The restraining order comes as a setback for the Indian drug maker which was running clinical trials in India for the launch of the biosimilar versions of nivolumab. The earliest patent for the drug expires in India on May 2, 2026. The next hearing for the case is August 8.
The 101-page order issued on July 18 by Justice Mini Pushkarna ruled that the defendants, and all others acting on its behalf, are restrained from manufacturing, using, selling, offering for sale, importing, exporting, advertising, or dealing in any biosimilar/similar biologic of nivolumab, the suit patent, during the pendency of the present suit. The order stated the plaintiffs shall suffer irreparable loss, in case the interim relief as prayed for, was not granted.
Opdyta injections are one of the many latest generation immunotherapy drugs also known as checkpoint inhibitors increasingly used to treat several types of cancers including skin, lungs, kidneys, and Hodgkin lymphoma. It works by activating the body’s T-cells or immune cells by targeting a protein called PD-1, thereby unleashing an attack on the cancer cells.
Opdyta vials are sold in India for roughly ‘2 lakh but for patients who are part of the company’s assistance or access programs, the drug is available at a slab-wise discounted rate.While the India data is not available, globally Bristol Myers Squibb recorded Opdivo sales of $9.3 billion in 2024. Indian companies have launched biosimilars at half the cost of those charged by their global counterparts.Experts in Indian patent laws told ET that the court has taken a view that stockpiling of a product during its active patent life amounts to infringement and to release it or flood the market is not legally valid.
“This opinion may have implications for the other ongoing disputes like the weight-loss drug semaglutide (branded Wegovy) case between Novo Nordisk and Dr. Reddy’s Labs or Roche versus Natco for Risdiplam (drug used for a rare disease called spinal muscular atrophy or SMA) case,” a senior lawyer said.
The petition from BMS noted that Zydus Lifesciences was conducting clinical trials for nivolumab and on its investigation found that the company had plans to launch it during the patent period. The Indian company, it said, had applied for a marketing approval with the central drug regulatory agency.
For its part, lawyers on behalf of Zydus defended saying its product ZRC-3276 does not infringe upon the existing patents and is following the regulatory provisions.
Zydus was represented by a battery of top lawyers including Harish Salve, Dushyant Dave, and Rajiv Nayar, while Squibb & Sons was represented by Sandeep Sethi, PS Raman, Amit Sibal and Pravin Anand, among others.
