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.

The Antwerp Commercial Court dismissed Merck’s claim for injunctive relief against Teva, ruling that Teva’s montelukast-based generic medicines do not infringe Merck’s European patent (EP 0 737 186) with respect to an improved process for preparation of the active ingredient montelukast, either literally or by equivalents. A full summary of this case has been published…

The Brussels Court of Appeal ruled that, in calculating the period of validity of an SPC, the ‘first authorisation to place the product on the market in the Community’, within the meaning of Article 13 of the SPC Regulation, does not necessarily need to be an authorisation issued in accordance with Directive 65/55/EEC or Directive…

The court found that the annexes to the expert’s report, filed in the framework of descriptive seizure proceedings, contained confidential information which was not relevant to assess the alleged infringement. It therefore ordered the expert to remove the annexes from the report and enjoined Novartis from using the information contained therein, subject to a civil…