The Delhi High Court has allowed Zydus Lifesciences to sell and market its biosimilar version of the anti-cancer drug nivolumab in India, despite a patent infringement suit filed by the innovator and patent holder, E.R. Squibb & Sons LLC. The court modified a previous order that had restrained the launch of Zydus’ biosimilar, citing public interest and the fact that the patent is set to expire on May 2, 2026. The bench of justices C. Hari Shankar and Om Prakash Shukla permitted continued sales of the biosimilar, directing Zydus to maintain detailed and audited records of its sales during this period so that Squibb can be compensated if it ultimately succeeds in the patent infringement suit.
Nivolumab is a life-saving cancer drug used to treat several types of cancer, including lung and head and neck cancer. The drug is expensive, with a vial costing between ₹21,500 to over ₹1,00,000, making affordability a concern. The dispute began when Squibb approached the Delhi High Court in 2024, alleging that Zydus was preparing to launch a biosimilar version of nivolumab before the expiry of its Indian patent. Squibb claimed that Zydus had developed a biosimilar, applied for regulatory approvals, and conducted clinical trials, indicating an imminent commercial launch during the patent term.
Zydus argued that its product did not infringe the patent and that it was developing a biosimilar in accordance with regulatory norms. The company also pointed to a pending post-grant opposition against Squibb’s patent filed by its group company. The court’s decision is a relief for Zydus and is expected to increase access to the life-saving drug for cancer patients in India. The court’s order also highlights the importance of balancing the rights of patent holders with the need to ensure access to affordable medicines, particularly in cases where the patent is nearing expiry.
The case is significant as it involves a biosimilar version of a critical cancer drug, and the court’s decision has implications for the pharmaceutical industry and patients in India. The court’s order is also a testament to the Indian judiciary’s commitment to ensuring that patent laws are balanced with the need to provide access to affordable medicines. The decision is expected to have a positive impact on the availability and affordability of cancer treatments in India, where the rate of cancer incidence is on the rise.