\n\tThe 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.<\/p>\n
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\n\tJustice 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\u2019 Indian patent. The undertaking has been made part of the court\u2019s decree and is binding on Zydus.<\/p>\n
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\n\tNovartis AG and Novartis India had approached the high court seeking a permanent injunction against Zydus and entities acting on its behalf.<\/p>\n
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\n\u00a0<\/p>\n
\n\tThey 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.<\/p>\n
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\n\tDabrafenib 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.<\/p>\n
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\n\tThe 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.<\/p>\n
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\n\tDuring the proceedings, Zydus\u2019 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.<\/p>\n
\u00a0<\/p>\n
\n\tThe 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\u2019 statutory rights under Section 107A of the Patents Act, 1970, commonly known as the \u201cBolar\u201d provision.<\/p>\n
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\n\tThe 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.<\/p>\n
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\n\tThe order, therefore, prevents Zydus from commercially exploiting dabrafenib during the remaining term of Novartis\u2019 patent while preserving the statutory exception available for research and regulatory purposes.<\/p>\n
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\n\tQueries sent to Zydus were not answered till the time of going to press.<\/p>\n
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