The Delhi High Court on Thursday dismissed an appeal filed by Swiss drugmaker F. Hoffmann-La Roche AG, which had sought to stop Indian company Natco Pharma from launching a cheaper version of Risdiplam, the only medicine available for treating spinal muscular atrophy (SMA), which is a rare genetic disease that weakens muscles and affects movement.
The court said it would not grant the injunction as public interest and access to affordable medicine were more important. Roche’s branded version, sold under Roche’s brand name Evrysdi, costs over Rs 6 lakh per bottle, while Natco’s generic version is expected to be priced at just Rs 15,900, making it about 97% cheaper. The ruling comes as a big relief for Indian SMA patients.
Roche vs Natco: All you need to know
After months of hearings, the Delhi High Court delivered the landmark ruling which cleared the way for Natco Pharma to launch a low-cost generic version of Risdiplam.
In its judgment dated March 24, 2025, the single-judge bench of the Delhi HC had noted that SMA is one of the main causes of death in infants due to the loss of nerve cells, and that there are currently no curative treatments available. The court said most existing options are far too expensive for Indian patients.
Roche’s patent on the drug is valid until March 2035. However, in September 2022, Natco applied for a separate patent for an improved method to make Risdiplam and its ingredients. The court found that Natco had presented strong initial arguments questioning the validity of Roche’s patent and therefore ruled in Natco’s favour.
While hearing the case, the judge also considered challenges to the validity of Swiss drugmaker Roche’s patent and stressed the importance of public interest, pointing out that the company’s high prices had made the medicine out of reach for most people.
Roche later appealed the order, but the Delhi High Court’s division bench dismissed the appeal, removing the final obstacle to making Risdiplam affordable in India. The court said the ruling would help thousands of SMA patients and their families who have long struggled with the disease.
Following the verdict, Natco Pharma announced it will immediately launch the drug in India at Rs 15,900 per bottle, which is in line with what it told the court. The company also plans to provide further discounts to eligible patients through its patient access programme.
Roche Pharma ‘disheartened’, but considering options ‘within scope of Indian law’
Commenting on the development, Roche Pharma India spokesperson said that the company was “extremely disappointed”, and is considering “options within the scope of the Indian law.” Roche in a statement said that they are “committed to protecting its innovation.”
“IP protection is a cornerstone for any pharmaceutical innovation. We believe that strong IP protection, including patents, is essential for innovation to thrive in India, drive access to innovative treatments that address the healthcare challenges we face today, and a critical lever for Viksit Bharat,” the statement said.