Natco Pharma Updates Legal Proceedings on Risdiplam Launch in India

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Natco Pharma is engaged in ongoing legal proceedings regarding its planned launch of Risdiplam, a drug for spinal muscular atrophy (SMA). The Delhi High Court has maintained a status quo on the product launch amid patent disputes with Roche, citing public interest in affordable access to this life-saving medicine.

Main News Body:

Natco Pharma Limited is currently navigating a crucial patent litigation case linked to its generic launch of Risdiplam, an oral treatment for spinal muscular atrophy (SMA), a rare neuromuscular disease. The litigation pivots around Roche’s patent claims, with the Swiss multinational holding a registered species patent for Risdiplam set to expire in May 2035.

In March 2025, a single judge of the Delhi High Court denied Roche’s plea for an interim injunction to restrain Natco from manufacturing and launching the generic drug in India. The court recognized the compelling public interest due to the exorbitant cost of Roche’s branded drug Evrysdi, which retails at approximately ₹6 lakh per bottle, making it largely inaccessible for Indian patients.

However, Roche appealed the decision, and the Division Bench has since ordered that a status quo be maintained pending appeal resolution. Natco has agreed to hold off on commercial launch until further court direction while continuing to prepare regulatory and market strategies.

The court has acknowledged Natco’s credible challenge to Roche’s patent validity and the stark price disparity favoring Natco’s generic, which could cost 80-90% less. Patient testimonies underscored the life-saving nature of Risdiplam and the critical need for affordable treatment options.

Key Highlights:

Delhi High Court denied Roche’s initial injunction request against Natco.

Status quo on Risdiplam launch maintained pending appeal hearing.

Roche’s patent protection valid until May 2035; challenged by Natco.

Roche’s branded Risdiplam priced at approx. ₹6 lakh per bottle; Natco’s generic planned at 80-90% lower price.

Public interest and patient access prioritized by the court in interim stage.

Natco to provide quarterly accounting of manufacture and sales during litigation.

Next court hearing expected to determine substantive patent validity and launch permissions.

This high-profile legal case underscores the complex balance between intellectual property rights and patient access to affordable medicines in India’s pharmaceutical ecosystem.

Sources: First Word Pharma, Economic Times, Angel One, Spicy IP, Lakshmishri, Navlin Daily