NEW DELHI: In a significant ‘public interest’ move, the Delhi High Court has allowed Zydus Lifesciences to manufacture and sell a biosimilar of Bristol Myers Squibb’s blockbuster cancer therapy, Nivolumab. Priced around 70% less than the patented therapy, the Zydus biosimilar is expected to improve patient access and affordability significantly.A division bench of Justices C Hari Shankar and Om Prakash Shukla on Monday set aside an earlier single-judge order that had blocked the entry of Zydus’ version. The court observed that “where the product in question is a life-saving drug, the court has to err in favour of public interest,” adding that the innovator’s interests could be protected through alternative safeguards.Last year, a single bench had stopped Zydus from marketing the biosimilar, ZRC 3276, an anticancer drug which is essential for treatment of a wide variety of life-threatening cancers, on the ground that the product infringes the innovator’s patent.The order comes four months ahead of the expiry of BMS’ patent on Nivolumab, marketed as Opdiva, on May 2, 2026. “Given the nature of the product, and applying the principle of balance of convenience, too, the interests of justice would require the appellant to be bound down to maintain accounts of the realizations from the sale of its product till the expiry of the suit patent, rather than depriving the ailing public of access to the product’’, the order, accessed by TOI, said.The order has directed Zydus to maintain accounts of the biosimilar sales till the patent expires.Noting that the courts have to walk a tightrope between public interest and intellectual property, they said in the order: “Courts have to be acutely conscious of their duties in such matters. The tightrope is shaky, and walking it is not always an enviable enterprise. Our oath of office, however, obligates us to do so and, while doing so, we have to bear in mind our duty to the teeming citizenry of this country who may be in dire need of the therapy, the release of which a plaintiff seeks to injunct”.Further, it added “There is, at the same time, also a pre-eminent element of public interest in ensuring protection of valuable patents, which should not be forgotten. If Courts are to swing to the other extreme, and openly allow circulation, in the market, of drugs which infringe valuable pharmaceutical patents, the incentive to invent would be altogether lost, which might result in ebbing the stream at the source. There would be no incentive to expend valuable time, energy and often cripplingly huge financial resources in inventing a new and more efficacious drug, if one is not ensured of patent protection as available in law”.
About the Author
