The provided HTML content discusses a legal ruling regarding a generic version of Risdiplam, a drug used to treat Spinal Muscular Atrophy (SMA). It focuses on patient access, affordability, patent law, and the implications of “patent evergreening.”
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The Delhi High Court recently dismissed an appeal by Swiss pharmaceutical giant Roche, thereby clearing the path for Indian company Natco Pharma to launch a Risdiplam generic version. This landmark decision brings substantial relief to patients in India afflicted with spinal muscular atrophy (SMA), a debilitating rare genetic disorder. The ruling makes the only available drug to treat SMA significantly more affordable, emphasizing patient access over patent protection.
Affordable Access to Risdiplam Generic
Previously, Roche’s patented version of Risdiplam, marketed as Evrysdi, carried a prohibitive cost. A single bottle of Roche’s medicine cost approximately Rs 6 lakh. An adult patient typically requires 2.5 to 3 bottles monthly, equating to an annual treatment cost of around Rs 60-72 lakh, even with Roche’s offer of two free bottles for every one purchased. Such pricing rendered the life-saving treatment largely inaccessible for most Indian families, despite government aid for rare diseases increasing to Rs 50 lakh in September 2024. However, Natco Pharma announced its generic Risdiplam will be priced at Rs 15,900 per 60mg bottle, drastically reducing the annual treatment cost to less than Rs 5 lakh. Health activists suggest bulk government purchases could lower this further to Rs 3.1 lakh per year. This affordability means patients could sustain treatment for up to 16 years with existing government support.
The Legal Battle and Public Interest
The court’s decision follows a protracted legal dispute. In March 2025, a single-judge bench of the Delhi High Court initially rejected Roche’s plea for an injunction against Hyderabad-based Natco Pharma. Roche’s patent for Risdiplam was set to expire in March 2035. Nevertheless, Natco had sought a patent for an improved process for preparing Risdiplam and its intermediates in September 2022. The court found that Natco had presented credible challenges to the validity of Roche’s patent, ultimately ruling in Natco’s favor. Public health groups strongly supported Natco, arguing that Roche’s patent infringement lawsuit prioritized corporate profits over patients’ fundamental right to affordable healthcare, potentially contravening India’s National Rare Disease Policy. The court underscored the public interest in ensuring wider access to the life-saving drug. Understanding the nuances of pharmacy and drug regulations is crucial in such cases.
Implications for Patent Evergreening
The Working Group on Access to Medicines and Treatment applauded the High Court’s ruling. This decision importantly highlights the detrimental effects of “patent evergreening.” This practice often involves minor modifications to existing drugs to extend patent monopolies, delaying the entry of more affordable generic alternatives. Such tactics can lead to unnecessary litigation and restrict access to essential medicines. Therefore, this judgment reinforces the principle that access to life-saving treatments should not depend solely on a patient’s financial capacity. This sets a significant precedent for future patent disputes involving critical drugs in India.
Frequently Asked Questions
Q1: What is Risdiplam used for?
Risdiplam is currently the only available oral drug approved to treat spinal muscular atrophy (SMA), a rare genetic disorder characterized by progressive muscle weakness and loss of motor function.
Q2: How much cheaper is Natco’s generic Risdiplam compared to Roche’s?
Natco Pharma’s generic Risdiplam is priced at Rs 15,900 per 60mg bottle. This represents a reduction of approximately 97% compared to Roche’s patented version, which costs roughly Rs 6 lakh per bottle. This significantly lowers the annual treatment cost.
Q3: Why did the Delhi High Court rule in favor of Natco Pharma?
The Delhi High Court upheld a previous ruling, acknowledging Natco Pharma’s credible challenges to the validity of Roche’s patent for Risdiplam. The court emphasized the strong public interest in making the life-saving drug accessible and affordable to patients in India, noting concerns about patent evergreening.
References
- HC bins Roche’s injunction plea, allows generic version of only drug for SMA – ETHealthworld
Disclaimer: This article was automatically generated from publicly available sources and is provided for informational and educational purposes only. OC Academy does not exercise editorial control or claim authorship over this content. It is not a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider and refer to current local and national clinical guidelines.