Risdiplam Litigation Chronology : F.Hoffmann-La Roche Ag & Anr. vs Natco Pharma Limited

Name of the case: F.Hoffmann-La Roche Ag & Anr. vs Natco Pharma Limited 

Citation : CS(COMM) 567/2024

Facts: 

The case concerns the alleged infringement of Patent No. IN 334397, plaintiffs(F.Hoffmann-La Roche AG, the swiss pharmaceutical company) seeking an interim injunction for restraining infringement of their patent, i.e., "titled Compounds for treating Spinal Muscular Atrophy (SMA)", the suit patent which IN" 397" is related to a Species Patent for the product, Risdiplam i.e. a compound associated with Survival Motor Neuron 2 in the treatment of SMA. The Plaintiff initiated the suit against the defendant (Natco Pharma Limited) in 2024, when the Plaintiff came across the listing of Risdiplam on the defendant's website and the patent application bearing no. 202241055182 in 2022 under the title "Improved process for the Preparation of Risdiplam and its Intermediates for manufacturing of Risdiplam. The Plaintiff filed the suit on the grounds of Novelty and Non-obviousness, due to Public Interest, they had offered discounted rates to the Government of India, and they had spent much money on R&D, especially for a rare disease like SMA, thus it argued that allowing generic entry would threaten the innovation ecosystem. The Plaintiff also rejected the notion of evergreening in the case, suggesting that evergreening does not apply to new compounds. Risdiplam is a new compound. Whereas, the defendant based its argument that Plaintiff resorted to evergreening and unlawful PTE in India by applying for a species patent instead of a Genus Counterpart to US "95/WO "916 [ WO - Patent application filed with World Intellectual Property Organisation]. Furthermore, the defendant pointed out that the Plaintiff's product is expensive for many people in India and its access is also limited, thus the defendant's patent would be a generic entry, which would serve public interest by reducing the cost, as it would be manufactured in India, unlike the Plaintiff.

Analysis of 24th March, 2025 Judgement by Hon’ble Ms. Justice Mini Pushikarna, Delhi High Court : 

The Hon’ble Justice analyzed the judgment in three criterias : i) prima facie case, ii) balance of convenience, iii) irreparable harm/damages and also public interest. Under the first criterion, the Court examined the defendant’s challenge to the validity of the suit patent under Sections 64(1)(e) and 64(1)(f) of the Patents Act, which provide for revocation if the claimed invention lacks novelty or inventive step in light of prior public knowledge or publication. The Court found that the defendant had raised a credible challenge on both counts, novelty and obviousness. Whereas the plaintiff had not produced sufficient evidence at the interim stage to firmly establish the patent’s validity. The Court, however, took note of the plaintiff’s argument that “coverage is not the same as disclosure”, meaning that a broad genus patent does not automatically anticipate or disclose a specific species compound.

In addition, the Court considered the defendant’s procedural objections under Sections 64(1)(m) and 64(1)(j), relating to alleged non-compliance with Section 8 (failure to disclose foreign filings) and false representation in obtaining the patent.

While analysing the relationship between the plaintiff’s international genus patent (WO’916) and the Indian species patent (IN’397), the Court observed that both covered compounds developed for the treatment of Spinal Muscular Atrophy (SMA). The defendant argued that the plaintiff was attempting to extend its monopoly by filing successive patents on similar compounds — an act amounting to evergreening. During the proceedings, it was also noted that the plaintiff had initiated litigation against the defendant in the United States on similar grounds, where the U.S. Court had ruled that the genus patent which is its own prior patent did not render the species patent (US '754) novel and it was obvious to persons skilled in the art, thus finding in favour of the defendant.

Drawing a parallel, the Delhi High Court held that the same reasoning applied here. The defendant’s argument that the species patent merely replicated elements of the genus patent and lacked novelty presented a substantial and credible challenge to its validity under Section 64. The plaintiff was unable to make out a prima facie case for the injunctions being asked in the application.

Therefore, leading to the second issue of balance of convenience, where the very first point noted by the court was the cost of the product. The defendant’s manufacturing of the drug in India would lead to a cut in the price to nearly 80-90%, which is a crucial factor. The plaintiff during the proceedings proposed price as a part of a patient Assistance program to National Rare Diseases Committee, which was formed under National Rare Diseases Policy. The court reasoned that the proposed price would only be beneficial for the patients enrolled in the Patient Assistance program, the remaining would be buying it for such a high price.  Whereas, the defendant's generic drug would reduce the price and cause relief to the patients. Thus the issue of Balance of convenience was decided in favour of the defendant.

Moving on to the third issue i.e., Irreparable Damage/Prejudice. Under this issue it was reasoned during the judgement that the cost of the drug is way too high as they are importing it to India, Therefore if they were to succeed the trial then the plaintiff would be compensated in the damages and no prejudice done to the plaintiff.

But there still stands the main critical point of Public Interest, it being a decisive factor in pharmaceutical patent injunction cases. The justice made the point that in case of pharmaceutical patents, it brings out the good of the public at large, which is health and that cannot be taken lightly. Also, a disease being this rare, the public interest needs to be taken very seriously. Thus, it was analysed that the drug for such a rare disease and when it is the only available treatment in the country, then it should be economical to the public. Besides, the plaintiff can be compensated by the way of damages. 

Therefore, as the judgment in March, 2025 preceded the balance of convenience and prima facie were both not in favour of the plaintiff and the application was dismissed.

Appeal before the Division Bench of the Delhi High Court:

Citation : FAO(OS) (COMM) 43/2025, CM APPL. 117608/2025

Pronounced on : 9th October, 2025 

The Appeal was filed before Hon’ble Mr. Justice C.Hari Shankar and Hon’ble Mr. Justice Ajay Digpaul and judgment was pronounced on 9th October, 2025. The court refused to interfere with the Single Judge’s judgment and stating that the valid points had been made by the respondent(Natco Pharma) relating to Section 64(1)(f) and (e), as the appellant’s prior patent was rendering its novelty and making it obvious for the persons skilled in the art. THus a valid point for the revocation of a patent. Thus, again leading the judgment favour respondent, by emphasizing on the public interest being of great importance while pronouncing these judgments.

Plea before the Supreme Court of India: 

On 17th October, 2025 the Supreme Court rejected a plea seeking the Respondent to stop selling the generic version of the Risdiplam, led by the bench of Hon’ble Justice P.S Narasimha and Hon’ble Justice A.S Chandurkar. They upheld the ruling of the single judge of Delhi high court which was pronounced in March  of this year.