Patent Infringement: Delhi High Court Restrains Zydus From Manufacturing Biologic Similar To 'Nivolumab' Cancer Drug

The Delhi High Court has restrained Zydus Lifesciences Limited from manufacturing, selling importing, exporting or dealing in any biologic which is similar to Nivolumab, a drug used to treat cancer, sold under the brand name “Opdivo.”

Justice Mini Pushkarna passed the interim order in favour of Nivolumab's manufacturer company- E.R. Squibb and Sons LLC, in its patent infringement suit against Zydus.

Scquibb and Sons filed the suit seeking permanent injunction for restraining infringement of its patent “Human Monoclonal Antibodies to Programmed Death 1 (PD-1) for use in treating Cancer” by Zydus.

The suit patent has a term of 20 years, starting from May 02 2006, which expires on May 02, 2026. A post-grant opposition was filed by Zydus Healthcare Limited, a sister concern of the Zydus Lifesciences, which is pending.

It was Squibb and Sons' case that Zydus Lifesciences had registered a clinical trial for its bio-similar ZRC-3276 in which it had mentioned product Nivolumab, identifying Opdivo®, as the reference product.

The suit was filed after Squibb and Sons apprehended that Zydus intended to manufacture, launch and deal in Nivolumab during the term of the suit patent without authorisation.

Granting relief to Scquibb and Sons, Justice Pushkarna restrained Zydus from launching product, if any, manufactured during the pendency of the suit patent.

The Court directed Zydus to file an affidavit disclosing the quantity of its manufactured bio-similar product of Nivolumab, within four weeks.

“It is to be seen that the patent expires in May, 2026. The defendant will be free to launch its product thereafter. The patent in question is valid in fifty countries across the world. The validity of the patent was challenged in thirty countries and has successfully been sustained. Further, the plaintiffs were granted the suit patent after fourteen years, thereby, shortening the limited monopoly of the plaintiffs,” the Court said.

It observed that any infringing products manufactured, offered for sale or sold, etc., during the life or term of the patent, do not gain credibility and thus, their manufacture and stockpiling m during the said period, would also amount to infringement.

The Court said that Zydus was not able to lay a credible challenge to the validity of the suit patent and the incidence of infringement by it also stood established.

Title: E. R. SQUIBB AND SONS, LLC & ORS v. ZYDUS LIFESCIENCES LIMITED

Citation: 2025 LiveLaw (Del) 825

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