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2026 Supreme(Online)(Del) 131

IN THE HIGH COURT OF DELHI AT NEW DELHI
C. Hari Shankar, Om Prakash Shukla, JJ
ZYDUS LIFESCIENCES LIMITED – Appellant
Versus
E. R. SQUIBB AND SONS, LLC – Respondent
FAO(OS) (COMM) 120/2025 | CM APPL. 44383/2025 | CM APPL. 44386/2025 | CM APPL. 44388/2025



Advocates:
For the Appellants/Petitioners: Dr. Abhishek Manu Singhvi, Mr. Dayan Krishnan, Mr. Adarsh Ramanujan, Ms. Bitika Sharma, Ms Vrinda Pathak, Mr. P.S. Manjunathan, Mr. Rajnish Kumar, Ms. Aakashi Lodha, Mr. Shreedhar Kale, Mr. Parth Singh, Mr. Chanan Parwani, Mr. Rishi Agrawala
For the Respondents: Mr. Sandeep Sethi, Mr. Pravin Anand, Ms. Archana Shanker, Ms. Prachi Agarwal, Mr. Devinder Singh Rawat, Ms. Elisha Sinha, Mr. Manan Mondal, Mr. Krisna Gambhir, Ms. Shreya Sethi

In patent infringement cases, public interest and product-to-claim mapping are crucial, and an injunction cannot be justified without decisive mapping, especially for life-saving drugs.

Headnote:(A) Patents Act, 1970 - Section 48 - High Court of Delhi Rules Governing Patent Suits, 2022 - Injunction on manufacturing of anti-cancer drug ZRC 3276 due to alleged patent infringement - The court emphasized public interest alongside patent protection and highlighted the necessity of product-to-claim mapping in infringement cases - The absence of such mapping led to the conclusion that the injunction was not justified. (Paras 3, 5, 21, 26.5.6)

Facts of the case:
The appellant’s product ZRC 3276 is claimed to be a biosimilar of the respondent’s patented product, 5C4, a life-saving anti-cancer drug, but no mapping between the products and the claims of the respondent’s patent was established. The injunction against the appellant was based on the respondent’s assertion of anticipated future infringement. (Paras 23, 25.2)

Findings of Court:
The court concluded that since no product-to-claim mapping was performed, and considering the product's significance for public health, the injunction should be vacated, allowing the appellant to market its product while keeping track of earnings to ensure compliance with any future ruling. (Paras 20, 27)

Issues: The main issues were whether the injunction was valid without product-to-claim mapping and the public interest in allowing access to life-saving drugs. (Paras 20, 26.5.4)

Ratio Decidendi: The court held that mere anticipation of infringement without definitive evidence of product-to-claim mapping does not justify an injunction, particularly for a product critical to public health, emphasizing the balance between patent rights and public interest. (Paras 3, 4, 27)

Result: The appeal is allowed, and the injunction is vacated with directions for the appellant to file accounts of earnings from the sales of ZRC 3276 until the patent expires. (Paras 28, 29)

JUDGMENT

% 12.01.2026C. HARI SHANKAR, J.A Prefatory Note summarizing the judgment in conspectus

1. This appeal throws up issues, for consideration, which are of fundamental importance, not merely as legal principles relating to the patent regime, but also vitally of public interest.

2. The impugned order restrains the appellant from manufacturing or releasing, in the market, its product ZRC 3276, which is an anti- cancer drug and is essential for treatment of a wide variety of life- threating carcinomas, on the premise that the product infringes the respondent’s patent. According to the appellant, treatment, using the appellant’s product, would be 70% cheaper than treatment using the respondent’s patented drug 5C4.

3. The Supreme Court has, in its decisions in Ramnik Lal Bhutta v. State of Maharashtra , (1997) 1 SCC 134 and Raunaq International v. I.V.R. Construction Ltd , (1999) 1 SCC 492 , held that, while considering pleas for injunction or stay, public interest is also a consideration to be borne in mind, apart from the classical troika of a prima facie case, balance of convenience and irreparable loss.

4. That said, we have no doubt about the fact that the mere fact that the injuncted product is a life saving drug is no absolute armour against injunction. Products which infringe patents of others cannot be permitted to circulate in the market. Intellectual property rights are entitled to protection.

5. This case, however, is peculiar, as there is admittedly no mapping of the appellant’s product ZRC 3276 onto the claims in the respondent’s suit patent at any stage. Injunction has, therefore, been granted without any product-to-claim mapping.

6. The impugned order seeks to justify this course of action on the ground that the suit is a quia timet action, instituted in anticipation of future infringement and that, therefore, as the appellant’s product is not commercially available, no product-to-claim mapping is possible.

7. Rule 3(A)(ix), A. Plaint: of the High Court of Delhi Rules Governing Patent Suits, 2022 , “the DHC Patent Suits Rules” hereinafter specifically requires product-to-claim mapping as one of the necessary ingredients of a patent infringement suit. However, the impugned judgment holds that the words “to the extent possible”, in Rule 3A may, in a quia timet action, justify doing away with the requirement of product-to-claim mapping altogether.

8. This is of vital importance, as Section 485 of the Patents Act, 1970 confers, on the holder of a registered patent, the exclusive right to prevent third parties from using, offering, selling or importing that The Plaint in an infringement action shall, to the extent possible, inter alia, contain a description of the following:

*****

(ix) Precise claims versus product (or process) chart mapping including claim chart mapping through standards;

5 48. Rights of patentees.—Subject to the other provisions contained in this Act and the conditions

specified in Section 47, a patent granted under this Act shall confer upon the patentee—

(a) where the subject-matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for those purposes that product in India;

(b) where the subject-matter of the patent is a process, the exclusive right to prevent third parties, who do not have his consent, from the act of using that process, and from the act of using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India:

product in India, without consent of the patentee. The issue of whether, in the absence of any mapping of the defendant’s product to the plaintiff’s granted claim in the suit patent, the defendant’s product can be said to be that product, therefore, requires serious consideration. Especially so as the product is a life-saving drug needed for cancer therapy.

9. The learned Single Judge holds that, even in the absence

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