In a major setback for Swiss pharmaceutical giant Roche, the Supreme Court of India on Friday dismissed its petition challenging a Delhi High Court verdict that permitted Hyderabad-based Natco Pharma to launch a generic version of Risdiplam, the only oral medication available in India for spinal muscular atrophy (SMA).
Supreme Court Declines to Intervene
A bench comprising Justices P.S. Narasimha and A.S. Chandurkar refused to interfere with the October 9 ruling of the Delhi High Court’s division bench. The Court reaffirmed that public health must take precedence over monopolistic practices and patent evergreening, according to sources cited by The Times of India.
The Supreme Court observed that both the single bench and division bench had reached concurrent findings and thus saw no reason to intervene. However, it urged the Delhi High Court to expedite the ongoing suit filed by Roche against Natco.
Balancing Patent Rights and Public Interest
The Delhi High Court’s October ruling upheld its March 2025 single-judge decision, which had denied Roche’s plea for an injunction against Natco. The Court emphasized that in patent disputes, public interest in drug availability and affordability is a crucial factor when deciding whether to grant or deny injunctions.
The single judge had noted, “In a patent suit, public interest in terms of availability and accessibility of the drug is a relevant factor to grant or to refuse the injunction. The price under Roche’s Patient Support Program in India is also unaffordable.”
Landmark Win for Affordable Healthcare
Natco’s generic Risdiplam offers a dramatic price reduction—around ₹16,000 per bottle, compared to Roche’s Evrysdi, which costs approximately ₹6.2 lakh per bottle. The therapy, which is lifelong for SMA patients, can amount to over ₹1 crore per patient under Roche’s pricing.
By contrast, Natco’s version slashes the cost by about 97%, offering renewed hope to families struggling with the high cost of treatment. The company announced its immediate market launch last week, making the drug far more accessible.
Roche’s Patent and Legal Challenge
Roche, which holds an Indian patent for Risdiplam valid until May 2035, claims the molecule is a new chemical entity distinct from earlier patents. The company filed its case in 2024 after learning of Natco’s plan to launch a generic version.
Natco, on the other hand, argued that Roche was engaging in “evergreening” and unlawful patent term extension to maintain its monopoly in India.
Legal Teams and Representation
Natco’s legal team included senior advocates Mukul Rohatgi, Kapil Sibal, Gopal Subramaniam, and Sai Deepak, along with the law firm S. Majumdar & Co. Roche was represented by Abhishek Manu Singhvi and Neeraj Kishan Kaul, supported by Anand & Anand law firm.
Ensuring Access to Lifesaving Drugs
This ruling underscores a growing judicial stance in favor of balancing intellectual property rights with the right to health and affordable medicines. It also strengthens India’s position as a defender of public access to essential drugs, particularly in cases involving life-threatening genetic conditions like SMA.