Request for a preliminary ruling concerning the disclosure of medicinal product characteristics by the Medicines Evaluation Board of the Netherlands

Print this page 07-09-2017
IP10059

Case C-423/17 Warner-Lambert Company. Request for a preliminary ruling. Court of Appeal The Hague.

 

Patent Law - Request for a preliminary ruling:

 

1. Must Article 11 of Directive 2001/83 or any other provision of Union law be interpreted as meaning that a notice by which the applicant or holder of a marketing authorization for a generic medicinal product within the meaning of Article 10 of Directive 2001/83 notifies the authority that the parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage forms covered by a third party patent right are not listed in the summary of product characteristics and package leaflet is considered a request for a restriction of the marketing authorization that should lead to a marketing authorization that is or becomes invalid for those patented indications or dosage forms?

 

2. If the answer to the first question is in the negative, do Article 11 and 21, third paragraph, of Directive 2001/83 or other provisions of Union law preclude that a competent authority when issuing an marketing authorization pursuant to Article 6 in conjunction with Article 10 of Directive 2001/83 discloses the summary of product characteristics and the packaging leaflet including those parts referring to indications or dosage forms covered by a third party patent right in the event that the applicant or holder of a marketing authorization has informed the authority that those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage form covered by a third party patent right are or will not be included in the summary of product characteristics and the packaging leaflet?

 

3. When answering the second question, does it matter whether the competent authority requires the holder of the marketing authorization to include a reference in the packaging leaflet that the holder of the marketing authorization must include in the package of the medicinal product to the website of that authority where the summary of product characteristics is published including the parts referring to indications or dosage forms covered by a third party patent right, while those parts are not included in the packaging leaflet in accordance with Article 11 of Directive 2001/83?