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Informist, Tuesday, Aug. 18, 2026

 

--HC bars Zydus Life from launching drug with Novartis-patent Dabrafenib

 

By Surya Tripathi

 

NEW DELHI – The Delhi High Court Tuesday has restrained Zydus Lifesciences 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 Zydus Lifesciences' 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 Zydus Lifesciences 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 drugs 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.

 

When the case came up for hearing, Zydus Lifesciences' counsel said that it was willing to give 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 Zydus Lifesciences.

 

The high court decreed the suit in favour of the petitioners and said that Zydus Lifesciences shall be bound by its undertaking. "The suit is decreed in terms of the undertaking, which shall be formed as part of the decree. The suit be disposed of, all pending applications be disposed of," said Justice Anup Jairam Bhambhani. 

 

At 1142 IST, the shares of Zydus Lifesciences Ltd. were unchanged at INR 1,131.30 on the National Stock Exchange, the shares of Novartis India Ltd. were also unchanged at INR 1,589.50.  End

 

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

 

Edited by Akul Nishant Akhoury

 

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