India Pharma Outlook Team | Thursday, 24 July 2025
In a courtroom defeat for Zydus Lifesciences, the Delhi High Court has stayed the company from marketing its proposed biosimilar of the cancer drug Nivolumab (Opdivo) until May 2, 2026, the date of expiry of the patent suit.
An interim injunction was issued in favour of Bristol Myers Squibb (BMS) and its group companies, E.R. Squibb & Sons LLC, Ono Pharmaceutical Co. Ltd., and BMS India, who had claimed that Zydus's biosimilar infringed their Indian Patent No. IN 340060. The patent, which was issued in July 2020, is for monoclonal antibodies for PD-1, such as Nivolumab.
Plaintiffs claimed that Zydus's clinical and regulatory conduct and trial registration of biosimilar ZRC-3276 made plans for commercial sale within the term of the patent. Zydus replied by claiming the Bolar exemption under experimental use and patent nonvalidity due to prior art.
But the court turned down Zydus's arguments, citing that the company did not show that the patent was lacking in novelty or inventive step. The judge ruled that none of the referred prior art disclosed the particular amino acid sequences contained in the patent.
The court ruled that a prima facie case of infringement had been made by BMS, and that the balance of convenience as well as risk of irreparable harm supported injunctive relief.
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Zydus was directed to make available within four weeks the amount of any biosimilar produced so far. The direction, originally issued in May 2024, will continue to run until patent expiration on May 2, 2026.
