The Delhi High Court delivered a landmark judgment on October 9, 2025, dismissing Swiss pharmaceutical giant F. Hoffmann-La Roche AG’s appeal and clearing the path for Indian drugmaker Natco Pharma to manufacture and sell a generic version of Risdiplam, a life-saving medication for Spinal Muscular Atrophy (SMA). The Division Bench comprising Justices C. Hari Shankar and Ajay Digpaul upheld the single judge’s March 2025 order that had refused Roche’s plea for an interim injunction against Natco’s production plans.
Both the Learned Single Judge and the Division Bench have held that the Defendant, NATCO Pharma, had demonstrated the existence of a credible challenge to the validity of the species patent by relying on the Plaintiff’s own genus patent, which admittedly claimed the very same drug.
This decision represents a significant victory for public health advocacy in India’s pharmaceutical landscape, prioritising patient access to affordable medication over patent enforcement. The court’s ruling immediately removes all legal barriers for Natco to launch its generic version, which the company announced it would do with immediate effect at an MRP of ₹15,900 per bottle, which was currently priced around Rs 6.2 lakh per bottle, taking the therapy up to 1 crore for certain patients.
Roche was represented by Senior Advocate Sandeep Sethi with advocates Pravin Anand, Archana Shanker, Shrawan Chopra, Prachi Agarwal, Devinder Rawat, Elisha Sinha, Achyut Tewari, Krisha Baweja, Aayush Maheshwari and Sumer Dev Seth from ANAND AND ANAND.
Natco was represented by Senior Advocate Sai Deepak J and advocates Afzal Badr Khan, Samik Mukherjee, Amrita Majumdar, Dominic Alvares, Avinash Sharma and Sharad Besoya from S. MAJUMDAR & CO.
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