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Informist, Wednesday, Mar. 26, 2025

 

--HC to Natco Pharma: Maintain status quo in launching Risdiplam till Apr 2 

--CONTEXT: HC rejected Roche's plea vs Natco Pharma on Risdiplam patent 

--Two-judge HC bench to hear Roche's injunction plea vs Natco Pharma Apr 2 

 

 

NEW DELHI – The division bench of the Delhi High Court on Wednesday asked Natco Pharma Ltd. to maintain a status quo and not launch till Apr. 2 Risdiplam, an oral prescription medicine used for the treatment of spinal muscular atrophy in patients two months of age or older. The court said that it will hear on Apr. 2 for final hearing F. Hoffmann-La Roche AG's appeal against a single judge order that had refused to stop Natco Pharma from manufacturing Risdiplam in India for the rare disease.

 

On Monday, Justice Mini Pushkarna had rejected a plea by F. Hoffmann-La Roche AG and others seeking 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 (Risdiplam). 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 have to 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.

 

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 Risdiplam API, said the plaintiffs. Moreover, Natco Phrama 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 manufacturing of Risdiplam, said F. Hoffmann-La Roche.

 

At 1135 IST, shares of Natco Pharma traded 0.1% higher at INR 826.00 on the National Stock Exchange.  End

 

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

 

Reported by Surya Tripathi

Edited by Akul Nishant Akhoury

 

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