See: Dynamic Manufacturing, Inc. v. David A. Craze,

and Miller Industries, Inc., 1998 WL 241201]

xxx xxx xxx‖

(Emphasis Supplied)

110. Accordingly, the plaintiffs have failed to make out a prima facie case for

grant of interim injunction. Thus, considering the discussion as above with

respect to the balance of convenience and irreparable harm as well prima facie

case, this Court is not inclined to grant an injunction to the plaintiffs. If the

plaintiffs were to succeed at the end of the trial, they could be granted damages,

if proved, under the law.

111. Considering the fact that the defendant has already commenced

commercial manufacturing and marketing of the product in question, the

defendant shall place on record the details, quantum and value of the product

manufactured and sold.

112. It is clarified that the observations made hereinabove are only prima facie

in nature for the purpose of deciding the application for interim injunction, on

the basis of submissions made before this Court and facts brought forth at the

time of hearing. Nothing contained herein shall be construed as an expression

CS(COMM) 607/2024 Page 79 of 79

on the merits of the case, which shall be decided after trial, independent of any

observations made herein.

113. Accordingly, the present application for grant of injunction is dismissed.

CS(COMM) 607/2024 &C.O.(COMM.IPD-PAT) 7/2023

114. List before the Roster Bench for directions on 24

th

November, 2025.

MINI PUSHKARNA

(JUDGE)

NOVEMBER 17, 2025/au/kr

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