In a recent news MP Haris Beeran (Rajya Sabha) wrote to the Minister of Health and Family Welfare on December 20, 2024, urging the Central Government to invoke Section 100 (1) of the Patents Act with respect to local production of the rare disease Spinal Muscular Atrophy (SMA) treating drug Risdiplam. SMA is a genetic disease affecting the nerve cells that control voluntary muscle movement. SMA incidence in India is one in 10,000 live-born babies. Risdiplam is currently under patent protection in India till May 11, 2035 (subject to payment of Patent renewal fees) and is Patented as Indian Patent No. IN 334397.
Key Points:
High Treatment Costs: The annual cost of Risdiplam treatment is approximately ₹1 crore, which is huge and unaffordable for patients.
Government Intervention: Section 100 of the Patents Act empowers the government of India to authorize the local manufacturing of patented drugs in the extreme urgency, potentially reducing costs significantly.
Public Health Impact: SMA affects thousands of children in India annually, and the high cost of treatment has led to calls for government action to ensure access to essential medications.
By invoking Section 100, the government can enable local production of Risdiplam, potentially reducing the annual treatment cost to around ₹3,024, thereby improving access for patients in need. Section 100 empowers the central government to use, or authorise to use, an invention (application or grant) for the purposes of the government, on a non-commercial basis. Importantly, this is not a provision that requires abuse of patent by the patentee. This includes but is not limited to using the invention in case of national emergency or other situations of extreme urgency.
