The top court will hear BMS firm ER Squibb’s appeal against Zydus Lifesciences on February 4.
BMS markets the drug under the brand names Opdivo and Opdyta. It has challenged the Delhi High Court’s January 12 order that cleared the way for Zydus to market and sell a biosimilar version of nivolumab.
The US company had moved the court in 2024 alleging patent infringement by Zydus.
However, Zydus had claimed that treatment with its product would be 70% cheaper than that using the US firm’s patented drug.
While citing public interest that nivolumab is a life-saving drug, the high court said the balance of convenience lies in permitting the biosimilar’s sale for the remaining term of Squibb’s patent, which will expire on May 2.
“Where the issue is triable or involves complicated technical issues which would appropriately need a trial, then, in our opinion, where the product in question is a life-saving drug, the court has to err in favour of public interest,” the high court had said, adding, “Withholding such therapy from the public can cause untold and irreparable prejudice to lakhs of lives.”The court said in its judgment that “as a period of hardly four months remains till the suit patent expires, this arrangement would, to our mind, protect the interests of both sides and would also ensure that the availability of the appellant’s product to the public, who may be in need of it, is not restrained any further”.
While BMS alleged that Zydus was conducting clinical trials of nivolumab and had plans to launch it during its valid patent period, the Indian company denied it and said its product do not infringe upon existing patents.
The Indian company had argued that its product, ZRC-3276, did not infringe the patent, that the patent itself was open to challenge, and that it was developing a biosimilar in accordance with regulations.
It also pointed to a pending post-grant opposition against Squibb’s patent filed by its group company.
Zydus said ZRC-3276 is a biosimilar to Squibb’s nivolumab, but bio-similarity by itself did not substantiate infringement, as it is based upon product-to-product comparison, whereas infringement requires claim to product mapping.
