One of the new question marks introduced by Directive 2004/48 (the so-called “Enforcement Directive”) is what amount of indicia is required to prove that an act of infringement is “imminent” for the purposes of obtaining a preliminary injunction aimed at prohibiting such act. Although the declared goal of the Enforcement Directive was to strengthen the…

The questions referred to the Enlarged Board of Appeal were answered as follows: 1. A claimed imaging method, in which, when carried out, maintaining the life and health of the subject is important and which comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to…

On 18 June 2009 the IP Chamber of the Milan Court issued its official interpretation on whether the filing of an MA application for a generic drug when the patent is still in force results an act of infringement. This subject that had already been dealt with, with a different outcome, almost three years earlier…

During the past 9 months in Denmark, the pharmaceuticals manufacturer and patentee, H. Lundbeck A/S, has obtained two interlocutory injunctions in Denmark against wholesalers marketing generic versions of Escitalopram. In both cases H. Lundbeck A/S argued successfully that the patent-in-suit fulfilled the conditions of the Danish Patents Act § 64a (similar to the Art 35…

The District Court of The Hague granted Mundipharma a provisional injunction against Sandoz for infringement of its patent for a controlled release oxycodon formulation. The District Court suspended its decision on the validity and infringement of the patent in the main action until a final decision has been rendered in the opposition proceedings. The Court…

A second medical use claim can be based on a novel dosage regimen. In decision T317/95 a Board of Appeal decided that this type of claim was not allowable. It regarded the activity of administrating a medicine as a therapeutic treatment and, hence, an activity in a field excluded from patentability. Since the patent right…

In the beginning of 2010, Merck Sharp & Dohme (hereafter “Merck”) and E.I. Du Pont de Nemours (hereafter “Du Pont”) on the one hand and Mylan on the other hand entailed in a fight concerning the launch of a generic version of Cozaar Plus®. The Supplementary Protection Certificate (SPC) of Cozaar Plus®, a combination product consisting of losartan and HCTZ, would expire on 15 February 2010, but Merck and Du Pont tried to prevent the marketing of generic versions of Cozaar Plus® by invoking the SPC for Cozaar®, the monoproduct consisting of Losartan only. In Belgium and France, this case led to very diverging judgments on the interpretation of the SPC Regulation.