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TWN Info Service
on Intellectual Property Issues (Oct25/02) 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 pay with delays and 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.
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