Indian company can now make Spinal Muscular Atrophy drug, High Court cites public interest

Noting that SMA is a debilitating disease which has no cure, and the only approved drug, Risdiplam, marketed under the name ‘Evrysdi’, is not available at affordable prices in India, Justice Mini Pushkarna held, “…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 have to 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. Besides, the plaintiffs (Roche) can be compensated by way of damages. However, there exists no right for the public to lessen or compensate itself,” Justice Pushkarna noted.

Roche alleged that Natco Pharma was preparing to commercially manufacture the Risdiplam Active Pharmaceutical Ingredient (API), infringing its patent, expiring in May 2035.

Justice Pushkarna, while refusing to grant an injunction against Natco, said, “Clearly, the plaintiffs’ intention is to monetise the drug…”

“…The costs involved for the drug in question, as per the requirement of the patients for treatment of SMA, are much larger, as compared to the aid provided under the aforesaid National Policy for Rare Diseases…the Government of India itself has expressed concern about the financial burden in respect of providing economic/financial aid for supply of the drugs for rare diseases to the patients suffering from such rare diseases,” the order said.

The order also noted that the ‘Patient Assistance Program‘ of the plaintiffs does not resolve the issue of accessibility of the drug.

“…Even if the plaintiffs provide the drug in question at their proposed price, as indicated to this court in a sealed cover, even then, the same would not be a viable proposition in economic terms for the patients suffering from SMA… In contrast, the proposal of the defendant, would bring to effect price reduction to the drug in its entirety, which would for reasons that are apparent, be applicable to all patients suffering from SMA…,” the order further stated.

Roche had argued that NATCO’s only motive is to make profits, and that the larger public interest demands protection of patents, especially in cases of drugs for rare diseases.

In October last year, a division bench of the Delhi HC had flagged the exorbitant prices, noting that for rare disease drugs “the medicines are patented in India, not manufactured in India, not properly distributed in India and they are exorbitantly priced and outside price control. The position cannot continue in this manner especially when so many patients are suffering…”