The bench led by Justice Hari Shankar vacated its March order that had asked Hyderabad-based Natco Pharma to maintain status quo on launching the generic version of Risdiplam, an oral medicine for spinal muscular atrophy (SMA) in patients two months of age or older.
The order had come on an appeal by Roche against a single judge order that had refused to stop Natco Pharma from manufacturing Risdiplam in India.
Roche has a registered patent, which is a “species patent” for Risdiplam, an active pharmaceutical ingredient in the Swiss multinational’s commercial product marketed worldwide, including India, under the brand name Evrysdi.
Roche currently imports and sells the prescription medicine in India at a maximum retail price of about Rs 6 lakh per bottle containing 750 microgram/mL of Risdiplam, people said.
Natco Pharma, in its exchange filing, said it had decided to launch the product with immediate effect and price it at Rs 15,900, consistent with the company’s stand before the court that it will manufacture the drug locally and make it available at nearly 80-90% less price than Roche.Natco Pharma further said that it also intends to offer some discount to certain deserving patients through its patient access programme.Meanwhile, Roche Pharma India spokesperson on Thursday said they were “disheartened with this development and were considering their options within the scope of the Indian law. Roche is committed to protecting its innovation.”
“IP protection is a cornerstone for any pharmaceutical innovation. We believe that strong IP protection, including patents, is essential for innovation to thrive in India, drive access to innovative treatments that address the healthcare challenges we face today, and a critical lever for Viksit Bharat,” the spokesperson said in a press statement.
According to Roche, since the launch of Evrysdi®? in 2021 (the first drug for SMA in India), it has been actively collaborating with local authorities in India to implement tailored pricing solutions to ensure long-term equitable access. “In 2020, Roche initiated a Compassionate Use Program (CUP) for SMA patients under which 52 patients across India are benefitting free of cost,” the statement said, adding that about 300 SMA patients have benefitted from Evrysdi in India since its launch.
In March, 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 judge held that she was not inclined to accept Roche’s plea. “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,” she said.
However, the court said Roche can be compensated in damages if it succeeds in the trial.
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