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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 19th 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 Signature Not CS(COMM) Digitally Signed By:HARIOM SHARMA Signing Date:17.11.2025 15:20:13 against the judgement dated 19th September, 2022, wherein, the Division Bench of this Court by way of order dated 05th December, 2022, dismissed the appeal and affirmed the judgement dated 19th 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-
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 06th 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 19th 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 05th December, 2022, in FAO (OS)(COMM) 301/2022.

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 Signature NotCS(COMM) Digitally Signed By:HARIOM SHARMA Signing Date:17.11.2025 15:20:13 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.

"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)