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Delhi High Court Rejects Roche Appeal, Clears Natco’s Low-Cost Risdiplam for India

The ruling prioritizes public interest in affordable SMA treatment to enable government procurement of a ₹15,900 generic.

Overview

  • A division bench dismissed Roche’s injunction appeal, upholding a March 2025 single-judge order that denied interim relief.
  • Natco said it will launch its risdiplam immediately at ₹15,900 per bottle and will offer additional discounts through a patient access programme.
  • Judges emphasized access to medicine over injunctive patent enforcement and noted Natco’s strong initial challenge to Roche’s patent, reported valid until March 2035.
  • Advocacy groups say the roughly 97% price cut from about ₹6–6.2 lakh per bottle could allow purchases under India’s National Policy for Rare Diseases.
  • Roche said it was disappointed by the decision and is evaluating options within Indian law while asserting the importance of intellectual property protection.