Roche moves Supreme Court against Natco Pharma over sale of generic Risdiplam in India

New Delhi: Swiss drugmaker Roche has moved the Supreme Court, seeking to restrain Natco Pharma from selling the generic version of its life-saving spinal muscular atrophy (SMA) drug Risdiplam in India.

Roche approached the apex court after the Delhi High Court division bench on 9 October refused to bar Natco Pharma from selling the generic version, upholding a March single-judge order that had earlier denied Roche an injunction.

The plea for urgent listing was mentioned on Tuesday by Roche’s counsel before a bench led by Chief Justice B.R. Gavai, which agreed to hear the matter on Thursday or Friday.

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

In response to a query from Mint, a Roche spokesperson confirmed that the company had filed an appeal in the apex court, but declined to comment further.

Queries sent to Natco Pharma remained unanswered till press time.

The division bench’s 9 October ruling had cleared the way for a far cheaper version of the drug to enter the Indian market.

Following the decision, Natco Pharma announced the immediate launch of its product at a maximum retail price (MRP) of ₹15,900 for a 60 mg/80 ml bottle, a sharp drop from Roche’s price of over ₹6,00,000. The Hyderabad-based company also said it would offer additional discounts under its patient access programme

In a statement to Mint after the Delhi High Court’s decision, Roche said it was “disappointed” with the outcome and was evaluating its legal options, reaffirming its commitment to protecting pharmaceutical innovation within the framework of Indian law.

According to Roche, it has sought to address affordability concerns through patient access and compassionate-use programmes, under which 52 patients currently receive Risdiplam free of cost. Since its launch in 2021, about 300 patients in India have used Evrysdi.

While there are no official estimates of SMA cases in India, studies suggest the condition affects one in 7,744 live births and remains a leading genetic cause of infant mortality. According to an affidavit filed by the central government in the Kerala High Court earlier this year, the total annual cost of treating SMA patients in India could range between ₹6,400 crore and ₹34,000 crore.

The dispute

Roche holds an Indian patent for Risdiplam, valid from May 2015 to May 2035. The company claims the molecule is a new chemical entity, distinct from earlier patents, and emphasizes the high cost of developing such treatments.

Natco Pharma, however, challenged Roche’s patent, alleging that the company was “evergreening” its monopoly by filing a narrowly defined patent with limited novelty. Natco argued that local manufacturing would drastically reduce costs, making the drug accessible to thousands of patients otherwise priced out of treatment.

The high court’s single-judge bench sided with Natco, holding that Roche’s earlier patent already covered similar compounds and that the company had not demonstrated a substantial technical advancement. The court cited public interest in ensuring affordable access to a life-saving medicine and took note of statements from SMA patients who said they were unable to afford the treatment.

The division bench later upheld that view, observing that public interest and access to affordable medicine can outweigh patent exclusivity in such cases.

The broader impact

The case has reignited debate over the balance between intellectual property rights and public health imperatives in India. Legal experts earlier told Mint that while India’s patent laws already provide for compulsory licensing in public health emergencies, bypassing those mechanisms and relying on broad judicial interpretations of “public interest” could create uncertainty for innovators.

Lawyers caution that while Natco’s ability to bring a generic version marks a significant win for Indian patients, it may also discourage global pharmaceutical companies from introducing or investing in new therapies in India, given the perceived unpredictability of patent enforcement.