The Delhi High Court has denied Swedish drug maker Vifor Pharma’s application to prevent four Indian companies from launching generic versions of its iron-deficiency anaemia drug.
Justice Jyoti Singh ruled on Monday, July 24, that a drug patent only covering process claims could not be used to restrict third parties who derived the same compound through different methods.
The decision marks the first time the court has delved into what constitutes a product-by-process claim.
Vifor had claimed that its patent covered a product featuring ‘ferric carboxymaltose’ (FCM) as well as a process to prepare it. The Swedish drugmaker sells its FCM products in India under the brand names Ferinject, Injectafer and Revofer.
The company argued that its patent was actually for a product even though it described a process. Therefore, irrespective of the defendants’ process, any FCM production would infringe its patent.
However, defendants Dr Reddy’s Laboratories, MSN Laboratories, Corona Remedies, and Virchow Biotech claimed that Vifor’s invention was limited to a product obtained through the specific process mentioned in its patent application.
The court sided with the defendants and found that Vifor’s claims covered a product-by-process patent. It said the process terms were limitations to, and not additional features of, the rights granted to the company.
The court held that Corona and Virchow's products were different from Vifor’s and not infringing. It also found that the processes claimed by Dr Reddy’s and MSN were outside the scope of Vifor’s process and so were also non-infringing.
Corona had already placed its product on the market in 2020. This week’s decision paves the way for the other three companies to launch their products before Vifor’s patent expires in October.
