Swiss drugmaker F. Hoffmann-La Roche AG has approached the Supreme Court of India challenging a recent Delhi High Court order that allowed Hyderabad-based Natco Pharma to manufacture and sell a generic version of Risdiplam, a medicine used to treat Spinal Muscular Atrophy (SMA).
Roche’s counsel mentioned the matter before Chief Justice of India D.Y. Chandrachud for urgent listing, and the CJI agreed to list the case for hearing. The move marks the next chapter in a closely watched patent dispute that has significant implications for access to life-saving rare disease drugs in India.
The controversy stems from the Delhi High Court’s October 9 judgment, where a Division Bench of Justices C. Hari Shankar and Ajay Digpaul refused to grant an injunction in favour of Roche. The bench dismissed the company’s appeal against a Single Judge’s order that had previously allowed Natco Pharma to continue producing and selling its version of Risdiplam in India.
Roche claimed that Natco’s product infringes its Indian Patent IN’397, which covers certain compounds used in the treatment of spinal muscular atrophy and remains valid until 2035. The company argued that Natco’s manufacture and sale of Risdiplam violates its intellectual property rights and undermines innovation in rare-disease treatment.
Natco, however, relied on the statutory defence under Section 107(1) of the Patents Act, 1970, asserting that Roche’s patent lacked novelty and was “obvious” under Sections 64(1)(e) and 64(1)(f) of the Act. The High Court’s Division Bench agreed with Natco’s arguments, observing that the compound was indeed “vulnerable to invalidity” due to its similarity to Compound 809 disclosed in earlier patents (WO’916/US’955).
The court further noted that no “case for interference” was made out under the parameters set by the Supreme Court in the Wander judgment, thereby allowing Natco to continue its operations.
Roche’s appeal to the Supreme Court now seeks to challenge this interpretation and defend the validity of its patent, setting the stage for an important test of India’s patent law framework on innovation versus accessibility.
The case also reignites the broader debate over how India balances intellectual property protection with the affordability of critical medicines particularly those used for rare genetic conditions like SMA. The Supreme Court’s decision, once heard, could have far-reaching implications for the country’s pharmaceutical and biotech sectors.
