Overview

• A division bench of Justices C Hari Shankar and Ajay Digpaul upheld a March order denying an injunction, allowing Natco to make and sell risdiplam in India.
• Natco said it will launch immediately at a maximum retail price of ₹15,900 per bottle and will offer further concessions through a patient access programme.
• Roche’s Evrysdi is priced around ₹6–6.2 lakh per bottle in India, making the generic roughly 97% cheaper by the companies’ and advocates’ estimates.
• The court noted a credible challenge to the patent’s inventive step under Section 64(1)(f) and accepted a statutory defence under Section 107, cautioning against evergreening of essential medicines.
• Patient groups said the lower price enables broader treatment access and potential government procurement under the National Policy for Rare Diseases, while Roche expressed disappointment and is evaluating options under Indian law.