Supreme Court Clears Natco to Launch Low-Cost Version of Roche’s Spinal Drug in India: A Judgment That Redefines Access and Innovation in India’s Pharma Landscape.
The Supreme Court of India has just recently refused to interfere with the Delhi High Court’s order allowing Natco Pharma to manufacture and market a generic version of Roche’s spinal muscular atrophy (SMA) drug, Risdiplam (Evrysdi). This landmark development doesn’t just mark a legal win for generics — it revives the deep, ongoing debate between patent protection and public access to life-saving medicines.
A Ruling That Speaks the Language of Access:
On October 17–18, 2025, Roche’s plea seeking an injunction against Natco was dismissed by the Supreme Court, which found no reason to interfere with the Delhi High Court’s earlier decision.
The Delhi court had refused to grant Roche interim relief, noting credible grounds to challenge the patent’s validity and the public-interest urgency of allowing cheaper treatment for SMA — a devastating genetic disorder that affects infants and children.
The court’s reluctance to grant an interim injunction places patient affordability front and center — and that changes the dynamics of pharma patent battles in India.
The Price Gap That Altered the Equation:
Roche’s Evrysdi reportedly costs several lakh rupees per bottle in India, putting it beyond the reach of most families. Natco’s generic version, as reported, could be priced over 90% cheaper — transforming what was once an impossible dream into a realistic treatment option.
This price gap didn’t just influence public sentiment; it played a significant role in shaping the courts’ stance. Judges openly recognized that blocking a low-cost version could effectively deny treatment to children with SMA — a life-and-death consequence.
Why the Supreme Court’s Refusal Matters:
The Supreme Court’s decision not to grant Roche an interim injunction reinforces a growing Indian legal trend: interim injunctions in pharma patent cases are no longer automatic.
Courts now weigh:
- Patent strength and the credibility of validity challenges,
- Irreparable harm to the innovator, and
- Public interest, especially access to life-saving drugs.
This signals that the right to enforce a patent is conditional upon the broader social consequences of that enforcement.
Balancing Innovation and Access:
This case captures the perennial dilemma:
- Innovators argue that strong patent enforcement is essential for recouping high R&D investments and incentivizing new drug development.
- Public health advocates argue that patents cannot become instruments of exclusion in countries where millions live below the affordability line.
When prices put essential medicines out of reach, the courtroom becomes a public-health tool — not just a commercial arena.
The Natco–Roche case has forced policymakers, the judiciary, and especially the multinational pharmaceutical companies to re-examine that delicate balance.
Wider Ripples Across the Pharma Ecosystem:
This decision could shape the future of pharmaceutical litigation and policy in India in at least three ways:
- Fewer automatic injunctions:
Courts are likely to scrutinize the public-health impact before granting injunctions for high-priced patented drugs. - Pricing pressure on innovators:
Multinationals may increasingly adopt tiered pricing, voluntary licensing, or expanded patient-assistance programs to avoid reputational and legal setbacks. - Inspiration beyond India:
India’s judicial balancing act could influence other developing countries grappling with rare-disease affordability and IP rights.
What It Means for Stakeholders:
- For patients and caregivers: A crucial breakthrough — real hope for families fighting SMA who could never afford imported treatment.
- For Indian pharma: A signal that robust patent challenges and ethical pricing can reshape access debates.
- For global innovators: A call to re-engage with India through more collaborative models — not courtroom showdowns.
Access and innovation need not be enemies. The challenge is rewriting the incentives so they can be allies.
Conclusion:
A Broader Reflection:
This judgment underscores a truth India’s policymakers have long recognized — that patent law is not just about ownership, but about obligation. Society grants exclusivity to foster innovation, but that exclusivity loses legitimacy when it bars life-saving treatment for those who need it most.
While this verdict helps address immediate patient needs, the long-term path must include transparent pricing frameworks, stronger patent examination, and public–private partnerships to make rare-disease drugs sustainably accessible.
By: Tapan J. Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.
Sources and References:
- Supreme Court of India order (October 2025)
- Delhi High Court proceedings in Roche vs. Natco (2024–2025)
- Reporting: Moneycontrol, The Economic Times, LiveMint, SwissInfo, Knowledge Ecology International