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Informist, Thursday, Oct. 9, 2025

 

--HC junks Roche's injunction plea, allows Natco Pharma to launch Risdiplam 

 

NEW DELHI – Rejecting F. Hoffmann-La Roche AG's injunction plea, a division bench of the Delhi High Court Friday allowed Natco Pharma Ltd. to launch the drug risdiplam in India. The court lifted its earlier status quo order, wherein it had asked Natco Pharma not to launch the drug until its final ruling in the matter. Risdiplam is an oral prescription medicine used in the treatment of spinal muscular atrophy in patients two months of age or older.

 

Natco Pharma, in its 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.

 

In March, 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.

 

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. Meanwhile, the petitioners’ Indian spokesperson Thursday said they were disheartened by the order and were considering their options within the scope of Indian law.

 

Thursday, shares of Natco Pharma ended 0.6% higher at INR 813.55 on the National Stock Exchange.  End

 

Reported by Surya Tripathi

Edited by Rajeev Pai

 

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