Zydus can sell anti-cancer drug Nivolumab biosimilar in 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 anti-cancer drug nivolumab in India, citing public interest.
The court modified its July 2025 single judge order restricting the launch at the request of innovator and patent holder ER Squibb & Sons LLC, which sells the drug under the brand name Opdivo.
A panel of justices C. Hari Shankar and Om Prakash Shukla allowed the sales to continue, stating that Squibb’s patent will expire on May 2, 2026, and ordered Zydus to keep detailed and audited records of its sales during this period so that the inventor can receive compensation if he is ultimately successful in his patent infringement lawsuit.
“We are therefore unable to satisfy ourselves that the learned single judge was entirely justified in restraining the appellant from launching its product on the basis of this material,” the court said during an oral submission.
Noting that Nivolumab is a life-saving cancer drug and that the patent is about to expire, the board decided that the balance of convenience lies in allowing the sale of the biosimilar during the remaining patent term while protecting the interests of the patent owner. Accordingly, the court annulled the preliminary injunction and ordered Zydus to submit to the court and the defendant periodically audited income statements for the product until the patent expires.
A detailed written decision is awaited.
Nivolumab is a monoclonal antibody immunotherapy used to treat many cancers, including lung, head and neck, especially when chemotherapy has failed or is less effective. Medicine is gaining importance as the rate of cancer cases continues to rise in India.
Besides nivolumab, similar immunotherapy drugs such as Merck’s pembrolizumab, known under the brand name Keytruda, and AstraZeneca’s durvalumab (Imfinzi) are also available in India. While these treatments are extremely useful for difficult-to-treat cancers, affordability remains a concern. While the price of nivolumab varies by dose, supplier and location, the cost of the vial ₹more than 21,500 ₹1,00,000.
Questions sent to both companies were not responded to by press time.
Conflict
The dispute began when US-based ER Squibb & Sons LLC, the inventor of nivolumab (sold as Opdyta in India and globally as Opdivo), approached the Delhi High Court in 2024, alleging that Zydus Lifesciences was preparing to launch a biosimilar version before its Indian patent expires in May 2026.
Squibb holds an Indian patent covering the monoclonal antibody nivolumab, which is used to treat various cancers. It claimed that the Ahmedabad-based company had developed a biosimilar, applied for regulatory approvals, conducted clinical trials and designated nivolumab as a “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 stating that it was only conducting research and clinical trials protected under the Patents Act’s “Bolar exemption.”
Bolar exemption allows generic drug manufacturers to use, make, sell or import a patented drug for R&D to prepare for regulatory filings. This essentially allows Indian drug manufacturers to make or reverse engineer a patented drug and secure approvals so that they are ready for launch when the patent expires.
Squibb later went to court after receiving market information pointing to a possible launch in 2024 and filed a stay to prevent the anticipated breach.
Zydus argued that its product, ZRC-3276, did not infringe the patent, that the patent itself was open to challenge, and that it had developed a biosimilar that complied with regulatory norms. It also pointed out that post-approval opposition against Squibb’s patent submitted by the group company is ongoing.
In July, a single judge in the Delhi High Court had granted an interim injunction banning Zydus from manufacturing, selling, importing or trading any nivolumab biosimilar, ruling that Squibb had established a prima facie case and that its patent rights deserved protection pending trial. This order has now been modified by the division bench.
