The Indian court, Justice Mini Pushkarna, recently ruled against granting an injunction in favor of Roche, a pharmaceutical company, in a landmark case involving the patent dispute over the drug Risdiplam, used to treat Spinal Muscular Atrophy (SMA). The court’s decision was based on several crucial factors that challenged the validity of Roche’s patent. Firstly, the court found merit in NATCO’s arguments that Roche’s patent was vulnerable due to the similarity between its earlier Genus Patent (WO’916) and the Suit Patent for Risdiplam. Additionally, the court took note of statements made by Roche in foreign jurisdictions, such as its Patent Term Extension (PTE) applications in the US and Australia, which supported NATCO’s claims that Risdiplam was disclosed in the Genus Patent.
The court also concluded that the patented molecule, Compound 809, was an obvious modification of prior compounds, as described by “Grimm’s Hydride Displacement Law,” which made it a predictable adjustment for a chemist skilled in the art. Furthermore, the court highlighted the importance of making life-saving drugs accessible and the severe financial and medical burden imposed by Roche’s monopoly. The court recognized that many SMA patients in India could not afford Roche’s high pricing, and that NATCO’s commitment to manufacturing and supplying Risdiplam locally at significantly reduced costs would improve accessibility to the drug. Overall, the court’s decision prioritized public interest and the well-being of patients with SMA, ruling in favor of NATCO’s efforts to make the life-saving drug more accessible and affordable in India.