In a significant development for cancer treatment accessibility in India, the Delhi High Court has granted permission to Zydus Lifesciences to sell and market its biosimilar version of the critical anti-cancer drug, Nivolumab. The decision, delivered on Monday by a division bench, prioritizes public interest as the patent held by the innovator company nears its expiry.
Court Modifies Earlier Injunction, Balances Interests
The bench comprising Justices C. Hari Shankar and Om Prakash Shukla modified an earlier interim injunction order from July 2025. That order, passed by a single judge, had restrained Zydus from launching the biosimilar on a plea filed by the patent holder, US-based E.R. Squibb & Sons LLC. Squibb sells the drug under the brand names Opdivo globally and Opdyta in India.
The court noted that Squibb's Indian patent for Nivolumab is set to expire on 2 May 2026. Given that Nivolumab is a life-saving medication and the patent term is nearly over, the bench ruled that the balance of convenience lay in allowing the biosimilar's sale for the remaining period. However, to safeguard the patentee's rights, the court issued a crucial directive.
Zydus has been ordered to maintain detailed and audited records of all sales during this interim period. The company must file periodic audited revenue statements from the product with the court and Squibb. This measure ensures that if Squibb ultimately succeeds in its ongoing patent infringement lawsuit, it can be adequately compensated for any sales made by Zydus before the patent expiry.
Background of the Legal Dispute
The legal battle began when E.R. Squibb approached the Delhi High Court in 2024. The company alleged that Ahmedabad-based Zydus Lifesciences was preparing to launch a biosimilar version of Nivolumab before its patent expiry in May 2026. Squibb holds the Indian patent covering the monoclonal antibody used to treat various cancers.
Squibb's suit claimed that Zydus had developed the biosimilar, sought regulatory approvals, conducted clinical trials, and identified Nivolumab as the reference biologic—actions indicating an imminent commercial launch. Earlier, in May 2022, Squibb had sent a cease-and-desist notice to Zydus. In response, Zydus cited the 'Bolar exemption' under the Indian Patents Act, which permits research and trials for regulatory submissions even during a patent term.
Zydus defended its position, arguing that its product, ZRC-3276, did not infringe the patent, that the patent itself was vulnerable to challenge, and that its development activities were compliant with regulations. The company also highlighted a pending post-grant opposition against Squibb's patent filed by a group entity.
Significance for Cancer Treatment in India
Nivolumab is a monoclonal antibody immunotherapy used to treat several cancers, including lung and head and neck cancers, particularly when chemotherapy is ineffective. The drug's importance is underscored by India's rising cancer incidence rates.
While other immunotherapy drugs like Merck's pembrolizumab (Keytruda) and AstraZeneca's durvalumab (Imfinzi) are available, affordability remains a major hurdle. The price of Nivolumab varies widely, with a single vial costing between ₹21,500 to over ₹1,00,000. The entry of a biosimilar is expected to enhance competition and potentially improve access to this vital treatment.
The Delhi High Court's verbal observation underscored its rationale: "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." A detailed written judgment is currently awaited. Queries sent to both Zydus Lifesciences and E.R. Squibb remained unanswered at the time of reporting.
