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Informist, Friday, Oct. 17, 2025

 

--SC allows Natco Pharma to launch risdiplam drug, junks Roche's plea

 

By Surya Tripathi

 

NEW DELHI – The Supreme Court Friday upheld a Delhi High Court order allowing Natco Pharma Ltd. to launch the drug risdiplam in India and rejected a challenge by F. Hoffmann-La Roche. The apex court said it was not inclined to interfere with the high court's division bench order as it was only related to interim injunction. The top court asked the high court's single-judge bench to dispose of quickly F. Hoffmann-La Roche's permanent injunction plea against Natco Pharma on risdiplam drug.

 

Last week, the high court had lifted its earlier status quo order, wherein it had asked Natco Pharma not to launch the drug until its final ruling in the matter.

 

Thereafter, Natco Pharma, in an exchange filing, said it had decided to launch the product with immediate effect and price it at INR 15,900, consistent with the company's stand before the court. Natco Pharma said it also intends to offer some discount to certain deserving patients through its patient access programme. Risdiplam is an oral prescription medicine used in the treatment of spinal muscular atrophy in patients two months of age or older.

 

In March, a single-judge bench of Justice Mini Pushkarna of the high court had rejected a plea by F. Hoffmann-La Roche and others seeking an interim injunction against Natco Pharma to restrain infringement of the patent titled "compounds for treating spinal muscular atrophy". The patent, which is a "species patent" for the product risdiplam, relates to compounds which are survival motor neurons used in the treatment of spinal muscular atrophy. The patent is registered in the name of F. Hoffmann-La Roche AG.

 

Risdiplam is the active pharmaceutical ingredient in F. Hoffmann-La Roche's commercial product, which is marketed in various countries, including India, under the brand name Evrysdi. Justice Pushkarna had ruled that if a party is able to manufacture the drug and make it available at an affordable price, in such a case, the public interest would outweigh the need for grant of injunction. "A drug which is the only one available for treatment in India, for a rare disease, its availability to the public at large at very economical and competitive prices is a material factor which a court will consider at the time of dealing with an application for interim injunction," Justice Pushkarna had said. After no relief from the single judge, F. Hoffmann-La Roche had moved the division bench of the high court, which also rejected its petition last week.

 

F. Hoffmann-La Roche had come across the listing of risdiplam on Natco Pharma's website under the "APIs under development" section. Further investigation revealed that the defendant was preparing for commercial production of the risdiplam active pharmaceutical ingredient, said the plaintiffs. Moreover, Natco Pharma was found to have filed a patent application in September 2022 under the title, "Improved Process for the Preparation of Risdiplam and its Intermediates" for the manufacture of risdiplam, said F. Hoffmann-La Roche.  

 

At 1217 IST, the shares of Natco Pharma were up 1.4% at INR 833 on the National Stock Exchange.  End

 

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

 

Edited by Vandana Hingorani

 

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