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Informist, Friday, Jul. 31, 2026

 

--HC bars Torrent Pharma from launching drug with Novartis Dabrafenib patent 

--HC: Restraint on Torrent Pharma till Novartis patent on Dabrafenib expires 

--CONTEXT: Novartis' Dabrafenib is marked for treatment of cancer 

 

By Surya Tripathi

 

NEW DELHI – The Delhi high Court has restrained Torrent Pharmaceuticals Ltd. from commercially manufacturing, launching, importing, exporting or dealing in any active pharmaceutical ingredient, pharmaceutical products or formulations containing the Novartis AG's patented compound Dabrafenib during the validity of the latter's patent. The high court said Torrent Pharmaceuticals' rights under Section 107A of the Patents Act, 1970 to use Dabrafenib for the purpose of research, be protected, subject to compliance of this provision.

 

Dabrafenib is an anti-cancer medication. It works by blocking the activity of BRAF, a mutated protein that regulates cell growth. Dabrafenib is used alone or in combination with other medicines to treat a type of skin cancer called melanoma.

 

 

Novartis AG and Novartis India Ltd. had moved the court seeking a decree of permanent injunction restraining Torrent Pharmaceuticals and all others acting on its behalf from manufacturing, either itself or through third parties, using, stockpiling, importing, selling or dealing in active pharmaceutical ingredient, containing Dabrafenib by itself or Dabrafenib in salt or in crystalline or in any other form. The petitioners said that manufacture and sale of standalone or in combination of drug including Dabrafenib will amount to infringement of its patent.

 

The application for the registration of Dabrafenib patent was earlier filed by GlaxoSmithKline LLC. which was further assigned with all rights, title and interest to Glaxo Group Ltd. Thereafter, the patent was assigned to Novartis AG in 2016. The patent to Novartis AG remains in force in around 70 countries. In India, Novartis AG's patent will expire on May 4, 2029.

 

The patent of Novartis AG on Dabrafenib protects the novel and inventive compound Dabrafenib in all its forms, including Dabrafenib mesylate, as well as pharmaceutical compositions comprising Dabrafenib and its mesylate salt. Dabrafenib was developed to address a clinical problem in cancer treatments arising from mutations in the BRAF gene. Certain BRAF mutations, particularly the BRAF V600E mutation, cause the BRAF protein to become abnormally and continuously active. The abnormal activation triggers the Mitogen-Activated Protein Kinase or Extracellular Signal-Regulated Kinase signalling pathway, an intra-cellular pathway which controls cell growth and division, leading to persistent and uncontrolled cell proliferation that drives cancer development. Dabrafenib was specifically designed to target this disease causing mechanism.

 

When the case came up for hearing, Torrent Pharmaceuticals' counsel submitted an undertaking that the company will not manufacture or launch any product containing Novartis AG's patent till its expiry. The petitioners said that its suit may be disposed of noting the undertaking of Torrent and it will not press monetary relief against the respondent. 

 

The high court decreed the suit in favour of the petitioners and said that Torrent Pharmaceuticals shall be bound by its undertaking. "The suit is accordingly decreed in terms of the undertaking given by the defendant, which shall form a part of the decree and disposed of along with pending applications," said Justice Jyoti Singh.

 

Friday, the shares of Novartis India ended 2.4% lower at INR 1,537.10 on the National Stock Exchange and those of Torrent Pharmaceuticals ended 5.2% higher at INR 5,122.80.  End

 

Edited by Akul Nishant Akhoury

 

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