The Supreme Court of India has rejected a plea by Swiss pharmaceutical company F. Hoffmann-La Roche AG (Roche) to restrain Natco Pharma Ltd from selling a generic version of its life-saving spinal muscular atrophy (SMA) drug, Risdiplam, in India. The court upheld a previous Delhi High Court ruling, which denied Roche an injunction against Natco. Roche had initiated legal action against Natco in early 2024, after Natco planned to launch a lower-cost generic version of Risdiplam, marketed under the brand name Evrysdi.
Roche holds an Indian patent for Risdiplam, valid from May 2015 to May 2035, and claims the molecule is a new chemical entity. However, Natco’s generic launch challenges Roche’s exclusivity, raising debates around access to affordable medicines versus intellectual property (IP) protection in India. The Supreme Court’s decision allows Natco to continue selling the generic version of Risdiplam in India and also permits the company to export the drug, providing broader market access.
Roche expressed strong disappointment with the Supreme Court’s decision, emphasizing the importance of robust IP protection for fostering innovation and addressing critical healthcare challenges. The company believes that India must protect and enforce patent rights effectively to emerge as a global life sciences innovation hub. The dispute highlights the ongoing tension between the need for affordable medicines and the need to protect intellectual property rights in the pharmaceutical industry.
The Supreme Court’s decision is a significant development in the ongoing litigation between Roche and Natco. It allows Natco to continue providing a more affordable alternative to Roche’s proprietary drug, which could have a significant impact on the treatment of SMA in India. The decision also underscores the importance of balancing IP protection with the need for affordable medicines, particularly in countries with large populations and limited healthcare resources.
In response to the decision, Roche reiterated its commitment to innovation and IP protection, while Natco is likely to continue selling the generic version of Risdiplam in India and exploring export opportunities. The outcome of this case may have broader implications for the pharmaceutical industry in India and beyond, as companies navigate the complex landscape of IP protection, affordability, and access to life-saving medicines.