Delhi High Court Clears Path for Affordable Cancer Treatment
The Delhi High Court has made a significant ruling that prioritizes public health over patent restrictions. On Monday, a division bench cleared Zydus Lifesciences to manufacture and sell a biosimilar version of the blockbuster anti-cancer drug Nivolumab in India. This decision comes just months before the original patent held by Bristol-Myers Squibb expires on May 2 this year.
Court Prioritizes Public Interest in Life-Saving Medication
The bench comprising Justices C Hari Shankar and Om Prakash Shukla emphasized that courts must favor public interest when dealing with life-saving drugs. They stated clearly that withholding such therapy from the public could cause irreparable harm to countless lives. The judges explained that injunctions should only be granted when there is irrefutable evidence of patent infringement without permission.
"Where the product in question is a life-saving drug, the Court has to err in favour of public interest," the bench declared in their order. "Withholding such therapy from the public can cause untold and irreparable prejudice to lakhs of lives."
Overturning Previous Restriction
This ruling reverses a previous decision from July 18, 2025, where a single judge had temporarily restrained Zydus from manufacturing and selling the drug. Bristol-Myers Squibb had filed a suit alleging patent infringement by the Indian pharmaceutical company. The division bench considered several factors in their decision:
- The imminent patent expiration in just four months
- The substantial public interest in affordable cancer treatment
- Technical differences in how patent infringement was assessed
The court noted that the single judge had used product-to-product mapping instead of the legally appropriate product-to-claim mapping when determining potential infringement.
Significant Cost Reduction for Patients
According to Zydus, their biosimilar version will make cancer treatment dramatically more affordable. The company claims treatment using their product would be approximately 70% cheaper than using Bristol-Myers Squibb's patented drug. This price difference could make life-saving treatment accessible to thousands more patients across India.
Nivolumab, a monoclonal antibody drug developed by Bristol-Myers Squibb, is currently marketed in India under the brand name Opdyta. The drug has become essential in treating various cancers, making its affordability a critical public health concern.
Regulatory Background and Timing
Zydus received regulatory support for their biosimilar in July 2024 when the Subject Expert Committee of the Central Drugs Standard Control Organization recommended granting permission for manufacturing and marketing. The Delhi High Court's decision now provides the legal clearance needed to bring this affordable alternative to market.
The timing is particularly significant with the patent set to expire in early May. The court's ruling acknowledges that restricting access to affordable medication during these final months would disproportionately harm patients who cannot afford the branded version.
This case highlights the ongoing tension between intellectual property rights and public health needs in pharmaceutical regulation. The Delhi High Court's decision establishes an important precedent for balancing these competing interests, particularly when dealing with essential medications that treat life-threatening conditions.
