CJEU on communication of carve out is request to limit the scope of the marketing authorisation of the generic medicinal product
01-03-2019 Print this page
In a marketing authorisation procedure, a communication of the package leaflet or summary of the product characteristics of a generic medicinal product, which does not include indications or dosage forms which were still covered by patent law at the time that medicinal product was placed on the market ("carve out"), constitutes a request to limit the scope of the marketing authorisation of the generic medicinal product in question
Gerechtshof Den Haag (Regional Court of Appeal, The Hague, Netherlands) decided to refer questions to the Court of Justice for a preliminary ruling on publication of by carve out excluded product characteristics by the CBG. The Court of Justice confirms that the communication of carve out is a request to limit the scope of the marketing authorisation of the generic medicinal product. Having regard to the positive answer given to the first question, there is no need to answer the other questions.
The Court answers the questions as follows:
"In the light of all the foregoing considerations, the answer to the first question is that the second paragraph of Article 11 of Directive 2001/83 must be interpreted as meaning that, in a marketing authorisation procedure such as that at issue in the main proceedings, communication to the competent national authority by the applicant or holder of a marketing authorisation for a generic medicinal product of the package leaflet or a summary of the product characteristics of that medicinal product which does not include any reference to indications or dosage forms which were still covered by patent law at the time that medicinal product was placed on the market constitutes a request to limit the scope of the marketing authorisation of the generic medicinal product in question."
IPPT20190214, CJEU, De Staat v Warner-Lambert
