HC lifts ban on Zydus cancer biosimilar till patent expiry

In a relief for Zydus Lifesciences, a division bench of the Delhi High Court on Monday allowed the drugmaker to sell and market its biosimilar of the anticancer drug nivolumab in India, citing public interest.

- Krishna Yadav & Jessica Jani

The court modified a July 2025 single-judge order that had restrained the launch on the plea of innovator and patent holder E.R. Squibb & Sons LLC, which sells the drug under the brand Opdivo.

A bench of justices C. Hari Shankar and Om Prakash Shukla permitted continued sales, noting that Squibb's patent is due to expire on 2 May 2026, and directed Zydus to maintain detailed and audited records of its sales during this period so that the innovator can be compensated in case it ultimately succeeds in the patent infringement suit. "We are therefore unable to satisfy ourselves that, on this material, the learned single judge was justified in entirely injuncting the appellant from releasing its product in the market," the HC observed during a verbal pronouncement.