“Availability of Drug for Rare Disease at Economical Price a Material Factor”: Delhi High Court Declines Interim Injunction in Patent Suit Over Risdiplam
Kiran Raj
The Delhi High Court declined to grant interim injunctive relief in a patent dispute concerning the pharmaceutical compound Risdiplam, holding that the plaintiffs failed to demonstrate a prima facie case and that the balance of convenience and public interest weighed against an injunction. The Court stated that “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.”
The Single Bench of Justice Mini Pushkarna found that the defendant, NATCO Pharma Limited, had raised a credible challenge to the validity of the suit patent. The Court further held that damages would be an adequate remedy for the plaintiffs should they succeed at trial and directed the defendant to file asset disclosures and maintain detailed accounts of sales and manufacture.
The plaintiffs filed the suit alleging infringement of Indian Patent No. IN 334397 titled “Compounds for Treating Spinal Muscular Atrophy.” The patent covers Risdiplam, an oral medication used to treat SMA, a rare genetic neuromuscular disorder. The plaintiffs claimed that the defendant was preparing to manufacture and market Risdiplam, evidenced by the product’s listing on its website and the filing of a process patent application for its preparation.
The plaintiffs asserted that the compound is a novel chemical entity not disclosed in the earlier genus patent WO 2013/119916 (WO’916). They submitted that the patent was granted in over 60 jurisdictions without revocation and that WO’916 did not contain a specific disclosure of Risdiplam. The plaintiffs emphasized that the drug had been developed after extensive research and clinical trials, asserting “coverage is not the same as disclosure.” They stated that the product had been made available to the Indian Government at discounted rates and that a balance must be maintained between innovation and access.
In response, the defendant contended that the suit patent was invalid on multiple grounds under Sections 64(1)(d), (e), (f), (j), and (m) of the Patents Act, 1970. The defendant submitted that the compound was anticipated and obvious in light of prior art, particularly WO’916, and that the plaintiffs had earlier enforced the genus patent US 9,586,955 (US’955), corresponding to WO’916, against them in the United States. It was argued that “if the genus patent can be enforced for infringement of the same product, then it equally anticipates the species patent.”
The defendant further contended that the plaintiffs’ pricing made the drug unaffordable and that its own version would be priced nearly 90% lower. The plaintiffs were also alleged to have failed to work the patent in India, relying solely on imports.
Two SMA patients were permitted to address the Court. One stated that the annual cost of treatment under the plaintiffs’ product was approximately ₹1.48 crore and unaffordable despite existing government schemes. Another, whose treatment under the ₹50 lakh National Rare Disease Policy cap was nearly exhausted, submitted that local manufacture by the defendant would dramatically improve accessibility. It was argued that public interest required refusal of any injunctive relief.
The Court considered the statutory framework under the Patents Act, including Section 2(1)(l) which defines “new invention,” and held that India follows the principle of absolute novelty. It observed that prior art, whether domestic or international, could anticipate a patent.
Quoting the Supreme Court in Novartis AG v. Union of India (2013) 6 SCC 1, the Court stated: “To say that the coverage in a patent might go much beyond the disclosure seems to negate the fundamental rule underlying the grant of patents.” It also referred to Bayer Healthcare LLC v. NATCO Pharma Ltd. and Schering Corp. v. Geneva Pharmaceuticals to hold that disclosure could be implicit or inherent.
The Court examined the plaintiffs’ own pleadings and noted their admission that Risdiplam belongs to the class of compounds covered by WO’916. It further observed that the plaintiffs had enforced the US genus patent (US’955) against the defendant in parallel litigation, thereby acknowledging that Risdiplam was disclosed therein. The Court held that “the plaintiffs, on account of this fact, cannot as per convenience, agitate their claims in different jurisdictions... and thereafter assert non-disclosure of Risdiplam.”
The Court referred to a December 2024 order of the Supreme Court, which noted the Union Government’s concern over the financial burden of subsidizing treatment for rare diseases. The apex court directed the Government to comply with a Ministry notification and stated:
“There will be stay of operation of the impugned judgment, subject to the petitioner, Union of India, complying with the aforesaid notification and also issuing directions for payment on a case-to-case basis, wherever it is required.”
The Court also recorded that in Union of India v. Seba P.A. (SLP (C) 4684/2025), the Supreme Court directed the Government to liaise with pharmaceutical companies to explore economical options for SMA treatment.
In view of these developments and the price disparity between the plaintiffs’ and defendant’s product, the Court held: “It cannot be stated that balance of convenience for grant of injunction lies in favour of the plaintiffs.”
On irreparable injury, the Court found that the plaintiffs were importing the drug and seeking to monetize the invention. It stated that:
“At the end of the trial, if they were to succeed, they could be granted damages, if proved, under the law.”
Relying on Astrazeneca AB v. Intas Pharmaceuticals Ltd. and Bayer Healthcare LLC v. NATCO Pharma Ltd., the Court stated that when damages are an adequate remedy and credible challenge exists, injunctive relief is unwarranted, particularly in pharmaceutical cases involving life-saving drugs. It recorded that “the plaintiffs can clearly be compensated in damages if they were to succeed at the end of trial.”
Citing legal commentary from Prathiba M. Singh on Patent Law, the Court held that public interest is a recognized factor in assessing interim relief in patent cases. Referring to F. Hoffmann-La Roche Ltd. v. Cipla Ltd., the Court stated:
“In a country like India where question of general public access to life saving drugs assumes great significance, the adverse impact on such access which the grant of injunction... is likely to have, would have to be accounted for.”
The Court observed that Risdiplam was not locally manufactured by the plaintiffs and that its high cost rendered it inaccessible to most patients. It held:
“In relation to pharmaceuticals, which not just borders on the public good, but brings about the foremost good of the public, i.e., health, is not something that should be dealt with lightly.”
The Court concluded that interim relief could not be granted and issued the following directions:
“The defendant shall file its list of assets, encumbered and unencumbered, along with its market value, before this Court within a period of four weeks.”
“The defendant shall maintain complete accounts of the manufacture, sale and supply of the products. The defendant shall file statements of accounts before this Court on quarterly basis, duly supported by affidavit.”
“The defendant shall also file the annual statements of sales of their products, duly authenticated by its auditor.”
The application for interim injunction was dismissed.
“CS(COMM) 567/2024 – List before the Joint Registrar (Judicial) on 21st April, 2025.”
Advocates Representing the Parties
For the Petitioners: Mr. Pravin Anand, Ms. Shrawan Chopra, Ms. Prachi Agarwal, Mr. Devinder Rawat, Mr. Achyut Tewari, Mr. Aayush Maheshwari, Ms. Elisha Sinha, Ms. Krisha Baweja, Mr. N. Mahabir, and Ms. Archana Shanker, Advocates
For the Respondents: Mr. J. Sai Deepak, Senior Advocate with Mr. Afzal B. Khan, Mr. Samik Mukherjee, Ms. Amrita Majumdar, Mr. Dominic Alvares, Mr. Avinash Kr. Sharma, and Mr. Sharad Besoya, Advocates
Case Title: F. Hoffmann-La Roche AG & Anr. v. Natco Pharma Limited
Neutral Citation: 2025:DHC:1615
Case Number: CS(COMM) 567/2024
Bench: Justice Mini Pushkarna
[Read/Download order]
