Whalesbook
Court Greenlights Zydus Biosimilar Sales
The Delhi High Court has permitted Zydus Lifesciences to manufacture and sell a biosimilar version of Bristol Myers Squibb's (BMS) critical cancer medication, Nivolumab. This decision by a division bench on Monday overturns a prior order that had temporarily barred the Ahmedabad-based pharmaceutical firm.
The ruling is seen as a substantial boost for Zydus, particularly as the patent protection for BMS's Nivolumab in India is set to expire on May 2. The court emphasized the need to provide affordable treatment options to patients, stating that "the ailing public cannot be deprived of Zydus' drug."
Overturning Previous Restraint
This verdict supersedes a July 18 order issued by Justice Mini Pushkarna, which had restrained Zydus from launching its biosimilar, citing potential irreparable harm to BMS. BMS had contended that Zydus's planned launch during the patent's validity period constituted an infringement.
Zydus, however, countered these claims, asserting that its product, ZRC-3276, does not infringe the patent and adheres to Indian regulatory standards. The company had already sought marketing approval from India's drug regulator. It also pointed to previous legal challenges by its subsidiary that recommended the patent's revocation.
Balancing Access and Patents
The court directed Zydus to maintain detailed sales records until the patent formally lapses. This move balances the immediate need for accessible, potentially lower-cost medications with the rights of the patent holder during the remaining patent term.