Delhi High Court Directs BDR To Seek Prior Approval Before 'Dabrafenib' Launch In Novartis Patent Suit

The Delhi High Court on 17 August directed BDR Pharmaceuticals International Private Limited to seek the Court's prior approval before taking any steps towards commercial manufacture or launch of Dabrafenib, in a patent infringement dispute brought by Novartis AG.

Justice A. J. Bhambhani passed the direction while hearing Novartis' interim injunction application in a quia timet action, which seeks to prevent an apprehended patent infringement before it occurs.

The Bench directed that "before taking any steps towards commercial manufacturing or launch of 'DABRAFENIB' as an API or as tablets for export and/or for the domestic market," the defendants would first have to move an appropriate application before the Court seeking "prior approval" for that purpose.

The dispute arose from Novartis' apprehension that BDR Pharmaceuticals and BDR Lifesciences Pvt Ltd could commercially manufacture and launch Dabrafenib. The apprehension was based on an RTI response dated 17 October 2025 from the Commissioner of Foods and Drugs Control Administration, Gandhinagar, Gujarat.

The response stated that manufacturing licences for Dabrafenib, its active pharmaceutical ingredient (API) and its formulations had been applied for and granted to certain entities, and named BDR Lifesciences Pvt Ltd and BDR Pharmaceuticals International Pvt Ltd among the entities granted such licences.

On 23 March 2026, Senior Advocate J. Sai Deepak, appearing for the defendants, sought to allay Novartis' apprehension by submitting that the defendants did not hold a commercial licence to manufacture Dabrafenib. He submitted that their existing licence was limited to manufacturing the drug for examination, testing or analysis and specifically stated that it was "Not for clinical trial unless or otherwise permitted by the licensing authority."

Sai Deepak also submitted that Section 107A of the Patents Act, 1999, which permits the use of a patented invention for tests and experiments necessary for regulatory approval, was available to the defendants at that stage.

Pursuant to the order, the defendants filed an affidavit dated 25 March 2026 stating that they had obtained a licence to manufacture Dabrafenib strictly for examination, testing and analysis, and that the licence did not permit clinical trials without specific permission.

Senior Advocate Amit Sibal, appearing for Novartis, however, argued that clinical trials were not required in the case of an API and that the defendants' affidavit was therefore inaccurate and misleading. He submitted that Novartis' apprehension underlying the quia timet action was justified.

In response, Sai Deepak, maintained that the only licence presently held by the defendants permitted manufacture of the drug for examination, testing or analysis. He submitted that bioequivalence studies on the formulation were still required and that the defendants were "nowhere close to obtaining a license for manufacturing, distributing or marketing 'DABRAFENIB' as an API or as tablets."

Taking note of this submission, the Bench directed the defendants to seek prior approval before taking any steps towards commercial manufacturing or launch of Dabrafenib as an API or tablets for export or the domestic market. It clarified that once such an application was moved, it would consider whether any further orders were required in relation to the relief sought by Novartis.

The matter has been listed before the Joint Registrar on 17 November 2026 for completion of pleadings.