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Informist, Wednesday, Feb. 11, 2026

 

--SC refuses to stop Zydus Life from selling biosimilar of Nivolumab

--CONTEXT: SC order on ER Squibb's plea against Zydus Life in Nivolumab case

--SC asks ER Squibb to conduct mapping of Zydus Life pdt, move HC accordingly

 

NEW DELHI – The Supreme Court Wednesday refused to stop Zydus Lifesciences Ltd. from manufacturing and selling a biosimilar of E.R. Squibb and Sons LLC.'s patented nivolumab drug, noting that Zydus Life had already marketed its product in the market. However, the top court asked E.R. Squibb to go for direct mapping of Zydus Life's product and depending on the result, approach the Delhi High Court. For the purpose of direct mapping, the apex court said Zydus Life should give a sample of its product to E.R. Squibb within 24 hours.

 

The Supreme Court bench, led by Chief Justice of India Surya Kant, said that E.R. Squibb can be compensated if Zydus Life's product was found to be in infringement. However, Chief Justice Kant said no one can compensate a person who loses their life in want of medicine due to the high cost of E.R. Squibb's medicine. Nivolumab is a therapeutic antibody used in the treatment of various forms of cancer.

 

On Jan. 12, a division bench of the Delhi High Court had allowed Zydus Life to manufacture and sell a biosimilar of nivolumab till E.R. Squibb's permanent injunction suit was decided by its single judge bench. Following this, Zydus Life launched a biosimilar under the brand name 'Tishtha' in India. The drug is available in dosages of 100 milligrams and 40 milligrams priced at INR 28,950 and INR 13,950, respectively.

 

Zydus Life had said that treatment using its product would be 70% cheaper than treatment using E.R. Squibb's patented drug. "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 of the high court.

 

The division bench said that there was admittedly no mapping of Zydus Life's product onto the claims in E.R. Squibb's patent at any stage and the single judge bench had 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 steps of a patent infringement suit, said the division bench.

 

The case dates back to 2024, when E.R. Squibb came to know that Zydus Life was planning to launch a biosimilar of nivolumab without its authorisation. It also came to light that Zydus Life had applied for regulatory approval from the Central Drugs Standard Control Organisation and the Directorate General of Commercial Intelligence and Statistics for marketing the biosimilar.

 

E.R. Squibb filed for permanent injunction against Zydus Life before a single-judge bench of the Delhi High Court, seeking to restrain Zydus Life from infringing its patent for the cancer-treating drug. E.R. Squibb's patent had a term of 20 years, expiring in May 2026. Outside India, Nivolumab is sold under the brand name Opdivo. In India, nivolumab is imported and marketed as Opdyta.

 

At 1405 IST, shares of Zydus Life were up nearly 1% at INR 894.75 on the National Stock Exchange.  End

 

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

 

Reported by Surya Tripathi

Edited by Ashish Shirke

 

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