Today, On 17th October, The Supreme Court dismissed Roche’s appeal challenging the Delhi High Court’s refusal to restrain Natco Pharma from producing Risdiplam for Spinal Muscular Atrophy, observing it would not interfere since the High Court’s concurrent findings were interim in nature.
The Supreme Court dismissed Swiss pharmaceutical company Roche’s appeal , which challenged the Delhi High Court’s decisions that denied Roche’s request to prevent Natco Pharma from producing Risdiplam, the active pharmaceutical ingredient (API) for treating Spinal Muscular Atrophy (SMA).
A Bench comprising Justices PS Narasimha and AS Chandurkar chose not to interfere with the Delhi High Court’s findings, which concluded that Roche had not established a case for an interim injunction.
The Bench remarked,
“We are not inclined to interfere with the order passed by the High Court for the reason that it is interim in nature and the findings are concurrent,”
The ongoing trial court proceedings will remain unaffected by any observations made during the interim phase, the Supreme Court added.
During the hearing, Senior Advocate Neeraj Kishan Kaul, representing Roche, argued that the High Court had wrongly interpreted the principles related to genus and species patents. He asserted that Risdiplam, the API in Roche’s commercial product Evrysdi, was developed through extensive research and was neither disclosed nor made obvious by its prior genus patent.
Kaul emphasized that Roche holds valid patents in over sixty countries and claimed that the Delhi High Court mistakenly accepted Natco’s “credible challenge,” which was based on an academic theory of bioisosterism introduced only during the counterclaim phase.
He also argued that public interest cannot undermine statutory patent rights simply because a competing product is offered at a lower price.
The Delhi High Court’s Division Bench, including Justices C Hari Shankar and Ajay Digpaul, had previously upheld the March 2025 order of Justice Mini Pushkarna, who denied interim relief after determining that Natco’s challenge to the patent validity was credible and that patient affordability was a significant factor against Roche’s claim of exclusivity.
Justice Pushkarna noted that Roche’s own statements in foreign patent applications indicated a connection between Risdiplam and an earlier genus patent.
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The single-judge had also heard from SMA patients who underscored the high price of Evrysdi, which costs around Rs.6.2 lakh per bottle, amounting to Rs.70 lakh–Rs.1.4 crore annually. In contrast, Natco’s proposed version is priced at Rs.15,900 per bottle, reducing the annual treatment cost to approximately Rs.5–7 lakh.
In the Supreme Court, Roche reiterated its argument that being covered under a genus patent does not imply disclosure of a specific compound. It referenced the Court’s ruling in Novartis AG v. Union of India and international legal precedents that allow for a reasonable distinction between the two.
Natco countered the appeal, asserting that Roche’s patent lacked novelty and that its own process patent filing did not constitute infringement.
After considering both parties, the Bench chose not to intervene, noting that the High Court’s decision to deny an interim injunction was based on consistent factual findings.
However, the Court instructed the Delhi High Court to expedite the resolution of the underlying suit, which will now move forward on its merits.
Kaul was supported by advocates Pravin Anand, Ruby Singh Ahuja, and Shrawan Chopra from Anand & Anand and Karanjawala & Co., while Natco was represented by Senior Advocates Kapil Sibal, Gopal Subramonium, and J Sai Deepak, along with advocates Afzal B Khan, Samik Mukherjee, Amrita Majumdar, Dominic Alvares, Avinash Kr Sharma, and Sharad Besoya from S Majumdar & Co.