The Delhi High Court delivered a decisive ruling in the patent infringement case brought by F Hoffmann-La Roche AG against NATCO Pharma Limited, concerning Roche's patent for "Risdiplam," marketed under the brand name "EVRYSDI®." This drug is the only approved oral treatment in India for Spinal Muscular Atrophy (SMA), a rare genetic neuromuscular disorder. Roche sought an interim injunction against NATCO Pharma for alleged patent infringement, claiming that NATCO's manufacturing of a similar drug violated its rights under Indian Patent No. IN 334397. However, the Court refused to grant the injunction, emphasizing the public interest in making life-saving drugs affordable and accessible.

Roche's patent, IN 334397 (also referred to as IN’397 or the Suit Patent), titled "COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY," specifically concerns the molecule Risdiplam. This patent grants exclusivity over Risdiplam until May 2035. The key specifications of the patent are as follows:

• Indian Application No.: 201647038542

• Date of Grant: March 11, 2020

• Priority Date: May 11, 2015

• Expiry Date: May 11, 2035

• Risdiplam is described chemically as 7-(4,7-diazaspiro[2.5]octan-7-yl)-2-(2,8-dimethylimidazo[1,2-b]pyridazin-6-yl)-4H-pyrido[1,2-a]pyrimidin-4-one. The drug modifies SMN2 gene splicing, improving motor neuron functionality.

The plaintiffs, Roche, alleged that NATCO Pharma infringed their patent by initiating production of Risdiplam API (Active Pharmaceutical Ingredient). NATCO challenged the patent’s validity, raising multiple legal and technical objections:

1. Anticipation by Prior Publication: NATCO asserted that Risdiplam was disclosed in Roche's earlier Genus Patent, WO’916. They argued that the International Genus Patent encompassed Risdiplam as an anticipated compound, making it vulnerable to invalidation under Section 64(1)(e) of the Patents Act.

2. Obviousness: NATCO contended that Risdiplam constituted a predictable modification of compounds disclosed in the Genus Patent, undermining its inventive step.

3. Misrepresentation: NATCO alleged that Roche misrepresented data during the examination of its Species Patent in India, particularly concerning WO’916.

4. Public Interest: NATCO pointed to Roche's exorbitant pricing—₹1.48 crore annually for the imported drug—and argued that their domestic manufacturing could reduce costs by up to 90%.

Justice Mini Pushkarna ruled against granting an injunction in favor of Roche, focusing on several crucial factors:

1. Prima Facie Challenge to Patent Validity

The Court found merit in NATCO’s arguments about the vulnerability of Roche’s patent. It highlighted the overlap between Roche’s earlier Genus Patent (WO’916) and the Suit Patent for Risdiplam. Notably, statements made by Roche in foreign jurisdictions, such as its Patent Term Extension (PTE) applications in the US and Australia, supported NATCO’s claims that Risdiplam was disclosed in the Genus Patent.

2. Obviousness and Lack of Inventive Step

Upon reviewing Compound 809 disclosed in WO’916 and its structural similarity to Risdiplam, the Court concluded that the patented molecule was an obvious modification of prior compounds. The Court referred to "Grimm’s Hydride Displacement Law," emphasizing that substituting CH with Nitrogen was a predictable adjustment for a chemist skilled in the art.

3. Public Interest

The Court highlighted the importance of making life-saving drugs accessible, noting that many SMA patients in India could not afford Roche’s high pricing. It also emphasized NATCO’s commitment to manufacturing and supplying Risdiplam locally at significantly reduced costs, which would improve accessibility to the drug. The Court cited patient testimonies and cases to underscore the severe financial and medical burden imposed by Roche’s monopoly.

This ruling has profound implications for SMA patients in India. With Roche’s imported drug costing over ₹1 crore annually, many families are unable to afford treatment. NATCO’s planned production of Risdiplam in India promises relief, making SMA treatment economically viable for a broader population. The Court’s refusal to grant an injunction sets a precedent prioritizing public health over commercial monopoly.

The Delhi High Court’s judgment reaffirms the principle that patents must balance innovation with the public interest. While Roche retains the right to pursue damages, its inability to block NATCO’s drug production ensures affordable access to life-saving medicine for SMA patients. By emphasizing affordability, accessibility, and public interest, the judgment sets a critical precedent in pharmaceutical patent cases.

The Court’s decision in this matter marks a significant moment in the broader conversation about intellectual property rights, particularly concerning medications vital for public health. The Court considered the intersection of innovation, public interest, and the essential balance between profit motives and healthcare accessibility in its judgment, setting important precedents for future legal determinations in the field of pharmaceuticals and patent law.

About the authors: Mahua Roy Chowdhury is the Managing Partner of Royzz & Co. Muthu Pandi is a Partner at the Firm.

Disclaimer: The opinions expressed in this article are those of the author(s). The opinions presented do not necessarily reflect the views of Bar & Bench.

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