Delhi High Court: Availability Of Only One Drug Available For Treatment Of Rare Disease For Public At Economical Prices A Material Factor For Interim Injunction
The Delhi High Court emphasised that if a party can 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 the grant of injunction.
The Delhi High Court held that an availability of a drug which is the only one available for treatment of a rare disease for public at very economical prices, is a material factor while dealing with an Application for Interim Injunction.
The Court held thus in a Suit filed against a pharma company namely NATCO Pharma Limited, alleging infringement of patent and seeking interim injunction for restraining the infringement of the Suit Patent titled “COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY”.
A Single Bench of Justice Mini Pushkarna observed, “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. 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.”
The Bench emphasised that 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 the grant of injunction.
Advocate Pravin Anand represented the Plaintiffs while Senior Advocate J. Sai Deepak represented the Defendant.
Background
The Suit Patent which was a ‘Species Patent’ for the product ‘Risdiplam’, was related to compounds which are Survival Motor Neuron 2 (SMN2) used in the treatment of Spinal Muscular Atrophy (SMA). The Suit Patent was registered in the name of the Plaintiffs and it had a term of 20 years from May 11, 2015 which was to expire on May 11, 2035. There was no pre-grant opposition, post-grant opposition, or any revocation proceedings filed against the Suit Patent in India. The corresponding patents to the same were granted in about 60 countries worldwide. The Suit Patent claims a compound having an International Non-Proprietary Name (INN), ‘Risdiplam’, assigned by the World Health Organization (WHO), in the year 2018. Risdiplam is the Active Pharmaceutical Ingredient (API) in the Plaintiffs’ commercial product, which is marketed in various countries worldwide, including, India, under the brand name, ‘EVRYSDI®’. Risdiplam is an oral prescription medicine indicated for the treatment of SMA in patients two months of age or older. SMA is a rare genetic neuromuscular disorder caused by the mutation of the Survival Motor Neuron 1 (SMN1) gene, leading to a deficiency of SMN protein, which affects motor nerve cells, diminishing the ability to walk, sit, eat, and breathe.
Dispute
The Plaintiffs came across the listing of Risdiplam on the Defendant’s website under the “APIs under development” section. Further investigation revealed that the Defendant was preparing for commercial production of Risdiplam API. Moreover, the Defendant was found to have filed a Patent Application in September, 2022 under the title “Improved Process for the Preparation of Risdiplam and its Intermediates” for manufacturing of Risdiplam. Thus, the Suit was filed by the Plaintiffs alleging infringement by the Defendant of their patent rights.
Court’s Observations
The High Court in view of the above facts, noted, “The plaintiffs are currently importing the drug in India, on account of which, the cost of the drug is highly exorbitant. Clearly, the plaintiffs‟ intention is to monetize the drug. Therefore, the plaintiffs can clearly be compensated in damages, if they were to succeed at the end of trial.”
The Court reiterated that the Plaintiffs can be appropriately compensated by way of damages if their case is proved after trial and public interest would also demand that injunction be refused if there is a huge disparity between the price offered by the Plaintiffs and the Defendants.
“… it is held that no prejudice shall be caused to the plaintiffs, as the plaintiffs can be compensated by damages, as discussed hereinabove. … In the book titled as ‘Prathiba M. Singh on Patent Law’, in Chapter 13, it has been clearly elucidated that at the interim stage, the impact of an injunction, if granted, on the public would also be considered by the Court”, it added.
The Court said that the spirit of considering public interest while granting injunction is reflected in the jurisprudence that has developed in the country in this regard.
“This Court also takes note of the submissions made on behalf of the interveners, wherein, it has been brought forth that SMA is a debilitating disease and there is no cure for the same. The approved drug, i.e., Risdiplam, which is marketed under the name Evrysdi, is not available at reasonably affordable prices in India”, it further noted.
The Court, therefore, held that the Defendant has prima facie raised a credible challenge to the validity of the Suit Patent.
“Thus, this Court is not inclined to grant any injunction in favour of the plaintiffs and against the defendant. Besides, the plaintiffs can be compensated in damages, as held in the preceding paragraphs. Further, balance of convenience is also against the plaintiffs and is in favour of the defendant”, it also held.
The Court clarified that in case the Plaintiffs ultimately succeed in the trial, the Defendant shall be liable to pay damages to the Plaintiffs and for this purpose, the Defendant shall file its list of assets, encumbered and unencumbered, along with its market value, before the High 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”, it further directed.
Accordingly, the High Court dismissed the Application and declined to grant any injunction in favour of the Plaintiffs.
Cause Title- F. Hoffmann-LA Roche AG & Anr. v. NATCO Pharma Limited (Neutral Citation: 2025:DHC:1907)
Appearance:
Plaintiffs: Advocates Pravin Anand, Shrawan Chopra, Prachi Agarwal, Devinder Rawat, Achyut Tewari, Aayush Maheshwari, Elisha Sinha, Krisha Baweja, N. Mahabir, and Archana Shanker.
Defendant: Senior Advocate J. Sai Deepak, Advocates Afzal B. Khan, Samik Mukherjee, Amrita Majumdar, Dominic Alvares, Avinash Kr. Sharma, and Sharad Besoya.
