Below is a short note on good news on a court case in India concerning access to risdiplam, a treatment for spinal muscular atrophy (SMA). The note is followed by a statement on the case by Third World Network (TWN), followed by links to news media coverage in India.
On 9 October 2025, the division bench of the Delhi High Court upheld a ruling allowing Indian company Natco to produce a generic version of risdiplam, rejecting Swiss drugmaker Roche’s patent infringement claim. The Court found credible grounds that Roche’s patent lacked novelty, reinforcing the Court’s earlier March 2025 decision. Legally, the ruling addressed Roche’s request for an injunction preventing Natco from making its generic version available in the India market.
The ruling clears the way for Natco’s generic risdiplam to enter the Indian market at an estimated 97% lower price than Roche’s product. Natco received approval for their generic risdiplam from the Drugs Controller General of India and has decided to launch the product with immediate effect at ₹15,900 MRP ($179 USD), consistent with the company’s stand before the Court. Natco also intends to offer some discounts to certain deserving patients through its patient access programme.
Roche may appeal the decision to the Supreme Court, a process could take time. In the meantime, this represents a significant victory for patients seeking affordable access to treatment.
In March 2025, The Single Judge (Justice Mini Pushkarna) of the Delhi High Court issued a detailed order denying Roche’s request for an interim injunction. Roche subsequently appealed the decision, and in April 2025, the Division Bench of the Delhi High Court began hearing the matter. During the appellate process, an application was filed on behalf of the respondents (Natco) and in the related matter of Ms Seba P.A. V. Roche, seeking to include research documents prepared by Knowledge Ecology International (KEI) to aid in the adjudication of the case. The first document presented data demonstrating the cost of trials used to support the initial FDA approval of risdiplam, while the second outlined the timeline of risdiplam’s development.
2025:1 KEI Research Note: Timeline: Development of Risdiplam
Prior to the Delhi High Court’s October 9, 2025, decision, patient groups, supported by Third World Network (TWN) and the Lawyers Collective made submissions to the court the related case Seba P.A V. Roche, and also conducted a social media and public relations campaign that focused on the access challenges of the patients, and included KEI’s research on the R&D related to the development of risdiplam (see https://www.instagram.com/reel/DN7HcDTDew9/) and previous unsuccessful efforts to obtain voluntary licenses (https://www.keionline.org/37955).
We will continue to follow developments closely and share updates.
TWN Statement (9 October 2025)
Indian Court rules against Roche and allows generic SMA drug
Patients living with spinal muscular atrophy (SMA) have waged a two-year legal battle and may finally access a generic and affordable treatment for this rare disease, the Delhi High Court ruled. “We are deeply grateful to the judiciary for delivering a verdict that prioritizes life, compassion, and justice. This is a decision that will help save the lives of countless SMA patients like me and offer hope where it is needed most,” said 24-year-old Purva Mittal.
This Thursday (9 October), a Delhi High Court division bench upheld a previous Court decision issued last March against a stop-order Swiss company Roche had launched against Indian generic manufacturer NATCO for patent infringement of the drug risdiplam. The Court said there were legal grounds to believe that the patent could be revoked for not being new.
Third World Network (TWN) has been supporting SMA patients with their legal representations before the Indian Court. For Chetali Rao, scientific researcher with TWN, the Court’s decision sends a message to pharmaceutical companies. “Today’s decision underscores a simple truth, evergreening is not innovation. When patents on life saving drugs are allowed to be evergreened through minor modifications to emulate a new invention when clearly there is none, it delays generic entry and keeps prices high forcing patients to unaffordable treatment,” she said.
The previous ruling in March also emphasized how the Court understood that making generic risdiplam available was intended to promote public health since risdiplam is the only drug for SMA in the Indian market and outweighed any harms Roche might have. Currently, in India, risdiplam costs $ 81,000 per year for an adult patient. Consequently, patients cannot access the medicine on their own and the government is also not able to offer enough for India’s over 5,000 patients currently living with SMA and 3,200 children born every year with the disease.
With the ruling, NATCO’s generic version could be available within a short time and it is estimated to cost $ 179 dollars per bottle, 97% of Roche’s $ 6,982 price. “This is indeed a huge relief for me and my friends with SMA. The government will certainly be able to purchase and provide the medicine to patients for several years using the 5 million Indian rupees under the National Policy for Rare Diseases fund,” said 26-year-old patient Seba P.A..
As of October 2024, only 168 patients in India were able to access risdiplam through the Indian government’s and Roche’s charity programs. Children accessing risdiplam from a young age will be able to stop the disease’s progression and lead normal lives and adults with risdiplam can have a better quality of life and ease the disease’s debilitating symptoms.
Going forward, Roche has vowed to seek legal options against the ruling, which might take the case to the Supreme Court. The ruling could have larger implications, though. For TWN’s senior researcher, K.M. Gopakumar, other countries should seize this opportunity and promote access for the many SMA patients around the world. “They can source generic risdiplam from India if risdiplam’s patents are not valid in their countries or consider issuing a compulsory license,” he said.
Media Coverage (as of 9 October 2025)
There are some reports on the High Court decision in the India press from October 9.
NATCO wins legal battle to launch generic drug treating severe muscle disorder in infants
CNBC TV18
https://www.cnbctv18.com/market/natco-pharma-share-price-wins-legal-battle-to-launch-generic-drug-treating-severe-muscle-disorder-in-infants-19709867.html
Delhi HC dismisses Roche plea, allows Natco to sell generic Risdiplam – Business Standard
Business Standard
https://www.business-standard.com/companies/news/delhi-hc-dismisses-roche-plea-natco-can-keep-selling-generic-risdiplam-125100901357_1.html
Delhi HC allows Natco Pharma to sell generic Risdiplam, rejects Roche plea – Mint
Mint
https://www.livemint.com/companies/news/natco-pharma-vs-roche-evrysdi-genric-risdiplam-sma-spinal-muscular-atrophy-11760003764054.html
Delhi HC allows Natco Pharma to launch risdiplam, rejects Roche plea
The Economic Times
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/delhi-hc-allows-natco-pharma-to-launch-risdiplam-rejects-roche-plea/articleshow/124424884.cms
Natco Pharma to launch generic of SMA drug Risdiplam with Delhi HC ruling on Roche’s appeal
The Hindu
https://www.thehindu.com/business/natco-pharma-to-launch-generic-of-sma-drug-risdiplam-with-delhi-hc-ruling-on-roches-appeal/article70145029.ece
Roche faces setback as Delhi high court clears Natco Pharma’s low cost generic Risdiplam
TradingView
https://www.tradingview.com/news/moneycontrol:2bcf4b897094b:0-roche-faces-setback-as-delhi-high-court-clears-natco-pharma-s-low-cost-generic-risdiplam/
Delhi HC dismisses Roche appeal on rare diseases drug risdiplam, paves way for generics
The Hindu Business Line
https://www.thehindubusinessline.com/news/national/delhi-hc-dismisses-roche-appeal-on-rare-diseases-drug-risdiplam-paves-way-for-generics/article70144544.ece
Delhi High Court Allows Natco Pharma to Sell Generic Risdiplam, Dismisses Roche Plea
Outlook India
https://www.outlookindia.com/national/delhi-high-court-allows-natco-pharma-to-sell-generic-risdiplam-dismisses-roche-plea