Roche Moves SC Against Delhi HC Nod to Natco's Rs 15,900 Generic Risdiplam for Spinal Atrophy
New Delhi: In a major escalation of the patent battle over a life-saving rare disease drug, Swiss pharmaceutical giant F. Hoffmann-La Roche AG has approached the Supreme Court of India challenging the Delhi High Court's order that permitted Natco Pharma Ltd to manufacture and market a generic version of Risdiplam, used in the treatment of Spinal Muscular Atrophy (SMA).
The High Court had earlier dismissed Roche’s plea seeking an injunction, ruling in favor of public interest and affordability.
The legal dispute revolves around Roche’s Indian patent IN 334397, titled “Compounds for Treating Spinal Muscular Atrophy,” which remains valid until May 2035. The division bench of the Delhi High Court, on October 9, upheld the single-judge order that refused to restrain Natco, noting that the Indian company had raised credible challenges to Roche’s patent, including claims of evergreening and lack of inventive step.
The bench emphasized that, in the case of a life-saving drug, public health considerations must take precedence over monopoly rights, reports The Economic Times.
Following this setback, Roche moved the Supreme Court seeking to overturn both the single-judge and division bench rulings, arguing that the order undermines the integrity of India’s patent regime and could discourage future investment in pharmaceutical innovation. According to a recent media report in the Business Standard, Roche’s counsel mentioned the case before Justice B. R. Gavai, requesting urgent listing of the petition. The apex court is expected to hear the matter this week.
In its filings, Roche reiterated that Risdiplam is a novel molecule with a distinct chemical composition that deserves patent protection and cannot be dismissed as an incremental modification of earlier compounds. However, Natco Pharma maintained that Roche’s patent overlapped with its international genus patent (WO 2013/119916) and failed to meet the inventive step requirement under Indian patent law. The company asserted that the High Court’s decision rightly upheld public access to affordable treatment, reports LiveLaw.
As per LiveMint report, Natco plans to market its generic version of Risdiplam at a maximum retail price (MRP) of ₹15,900 per 60 mg/80 mL bottle, compared to Roche’s imported product, which costs over ₹6 lakh per bottle. The company also intends to offer additional discounts under a patient access programme to further reduce treatment costs for SMA patients in India.
With Roche’s appeal now pending before the Supreme Court, the outcome is expected to set a precedent for future patent litigation in India, defining how courts weigh innovation against accessibility in the healthcare sector.
