Context:
The Supreme Court has dismissed a plea by Swiss pharma giant Roche challenging Natco Pharma’s production of a generic version of spinal muscular atrophy (SMA) drug Risdiplam.
Key Highlights / Details:
- Background of the Case:
- Roche opposed a Delhi High Court order allowing Natco Pharma to sell a generic version of Risdiplam.
- The SC upheld the lower court’s decision, stating no valid reason to interfere.
- Drug Pricing Issue:
- Roche’s original drug is priced extremely high globally.
- Natco’s generic version is to be sold at ₹15,900, much cheaper and accessible.
- Legal Proceedings:
- The Supreme Court found Roche’s plea unsustainable.
- The case now proceeds to trial stage in the Delhi High Court.
- The decision is seen as a win for access to affordable medicines in India.
- Intellectual Property Aspect:
- Case highlights patent litigation and generic drug production issues in India under TRIPS flexibilities.
Relevant Prelims Points:
- SMA (Spinal Muscular Atrophy) is a rare genetic neuromuscular disorder.
- TRIPS Agreement – Trade-Related Aspects of Intellectual Property Rights (WTO).
- India’s Patent Act allows compulsory licensing under Section 84.
- Natco Pharma is based in Hyderabad.
Relevant Mains Points:
- Balancing public health and intellectual property rights.
- Role of judiciary in ensuring medicine affordability.
- India as a global pharma hub for generic medicines.