A leading expert on patents and intellectual property rights told ET that in India, Roche had not filed for a patent that covered the broad product claims (#9586955) while its existing patent (#9969754) covered only the specific compound patent for the drug. “Due to this peculiar error, Natco could get a favourable decision from the court,” the expert told ET, asking not to be named.
The court’s decision paves the way for Natco to launch the generic versions of Evrysdi, which is used to treat spinal muscular atrophy (SMA-1) at a significantly lower price of ₹15,900 per bottle against the label price of roughly ₹6 lakh charged by Roche. Roche’s drug was available at heavy discounts for the needy patients, but the costs were still prohibitively high.
Depending on the age and weight, a patient needs two bottles of the drug every month. The debilitating condition that affects children progressively weakens the muscles and leads to issues like breathing distress, difficulty in swallowing and normal movement. Using risdiplam stops the condition from worsening, resulting in a longer life for patients.
Natco said it has decided to launch the product with immediate effect and price the product at ₹15,900 consistent with the company’s stand before the court. The company also intends to offer some discount to certain deserving patients through its patient access programme.Natco added Roche’s appeal was refused and the status quo has been removed. In March, the same court had denied an appeal from Roche but an appellate bench had ordered a status quo till further arguments on the case were heard.”Currently, there are no curative treatment options for SMA and most of the available options are not financially feasible for Indian patients. The single judge had factored the challenge of invalidity of Roche’s patent and laid special emphasis on the public interest, considering the Swiss company’s pricing had rendered the drug inaccessible and unaffordable to the bulk of its patients,” Natco added.
In a separate statement, the Working Group on Access to Medicines and Treatment, a patient advocacy group, said the judgment marks a significant step towards access to affordable treatment for SMA in India.
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