On 12 January 2026, an appellate Division of the High Court of Delhi issued its judgment overturning the grant of a preliminary injunction awarded to Bristol Myers Squibb (BMS) in July 2025, restraining Zydus’ Indian launch of nivolumab ZRC-3276, biosimilar to BMS’ Opdivo®.
The proceedings were brought by BMS, alleging that ZRC-3276 infringes its Indian patent IN340060, titled “Human Monoclonal Antibodies to Programmed Death 1 (PD-1) for use in treating Cancer”. The relevant independent claim of IN340060 includes a functional protein-binding affinity limitation as well as specifying an amino acid sequence. The two appeal judges found that the first instance judge was wrong to find that ZRC-3276 was likely to have an infringing amino acid sequence merely because it was a biosimilar to nivolumab when there was no evidence of the actual sequence of ZRC-3276. The appeal court noted that biosimilarity is assessed based on comparable safety, efficacy and quality, not amino acid sequence, separating the regulatory issues from issues of patent infringement.
The Appeal Court accepted that there was evidence that neither ZRC-3276 nor Opdivo® satisfied the protein-binding affinity limitation of the claims, further weakening the infringement case based on a product-to-product comparison.
Given the weakened infringement case, and the fact IN340060 will expire in just over 4 months, the Appeal Court held that the public interest in the availability of lower-cost, life-saving drugs tipped matters in favour of the injunction being overturned. However, Zydus was ordered to provide an account of profits for sales of the allegedly infringing product until expiry of the patent in suit.
Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.
Nivolumab biosimilars aimed at the Indian market are also under development by Enzene and Reliance Life Sciences. At least Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius and Biocon also have nivolumab biosimilars under development.