Supreme Court Allows Patent Mapping in Cancer Drug Dispute Between Bristol Myers Squibb and Zydus
Bench directs Zydus to supply product sample for detailed comparison with Squibb’s patent claims
Case highlights growing tension between innovator pharma companies and Indian generics over affordability and IP rights
By Legal Reporter
New Delhi: February 14, 2026:
In a significant development in India’s pharmaceutical sector, the Supreme Court of India has permitted Bristol Myers Squibb (BMS) to undertake a patent mapping exercise against Zydus Lifesciences Limited in relation to its biosimilar version of the cancer drug nivolumab, marketed globally by BMS under the brand name Opdivo.
The Court’s order, delivered on February 11, 2026, allows BMS to compare each feature of Zydus’ product with the specific elements of its patent claims to determine whether infringement has occurred. The bench, comprising Chief Justice of India Surya Kant and Justice Joymalya Bagchi, directed Zydus to supply a sample of its product within 24 hours to facilitate the mapping exercise.
Case Background
- The drug in question: Nivolumab is a monoclonal antibody used in the treatment of multiple cancers, including lung cancer, melanoma, and kidney cancer.
- BMS position: The US-based innovator company argued that Zydus’ biosimilar infringes its intellectual property rights and sought to restrain its manufacture and sale.
- Zydus position: The Ahmedabad-headquartered firm maintained that its biosimilar formulation does not violate BMS’ patents and would reduce treatment costs by nearly 70%, making cancer therapy more affordable in India.
- Delhi High Court ruling: On January 12, 2026, the Delhi High Court allowed Zydus to commercialize its version of nivolumab. BMS challenged this before the Supreme Court.
- Supreme Court’s response: While refusing to halt Zydus’ launch, the apex court directed BMS to conduct patent mapping and seek interim relief before the High Court based on the findings.
What is Patent Mapping?
Patent mapping, also known as product-to-claim mapping, is a technical exercise where:
- Each feature of the allegedly infringing product is compared with the specific elements of the patent’s claims.
- The process determines whether the product falls within the scope of the patented invention.
- It is often used in complex pharmaceutical disputes where formulations and processes are highly technical.
Supreme Court’s Key Observations
- No stay on Zydus’ launch: The Court refused to stop Zydus from manufacturing and selling its biosimilar, noting that the product is already available in the market.
- Patent mapping essential: Directed BMS to undertake detailed mapping to establish infringement.
- Role of High Court: Stated that interim relief must be sought before the Delhi High Court after mapping results.
- Limited patent term: Observed that BMS’ patent protection is nearing expiry, which influenced the decision not to halt Zydus’ launch.
Implications of the Judgment
- For Innovator Companies: Reinforces the need for detailed technical evidence before seeking injunctions against generics.
- For Generic Manufacturers: Provides breathing space to launch affordable alternatives while litigation continues.
- For Patients: Ensures access to cheaper cancer drugs, potentially reducing treatment costs significantly.
- For Judiciary: Highlights the balancing act between protecting intellectual property and ensuring public access to life-saving medicines.
Broader Legal Significance
This case reflects the global tension between patent rights and public health. India, known as the “pharmacy of the world,” has often prioritized affordability and access over strict IP enforcement. The Supreme Court’s decision to allow patent mapping but not halt Zydus’ launch demonstrates a pragmatic approach—ensuring that patients benefit from affordable medicines while respecting the rights of innovator companies.
It also sets a precedent for future disputes in India’s pharmaceutical sector, where biosimilars and generics increasingly challenge multinational corporations’ patents.
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Conclusion
The Supreme Court’s decision in the BMS vs. Zydus cancer drug dispute is a landmark in India’s pharmaceutical litigation. By allowing patent mapping but refusing to halt Zydus’ biosimilar launch, the Court has struck a balance between intellectual property protection and public health needs.
This ruling underscores India’s commitment to affordable healthcare while ensuring that patent disputes are resolved through detailed technical analysis rather than blanket injunctions.
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