The Delhi High Court (HC) on Tuesday barred Zydus Lifesciences from commercially manufacturing, selling, importing, exporting, or otherwise dealing in pharmaceutical products containing dabrafenib, a cancer drug protected by a patent held by Novartis AG.
Justice Anup Jairam Bhambhani passed the decree after Zydus agreed to not manufacture or launch any product containing the patented compound until the expiry of Novartis’ Indian patent. The undertaking has been made part of the court’s decree and is binding on Zydus.
Novartis AG and Novartis India had approached the high court seeking a permanent injunction against Zydus and entities acting on its behalf.
They alleged that commercial manufacture, stockpiling, import, sale or distribution of dabrafenib, either as a standalone active pharmaceutical ingredient (API) or in formulations, would infringe on their patent rights.
Dabrafenib is an anti-cancer medicine that targets the BRAF protein, which plays a role in regulating cell growth. It is used, including in combination with other medicines, in the treatment of melanoma, a form of skin cancer.
The patent application was originally filed by GlaxoSmithKline LLC and subsequently assigned to Glaxo Group Ltd. The rights were later transferred to Novartis AG in 2016. The patent remains valid in about 70 countries. In India, the patent is scheduled to remain in force until May 4, 2029.
During the proceedings, Zydus’ counsel offered an undertaking that the company would not manufacture or launch products containing the patented compound before the patent expires. Novartis agreed that the suit could be disposed of on the basis of this undertaking.
The court accordingly decreed the suit in favour of the petitioners and directed that Zydus remain bound by its undertaking. It also disposed of all pending applications. The high court clarified that the restraint would not take away Zydus’ statutory rights under Section 107A of the Patents Act, 1970, commonly known as the “Bolar” provision.
The Bolar provision (also called the Bolar exemption) is a legal rule that lets generic drug companies test and study a patented medicine before its patent expires without breaking the law.
The order, therefore, prevents Zydus from commercially exploiting dabrafenib during the remaining term of Novartis’ patent while preserving the statutory exception available for research and regulatory purposes.
Queries sent to Zydus were not answered till the time of going to press.