Delhi High Court Restrains Intas From Selling Chemotherapy-Induced Nausea Drug In Helsinn Patent Suit

The Delhi High Court has restrained Intas Pharmaceutical Limited from manufacturing or selling its generic drug 'NO-CINV', used to prevent chemotherapy-induced nausea and vomiting (CINV), in a patent infringement suit filed by Swiss pharmaceutical company Helsinn Healthcare SA and its Indian exclusive licensee.

Justice Manmeet Pritam Singh Arora held that infringement of the patent claims was prima facie evident and was not contested by Intas during arguments. The injunction will remain in force until the next hearing.

The patent, titled 'Compositions and Methods for Treating Centrally Mediated Nausea and Vomiting', was granted on March 23, 2023, and is valid until November 18, 2030.

It covers an oral dosage form combining Netupitant (200–400 mg) and Palonosetron hydrochloride (0.56 mg), equivalent to 0.5 mg of Palonosetron free base, to treat CINV. Helsinn commercialises the patented formulation in India under the brand name 'AKYNZEO', launched in May 2018.

Helsinn learnt through a market surveyor on November 7, 2026, that Intas was preparing to launch 'NO-CINV', a combipack containing one 300 mg Netupitant tablet and one 0.5 mg Palonosetron tablet. It issued a cease-and-desist notice the same day but received no response.

Senior Advocate Sandeep Sethi, appearing for Intas, submitted that the product had already been launched nationwide on November 7. He produced three invoices worth approximately ₹14 lakh, showing dispatches to one entity in Patna and another in Meerut.

Sethi argued that both molecules were known substances and that combining them could not constitute an invention. He also admitted that Intas had not initiated any proceedings challenging the patent's validity.

The court observed that Helsinn had acted with "alacrity" by approaching it within two days of learning about the proposed launch.

Relying on its earlier order in Helsinn v. Hetero Healthcare (2024), the court observed that packaging the two tablets together as an integrated combipack did not make the infringement defence tenable, at least prima facie.

On the patent's validity, the court noted that two pre-grant oppositions filed by Panacea Biotech and Zydus Healthcare had been rejected by the Assistant Controller of Patents and Designs. Zydus's subsequent challenge was dismissed by the High Court on December 24, 2025, for lack of territorial jurisdiction, without examining the patent's validity on merits. No order staying the operation of the patent grant had been brought to the court's notice in the pending appeal.

The court also noted that Intas, an established pharmaceutical company, had launched the product without first challenging the patent through available legal remedies. Citing Merck Sharp and Dohme v. Glenmark and FMC Corporation v. Natco Pharma, it described this as a "calculated commercial risk".

It observed that Intas's argument that combining two known substances lacked novelty required a detailed examination of the patent specification, claims, and the Controller's orders. The issue could not be decided at this preliminary stage.

The court further noted that the product was manufactured in October 2026 and had only recently been launched. It found that restraining its sale until the next hearing would not prejudice Intas.

Intas, its directors, officers, employees, servants, agents, distributors, stockists and others acting on its behalf have been restrained from manufacturing, using, selling, offering for sale, distributing, advertising, exporting or otherwise dealing in 'NO-CINV' or any other product infringing the patent.

The court clarified that its observations were only prima facie and would not prevent Intas from raising all permissible defences. The matter will be heard next on November 1.