Delhi HC Clears Natco Pharma to Launch Low-Cost Risdiplam

“Delhi High Court Clears Natco Pharma to Launch Low-Cost Risdiplam, Rejects Roche’s Plea

Patent fight over rare disease drug raises questions on access and innovation

Families of SMA patients hope for cheaper treatment as case unfolds

By Our Legal Reporter

New Delhi: October 10, 2025:

A major legal battle is unfolding in India between Natco Pharma, a Hyderabad-based generic drug maker, and Roche, the Swiss multinational pharmaceutical giant. At the heart of the dispute is Risdiplam, a life-saving oral drug used to treat Spinal Muscular Atrophy (SMA), a rare genetic disorder that weakens muscles and affects movement.

The case is being closely watched not only by the pharmaceutical industry but also by thousands of families of SMA patients in India, who are hoping that the outcome will make treatment more affordable.

What is Spinal Muscular Atrophy (SMA)?

SMA is a rare genetic disease that affects about 1 in 10,000 live births worldwide.
It causes progressive muscle weakness, difficulty in movement, and in severe cases, breathing problems.
Without treatment, many children with SMA do not survive beyond early childhood.

Until recently, treatment options were extremely limited and prohibitively expensive. Drugs like Spinraza (Biogen) and Zolgensma (Novartis) cost crores of rupees, making them inaccessible for most Indian families.

Roche’s Evrysdi (Risdiplam)

Roche launched Evrysdi, the brand name for Risdiplam, as the first oral treatment for SMA. Unlike injections or gene therapy, Evrysdi can be taken at home in liquid form, making it easier for patients and caregivers.

Approved by the US FDA in 2020 and later in India.
Price in India: around ₹6–7 lakh per month, depending on dosage.
For many families, this cost is still far beyond reach.

Natco Pharma’s Move

Natco Pharma, known for producing affordable generic versions of expensive drugs, has applied to launch a generic version of Risdiplam in India.

Natco argues that Roche’s patent on Risdiplam is weak and not innovative enough to block generic competition.
The company has filed a pre-grant opposition at the Indian Patent Office, challenging Roche’s claims.
If Natco succeeds, it could launch a much cheaper version, possibly reducing the cost by 70–80%.

Roche’s Stand

Roche has strongly opposed Natco’s move, saying that:

Risdiplam is a novel innovation developed after years of research.
Patent protection is necessary to recover R&D investments and encourage future innovation.
Allowing generics too early could discourage global pharma companies from bringing new drugs to India.

Why This Case Matters

This is not just a corporate battle—it has direct consequences for patients.

India has an estimated 8,000–10,000 SMA patients, many of them children.
Most families cannot afford Roche’s Evrysdi.
A generic version could bring the price down to a few thousand rupees per month, making treatment accessible to many more patients.

The case also highlights the tension between intellectual property rights and public health needs. India has a history of allowing generic competition in life-saving drugs, especially in HIV/AIDS and cancer treatments.

Legal and Policy Context

India’s Patent Act allows challenges to patents that are not considered truly innovative.
Section 3(d) of the Act prevents patents on minor modifications of existing drugs.
In the past, Indian courts have ruled against big pharma companies, such as in the Novartis Glivec case (2013), where the Supreme Court denied a patent extension.

This case could set another important precedent for how India balances innovation vs. access.

Global Angle

The outcome in India could influence other developing countries. If Natco succeeds, it may encourage generic makers in other markets to challenge Roche’s patents.

At the same time, global pharma companies are watching closely, as India is a key market for both innovation and generics.

Patient Voices

Families of SMA patients have been vocal in demanding affordable treatment. Many have turned to crowdfunding platforms to raise money for Evrysdi or Zolgensma.

Parents argue that life-saving drugs should not be priced beyond reach.
Patient advocacy groups are urging the government to intervene and ensure access.

What Happens Next

The Indian Patent Office will decide whether Roche’s patent on Risdiplam is valid. Possible outcomes:

If Roche wins: Natco cannot launch its generic, and Evrysdi remains the only option. Prices may remain high.
If Natco wins: A generic version could be launched, drastically reducing costs and improving access.
Middle ground: Compulsory licensing or price negotiations could be explored.

Wider Implications for Pharma Industry

For Roche: Losing the case could mean losing a major revenue stream in India.
For Natco: A win would strengthen its reputation as a champion of affordable medicines.
For India: The decision will shape its image as a country that balances innovation with public health needs.

Conclusion

The Natco vs Roche battle over Risdiplam is more than a patent dispute—it is a fight over who gets to live and at what cost. For families of SMA patients, the hope is simple: that life-saving treatment becomes affordable and accessible.

As the case progresses, it will test India’s ability to uphold both intellectual property rights and the right to health. The outcome could change the future of rare disease treatment in the country.