Supreme Court rejects Roche’s appeal against Natco Pharma in spinal muscular atrophy drug dispute

The Supreme Court on Friday dismissed Swiss drugmaker Roche’s appeal challenging Delhi High Court orders that refused to restrain Natco Pharma from manufacturing Risdiplam, the active pharmaceutical ingredient (API) used in the treatment of Spinal Muscular Atrophy (SMA). [F Hoffman- LA Roche Vs Natco Pharma]..A Bench of Justices PS Narasimha and AS Chandurkar declined to interfere with the findings of the Delhi High Court, which had found no case for interim injunction in favour of Roche.“We are not inclined to interfere with the order passed by the High Court for the reason that it is interim in nature and the findings are concurrent,” the Bench observed.The trial court proceedings would continue uninfluenced by any observations made in the interim stage, the top court added..During the hearing, Senior Advocate Neeraj Kishan Kaul, appearing for Roche, argued that the High Court had misapplied the principles governing genus and species patents. He submitted that Risdiplam, the API in Roche’s commercial product Evrysdi, was developed after years of research and was neither disclosed nor rendered obvious by its earlier genus patent.Kaul contended that Roche held valid patents in more than sixty countries and that the Delhi High Court erred in accepting Natco’s “credible challenge” based on an academic theory of bioisosterism raised only at the counterclaim stage. He also submitted that public interest cannot override statutory patent rights merely because a competing product is priced lower..The Delhi High Court’s Division Bench of Justices C Hari Shankar and Ajay Digpaul had earlier upheld the March 2025 order of Justice Mini Pushkarna, who refused interim injunction after finding that Natco’s validity challenge was credible and that patient affordability weighed against Roche’s claim of exclusivity.Justice Pushkarna had recorded that Roche’s own statements in foreign patent filings suggested that Risdiplam was linked to an earlier genus patent. The single-judge had also heard submissions from patients with SMA who highlighted the steep pricing of Evrysdi, around ₹6.2 lakh per bottle, translating to ₹70 lakh–₹1.4 crore per year. Natco’s proposed version, by contrast, was priced at ₹15,900 per bottle, bringing annual treatment costs down to roughly ₹5–7 lakh..In the Supreme Court, Roche reiterated its contention that coverage under a genus patent does not equate to disclosure of a specific compound. It cited the Court’s decision in Novartis AG v. Union of India and foreign jurisprudence that permits a reasonable gap between the two.Natco opposed the appeal, maintaining that Roche’s patent lacked novelty and that its own process patent filing did not amount to infringement.After hearing both sides, the Bench refused to interfere, observing that the High Court’s refusal to grant an interim injunction was based on concurrent factual findings. The Court, however, directed the Delhi High Court to expedite disposal of the underlying suit, which will now proceed on merits..Kaul was briefed by advocates Pravin Anand, Ruby Singh Ahuja and Shrawan Chopra from Anand & Anand and Karanjawala & Co. .Natco was represented by Senior Advocates Kapil Sibal, Gopal Subramonium and J Sai Deepak with advocates Afzal B Khan, Samik Mukherjee, Amrita Majumdar, Dominic Alvares, Avinash Kr Sharma and Sharad Besoya from S Majumdar & Co.