Court orders BDR Pharmaceuticals to seek prior approval before commercializing the drug 'Dabrafenib' amidst patent infringement concerns.
In a significant development in the ongoing legal battle over patent rights, the Delhi High Court has granted interim relief to Novartis AG against BDR Pharmaceuticals International Private Limited. The court, presided over by Justice A. J. Bhambhani, issued an order restraining BDR Pharmaceuticals from proceeding with the commercial manufacturing, distribution, or marketing of the drug 'Dabrafenib' without first obtaining permission from the court.
The case, filed as a quia timet action, hinges on Novartis's apprehension that BDR Pharmaceuticals might commercially exploit the patented product, 'Dabrafenib', an Active Pharmaceutical Ingredient (API) used in cancer treatment. Novartis's concerns were fueled by an RTI response revealing that BDR Pharmaceuticals had applied for and been granted licenses for manufacturing the API and tablets for both export and domestic markets.
Representing Novartis, senior counsel Mr. Amit Sibal emphasized that the defendants' licenses were not intended for commercial production, as they were strictly limited to examination, testing, and analysis. He argued that in the case of APIs, no clinical trials are required, thereby justifying Novartis's apprehensions and the need for the present action.
On the defense, Mr. J. Sai Deepak, representing BDR Pharmaceuticals, contended that the licenses held by the company did not allow for commercial manufacturing at this stage. He assured the court that BDR Pharmaceuticals was only conducting necessary bioequivalence studies and was far from launching the product commercially.
The court, acknowledging the defendants' assurances and the ongoing dispute, directed BDR Pharmaceuticals to seek prior approval from the court before taking any steps toward the commercial launch of 'Dabrafenib'. This decision aims to safeguard Novartis's patent rights while allowing BDR Pharmaceuticals to continue their non-commercial research activities.
The court also addressed procedural matters, directing both parties to file necessary replies and rejoinders within the stipulated timelines. The matter is scheduled for further proceedings before the Joint Registrar on November 17, 2026.
This case underscores the ongoing challenges in balancing patent rights with the development of pharmaceutical products, highlighting the judicial system's role in mediating such disputes.
Bottom Line :
Quia timet action under patent law - Interim relief granted to prevent the defendants from commercially manufacturing, distributing, or marketing the drug 'DABRAFENIB' without prior approval of the court.
Statutory provision(s):
Patents Act, 1970 Section 107A, Civil Procedure Code, 1908 Order VII Rule 11
