Opinion of the Advocate General — ECLI:EU:C:2018:822
Date: 2018-10-04
Language of the case: Dutch
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling;Reference for a preliminary ruling - decision unnecessary
Origin: Netherlands

Summary of Product Characteristics and the package leaflet those parts of the Summary of Product Characteristics for the reference medicine which refer to indications or dosage forms covered by the patent right of a third party, should be considered as a request to limit the marketing authorisation which must result in the marketing authorisation not applying, or no longer applying, to the patented indications or dosage forms? If the answer to question 1 is in the negative, do Articles 11 and 21(3) of Directive 2001/83 or any other provisions of EU law preclude the competent authority from making public, by means of an authorisation granted under Article 6 in conjunction with Article 10 of Directive 2001/83, the Summary of Product Characteristics and the package leaflet, including those parts which refer to indications or dosage forms which fall under the patent rights of a third party, in a situation where the marketing authorisation applicant or holder has notified the authority that he is not including in the Summary of Product Characteristics and the package leaflet those parts of the Summary of Product Characteristics for the reference medicine which refer to indications or dosage forms covered by the patent right of a third party? Does it make any difference to the answer to question 2 that the competent authority requires the authorisation holder to include in the package leaflet which the authorisation holder must insert in the packaging of the medicine a reference to the authority’s website on which the Summary of Product Characteristics is published, including the parts which refer to indications or dosage forms covered by the patent rights of a third party, whereas those parts, pursuant to Article 11 of Directive 2001/83, are not included in the package leaflet? ____________ 1 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).