HC notice to ER Squibb on Zydus Lifesciences plea in Nivolumab patent case
This story was originally published at 18:11 IST on 24 July 2025
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NEW DELHI – The division bench of the Delhi High Court on Thursday issued notices to E.R. Squibb and Sons, LLC and others on Zydus Lifesciences Ltd.'s plea against a single judge's order barring the latter company from manufacturing, selling biosimilar of E.R. Squibb's patent Nivolumab. Nivolumab is a therapeutic antibody used in treatment of various forms of cancer.
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 has 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.
On Thursday, the shares of Zydus Lifesciences Ltd. ended 1.0% higher at INR 971.25 on the National Stock Exchange. End
Reported by Surya Tripathi
Edited by Vandana Hingorani
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