Court Update: Delhi HC Dismisses Roche’s Petition on Risdiplam

New Delhi, October 2025: The Delhi High Court has allowed Natco Pharma to continue selling its generic version of Risdiplam, dismissing a plea filed by Swiss pharmaceutical giant F. Hoffmann-La Roche AG (Roche).

A division bench comprising Justices C. Hari Shankar and Ajay Digpaul upheld the March 2025 single-judge order that had refused Roche’s request for an injunction. A detailed judgment is expected soon.

⚖️ Court Upholds Earlier Ruling Supporting Affordability and Access

Risdiplam is an oral treatment for Spinal Muscular Atrophy (SMA) — a rare, progressive genetic disorder that weakens muscles by affecting motor neurons in the spinal cord.

The earlier single-judge order, delivered by Justice Mini Pushkarna, had declined Roche’s plea to restrain Natco from manufacturing the generic version, emphasizing public interest and affordability.

The court observed that SMA is a rare disease and that life-saving drugs must remain accessible at an affordable price to patients who cannot afford expensive patented medicines.

💊 Roche’s Patent Claim

Roche holds a registered patent for Risdiplam, the active pharmaceutical ingredient in its global brand Evrysdi, which is protected in India until May 2035.

The company had argued that Risdiplam is a new chemical entity resulting from extensive research and development, and that Natco’s product infringed on its patent rights.

🧪 Natco’s Defence: Allegations of “Evergreening”

Natco Pharma accused Roche of “evergreening” — attempting to extend its monopoly by filing repetitive or overlapping patents with minor changes.

Natco stated that it could produce Risdiplam at a far lower cost, making the life-saving drug accessible to thousands of Indian patients. The company announced that its version would be priced at ₹15,900 per bottle, compared to Roche’s ₹6.2 lakh per bottle for Evrysdi.

🗣️ Roche Expresses Disappointment

A Roche Pharma India spokesperson expressed disappointment over the verdict, saying:

“We are disheartened with this development and are reviewing our legal options under Indian law. Intellectual Property protection is crucial for pharmaceutical innovation and patient welfare. Roche remains committed to protecting its innovations and ensuring access to advanced medical treatments.”

📊 Summary

The Delhi High Court’s ruling reinforces the balance between patent rights and affordable healthcare access — a key debate in India’s pharmaceutical landscape. This decision could set an important precedent for future patent disputes involving life-saving drugs and generic competition.

⚠️ Disclaimer: The information provided in this article is for educational and informational purposes only. We do not provide medical or legal advice. Readers are advised to verify facts from official court documents and consult healthcare professionals for medical decisions.