(MENAFN- Live Mint) The Supreme Court on Friday rejected Swiss pharmaceutical giant F. Hoffmann-La Roche AG's (Roche) plea seeking that Natco Pharma Ltd be restricted from selling the generic version of its life-saving spinal muscular atrophy (SMA) drug, Risdiplam, in India until the conclusion of the case.

The bench of Justices P.S. Narasimha and A.S. Chandurkar declined to interfere with a 9 October Delhi high court division bench ruling that had upheld a March single-judge order denying Roche an injunction.

The top court also rejected Roche's plea to bar Natco from exporting the drug but asked the Delhi high court to expedite the hearing.

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“We are not inclined to interfere with the order passed by the high court for the reason that it is interim in nature and the findings are concurrent,” the bench said.

During the hearing, senior advocate Neeraj Kishan Kaul, representing Roche, argued that public interest cannot override patent rights.“We have cooperated, given millions of drugs free, and participated in the national drug policy of the Government of India. But after spending millions, it is very easy to bring in the public interest element,” Kaul said.

“I won't say anything more, except that at the very least they should maintain proper accounts and refrain from exporting the drug in the meantime,” he further urged the court,

With Roche's interim pleas rejected, the case will now be heard by a single bench of the Delhi high court for a final ruling.

The dispute

Roche sued Natco in early 2024 after learning of the Hyderabad-based company's plan to launch a lower-cost generic version of Risdiplam, sold under the brand name Evrysdi, which treats SMA-a rare genetic disorder causing progressive muscle weakness and loss of motor function.

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Roche holds an Indian patent for Risdiplam valid from May 2015 to May 2035, claiming the molecule is a new chemical entity distinct from earlier patents.

Natco 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 who can not afford treatment.

The single-judge bench sided with Natco, holding that Roche's earlier patent already covered similar compounds and that the company had not demonstrated substantial technical advancement.

The court cited public interest in ensuring affordable access to a life-saving medicine and noted statements from SMA patients who said they could not afford treatment. The division bench later upheld this view, observing that public interest and access to affordable medicine can outweigh patent exclusivity in such cases.

The impact

Following the Delhi high court's division bench decision, Natco Pharma immediately launched its generic version 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 company also announced additional discounts under its patient access programme.

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Since the launch of Evrysdi in India in 2021, about 300 patients have received treatment, with 52 patients benefiting from free access under Roche's compassionate-use programme. SMA is estimated to affect one in 7,744 live births in India and remains a leading genetic cause of infant mortality. The central government has estimated that the annual cost of treating SMA patients in the country could range between ₹6,400 crore and ₹34,000 crore.

Broader implications

The case has reignited debate over balancing intellectual property rights and public health imperatives in India.

Experts have noted that while India's patent laws provide for compulsory licensing in public health emergencies, 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 is a major win for Indian patients, it may also discourage global pharmaceutical companies from introducing or investing in new therapies in India due to perceived unpredictability in patent enforcement.

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