Staat der Nederlanden v Warner-Lambert Company LLC

European Union – Medicinal products. The second paragraph of art 11 of Directive (EC) 2001/83 should be interpreted as meaning that, in a marketing authorisation (MA), communication to the competent national authority by the applicant or holder of a MA for a generic medicinal product of the package leaflet or a summary of the product characteristics of that medicinal product which did not include any reference to indications or dosage forms which were still covered by patent law at the time that medicinal product had been placed on the market constituted a request to limit the scope of the MA of the generic medicinal product in question. The Court of Justice of the European Union so held in a preliminary ruling in proceedings concerning the decentralised MA procedure for a generic medicinal product provided for in art 28 of that directive.

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