Setback to Roche: Plea Against Natco on Risdiplam Patent Rejected by Delhi HC

Justice Mini Pushkarna ruled that public interest in affordable treatment outweighs corporate profits, particularly when the drug is the only available treatment for a rare disease in India. The court held;

"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 can be compensated by way of damages. However, there exists no right for the public to lessen or compensate itself.”

Background on Spinal Muscular Atrophy and Risdiplam

SMA is a severe neuromuscular disorder that causes motor neuron degeneration, leading to progressive muscle weakness. It is the leading genetic cause of infant mortality, affecting approximately one in 10,000 live births worldwide and one in 7,744 live births in India.

Until recent advancements, SMA treatment was limited to supportive care. However, Evrysdi (Risdiplam), developed by Roche, became a major breakthrough as the first oral therapy for SMA. Roche launched Evrysdi in India in July 2021, but its high cost remains a significant barrier. The annual treatment cost ranges between Rs 2.2 million to Rs 7.2 million, depending on patient weight and dosage.

With the unaffordability of the treatment, many families have turned to legal petitions seeking assistance for their children's treatment.

Patent Dispute Between Roche and Natco

Roche alleged that Natco Pharma was preparing to commercially manufacture Risdiplam, violating its Indian patent, valid until 2035.

Natco challenged the patent’s validity, arguing that Roche’s original international patent already covered the drug. The company contended that Roche was engaging in "evergreening" by filing a new patent specifically in India to extend its monopoly, despite not initially filing the broader patent.

The Delhi High Court found merit in Natco’s argument, stating that Roche’s patent could be invalidated under various grounds, including:

Anticipation by prior publication (Section 64(1)(e)),

Obviousness (Section 64(1)(f)), and

Misrepresentation (Section 64(1)(j)).

The Court noted that Risdiplam was implicitly covered under Roche’s previous international patent, a fact evident from Roche’s admissions in US, Australian, and Canadian patent filings.

Public Interest Consideration and Patent Injunctions

Justice Pushkarna underscored the importance of public interest in deciding whether an injunction should be granted. Citing Justice Prathiba M Singh's book on Patent Law, the Court reiterated that:

"At the interim stage, the impact of an injunction if granted on the public would also be considered by the Court. In addition to the three conditions for grant of injunctions, a fourth factor, i.e., public interest, has also been applied in few patent cases."

The court referenced past Delhi High Court rulings, where injunctions were denied for life-saving cancer drugs due to high pricing and limited access.

Justice Pushkarna stated:

“The approved drug, i.e., Risdiplam, which is marketed under the name Evrysdi, is not available at reasonably affordable prices in India. Thus, 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.”

Since SMA has no cure, and Risdiplam (Evrysdi) is the only approved treatment in India, the court ruled that denying an injunction would ensure wider access to treatment, while Roche could still seek damages if it eventually won the case.

The Court concluded:

“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 can be compensated by way of damages. However, there exists no right for the public to lessen or compensate itself.”

To view the original order, click on the link below: