Delhi High Court allows Natco to make Roche's spinal muscular atrophy drug in public interest

The Delhi High Court on Monday dismissed an interim injunction application filed by Swiss pharmaceutical giant F Hoffmann-La Roche AG against Indian drugmaker Natco Pharma Limited alleging that the latter company was unauthorisedly manufacturing its drug Risdiplam, an oral medicine for Spinal Muscular Atrophy (SMA). .In what could be a significant ruling, the Court has held that the public good outweighs the profits of a company, considering that the drug is not available at an affordable price in India. .Justice Mini Pushkarna 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.”.SMA is a severe, progressive neuromuscular disorder that leads to the degeneration of motor neurons, resulting in muscle weakness and atrophy. It is the leading genetic cause of infant mortality, affecting approximately one in 10,000 live births globally and one in 7,744 live births in India. The disease is caused by mutations in the SMN1 gene, leading to a deficiency of the survival motor neuron (SMN) protein, which is crucial for the proper functioning of motor neurons.Until recent years, SMA management was limited to supportive care, but advancements in medical science have led to the development of disease-modifying therapies. Evrysdi (Risdiplam), developed by Roche, is a major breakthrough in SMA treatment as it is the first oral therapy for the disease. Roche introduced Evrysdi in India in July 2021, bringing hope to many SMA patients. However, the high cost remains a major barrier. A year’s supply of Evrysdi can range from ₹2.2 million to ₹7.2 million, depending on the patient’s weight and dosage requirements.Many parents have approached various High Courts seeking assistance to treat their children for SMA. .Roche alleged that Natco Pharma was preparing to commercially manufacture Risdiplam, infringing its Indian patent, which expires in 2035. Natco challenged the validity of Roche's patent for Risdiplam, arguing that the drug was already covered in Roche’s earlier international patent and its corresponding US patent. Natco claimed that Roche was trying to extend its patent rights unfairly (evergreening) by obtaining a new patent for a specific version of the drug in India while avoiding filing the broader original patent there, which would have expired sooner..The Court found that Natco had raised a strong challenge to the validity of Roche’s patent for Risdiplam. It cited anticipation by prior publication [Section 64(1)(e)], obviousness [Section 64(1)(f)] and misrepresentation [Section 64(1)(j)] as key reasons. It noted that Risdiplam was implicitly covered in Roche’s earlier international patent, as proven by Roche’s own admissions in US, Australian and Canadian patent filings..Justice Pushkarna also emphasised the importance of public interest in deciding whether to grant an injunction. Referring to Justice Prathiba M Singh's book on Patent Law, the Court highlighted that at the interim stage, courts must consider the impact of an injunction on public access to essential medicines. Quoting the book, the Court said:"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 also referenced previous rulings where the Delhi High Court refused an injunction for a cancer drug due to high pricing and limited availability.“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.”Applying the same principle, the Court noted that SMA is a debilitating disease with no cure, and Risdiplam (Evrysdi) is the only approved drug for treatment in India.Finally, the Court concluded that denying an injunction would ensure wider access to treatment, while Roche could still be compensated through damages if it later won the case..Roche was represented by Advocates Pravin Anand, Archana Shanker, Shrawan Chopra, Prachi Agarwal, Devinder Rawat, Achyut Tewari, Aayush Maheshwari, Elisha Sinha, Krisha Baweja and N Mahabir from Anand & Anand. .Natco Pharma was represented by Senior Advocate J Sai Deepak with Advocates Afzal B Khan, Samik Mukherjee, Amrita Majumdar, Dominic Alvares, Avinash Sharma and Sharad Besoya from S Majumdar & Co. .[Read Judgment]