The Supreme Court on Friday dismissed the petition filed by Swiss pharmaceutical giant F. Hoffmann-La Roche AG (Roche) seeking to restrain Hyderabad-based drugmaker Natco Pharma from manufacturing and selling generic drug of Risdiplam, a drug used to treat Spinal Muscular Atrophy (SMA).
A bench comprising Justice PS Narasimha and Justice Atul S Chandurkar declined to interfere with the Delhi High Court's order, observing that it was only an interim order. The bench also noted that both the single bench and the division bench of the High Court have entered concurrent findings and urged the (Delhi) High Court to dispose of the suit filed by Roche against Natco expeditiously.
A two-judge bench of Delhi High Court dismissed Roche’s plea for an injunction early this month, citing public interest and the need for affordable access to the drug, which currently retails at over Rs 600,000 per bottle under Roche’s brand name Evrysdi. Natco’s version is expected to cost just Rs 15,900 — a staggering 97% price cut.
The company also said it will offer further discounts on the drug to certain deserving patients through its patient access programme.
Natco in a statement to stock exchanges on Friday, said the apex court took note of the concurrent findings of the single judge as well as the division bench of the Delhi High Court in denying injunctions against NATCO Pharma.
"Having the benefit of the two successive orders, the Supreme Court was not convinced about the maintainability of the challenge by Roche and, therefore, dismissed the petition," Natco statement said.
"This marks the final challenge Roche could have posed at the interim stage in the suit, which shall now proceed for trial in accordance with the law," the statement added.
In the Supreme Court, Natco was represented by senior advocates Kapil Sibal, Gopal Subramanium and J. Sai Deepak and were instructed by S. Majumdar and Co and KMNP Law.
Spinal Muscular Atrophy (SMA) is one of the leading causes of death in infants related to the degeneration of neurons. Currently, there are no curative treatment options for SMA, and most of the available options are not financially feasible for Indian patients. This ruling would bring some hope to the countless lives that have been debilitated by an ailment like SMA.
Roche in a statement said it was extremely disappointed with the Supreme Court’s decision to dismiss plea concerning the Risdiplam preliminary injunction.
"Strong IP protection, including patents, is the cornerstone for any innovation to thrive and address critical healthcare challenges," Roche statement said.
"For India to truly emerge as a global life science innovation hub, it must protect and enforce the integrity of IP. This is crucial to build an ecosystem like other developed nations, that rewards discovery & development while ensuring sustainable access to clinically validated treatment options for its people," the statement added.
Roche said that it is fully committed to protecting its innovations.
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