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Delhi HC allows Zydus to sell biosimilar of blockbuster anti-cancer drug Nivolumab

'Where the product in question is a life-saving drug, the Court has to err in favour of public interest', said the bench

2 min readNew DelhiJan 13, 2026 09:25 AM IST

The relief from the division bench for Zydus comes months before the patent is set to expire on May 2 this year.

The Delhi High Court on Monday cleared the way for Zydus Lifesciences to manufacture and sell an anti-cancer drug, a biosimilar of an ER Squibb and Sons (better known as Bristol-Myers Squibb), in India.

The decision by a division bench of the High Court overturns a single judge’s decision from July 18, 2025, which had restrained Zydus from manufacturing and selling the drug, as an interim measure, in a suit by Bristol-Myers Squibb (BMS) alleging patent infringement by the Indian firm.

The relief from the division bench for Zydus comes months before the patent is set to expire on May 2 this year.

In July 2024, Zydus’ Nivolumab was recommended by the SEC’s CDSCO for grant of permission to manufacture and market. Nivolumab, the monoclonal antibody drug by BMS, is marketed in India as Opdyta.

According to Zydus, as recorded in the court’s order, treatment using Zydus’ product, “would be 70% cheaper than treatment using the respondent’s (BMS) patented drug 5C4.”

A division bench of Justices C Hari Shankar and Justice Om Prakash Shukla on Monday held that “where the product in question is a life-saving drug, the Court has to err in favour of public interest… Withholding such therapy from the public can cause untold and irreparable prejudice to lakhs of lives, and it is, therefore, only where the Court is in possession of irrefutable material to indicate that a patented product is being released in the market without permission of the patentee… that an injunction can issue.”

The division bench took into account the public interest involved, that the patent is due to expire in four months’ time, and the fact that the single judge had mapped product-to-product claim to arrive at a conclusion of prima facie patent infringement, instead of product-to-claim mapping.

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Product-to-product mapping involves comparison of the plaintiff’s patented product with the defendant’s product while product-to-claim mapping is a legal test where the infringement is decided on the basis of mapping the said infringing product to the original patent claims.

Sohini Ghosh

Sohini Ghosh is a Senior Correspondent at The Indian Express. Previously based in Ahmedabad covering Gujarat, she recently moved to the New Delhi bureau, where she primarily covers legal developments at the Delhi High Court Professional Profile Background: An alumna of the Asian College of Journalism (ACJ), she previously worked with ET NOW before joining The Indian Express. Core Beats: Her reporting is currently centered on the Delhi High Court, with a focus on high-profile constitutional disputes, disputes over intellectual property, criminal and civil cases, issues of human rights and regulatory law (especially in the areas of technology and healthcare). Earlier Specialty: In Gujarat, she was known for her rigorous coverage in the beats of crime, law and policy, and social justice issues, including the 2002 riot cases, 2008 serial bomb blast case, 2016 flogging of Dalits in Una, among others. She has extensively covered health in the state, including being part of the team that revealed the segregation of wards at the state’s largest government hospital on lines of faith in April 2020. With Ahmedabad being a UNESCO heritage city, she has widely covered urban development and heritage issues, including the redevelopment of the Sabarmati Ashram Recent Notable Articles (Late 2025) Her recent reporting from the Delhi High Court covers major political, constitutional, corporate, and public-interest legal battles: High-Profile Case Coverage She has extensively covered the various legal battles - including for compensation under the aegis of North East Delhi Riots Claims Commission - pertaining to the 2020 northeast Delhi riots, as well as 1984 anti-Sikh riots. She has also led coverage at the intersection of technology and governance, and its impact on the citizenry, from, and beyond courtrooms — such as the government’s stakeholder consultations for framing AI-Deepfake policy. Signature Style Sohini is recognized for her sustained reporting from courtrooms and beyond. She specialises in breaking down dense legal arguments to make legalese accessible for readers. Her transition from Gujarat to Delhi has seen her expand her coverage on regulatory, corporate and intellectual property law, while maintaining a strong commitment to human rights and lacuna in the criminal justice system. X (Twitter): @thanda_ghosh ... Read More

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