On 18 July 2025, the Delhi High Court issued a preliminary injunction restraining Zydus Lifesciences from launching its nivolumab biosimilar (ZRCr-4276) in India. The injunction was granted in proceedings brought by BMS alleging Zydus’ Indian launch of its nivolumab biosimilar will infringe Indian patent no. 340060 (IN ’060).
The Court found that IN ‘060, which expires on 2 May 2026, covers BMS’ Opdivo® (nivolumab), sold as Opdyta® in India. The Court also held that the patent’s validity was not sufficiently in doubt. IN ‘060 had survived four pre-grant oppositions, filed by Indian Pharmaceutical Alliance (IPA), Pankaj Kumar Singh, Restech Pharmaceuticals and Dr. Reddy’s. In addition, the validity of corresponding foreign patents had been upheld. While IN ‘060 was currently facing a post-grant opposition filed by Zydus, that opposition had not yet been finalised.
As well as preventing launch before the patent’s expiry, the preliminary injunction prohibits the post-expiry sale of ZRCr-4276 manufactured before that expiry date. Under Indian law, infringing goods manufactured during the term of a patent remain infringing after the patent expires. Zydus has therefore been ordered to file an affidavit disclosing the quantity of biosimilar nivolumab it has already manufactured.
Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024. At least Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development.
Zydus is no stranger to patent infringement proceedings in India, having faced patent infringement litigation brought by Roche in relation to its pertuzumab biosimilar.