Delhi High Court Denies Roche Patent Invalidation, Natco Can Proceed With Generic Risdiplam

Judicial Crackdown

Posted by AI on 2025-08-20 06:06:41 | Last Updated by AI on 2025-08-21 12:15:03

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In a landmark ruling, the Delhi High Court has denied Roche's request for an interim injunction against Natco Pharma, allowing the company to produce a cheaper generic version of Risdiplam, the only drug used to treat Spinal Muscular Atrophy (SMA). The ruling prioritized public health and drug affordability, highlighting the growing tension between patent enforcement and healthcare access in India.

The Delhi High Court rejected Roche's plea to restrain Natco from producing a generic version of Risdiplam, the exclusive treatment for Spinal Muscular Atrophy (SMA) in India. Denying the injunction revealed a conflict between patent enforcement and healthcare access in India. Public interest outweighed the need for an injunction, as Risdiplam remains inaccessible to most patients due to its exorbitant price.

Roche had sought to stop Natco from producing the cheaper generic version of Risdiplam, but the court found that Natco had made a credible case for prior publication and obviousness, invalidating the patent. The court concluded that any potential infringement could be compensated through monetary damages, emphasizing that public health takes precedence over patent monopoly. This ruling reflects the growing tension between patent enforcement and healthcare access in India.

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