Supreme Court Allows Product-To-Claim Mapping In Nivolumab Patent Dispute Between ER Squibb and Zydus

The Supreme Court on Wednesday disposed of a special leave petition filed by E.R. Squibb and Sons LLC against Zydus Lifesciences Ltd in a patent dispute over the anti-cancer immunotherapy drug Nivolumab, arising from a January 12 judgment of the Delhi High Court's Division Bench.

A Bench of the Chief Justice Surya Kant and Justice Joymalya Bagchi noted that since Zydus had already marketed its product and it was readily available in the market, the petitioners would be at liberty to undertake a direct product-to-claim mapping and, depending on the outcome, approach the Division Bench of the High Court for appropriate interim relief.

“In view of the fact that the respondent has already marketed its product, which is readily available in market, the petitioners shall be at liberty to go for mapping of the product with the patented claim and subject to the outcome of such mapping, may approach the Division Bench of the High Court for appropriate interim directions,” the Court observed.

The Court further directed Zydus to supply a sample of its product to E.R. Squibb through counsel within 24 hours to enable such mapping. “For the purpose of direct mapping, let sample of the product be supplied by the respondent to the petitioners through the learned counsel within 24 hours,” it ordered.

The dispute arises from a patent infringement action relating to Indian Patent No. IN 340060, titled “Human Monoclonal Antibodies to Programmed Death 1 (PD-1) for use in treating Cancer.” The patent claims an isolated monoclonal antibody that binds specifically to PD-1 and contains specified amino acid sequences. The suit patent is set to expire on May 2, 2026.

Zydus Lifesciences developed ZRC 3276, claiming it to be a biosimilar of Nivolumab. Apprehending infringement, Squibb filed a quia timet patent suit before the Delhi High Court prior to commercial launch. A Single Judge had, by an interim order dated May 8, 2024, restrained Zydus from manufacturing or releasing ZRC 3276 in the market.

However, the Division Bench of the Delhi High Court, by judgment dated January 12, 2026, vacated the injunction, holding that in the absence of product-to-claim mapping, the restraint could not be sustained. The Bench emphasised that patent infringement must be assessed by comparing the defendant's product with the specific claims of the patent, and not through product-to-product similarity or biosimilarity.

Taking note of the technical complexity of the issues, the public interest in access to a life-saving cancer therapy, and the impending expiry of the patent, the Division Bench directed Zydus to file audited accounts of the amounts earned from the sale of the product until expiry of the patent, in order to secure the patentee's interests in the event of success in the suit.

With the Supreme Court now disposing of the SLP and permitting direct mapping of the marketed product, Squibb may return to the High Court to seek appropriate interim directions depending on the outcome of that exercise.

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