Natco Pharma has announced plans to introduce a generic version of Roche Pharma’s patented drug, Risdiplam, used in treating Spinal Muscular Atrophy (SMA). The launch is subject to the outcome of an ongoing patent infringement case at the Delhi High Court. The Hyderabad-based company has said it intends to price the drug at a significantly lower MRP of ₹15,900, marking a bold move toward affordable treatment for SMA patients in India.

The Legal Battle Over Risdiplam

Roche Pharma, the innovator of Risdiplam marketed as Evrysdi, had earlier sought an interim injunction from the Delhi High Court to block Natco’s entry with a generic version, citing its patent rights under Suit Patent No. IN 334397, valid from May 2015 to May 2035. In March 2024, a single judge bench denied Roche’s plea, which was seen as a potential opening for the introduction of generic Risdiplam in the Indian market.

However, Roche immediately challenged this ruling before the Appellate Bench of the Delhi High Court, which has ordered the parties to maintain the status quo until the matter is heard conclusively. Natco has since clarified that it will only proceed with the launch post a favourable and clear court decision.

Natco’s Stand on Pricing and Accessibility

Despite the legal uncertainty, Natco has chosen to disclose its planned pricing strategy, which aligns with the arguments it presented in court. The company said it has received numerous enquiries from patients and investors about the potential launch and availability of the drug.

Natco’s proposed price of ₹15,900 is a drastic reduction compared to Roche's current pricing structure, which places Evrysdi at ₹72 lakh annually for the first two years and ₹56 lakh annually from the third year onwards.

The pharmaceutical company also announced that it would implement a Patient Access Programme, where certain deserving patients could receive additional discounts to ensure affordability.

Why Risdiplam Matters

Risdiplam is a breakthrough drug for Spinal Muscular Atrophy (SMA), a rare genetic disorder that leads to the loss of nerve cells in the spinal cord, causing progressive muscle weakness and atrophy. SMA severely affects basic functions like walking, breathing, and swallowing, and often has life-threatening implications, especially in children.

Before Risdiplam, treatment options for SMA were extremely limited and unaffordable in India, with some patients depending on fundraisers or foreign grants to access therapy.

Patient Advocacy and the Right to Life

The significance of affordable access to Risdiplam is highlighted by two young SMA patients, Seba PA and Purva Mittal, who have intervened in the legal proceedings. Their intervention brought the right to life and affordable healthcare into the courtroom, urging the judiciary to consider real-world implications of high drug pricing on patients' survival.

This powerful move has ignited a broader discussion about access to life-saving drugs, patent laws, and the balance between innovation and public health needs.

Roche’s Position and Innovation Defense

In a statement to Moneycontrol, Roche reaffirmed its commitment to defending its patent and highlighted that Evrysdi is the first and only approved SMA treatment in India since its launch in 2021. The company also emphasized its efforts in collaborating with Indian authorities for tailored pricing models and providing support under its Patient Support Program (PSP).

Roche argued that its patent has faced no pre-grant or post-grant opposition, nor has there been any revocation petition in India, thereby reinforcing its exclusive right to the molecule under existing IP laws.

A Precedent in the Making?

The final verdict in this case is expected to set a major precedent in India’s pharmaceutical landscape, particularly for rare disease treatments and biologics. If Natco is granted clearance to launch, it could trigger wider generic manufacturing efforts for high-cost therapies, bringing much-needed relief to patients burdened by unaffordable medicines.

For now, Natco has exercised restraint, committing to compliance with the judiciary's directions, even as it prepares infrastructure and distribution channels for a potential launch.

Stock Market Response

Following the update, Natco Pharma’s stock rose 1.29% to close at ₹776.30 on the Bombay Stock Exchange (BSE) on Tuesday, reflecting positive investor sentiment around the company’s approach to affordable healthcare and its legal resilience.

Why This Matters for Indian Healthcare

This case serves as a flashpoint for broader healthcare issues in India, where the cost of patented medicines remains a major barrier to treatment. It puts a spotlight on:

• The tension between innovation and access

• The potential role of Indian generic companies in improving affordability

• The need for judicial sensitivity towards patients' rights and public health priorities

With India being a global hub for affordable generics, the outcome of the Natco-Roche legal standoff could influence policies, pricing models, and access frameworks for a range of critical medications beyond SMA.

Conclusion

In summary, Natco Pharma’s announcement regarding its generic Risdiplam launch at ₹15,900, pending a favourable court verdict, is a game-changer in rare disease treatment in India. The case’s legal, ethical, and social implications extend far beyond one drug, tapping into the very heart of India’s ongoing healthcare evolution.

The public, investors, patients, and policymakers now keenly await the Delhi High Court’s decision, which could reshape access to life-saving medicines in India — and possibly, beyond.

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