Supreme Court Rejects Roche's Plea Against Natco's Generic Risdiplam: Major Win for Patient Access
The Supreme Court has rejected pharmaceutical giant Roche's request to restrain Natco Pharma from selling a generic version of Risdiplam, a life-saving spinal muscular atrophy treatment. The landmark decision upholds previous lower court rulings prioritizing patient access to affordable medicines over patent exclusivity, reigniting debate about balancing intellectual property protection with public health imperatives in India.
Supreme Court's Landmark Decision
A bench of Justices P.S. Narasimha and A.S. Chandurkar declined to interfere with an October 9 Delhi High Court division bench ruling that had previously denied Roche's injunction request. The Supreme Court found the lower court's findings and reasoning sound, stating that it was "not inclined to interfere with the order passed by the high court for the reason that it is interim in nature and the findings are concurrent."
The Court also rejected Roche's request to bar Natco from exporting the generic drug, though it directed the Delhi High Court to expedite final proceedings on the case merits.
Roche's Response and Disappointment
Roche responded to the Supreme Court's decision with a formal statement expressing disappointment. The Swiss pharmaceutical company stated: "We are extremely disappointed with the Supreme Court's decision to dismiss our plea concerning the Risdiplam preliminary injunction."
The company emphasized its position that strong intellectual property protection is essential for innovation. Roche argued: "Strong IP protection, including patents, is the cornerstone for any innovation to thrive and address critical healthcare challenges. For India to truly emerge as a global life science innovation hub, it must protect and enforce the integrity of IP."
However, Roche declined to specify its next steps or whether it would pursue additional legal remedies.
Natco's Perspective on the Victory
In an exchange filing, Natco stated that the Supreme Court's dismissal of Roche's interim pleas represents a conclusive victory at the preliminary stage. Natco noted: "Having the benefit of the two successive orders, the Supreme Court was not inclined to interfere, therefore dismissed the petition."
The company added: "This marks the final challenge Roche could have posed at the interim stage in the suit, which shall now proceed for trial in accordance with the law."
The Background Dispute
Patent and Evergreening Allegations
Roche initiated legal action against Natco in early 2024 after discovering the Hyderabad-based company's plans to launch a lower-cost generic version of Risdiplam. Roche holds an Indian patent for Risdiplam valid from May 2015 to May 2035, claiming the molecule represents a new chemical entity distinct from earlier patents.
Natco contested Roche's patent, alleging that the company was engaging in "evergreening"—a practice of filing narrowly defined patents with limited novelty to extend monopoly protection beyond the original patent term. Natco contended that Roche's earlier patent already covered similar compounds and that the company had failed to demonstrate substantial technical advancement warranting a separate patent.
The Disease and Market Need
Risdiplam treats spinal muscular atrophy, a rare genetic disorder causing progressive muscle weakness and loss of motor function. SMA is estimated to affect one in 7,744 live births in India and represents a leading genetic cause of infant mortality. The central government has estimated that annual treatment costs for SMA patients could range between ₹6,400 crore and ₹34,000 crore.
Lower Court Rulings Supporting Natco
Both the single-judge bench and division bench of the Delhi High Court sided with Natco's position. Key findings included:
- Patent Validity: Roche's earlier patent already covered similar compounds
- Lack of Novelty: Insufficient technical advancement demonstrated for the contested patent
- Public Interest: Access to affordable life-saving medicine outweighs patent exclusivity
- Patient Impact: Substantial evidence presented by SMA patients regarding inability to afford treatment
The courts emphasized that public interest in ensuring affordable access to critical medicines can override patent protections in specific circumstances.
Dramatic Price Reduction for Patients
Following the Delhi High Court's division bench decision, Natco immediately launched its generic version at dramatically reduced pricing:
- Natco Generic Price: ₹15,900 for 60 mg/80 ml bottle
- Roche Brand Price: Over ₹6,00,000 for equivalent packaging
- Price Reduction: Approximately 97% reduction from branded price
- Additional Discounts: Natco announced supplementary discounts through patient access programs
This dramatic price reduction makes treatment accessible to thousands of patients previously unable to afford the branded medication.
Patient Access Impact
Since Roche launched Evrysdi in India in 2021, approximately 300 patients have received treatment. Of these, 52 patients benefited from free access through Roche's compassionate-use program. The availability of generic alternatives at affordable pricing is expected to dramatically expand access to treatment.
Roche's Legal Arguments
Senior advocate Neeraj Kishan Kaul, representing Roche before the Supreme Court, argued that public interest considerations cannot override patent rights. Kaul stated: "We have cooperated, given millions of drugs free, and participated in the national drug policy of the Government of India. But after spending millions, it is very easy to bring in the public interest element."
Kaul urged the court to at minimum require proper accounting of generic drug sales and prevent export of the medication during proceedings. The court did not accede to these requests.
Broader Implications for IP Rights and Public Health
The Supreme Court's decision has reignited fundamental debate over balancing intellectual property protection with public health imperatives in India. The case raises several important considerations:
Patent Protection and Innovation
Pharmaceutical companies argue that strong patent enforcement is essential for motivating research and development investments in new therapies. Roche's position emphasizes that weakening IP protection could discourage global pharmaceutical companies from introducing or investing in new treatments in India.
Public Health Access
Patient advocates emphasize that patent protections should not prevent access to life-saving medications for economically disadvantaged populations. The courts' recognition of public interest in affordable medicine reflects this perspective.
Compulsory Licensing Framework
While India's patent laws provide for compulsory licensing in public health emergencies, experts have noted that relying on broad judicial interpretations of "public interest" could create uncertainty for innovators. The question of when public health justifies overriding patent rights remains contested.
Legal Expert Perspectives
Legal analysts have highlighted conflicting concerns raised by this decision:
Support for Patient Access
Many acknowledge that Natco's ability to bring a generic version represents a major victory for Indian patients, potentially making treatment accessible to thousands who previously faced prohibitive costs.
Concerns About Innovation Incentives
Some legal experts caution that unpredictable patent enforcement due to broad "public interest" interpretations may discourage global pharmaceutical companies from introducing new therapies in India. Pharmaceutical firms might prioritize markets with clearer IP protections, potentially reducing treatment options for Indian patients overall.
India's Patent Law Framework
The case illustrates tensions within India's patent legal framework:
- Patent Protection: Laws provide substantial IP protections encouraging innovation
- Compulsory Licensing: Provisions allow public health exceptions in emergencies
- Evergreening Concerns: Concerns about extending monopolies through incremental innovations
- Public Interest: Courts' discretion to prioritize affordable medicine access
Path Forward for the Case
With all interim pleas rejected, the case will proceed to a single bench of the Delhi High Court for final determination on the merits. Key issues for resolution include:
- Final validity of Roche's patent for Risdiplam
- Whether Natco's generic version infringes any valid patent
- Appropriate remedies if infringement is established
- Potential damages assessments
International Context
This case reflects India's position as a critical player in global pharmaceutical debates. India's decisions on patent enforcement and public health balancing influence:
- Global pharmaceutical investment patterns
- Access to medicines for developing countries
- International standards on IP rights versus public health
- Precedents for other emerging market patent disputes
Investment and Industry Implications
The Supreme Court's ruling carries implications for pharmaceutical companies and investors:
For Global Pharma Companies
- Increased uncertainty regarding patent enforcement in India
- Potential reconsideration of drug launch decisions for India
- Greater scrutiny of patent strategy and evergreening allegations
- Need for careful valuation of Indian market opportunity
For Indian Pharma Companies
- Expanded opportunities to manufacture generic versions
- Reduced risk of injunctions restraining generic launches
- Potential for significant business growth in therapeutic areas
- Ability to address public health needs cost-effectively
Conclusion
The Supreme Court's rejection of Roche's interim pleas represents a significant victory for patient access to affordable medicines in India. The decision validates lower courts' findings that public interest in accessing life-saving treatment can outweigh patent exclusivity protections in appropriate circumstances.
The ruling enables Natco to provide Risdiplam at a fraction of the branded price, potentially treating thousands of spinal muscular atrophy patients previously unable to afford expensive branded therapy. However, the decision raises legitimate concerns about impacts on pharmaceutical innovation and investment in India.
The case exemplifies the complex balance between protecting intellectual property rights that encourage research and development, and ensuring that critical medicines remain accessible to economically disadvantaged populations. As the case proceeds to final hearing, courts will continue grappling with these fundamental tensions between IP protection and public health imperatives in emerging markets.
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