Pfizer successful in a leading case concerning substitution of medicinal products
Assisted by Plesner, Pfizer has been successful in a leading case before the Danish Maritime and Commercial High Court concerning Pfizer's product Lyrica® that contains pregabalin as an active ingredient. The Danish Maritime and Commercial Court ruled that all Danish pharmacies are to be enjoined from dispensing the medicinal product Pregabalin "Krka", a generic version of Lyrica®, for the treatment of pain.
Pfizer had instituted legal proceedings against the producer Krka and all pharmacies in Denmark and the Danish Health and Medicines Authority subsequently intervened at its own initiative in the case in support of the pharmacies.
The issue of the case was whether Pfizer holds a so-called "second-medical use" patent that protects the use of medicinal products containing pregabalin for the treatment of pain. Lyrica® is approved for the treatment of two additional indications, namely generalised anxiety and epilepsy, but they are not patented and as a result Pregabalin "Krka" can lawfully be dispensed for the treatment of such indications. The specific issue was that the pharmacies also dispensed Pregabalin "Krka" for the treatment of pain in compliance with the Danish Health and Medicines Authority's rules on the substitution of medicinal products.
This case is of general public importance, among other things because it is about whether it is possible to restrict patent rights through the Danish Health and Medicines Authority's rules on substitution. That was the fundamental view of both Krka, the pharmacies and the Danish Health and Medicines Authority, but this view was dismissed by the Danish Maritime and Commercial High Court.
The result of the case was that the pharmacies were enjoined from dispensing Pregabalin "Krka" for the treatment of pain as long as Pfizer's patent is in force. But a claim for an injunction against Krka was not allowed.
Attorney-at-law, partner Mikkel Vittrup represented Pfizer.