The Supreme Court on Friday dismissed the petition filed by Swiss pharmaceutical company F. Hoffmann-La Roche AG challenging the Delhi High Court’s decision permitting Natco Pharma to manufacture and sell a generic version of Risdiplam, a drug used for treating Spinal Muscular Atrophy (SMA).

A bench comprising Justice PS Narasimha and Justice AS Chandurkar refused to intervene in the High Court’s interim order, noting that both the single judge and division bench had reached concurrent findings. However, the Court urged the Delhi High Court to resolve Roche’s patent infringement suit against Natco without delay.

The bench observed, “We are not inclined to interfere as the order is interim in nature and the findings are concurrent. We have not commented on the merits, and the observations in civil applications are intended solely for disposing of the appeals. The High Court shall endeavor to dispose of the suit expeditiously.”

Senior Advocate Neeraj Kishan Kaul, representing Roche, contended that the company holds the patent for Risdiplam and accused Natco of relying on reverse engineering to manufacture the drug. He highlighted the significant investment and years of research Roche undertook to develop the medication.

Kaul argued that public interest cannot override patent rights under the Patents Act and emphasized that the matter required proper legal scrutiny. He noted that Roche’s drug is protected in over sixty countries, while Natco had not yet launched the product in India. He also sought directions to keep Natco’s profit accounts and restrain exports, though the bench did not comment on these requests.

Ultimately, while the Supreme Court did not grant interim relief, it agreed to request the Delhi High Court to expedite the disposal of Roche’s main patent suit. Senior Advocates Kapil Sibal and Gopal Subramanium appeared on behalf of Natco.

Earlier, on October 9, a division bench of the Delhi High Court rejected Roche’s appeal against a single judge’s order, allowing Natco to continue producing and selling the generic drug. Roche had argued that Natco’s product infringed its patent IN’397, valid until 2035, covering compounds for SMA treatment.

Natco relied on the statutory defense under Section 107(1) of the Patents Act, claiming that Roche’s patent was invalid under Sections 64(1)(e) (lack of novelty) and 64(1)(f) (obviousness). The High Court division bench upheld the single judge’s finding that Risdiplam may be invalid under Section 64(1)(f), citing prior art in Compound 809 (WO’916/US’955), and found no justification for interference under established legal parameters.

Case Reference: F. Hoffmann-La Roche AG vs Natco Pharma Limited | SLP(C) No. 29664/2025