Delhi HC tells Natco Pharma to pause launch of generic version of Risdiplam

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A division bench of the Delhi High Court on Wednesday asked Natco Pharma to pause the launch of its drug Risdiplam till April 2 amid a patent dispute with Swiss pharmaceutical giant F Hoffmann-La Roche AG (Roche).

 

Roche had appealed against a single judge order of March 24 that had refused to stop Natco Pharma from manufacturing a generic version of Risdiplam. Risdiplam is an oral medicine for the treatment of spinal muscular atrophy (SMA) in patients two months of age or older.

 

SMA is a rare, progressive, and genetic disease that affects the motor neurons in the spinal cord, causing muscle weakness and wasting.

 

Roche has a registered patent for Risdiplam, an active pharmaceutical ingredient in its worldwide commercial product under the brand name Evrysdi. It had sought an injunction against Natco Pharma to restrain infringement of its patent titled ‘compounds for treating spinal muscular atrophy’.

 

It alleged that Natco Pharma was planning to commercially manufacture Risdiplam and this would infringe Roche's patent for Risdiplam, set to expire in May 2035.

 

However, the single judge bench of Justice Mini Pushkarna on Monday rejected Roche's plea, saying public interest would outweigh the need for grant of injunction.

 

The annual treatment cost of SMA in India was expected to come down to just Rs 3,000 annually against the current Rs 22 lakh–72 lakh after the single judge verdict on Monday opened the door for domestic firm Natco Pharma to manufacture a generic version of Risdiplam.

 

While delivering the verdict, Justice Mini Pushkarna said, “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.”