SC refuses to restrain Natco from selling generic version of Roche's Risdiplam

The Supreme Court on Friday rejected Swiss pharmaceutical giant F. Hoffmann-La Roche AG’s (Roche) plea asking that Natco Pharma Ltd be restricted from selling the generic version of its life-saving spinal muscular atrophy (SMA) drug, Risdiplam, in India until the case is settled. The bench of Justices PS Narasimha and AS Chandurkar declined to interfere with an October 9 judgment of the Delhi High Court division that upheld a single-judge order in March denying Roche an injunction. The apex court also rejected Roche’s plea to bar Natco from exporting the drug, but asked the Delhi High Court to expedite the hearing. “We are not inclined to interfere with the order passed by the High Court as it is interim in nature and the findings are concurrent,” the bench said. During the hearing, senior advocate Neeraj Kishan Kaul, representing Roche, argued that public interest cannot override patent rights. “We have cooperated, given millions of drugs for free and participated in the National Drug Policy of the Government of India. But after spending millions, it is very easy to bring in the element of public interest,” Kaul said. “I won’t say anything more except that they should at least maintain proper accounts and refrain from exporting the drug in the meantime,” he further urged the court. With Roche’s interim pleas rejected, the case will now be heard by a single bench of the Delhi High Court for a final decision. The dispute Roche sued Natco in early 2024 after learning of the Hyderabad-based company’s plan to launch a lower-cost generic version of Risdiplam, sold under the brand name Evrysdi, which treats SMA – a rare genetic disorder that causes progressive muscle weakness and loss of motor function. Roche has an Indian patent for Risdiplam valid from May 2015 to May 2035, claiming that the molecule is a new chemical entity that differs from earlier patents. Natco contested Roche’s patent, claiming that the company was “greening” its monopoly by filing a narrowly defined patent with limited novelty. Natco argued that local manufacturing would drastically reduce costs, making the drug accessible to thousands of patients who cannot afford treatment. The single-judge bench sided with Natco, holding that Roche’s earlier patent already covered similar compounds and that the company had not demonstrated significant technical progress. The court cited public interest in ensuring affordable access to a life-saving medicine and noted statements from SMA patients who said they could not afford treatment. The division bench later upheld this view, noting that public interest and access to affordable medicine may outweigh patent exclusivity in such cases. The impact After the Delhi High Court ruling, Natco Pharma immediately launched its generic version at a maximum retail price (MRP) of ₹15,900 for a 60 mg/80 ml bottle—a steep drop from Roche’s price of over ₹6,00,000. The company also announced additional discounts under its patient access program. Since the launch of Evrysdi in India in 2021, around 300 patients have received treatment, with 52 patients benefiting from free access under Roche’s compassionate use programme. SMA affects an estimated one in 7,744 live births in India and remains a leading genetic cause of infant mortality. The central government has estimated that the annual cost of treating SMA patients in the country could range between ₹6,400 crore and ₹34,000 crore. Wider Implications The case has sparked debate about balancing intellectual property rights and public health requirements in India. Experts have noted that while India’s patent laws provide for compulsory licensing in public health emergencies, reliance on broad judicial interpretations of “public interest” can create uncertainty for innovators. Lawyers warn that while Natco’s ability to bring a generic version is a big win for Indian patients, it could also discourage global pharmaceutical companies from launching or investing in new therapies in India because of perceived unpredictability in patent enforcement.