M/S GENENTECH INC. vs DRUGS CONTROLLER GENERAL OF INDIA

The Supreme Court addressed the appeal against the Delhi High Court's interim order allowing M/s Reliance Life Sciences Pvt. Ltd. to market 'TrastuRel', a biosimilar of 'Trastuzumab'. The Court emphasized that the appellants, M/s Genentech Inc. and others, had lost their patent rights as of 2013, thus lacking enforceable rights over the drug. The Court held that the approval granted by the Drugs Controller General of India (DCGI) to Reliance was valid, and the appellants' claims regarding the lack of testing for safety and efficacy were insufficient to restrain the launch of the biosimilar.