The Plaintiff, F. Hoffmann-La Roche AG filed a suit seeking interim relief against the Defendant, alleging that the Defendant has infringed upon the Plaintiff’s patent for ‘Risdiplam’, an oral drug for Spinal Muscular Atrophy (SMA). The Plaintiff holds an Indian species patent for Risdiplam claiming a specific compound used to treat SMA and they sell it under the brand name ‘Evrysdi’. However, the Defendant challenged the validity of the Plaintiff’s species patent stating that it was anticipated by prior publication in light of their earlier genus patent which covered a wide class of related compounds, including Risdiplam.
A genus patent broadly claims a family of related chemical compounds, whereas, a species patent narrows down to a particular compound within that family. In India, species patents are permitted only if they demonstrate significant technical advancement and improved efficacy over the genus patent.
The Court found merit in the Defendant’s arguments and noted the Plaintiff’s own admissions in foreign jurisdictions wherein they have claimed Risdiplam was disclosed in the genus patent. Thus, by admitting that the Risdiplam is covered under the broader genus patent, the Plaintiffs have effectively made the species patent vulnerable to invalidity in India. The Court observed that the Plaintiff’s species patent for Risdiplam was an obvious modification of prior art. Thus, the Court held that the Defendant has presented a credible challenge to the validity of the Plaintiff’s patent and thus, no injunction can be granted. The Court further noted that in cases involving life-threatening diseases like SMA, affordable access to essential drugs can outweigh the right to injunction.
Source: F-Hoffman La Roche Ag & Anr. v. Natco Pharma Ltd. [(CS(COMM) 567/2024)]