The Delhi High Court has restrained Zydus Lifesciences from commercially manufacturing, selling, importing, exporting or otherwise dealing in pharmaceutical products containing dabrafenib, an anti-cancer drug protected by an Indian patent held by Novartis AG. The restriction will remain in place until the patent expires on May 4, 2029, while preserving Zydus’ statutory rights to conduct activities permitted under India’s patent law.
Justice Anup Jairam Bhambhani passed the decree after Zydus undertook that it would not manufacture or launch products containing the patented compound before the expiry of Novartis’ Indian patent. The undertaking was incorporated into the court’s decree and is binding on the company.
Novartis Sought Permanent Injunction Over Dabrafenib
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 the commercial manufacture, stockpiling, import, sale or distribution of dabrafenib, either as a standalone active pharmaceutical ingredient or in formulations, would infringe 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 was subsequently assigned to Glaxo Group Ltd. The rights were later transferred to Novartis AG in 2016. The patent remains valid in about 70 countries and is scheduled to remain in force in India until May 4, 2029.
Zydus Undertaking Made Binding by Court
During the proceedings, counsel for Zydus 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 that undertaking.
The High Court accordingly decreed the suit in favour of the petitioners and directed Zydus to remain bound by its commitment. All pending applications in the matter were also disposed of.
The order prevents Zydus from commercially exploiting dabrafenib during the remaining term of Novartis’ Indian patent. However, the court made clear that the restriction does not remove statutory rights available to Zydus under Section 107A of the Patents Act, 1970.
Bolar Rights for Research and Regulatory Work Preserved
Section 107A, commonly known as the Bolar provision or Bolar exemption, permits generic drug companies to test and study a patented medicine before the patent expires without infringing the patent, subject to the statutory framework.
The High Court’s order therefore restricts commercial manufacture and launch of dabrafenib products by Zydus while preserving the exception available for research and regulatory purposes.
The distinction allows preparatory activities protected by the Bolar provision to continue even as commercial exploitation of the patented compound remains prohibited until the patent expires.
Queries sent to Zydus had not received a response by the time of publication.
