The Supreme Court of India rejected Swiss pharmaceutical company F. Hoffmann-La Roche AG’s (Roche) plea seeking to restrain Natco Pharma Ltd from selling a generic version of its life-saving spinal muscular atrophy (SMA) drug, Risdiplam, in India until the conclusion of ongoing litigation. The bench, comprising Justices P.S. Narasimha and A.S. Chandurkar, upheld the 10 October Delhi High Court division bench ruling, which in turn had maintained a March single-judge order denying Roche an injunction against Natco.
Roche Expresses Disappointment
In response, Roche expressed strong disappointment with the Supreme Court’s decision. The company emphasized that robust intellectual property (IP) protection is essential for fostering innovation and addressing critical healthcare challenges. Roche added that for India to emerge as a global life sciences innovation hub, it must protect and enforce patent rights effectively. The Supreme Court also rejected Roche’s plea to prevent Natco from exporting the drug, allowing broader market access for the generic version.
Background of the Dispute
Roche initiated legal action against Natco in early 2024. This followed Natco’s plans to launch a lower-cost generic version of Risdiplam, marketed under the brand name Evrysdi. The drug treats spinal muscular atrophy (SMA), a rare genetic disorder causing progressive muscle weakness and loss of motor function.
As reported by livemint.com, Roche holds an Indian patent for Risdiplam, valid from May 2015 to May 2035. The company claims the molecule is a new chemical entity, distinct from previous patents. Natco’s generic launch challenges Roche’s exclusivity, raising debates around access to affordable medicines versus IP protection in India.
