# C_2016441EN.01000501.xml

| 28.11.2016 | EN | Official Journal of the European Union | C 441/5 |
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28.11.2016

EN

Official Journal of the European Union

C 441/5

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Judgment of the Court (Seventh Chamber) of 5 October 2016 (request for a preliminary ruling from the Riigikohus — Estonia) — F. Hoffmann-La Roche AG v Accord Healthcare OÜ

(Case C-572/15) (1)

((Reference for a preliminary ruling - Industrial and commercial property - Patent - Supplementary protection certificate - Regulation (EC) No 469/2009 - Article 21(2) - Transitional provisions - Certificate granted in accordance with the national legislation of a Member State prior to its accession to the European Union - Interpretation of Article 21(2) - Duration of validity of the certificate - Validity of Article 21(2) - Adjustment to secondary legislation resulting directly from the Act of Accession - Lack of jurisdiction of the Court))

(2016/C 441/06)

Language of the case: Estonian

Referring court

Riigikohus

Parties to the main proceedings

Applicant: F. Hoffmann-La Roche AG

Defendant: Accord Healthcare OÜ

Operative part of the judgment

| 1. | The Court of Justice of the European Union does not have jurisdiction to rule on the validity of Article 21(2) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 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. |
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1.

The Court of Justice of the European Union does not have jurisdiction to rule on the validity of Article 21(2) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 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.

| 2. | Article 21(2) of Regulation No 469/2009, as amended, 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. |
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2.

Article 21(2) of Regulation No 469/2009, as amended, 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.

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(1)  OJ C 27, 25.1.2016.

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