The court noted that the Roche’s approved drug Risdiplam, which is marketed under the name ‘Evrysdi,’ is not available at an affordable prices, thus the public interest would be to outweigh the need for grant of injunction (restraint order).
Roche had sought interim injunction against Natco Pharma to restrain infringement of its patent titled “compounds for treating spinal muscular atrophy”. The multinational company claimed that its suit patent has a term of 20 years from May 11, 2015 and expires on May 11, 2035.
Stating that the court is not inclined to grant any injunction in favour of Roche, Justice Mini Pushkarna in her interim order held that Natco Pharma “has prima facie raised a credible challenge to the validity of the suit patent,” thus it is not inclined to accept Roche’s plea Justice. Further, balance of convenience is also against the plaintiffs and is in favour of the defendant, she added.
However, the court said that Roche can be compensated in damages. “Nonetheless, it is clarified that in case the plaintiffs (Roche) ultimately succeed in the trial, the defendant (Natco) shall be liable to pay damages to the plaintiffs. For this purpose, Natco shall file its list of assets, encumbered and unencumbered, along with its market value, before this court within four weeks, the judge said.
The Hyderabad-based generic manufacturer was also directed to maintain complete accounts of the manufacture, sale and supply of the products and also file statements of accounts before the court on quarterly basis, duly supported by affidavit. Natco Pharma shall also file the annual statements of sales of their products, duly authenticated by its auditor, the court directed in its 95-page judgement.What also weighed on the judge’s mind is the submissions by a couple of patients suffering from the rare disease. They submitted that 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 multinational can be compensated by way of damages. However, there exists no right for the public to lessen or compensate itself.Roche’s registered patent, which is a “species patent” for the product ‘Risdiplam,’ relates to compounds which are survival motor neuron used in the treatment of spinal muscular atrophy. Risdiplam is the active pharmaceutical ingredient in the Swiss firm’s commercial product marketed worldwide, including India, under the brand name Evrysdi (risdiplam). Risdiplam is an oral prescription medicine indicated for the treatment of spinal muscular atrophy in patients two months of age or older.
Roche had come across the listing of Risdiplam on Natco Pharma’s website under the “APIs under development” section. Further investigation revealed that Natco was preparing for commercial prodsuction of Risdiplam API, it said. Moreover, the domestic pharma company 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, Roche told the court, while alleging infringement of its rights in the patent.
Natco argued that the Patents Act does not bestow presumptive validity on a patent, even if it has been granted pursuant to a failed pre-grant opposition, or even if it survives a post-grant opposition.
