IMAGE: Kindly note that this image has been posted for representational purposes only. Photograph: ANI Photo
Citing public interest, the Delhi high court has cleared the way for Zydus Lifesciences to proceed with the sale of its version of the cancer drug nivolumab in India.
A division bench of Justice C Hari Shankar and Justice Om Prakash Shukla set aside an “interim restraint” imposed by a single judge in July last year.
The restraint had debarred Zydus from launching the biosimilar following the objection of the patent holder, E.R Squibb & Sons LLC. Squibb markets nivolumab globally under the brand Opdivo.
A detailed written judgment is awaited.
Nivolumab is used to treat several types of cancer by activating the body’s immune system to target carcinogenic cells. The drug in India can cost more than ₹1 lakh per vial, depending on the dosage, supplier, and whether it is a branded product or a newer, cheaper biosimilar version.
The bench noted that Squibb’s Indian patent for nivolumab was due to expire on May 2 and found it unjustified, at this stage, to keep Zydus out of the market. While permitting the manufacture and sale of the biosimilar, the court directed Zydus to maintain detailed, independently audited accounts of all sales and revenues from the product.
These records are to be periodically filed before the court so that Squibb can be compensated if it succeeds in the infringement proceedings.
In its oral observations, the court said it was not convinced that the earlier injunction was warranted on the material available, particularly given the life-saving nature of the drug and the short remaining duration of the patent.
Fight over Nivolumab
Looking at both patient access and the innovator’s proprietary rights, the bench held that allowing sales with safeguards better served the balance of convenience.
The litigation traces back to 2024, when Squibb approached the Delhi high court, alleging that Zydus was on the verge of commercially launching a biosimilar of nivolumab before the expiry of its Indian patent.
Squibb said Zydus had done clinical trials, sought regulatory approvals, and named nivolumab as the reference biologic, signalling an imminent market entry during the patent term.
Zydus countered this, saying its activities were protected under statutory research exemption under the Patents Act, which allows using patented inventions for research and regulatory preparation. It also disputed infringement, questioned the validity of Squibb’s patent, and pointed to a pending post-grant opposition filed by a group entity.
In July, the single judge had accepted Squibb’s plea that a prima facie case of infringement was made out and restrained Zydus from manufacturing or selling any biosimilar of nivolumab pending trial.
The division bench has modified that order, lifting the blanket prohibition while preserving Squibb’s right to seek monetary relief, depending on the outcome of the suit.
