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Zydus can sell anti-cancer drug Nivolumab biosimilar in India: Delhi HC
Zydus can sell anti-cancer drug Nivolumab biosimilarin India, says Delhi high court
New Delhi: 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 anti-cancer drug nivolumab in India, citing public interest.
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 court observed during a verbal pronouncement.
Noting that nivolumab is a life-saving cancer drug and that the patent is nearing expiry, the bench held that the balance of convenience lay in permitting the biosimilar's sale for the remaining patent term, while safeguarding the patentee's interests. It accordingly vacated the injunction and directed Zydus to file periodic audited statements of revenue from the product with the court and the respondent until the patent expires.
A detailed written judgment is awaited.
Nivolumab is a monoclonal antibody immunotherapy which is used to treat several cancers, including lung, head and neck, especially in cases where chemotherapy fails or is less effective. The drug assumes significance as the rate of cancer incidence continues to rise in India.
Apart from nivolumab, similar immunotherapy drugs like Merck's pembrolizumab, known by the brand name Keytruda and AstraZeneca's durvalumab (Imfinzi) are also available in India. While these therapies are extremely useful for hard-to-treat cancers, affordability remains a concern. While nivolumab's price varies according to dosage, supplier and location, a vial costs ₹21,500 to over ₹1,00,000.
Queries sent to both companies are yet to elicit a response till press time.
The dispute
The dispute began when US-based E.R. Squibb & Sons LLC, the innovator of nivolumab (sold in India as Opdyta and globally as Opdivo), approached the Delhi High Court in 2024, alleging that Zydus Lifesciences was preparing to launch a biosimilar version before the expiry of its Indian patent in May 2026.Squibb holds an Indian patent covering the monoclonal antibody nivolumab used in the treatment of several cancers. It claimed that the Ahmedabad-based company had developed a biosimilar, applied for regulatory approvals, conducted clinical trials, and identified nivolumab as the “reference biologic” before drug regulators, indicating an imminent commercial launch during the patent term.
In May 2022, Squibb had issued a cease-and-desist notice to Zydus, which replied that it was only conducting research and clinical trials protected under the “Bolar exemption” of the Patents Act.
Bolar exemption allows generic drugmakers to use, make, sell or import a patented drug for R&D to prepare for regulatory filings. It essentially allows Indian drugmakers to make or reverse-engineer a patented drug and secure approvals so they are ready to launch once the patent expires
Squibb later moved court after receiving market information in 2024 suggesting a likely launch, filing a quia timet suit to prevent anticipated infringement.
Zydus argued that its product, ZRC-3276, did not infringe the patent, that the patent itself was open to challenge, and that it was developing a biosimilar in accordance with regulatory norms. It also pointed to a pending post-grant opposition against Squibb's patent filed by its group company.
In July, a single judge of the Delhi High Court had granted an interim injunction restraining Zydus from manufacturing, selling, importing or dealing in any biosimilar of nivolumab, holding that Squibb had made out a prima facie case and that its patent rights deserved protection pending trial. That order has now been modified by the division bench.
Source: LiveMint
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