Order made in injunction proceedings of general public importance concerning medicinal product substitution
The Maritime and Commercial High Court has made an order in the injunction proceedings commenced by Pfizer against all pharmacies in Denmark and Krka d.d. Novo mesto.
Bech-Bruun represented Krka d.d. Novo mesto in the proceedings. The Danish Pharmaceutical Association intervened in the proceedings, acting for the pharmacies. Furthermore, the Danish Health and Medicines Authority intervened in the proceedings due to its general public importance.
Pfizer's second medical use patent
Pfizer originally held a substance patent for the medicinal product pregabalin marketed under the name Lyrica. Pregabalin has traditionally been used for treatment of generalised anxiety and epileptic seizures. Pfixer's substance patent has expired, but a so-called second medical use patent has subsequently been obtained in respect of the medicinal product for treatment of neuropathic pain.
Krka's skinny labelling marketing authorisation
Upon expiry of Pfizer's substance patent, Krka applied for and was granted permission under the EU-based "skinny labelling" rules to market a generic version of the medicinal product for treatment of epileptic seizures and generalised anxiety, but not for the indication still subject to patent protection.
The rules on substitution of the Danish Medicines Act
The Danish Medicines Act contains rules on substitution ordering pharmacies to dispense to their customers the least expensive version of a medicinal product available having the same medical properties. The Danish Health and Medicines Authority has construed the set of rules to the effect that pharmacies are obliged to substitute medicinal products also in situations where some indications are subject to second medical use patent protection. Following its launch in the beginning of March 2015, Krka's product consequently took over the main part of the market for pregabalin in Denmark.
Prohibition against dispensing of medicinal products for the indication subject to patent protection, but dismissal of the claim against Krka
The Maritime and Commercial High Court, which as a consequence of the general public importance of the case included three professional judges, laid down that the rules of substitution must yield in the specific situation since the Court found that no (sufficiently) clear viewpoints supported that the rules had been intended by the Danish Parliament to interfere with patent protection. Consequently, a preliminary injunction was granted against pharmacies dispensing Krka's product for treatment of pain.
The Maritime and Commercial High Court, however, found for Krka in the case referring to the fact that Pfizer's primary claim was too unclear to form the basis of an injunction.
As a result, Krka is still allowed to sell pregabalin in Denmark.