Delhi HC allows Indian company Natco to manufacture and sell Risdiplam drug, medicine cost may get cheaper

The Delhi HC Division Bench upheld a Single Judge order that had refused Swiss pharma Roche’s plea for an injunction against Natco’s manufacturing and selling of the sole drug for SMA. A bottle of Roche’s Risdiplam in India can cost up to around Rs 6 lakh.

Written by Sohini Ghosh

New Delhi | October 10, 2025 10:58 AM IST

3 min read

The bench of Chief Justice DK Upadhyaya and Justice Tushar Rao Gedela has appointed senior advocate N Hariharan, who specialises in criminal law, as an amicus curiae in the case to assist the court.

Around 5.30 pm on Thursday, Natco Pharma, in an announcement on the National Stock Exchange, hailed the court order as a “landmark decision” and declared that it will launch a generic version of the drug. (File Photo)

In a significant ruling for rare disease patients, the Delhi High Court on Thursday upheld a Single Judge order that had allowed Indian drugmaker Natco Pharma to make and sell the generic version of the spinal muscular atrophy (SMA) drug called Risdiplam.

A Division Bench of Justices C Hari Shankar and Ajay Digaul upheld the earlier decision in March that had refused Swiss pharma multinational Roche’s plea for an injunction against Natco’s manufacturing and selling of the sole drug for SMA, approved in India. Roche had then appealed against the Single Judge’s order.

SMA, a debilitating genetic neuromuscular disease that leads to wasting of muscles, though not curable, can be better managed through Risdiplam, which is marketed under the name Evrysdi, but is not available at a reasonably affordable price in India.

The announcement reads, “The company has decided to launch the product with immediate effect and price the product at INR 15,900 MRP consistent with the company’s stand before the court. The company also intends to offer some discounts to certain deserving patients through its patient access programme.”

A bottle of Roche’s Risdiplam in India can cost up to around Rs 6 lakh.

Roche had alleged that Natco Pharma was infringing on the former’s patent with the drug’s suit patent term expiring in May 2035. Roche made the allegation after it came across the listing of Risdiplam on Natco Pharma’s website, and it was learnt by Roche that Natco was preparing for the commercial production of the Risdiplam Active Pharmaceutical Ingredient (API).

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Upholding the Single Judge’s decision, the Division Bench reasoned, “A person who patents one invention is entitled to exclusivity, over the patented invention, only for a period of 20 years. Thereafter, the patented invention falls into the public domain and is available for the public to exploit. In the case of drugs and pharmaceutical products, this principle acquires a superadded and predominant element of public interest. If patents relating to essential and life-saving drugs are permitted to be evergreened, the drug may forever remain outside the public domain and available only for the original inventor to exploit, which could result in calamitous and incalculable public harm.”

The court also stated, “By no means can an inventor be permitted, by making changes to an invented pharmaceutical preparation, which is essential or life-saving in nature, to keep the invention out of the public domain beyond the period of life of the patent, by making modifications which, perceptibly, would be obvious to the inventor – as the “person in the know” – and, by claiming the modified invention to be “new”, seek a fresh lease of patent life.”

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