# C_2018052EN.01001002.xml

| 12.2.2018 | EN | Official Journal of the European Union | C 52/10 |
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12.2.2018

EN

Official Journal of the European Union

C 52/10

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Judgment of the Court (Seventh Chamber) of 7 December 2017 (request for a preliminary ruling from the High Court of Justice (Chancery Division) -- United Kingdom) — Merck Sharp & Dohme Corporation v Comptroller General of Patents, Designs and Trade Marks

(Case C-567/16) (1)

1

((Reference for a preliminary ruling - Industrial and commercial property - Patent law - Medicinal products for human use - Regulation (EC) No 469/2009 - Article (3)(b) - Supplementary protection certificate - Conditions for obtaining - Article 10(3) - Granting of the certificate or rejection of the application for a certificate - Directive 2001/83/EC - Article 28(4) - Decentralised procedure))

(2018/C 052/13)

Language of the case: English

Referring court

Referring court

High Court of Justice (Chancery Division)

Parties to the main proceedings

Parties to the main proceedings

Applicant: Merck Sharp & Dohme Corporation

Applicant:

Defendant: Comptroller General of Patents, Designs and Trade Marks

Defendant:

Operative part of the judgment

Operative part of the judgment

| 1. | Article 3(b) 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 is to be interpreted as meaning that an end of procedure notice issued by the reference Member State in accordance with Article 28(4) 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, as regards pharmacovigilance, by Directive 2010/84/EU of the European Parliament and the Council of 15 December 2010, before the expiry of the basic patent, as defined in Article 1(c) of Regulation No 469/2009, may not be treated as equivalent to a marketing authorisation within the meaning of Article 3(b) of that regulation, with the result that a supplementary protection certificate may not be obtained on the basis of such a notice. |
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1.

Article 3(b) 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 is to be interpreted as meaning that an end of procedure notice issued by the reference Member State in accordance with Article 28(4) 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, as regards pharmacovigilance, by Directive 2010/84/EU of the European Parliament and the Council of 15 December 2010, before the expiry of the basic patent, as defined in Article 1(c) of Regulation No 469/2009, may not be treated as equivalent to a marketing authorisation within the meaning of Article 3(b) of that regulation, with the result that a supplementary protection certificate may not be obtained on the basis of such a notice.

| 2. | Article 10(3) of Regulation No 469/2009 is to be interpreted as meaning that the fact that no marketing authorisation has been granted by the Member State concerned at the time the supplementary protection certificate application is lodged in that Member State does not constitute an irregularity that can be cured under that provision. |
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2.

Article 10(3) of Regulation No 469/2009 is to be interpreted as meaning that the fact that no marketing authorisation has been granted by the Member State concerned at the time the supplementary protection certificate application is lodged in that Member State does not constitute an irregularity that can be cured under that provision.

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(1)  OJ C 22, 23.1.2017.

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