Delhi HC restrains Natco Pharma from launching generic of Roche's rare disease drug

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A two-judge bench of Delhi High Court on Wednesday refrained Natco Pharma from launching the generic version of Swiss drugmaker Roche Pharma's patented drug Risdiplam until the hearing on April 2.

Risdiplam used in treatment of Spinal Muscular Atrophy (SMA), a rare-genetic disease, that causes muscle weakness and atrophy, due to damage to nerve cells in the spinal cord, leading to difficulty with basic functions like walking, breathing, and swallowing.

A single judge of Delhi High Court had earlier denied an injunction request from Roche on March 24, in an alleged patent infringement case against Natco Pharma, potentially opening the door for access to a generic of the patented drug Risdiplam at a fraction of the marketed cost.

An injunction is an order issued by a court, to a party, requiring them to either perform or abstain from a specific act.

Roche has filed an appeal against the Delhi High Court order that allows Natco Pharma to go ahead with the launch of the copycat version, at a fraction of the cost.

Roche Pharma India has confirmed the stay on the Natco Pharma's launch.

"Roche has filed an appeal against the Hon. Delhi High Court order and the matter is subjudice in the appeal court," Roche Pharma India spokesperson told Moneycontrol.

“Roche is committed to protecting its innovation," the spokesperson added.

Roche Pharma said since the launch of Evrysdi (risdiplam) - the first and still the only approved solution for SMA in 2021 , the company has been actively collaborating with local authorities in India to implement tailored pricing.

Roche had moved the court seeking interim injunction for restraining the infringement of the Suit Patent No. IN 334397, arguing that it has a term of 20 years from May 2015 till May 2035. It said there has been no pre-grant or post-grant opposition, or any revocation proceedings filed against the suit patent in India.

"We are also supporting patients through our patient assistance program which makes Evrysdi more affordable. Our commitment to patients in India began well before it was commercially available. In 2020, Roche initiated a Compassionate Use Program (CUP) for SMA patients under which 52 patients across India are benefitting free of cost. Today we have over 270 SMA patients in India who have benefitted from Evrysdi since its launch in India," the company said.

Natco spokesperson couldn't be reached for the comment.

Seba PA and Purva Mittal, two young women battling SMA, had intervened in the case to highlight the urgent need for the court to consider their right to life in the matter, as well as the significant negative impact an injunction could have on access to the drug Risdiplam, given the price disparity between patented drug and its anticipated, low-cost generic.