CHENNAI: The Supreme Court of India on Friday dismissed an appeal filed by Swiss drugmaker F. Hoffmann-La Roche AG, which sought to restrain Hyderabad-based Natco Pharma from manufacturing and selling a generic version of Risdiplam, a key drug used to treat spinal muscular atrophy (SMA). The ruling effectively allows Natco to continue producing the generic version, though the final resolution of the underlying patent dispute remains pending.
A bench of Justices P.S. Narasimha and A.S. Chandurkar upheld earlier Delhi High Court orders that had refused Roche’s plea for an interim injunction. The Court noted that both the single judge and the division bench of the High Court had issued concurrent findings, and therefore no interference was warranted at the interim stage. It also made clear that the ruling does not express any opinion on the merits of the patent dispute.
Roche had argued that Natco’s product infringed its patent on Risdiplam, marketed globally as Evrysdi, and requested an order to prevent Natco from manufacturing or exporting the drug until the case was decided. The Supreme Court, however, declined to grant such relief and directed the Delhi High Court to expedite the main suit to reach a final judgment soon.
The Court’s refusal to block Natco’s production has major implications for patients suffering from SMA, a rare and debilitating genetic disorder. Roche’s branded version is priced at around Rs 6 lakh per bottle in India, while Natco has announced plans to sell its version at roughly Rs 15,900 per bottle—a 97 percent price reduction that could make the drug accessible to a far wider population.
The decision reflects the judiciary’s continuing effort to balance intellectual property rights with public health priorities. The High Court had earlier noted that affordability and availability of life-saving drugs can be important factors when considering interim injunctions in pharmaceutical patent cases.
While Natco’s position has been strengthened by the ruling, the central question of whether Roche’s patent on Risdiplam is valid remains unresolved. Analysts note that the High Court had raised preliminary concerns over the novelty and inventive step of Roche’s patent, suggesting it may be vulnerable to challenge under India’s patent law. The outcome of the main suit will ultimately determine whether Natco can continue long-term production of the generic.
For the pharmaceutical industry, the case marks another instance of India’s courts leaning toward accessibility in life-saving medicine disputes. It reinforces a broader trend of Indian patent jurisprudence giving weight to public health interests, particularly in the case of rare or critical diseases.
For now, Natco’s win paves the way for its affordable SMA drug to enter the market, offering relief to patients and families who had struggled to afford the original treatment. However, both companies continue to await a final legal verdict that will decide the future of Risdiplam’s patent protection in India.
