# C_2018166EN.01001301.xml

| 14.5.2018 | EN | Official Journal of the European Union | C 166/13 |
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14.5.2018

EN

Official Journal of the European Union

C 166/13

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Judgment of the Court (Second Chamber) of 14 March 2018 (request for a preliminary ruling from the Korkein hallinto-oikeus — Finland) — Astellas Pharma GmbH v Helm AG, Lääkealan turvallisuus- ja kehittämiskeskus (Fimea)

(Case C-557/16) (1)

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((Reference for a preliminary ruling - Directive 2001/83/EC - Medicinal products for human use - Articles 28 and 29 - Decentralised procedure for marketing authorisation for a medicinal product - Article 10 - Generic medicinal product - Data exclusivity period for the reference medicinal product - Power of the competent authorities of the Member States concerned to determine the point in time from which the exclusivity period starts to run - Jurisdiction of the courts of the Member States concerned to review the determination of the point in time from which the exclusivity period starts to run - Effective judicial protection - Charter of Fundamental Rights of the European Union - Article 47))

(2018/C 166/16)

Language of the case: Finnish

Referring court

Referring court

Korkein hallinto-oikeus

Parties to the main proceedings

Parties to the main proceedings

Applicant: Astellas Pharma GmbH

Applicant:

Defendants: Helm AG, Lääkealan turvallisuus- ja kehittämiskeskus (Fimea)

Defendants:

Operative part of the judgment

Operative part of the judgment

| 1) | Article 28 and Article 29(1) 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 decentralised marketing-authorisation procedure for a generic medicinal product, the competent authority of a Member State concerned by that procedure cannot itself determine the point in time from which the data exclusivity period for the reference medicinal product starts to run when adopting, under Article 28(5) of that directive, its decision on the placing on the market of that generic medicinal product in that Member State. |
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1)

Article 28 and Article 29(1) 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 decentralised marketing-authorisation procedure for a generic medicinal product, the competent authority of a Member State concerned by that procedure cannot itself determine the point in time from which the data exclusivity period for the reference medicinal product starts to run when adopting, under Article 28(5) of that directive, its decision on the placing on the market of that generic medicinal product in that Member State.

| 2) | Article 10 of Directive 2001/83, as amended by Directive 2012/26, read in conjunction with Article 47 of the Charter of Fundamental Rights of the European Union, must be interpreted as meaning that a court of a Member State involved in a decentralised procedure for marketing authorisations, hearing an action brought by the holder of the marketing authorisation for the reference medicinal product against the marketing-authorisation decision for a generic medicinal product in that Member State taken by its competent authority, has jurisdiction to review the determination of the point in time from which the data exclusivity period for the reference medicinal product starts to run. By contrast, that court does not have jurisdiction to review whether the initial marketing authorisation for the reference medicinal product granted in another Member State was granted in accordance with that directive. |
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2)

Article 10 of Directive 2001/83, as amended by Directive 2012/26, read in conjunction with Article 47 of the Charter of Fundamental Rights of the European Union, must be interpreted as meaning that a court of a Member State involved in a decentralised procedure for marketing authorisations, hearing an action brought by the holder of the marketing authorisation for the reference medicinal product against the marketing-authorisation decision for a generic medicinal product in that Member State taken by its competent authority, has jurisdiction to review the determination of the point in time from which the data exclusivity period for the reference medicinal product starts to run. By contrast, that court does not have jurisdiction to review whether the initial marketing authorisation for the reference medicinal product granted in another Member State was granted in accordance with that directive.

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(1)  OJ C 22, 23.1.2017.

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