Roche Takes Natco to Supreme Court Over Generic Risdiplam Launch in India

In a new twist to India’s ongoing debate over drug pricing and patent protection, Swiss pharma giant Roche has approached the Supreme Court of India to challenge a recent Delhi High Court ruling that allowed Natco Pharma to launch a generic version of Risdiplam, Roche’s breakthrough treatment for spinal muscular atrophy (SMA).

The case stems from Roche’s long-standing patent on Risdiplam, marketed globally under the brand name Evrysdi, which was declared invalid by the Delhi High Court on grounds of public interest and affordability. The court had reasoned that the exorbitant cost of Roche’s original formulation — priced at around ₹6 lakh per bottle, or roughly ₹70 lakh for a full year of treatment — rendered it inaccessible to most Indian patients suffering from this rare neuromuscular disorder.

Following the verdict, Hyderabad-based Natco Pharma moved quickly to announce its own generic Risdiplam, priced dramatically lower at about ₹15,900 per bottle. The news was hailed by patient advocacy groups as a milestone for affordable rare-disease care in India. However, Roche swiftly issued a statement expressing “deep disappointment” with the High Court’s decision, insisting that intellectual property protection is vital to encourage pharmaceutical innovation and sustain R&D investment.

The company’s latest move to seek relief from the Supreme Court signals its determination to defend its patent rights and possibly halt Natco’s launch pending further legal review. Meanwhile, the market reaction was immediate — Natco’s shares slipped over 3%, trading near ₹808 on the National Stock Exchange following reports of Roche’s appeal.

At the heart of this dispute lies a broader policy dilemma: how to balance innovation incentives with equitable access to life-saving medicines. India, known for its robust generic drug industry and patient-first legal approach, has historically prioritized affordability in rulings such as the Novartis–Gleevec case and Bayer–Nexavar compulsory license decision. The outcome of Roche vs. Natco could therefore shape the future of rare-disease drug access and patent enforcement across the country.