When Public Interest Tempers Interim Patent Relief: The Nivolumab Biosimilar Ruling

In Zydus Lifesciences Ltd. v. E.R. Squibb and Sons LLC & Ors. (FAO(OS) (COMM) 120/2025, CM APPL. 44383/2025, CM APPL. 44386/2025 & CM APPL. 44388/2025), the Division Bench of the Delhi High Court modified the interim order passed by the Single Judge, who had restrained Zydus from manufacturing, using, offering for sale, selling or importing its biosimilar version of the cancer immunotherapy drug Nivolumab in India. In doing so, the Division Bench placed particular emphasis on public interest, especially in the context of a life-saving drug.

Product-to-claim Mapping

E.R. Squibb had instituted a quia timet action to restrain the anticipated launch of Zydus’ product, ZRC-3276, prior to the expiry of the suit patent in May 2026. The patent in issue, IN 340060, titled “Human Monoclonal Antibodies to Programmed Death 1 (PD-1) for use in treating Cancer”, covers antibody 5C4, or Nivolumab, marketed outside India as Opdivo and in India as Opdyta. By order dated July 18, 2025, the Single