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Informist, Monday, Jan. 12, 2026

 

--HC allows Zydus Lifesciences to manufacture, sell biosimilar of Nivolumab 

--CONTEXT: Nivolumab is therapeutic antibody used in treatment of cancer 

 

NEW DELHI – The division bench of the Delhi High Court Monday allowed Zydus Lifesciences Ltd. to manufacture and sell biosimilar of E.R. Squibb and Sons, LLC.'s patent Nivolumab, a therapeutic antibody used in treatment of various forms of cancer, till the latter company's main suit was decided by its single judge. "Given the nature of the product and applying the principle of balance of convenience, the interests of justice would require the appellant (Zydus Lifesciences) to be bound down to maintain accounts of the realisations from the sale of its product till the expiry of the patent, rather than depriving the ailing public of access to the product," said the division bench of Justice C. Hari Shankar and Justice Om Prakash Shukla.

 

Vacating a single judge bench Justice Mini Pushkarna's Jul. 18 order that had barred Zydus Lifesciences from selling Nivolumab's biosimilar, the division bench asked the company to give audited accounts of the amounts earned by it through sale of the allegedly infringing product till the expiry of the suit on May. 2, 2026, noting that a period of hardly four months remains till the patent expires. This arrangement would protect the interests of both sides, and would also ensure the availability of Zydus Lifesciences' product to the public, who may be in need of it, said the division bench. 

 

The division bench said that there was admittedly no mapping of Zydus Lifesciences' product onto the claims in E.R. Squibb's patent at any stage and Justice Pushkarna granted an injunction without any product claim mapping. Rule 309 of the High Court of Delhi Rules governing patent suits specifically requires product claim mapping as one of the necessary ingredients of a patent infringement suit, said the division bench.

 

The case has its genesis from E.R. Squibb filing a suit of permanent injunction against Zydus Lifesciences before the single judge bench. E.R. Squibb sought the single judge to restrain Zydus from infringing its patent for the cancer-treating drug. E.R. Squibb's patent had a term of 20 years, expiring in May 2026. Nivolumab was sold under the brand name Opdivo outside India, whereas in India Nivolumab was imported and marketed as Opdyta. 

 

In 2024, E.R. Squibb came to know that Zydus was planning to launch a bio-similar version of Nivolumab without its authorisation. It was also revealed to E.R. Squibb that Zydus had applied for regulatory approval from the Central Drugs Standard Control Organisation and Directorate General of Commercial Intelligence and Statistics for marketing the bio-similar version of Nivolumab.

 

On Jul. 18, the single-judge bench of Justice Mini Pushkarna said that E.R. Squibb had established a prima facie case in its favour. Noting that E.R. Squibb shall suffer irreparable loss in case an interim relief was not granted, Justice Pushkarna restrained Zydus from selling a biosimilar of Nivolumab till the main injunction suit was pending.  End

 

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

 

Reported by Surya Tripathi

Edited by Deepshikha Bhardwaj

 

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