The Delhi High Court has restrained Zydus Lifesciences from commercially manufacturing, selling, or marketing any generic version of the cancer drug Dabrafenib until its patent expires in May 2029. Passing the decree in a patent infringement lawsuit filed by Swiss pharmaceutical giant Novartis AG and Novartis India, Justice Anup Jairam Bhambhani accepted a formal undertaking from Zydus, resolving the commercial dispute between the two companies.
Novartis had moved the court seeking an injunction after growing concerned that Zydus was gearing up to launch generic Dabrafenib before the patent ran its course. Dabrafenib is a targeted oral kinase inhibitor used to treat specific gene-mutated cancers, including metastatic melanoma, non-small cell lung cancer, and thyroid carcinoma. Sold internationally as Tafinlar and in India under brand names like Rafinlar, the drug was originally patented by GlaxoSmithKline before the rights were transferred to Novartis in 2016. Its Indian patent remains valid until May 4, 2029.
During the hearing, counsel for Zydus confirmed that the company would not commercially manufacture, distribute, or sell the drug in the open market before the patent expiration date. With Novartis accepting the undertaking, the court incorporated the agreement into its final decree and closed the lawsuit.
Importantly, the High Court clarified that the restraint does not affect Zydus’s statutory rights under Section 107A of the Patents Act, 1970—commonly known as the Bolar exemption. This provision allows generic drugmakers to conduct research, clinical trials, and manufacturing strictly for generating regulatory data to secure future market approvals.
By preserving these research rights, the ruling strikes a balance between protecting Novartis’s exclusive commercial rights until May 2029 and allowing domestic manufacturers to prepare generic alternatives for immediate launch once the patent enters the public domain.
