Judgment — ECLI:EU:C:2016:739
Date: 2016-10-05
Language of the case: Estonian
Court formation: Seventh Chamber
Subject matter: Intellectual, industrial and commercial property;Approximation of laws
Procedure: Reference for a preliminary ruling;Reference for a preliminary ruling - inadmissible
Origin: Estonia

Summary — Judgment of the Court (Seventh Chamber), 5 October 2016 1. Questions referred for a preliminary ruling — Assessment of validity — Jurisdiction of the Court — Provisions of secondary law amended by an Act of Accession — Not included (Art. 267, first para, (b), TFEU; European Parliament and Council Directive 469/2009, as amended by the 2012 Act of Accession, Art. 21(2); Council Regulation No 1768/92, Art. 20(2)) 2. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Duration of validity of the certificate — Certificate granted in a Member State prior to its accession to the European Union — Marketing authorisation recognised in the European Economic Area at an earlier date — Taking into account of the earlier authorisation for the purposes of determining the duration of validity of the certificate (European Parliament and Council Regulation No 469/2009, as amended by the 2012 Act of Accession, Arts 13 and 21(2)) 3. Accession of new Member States –2012 Act of Accession — Immediate applicability of measures adopted by the institutions before accession (European Parliament and Council Regulation No 469/2009, as amended by the 2012 Act of Accession, Art. 21(2)) 1. The Court of Justice of the European Union does not have jurisdiction to rule on the validity of Article 21(2) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products, as amended by the Act concerning the conditions of accession of the Republic of Croatia and the adjustments to the Treaty on European Union, the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community. Point (b) of the first paragraph of Article 267 TFEU confers jurisdiction on the Court to give preliminary rulings concerning both the interpretation of the acts of the institutions, bodies, offices or agencies of the European Union and the validity of those acts. That is not in the case as regards adjustments set out in an annex to an Act of Accession which are to be the subject of an agreement between the Member States and the applicant State and which do not constitute an act of an institution, but are provisions of primary law which may not be suspended, amended or repealed otherwise than by means of the procedures laid down for the revision of the original Treaties. In that regard, Article 20(2) of Regulation No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products was inserted into that regulation by the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded. Regulation No 469/2009 consolidated Regulation No 1768/92, so that Article 20(2) of Regulation No 1768/92 became Article 21(2) of Regulation No 469/2009. (see paras 26, 27, 29, 30, 33, operative part 1) 2. Article 21(2) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products, as amended by the Act concerning the conditions of accession of the Republic of Croatia and the adjustments to the Treaty on European Union, the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community, must be interpreted as meaning that it applies to a supplementary protection certificate, relating to a given medicinal product, granted by a Member State prior to its accession to the European Union. To the extent that that medicinal product was the subject, within the European Economic Area, of a marketing authorisation before that granted in that Member State, and, as the case may be, before its accession to the European Union, only the first marketing authorisation must be taken into account for the purposes of determining the duration of validity of the supplementary protection certificate. The effects of a first marketing authorisation recognised in a Member State of the European Economic Area are equivalent to those of a first marketing authorisation in the European Union, for the purposes of Article 13 of Regulation No 469/2009. (see paras 41, 47, operative part 2) 3. See the text of the decision. (see para. 43)