NEW DELHI: A division bench of the Delhi High Court on Monday permitted drugmaker Zydus Lifesciences to sell and market a biosimilar version of the anti-cancer medication Nivolumab in India, setting aside a single judge order that had temporarily restrained the firm from doing the same.
A bench of justices C Hari Shankar and Om Prakash Shukla vacated the July 2025 injunction in a patent infringement suit filed by E.R. Squibb & Sons LLC, which sells the Nivoiumab under the brand Opdivo, restraining Zydus from manufacturing its biosimilar, ZRC-3276.
Nivolumab is a monoclonal antibody-based immunotherapy used in the treatment of several cancers, including lung and head-and-neck cancers, particularly in situations where chemotherapy is ineffective or offers limited benefit.
The court noted that Squibb’s patent for Nivolumab in India is due to expire on May 2 this year, and granting such permission would be in the public interest. It also said that withholding such therapy from the public could cause untold and irreparable prejudice to lakhs of lives.
“Where the issue is triable or involves complicated technical issues which would appropriately need a trial, then in our opinion, where the product in question is a live saving drug, the court has to err in favour of public interest and ensure securing of the plaintiff’s interest by alternate methods, short of making the drug unavailable to the public during the entire period for which the suit would remain pending. Withholding such therapy from the public can cause untold and irreparable prejudice to lakhs of lives,” the court said in its 34-page ruling.
Directing Zydus to file a copy of the audited accounts of the amount earned by the drugmaker from the sale of ZRC-3276 until the expiry of Squibb’s patent, the court said: “As a period of hardly four months remains till the suit patent expires, this arrangement would, to our mind, protect the interest of both sides and would also ensure that the availability of the appellant’s (Zydus) product to the public, who may be in need of it, is not restrained any further.”