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Informist, Thursday, Jan. 29, 2026

 

--ER Squibb moves SC to bar Zydus Life from selling biosimilar of Nivolumab 

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

--SC to hear ER Squibb's plea against Zydus Lifesciences on Feb 4

  

NEW DELHI – E.R. Squibb and Sons LLC. Thursday moved the Supreme Court to bar Zydus Lifesciences Ltd. from manufacturing and selling biosimilar of the former's patent Nivolumab, a therapeutic antibody used in treatment of various forms of cancer. The apex court will hear E.R. Squibb's plea against Zydus Lifesciences next on Feb. 4.

 

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

 

Zydus Lifesciences had said that the treatment using its product would be 70% cheaper than treatment using the 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 Lifesciences' 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 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.

 

At 1230 IST, the shares of Zydus Lifesciences Ltd. were down 1.0% at INR 887.55 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 Deepshikha Bhardwaj

 

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