Delhi HC upholds order allowing Natco Pharma to sell generic Risdiplam, rejects Roche appeal

NEW DELHI: In a setback to Swiss pharma major Roche, the Delhi High Court has refused to restrain domestic drugmaker Natco Pharma from selling the generic version of life-saving drug Risdiplam in India, upholding a March single-judge order.

Sold under the brand name Evrysdi by Roche, Risdiplam is used to treat spinal muscular atrophy (SMA), a rare and severe genetic disorder that causes progressive muscle weakness and loss of motor function. Roche had filed the lawsuit in early 2024 after learning of Natco’s plans to launch a lower-cost generic version.

A division bench comprising justices C. Hari Shankar and Ajay Digpaul upheld the March 2025 single-judge bench order that had denied Roche an injunction against Natco Pharma. The single bench had cited public interest, noting that SMA is a rare disease and that wider access to an affordable drug would benefit patients who otherwise cannot afford treatment.

The written order had not been released by press time.

The ruling paves the way for a far cheaper version of Risdiplam to enter the Indian market. In a release on Thursday, Natco said it would launch the product immediately at a maximum retail price (MRP) of ₹15,900 per bottle, a steep drop from the current price of over ₹600,000. The company also said it plans to offer additional discounts to certain eligible patients under its patient access programme.

While there are no official figures on the number of people with SMA in India, existing studies suggest that the condition affects one in 7,744 live births and is the leading genetic cause of infant mortality. According to an affidavit filed by the central government in the Kerala High Court earlier this year, the estimated annual cost of treating all SMA patients in India could range between ₹6,400 crore and ₹34,000 crore.

Roche, which has appealed the order, is evaluating its next steps. “We are extremely disappointed with this development and are considering our options within the scope of the Indian law. Roche is committed to protecting its innovation,” a Roche Pharma India spokesperson said in an emailed statement to Mint.

“IP protection is a cornerstone for any pharmaceutical innovation. Roche is committed to protecting its innovation. We believe that strong IP protection, including patents, is essential for medical innovation in India, patient well-being, and for access to new and innovative treatment to address the healthcare challenges we face today,” the spokesperson said.

Roche said it has been collaborating with local authorities in India to implement tailored pricing solutions. Under its compassionate use programme, 52 patients across India are receiving the drug free of cost. Since its launch in 2021, about 300 patients have used Evrysdi in India, the company added.

The dispute

Roche holds an Indian patent (IN334397) for Risdiplam, valid from May 2015 to May 2035. The company argued that Risdiplam is a new chemical entity, distinct from earlier, broader patents, and cited the high cost of research and development.

Roche also pointed to patient assistance programmes that provide discounted medicine, though these reach only a limited number of patients.

Natco had challenged the patent, alleging that Roche was “evergreening” its monopoly by filing a specific patent that added little to the original broader claim. It argued that manufacturing the drug locally at a lower cost would make it accessible to thousands of patients who cannot afford Roche’s high-priced version.

The single bench had ruled in Natco’s favour, observing that the earlier patent already covered similar compounds and that Roche had not demonstrated a significant technical advancement. The court also considered statements from SMA patients describing the devastating impact of the disease and the prohibitive cost of treatment. The ruling emphasized the public interest in affordable access to this life-saving drug.

Roche appealed the order. Today's division bench ruling, which again favoured Natco, leaves Roche the option to approach the Supreme Court.

A similar dispute has escalated in another case involving Roche and Zydus Lifesciences over the cancer drug Sigrima. In November 2024, the Supreme Court directed Ahmedabad-based Zydus to approach the Delhi High Court division bench against a single-judge order restraining it from selling Sigrima—an injection used to treat breast cancer—until a hearing on 2 December 2024. Roche claims that Zydus’ drug is biologically similar to its own Perjeta (Pertuzumab). The case is still ongoing.

Natco’s record

Natco Pharma has a long history of challenging innovator patents in India, using the country’s patent laws to secure settlements or compulsory licences that allow the launch of cheaper generics.

Earlier this year, Natco sued Danish innovator Novo Nordisk over its weight-loss drug Wegovy (Semaglutide), claiming that its version does not infringe the innovator’s device or process patents.

The company has previously been involved in patent disputes with Bristol Myers Squibb over blood thinner Apixaban (Eliquis) and leukemia drug Dasatinib (Sprycel), as well as with Novartis over cancer drug Ceritinib.

In a landmark 2012 case, the Indian patent office granted the country’s first compulsory licence to Natco, allowing it to sell a generic version of Bayer’s cancer drug Nexavar. Under the ruling, Natco was required to pay a 6% royalty to Bayer. A compulsory licence allows the production of a patented drug when it meets public health needs and remains unaffordable to the public.

The impact

The current ruling is a major win for Indian patients suffering from SMA. However, experts caution that it could set a troubling precedent for patent protection, since the company has not been granted a compulsory or voluntary licence in this case.

“Patent rights granted under the Indian Patents Act can be modified or diluted under the extant provisions of the same Act - in this case, the public interest issue could very well be addressed by using statutory compulsory licensing provisions in the Patents Act itself. Voluntary Licensing could also have been a means to meet the objective,” said Ashwin Sapra, partner (head - pharma & healthcare) at law firm Cyril Amarchand Mangaldas.

A voluntary licence is an agreement where a patent holder grants a third party the right to use a patented invention without legal compulsion.

“Price control provisions are also there to address the affordability issue. Dilution of granted and subsisting patent rights sets a very bad precedent. This affects all innovators be it foreign or domestic,” said Sapra.