Supreme Court Declines to Intervene in Roche vs Natco Patent Dispute over SMA Drug

The Supreme Court on Friday refused to stay the Delhi High Court’s order allowing Natco Pharma to manufacture and sell a generic version of Risdiplam, a drug used to treat Spinal Muscular Atrophy (SMA), in a major patent dispute with Swiss pharmaceutical company F. Hoffmann-La Roche AG.

A bench comprising Justices PS Narasimha and AS Chandurkar declined to interfere, noting that the High Court’s ruling was interim in nature and that concurrent findings had already been rendered at both the single-judge and division bench levels. The Court, however, urged the Delhi High Court to expedite disposal of the main suit filed by Roche.

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Patent Dispute Background

Roche holds a patent for Risdiplam in India, valid until 2035, claiming specific compounds for treating SMA. The company argued that Natco’s generic version infringed this patent, developed after years of research and multi-million-dollar investment.

Senior Advocate Neeraj Kishan Kaul, representing Roche, contended that Natco was attempting to bypass patent rights through “reverse engineering,” and requested the Court to restrain Natco from exporting the drug while maintaining profit accounts.

Natco, represented by Senior Advocates Kapil Sibal and Gopal Subramanium, invoked statutory defences under the Patents Act, 1970, claiming the patent lacked novelty and was obvious in view of prior art, specifically Compound 809 in WO’916/US’955.

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High Court Ruling

On October 9, a division bench of the Delhi High Court dismissed Roche’s appeal against a Single Judge’s ruling, allowing Natco to continue manufacturing and selling Risdiplam in India. The Court observed that the drug was vulnerable to invalidity under Section 64(1)(f) of the Patents Act, which deals with obviousness in light of prior art.

The Supreme Court clarified that its order did not address the merits of the patent dispute, noting that all observations in civil applications were solely for disposing of the appeals.

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Implications

The ruling underscores India’s approach toward balancing patent rights and access to affordable medicines, particularly in life-saving drugs. Analysts suggest that if Natco’s generic remains on the market, it could improve affordability of SMA treatment for patients in India while Roche continues to pursue legal remedies.