Business

Delhi High Court Greenlights Zydus to Sell Affordable Cancer Drug Biosimilar, Citing Public Interest

The ruling comes just months before BMS’s patent on nivolumab—marketed globally as Opdivo and in India under similar brand names—is due to expire on May 2, 2026. With the patent lapse approaching, the court allowed Zydus to proceed with sales while directing the company to maintain detailed and audited records of revenues until the patent term ends. This mechanism is intended to protect the innovator’s financial interests if the patent challenge eventually succeeds.

• By Newsdesk
• New Delhi
• Jan 13, 2026

Business

In a significant ruling with implications for patient access and pharmaceutical patent law, the Delhi High Court on Tuesday permitted Zydus Lifesciences to manufacture and market a biosimilar version of the cancer drug nivolumab-a decision the court framed around public health priorities. 

The division bench of Justices C. Hari Shankar and Om Prakash Shukla overturned a prior single-judge order that had restrained Zydus from selling the drug amid a patent dispute with Bristol Myers Squibb (BMS). The original injunction had paused the launch of Zydus’s biosimilar, ZRC-3276, as BMS had claimed patent infringement. 

In its latest judgment, the court emphasised that when life-saving treatment is involved, decisions should lean in favour of wider patient access, especially when withholding therapy could harm public welfare. The bench also noted the nuance required in balancing intellectual property rights with urgent healthcare needs. 

The ruling comes just months before BMS’s patent on nivolumab—marketed globally as Opdivo and in India under similar brand names—is due to expire on May 2, 2026. With the patent lapse approaching, the court allowed Zydus to proceed with sales while directing the company to maintain detailed and audited records of revenues until the patent term ends. This mechanism is intended to protect the innovator’s financial interests if the patent challenge eventually succeeds. 

Zydus has maintained that its biosimilar complies with regulatory standards and argued that restricting its sale would deny patients access to a crucial therapy. Independent analyses cited by the company suggest the biosimilar could cost around 70% less than the patented version, a factor the court stressed could expand access for patients who have long faced steep treatment costs. 

Legal experts suggest the decision may set an important precedent in how Indian courts balance patent protection with public health imperatives, particularly for life-saving biologics. While patent holders retain rights to protect innovation, the judgement underscores the judiciary’s role in preventing barriers to essential medicines when lives are at stake.