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. This 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.
The Court's Decree
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. This undertaking was incorporated directly into the court's decree, making it legally binding on the company.
What Novartis Was Seeking
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's 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's Binding Undertaking
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 this undertaking.
The High Court accordingly decreed the suit in favour of the petitioners and directed Zydus to remain bound by its commitment, with all pending applications in the matter 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 this restriction does not remove statutory rights available to Zydus under Section 107A of the Patents Act, 1970.
The Bolar Exemption Still Applies
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 broader 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. This 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.
FAQs
Q1. What is dabrafenib, and why is this patent case significant?
Dabrafenib is an anti-cancer medicine used to treat melanoma by targeting the BRAF protein. The case is significant as it involves patent protection for a cancer treatment currently held by Novartis AG in India until 2029.
Q2. Can Zydus still conduct research on dabrafenib despite this ruling?
Yes, the court's order preserves Zydus' statutory rights under Section 107A (the Bolar exemption), allowing it to test and study the patented medicine for research and regulatory purposes without infringing the patent.
Q3. Until when is Zydus restrained from commercially launching this cancer drug?
Zydus is restrained from commercially manufacturing, selling, or otherwise dealing in dabrafenib products until the patent expires on May 4, 2029.