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Case C-423/17: Judgment of the Court (Sixth Chamber) of 14 February 2019 (request for a preliminary ruling from the Gerechtshof Den Haag — Netherlands) — Staat der Nederlanden v Warner-Lambert Company LLC (Reference for a preliminary ruling — Medicinal products for human use — Directive 2001/83/EC — Article 11 — Generic medicinal products — Summary of product characteristics — Exclusion of references referring to indications or dosage forms still covered by patent law at the time when the generic medicine was marketed)
ECLI:EU:UNKNOWN:62017CA0423
62017CA0423
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Official Journal of the European Union
C 131/6
(Case C-423/17) (<span class="super note-tag">1</span>)
(Reference for a preliminary ruling - Medicinal products for human use - Directive 2001/83/EC - Article 11 - Generic medicinal products - Summary of product characteristics - Exclusion of references referring to indications or dosage forms still covered by patent law at the time when the generic medicine was marketed)
(2019/C 131/07)
Language of the case: Dutch
Referring court
Parties to the main proceedings
Applicant: Staat der Nederlanden
Defendant: Warner-Lambert Company LLC
Operative part of the judgment
The second paragraph of Article 11 of 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, as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012, 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.
* Language of the case: Dutch.
(1) OJ C 318, 25.9.2017.