Official Journal of the European Union

C 118/8

(Case C-539/13) (<span class="super">1</span>)

((Reference for a preliminary ruling - 2003 Act of Accession to the European Union - Annex IV - Chapter 2 - Specific Mechanism - Importation of a patented pharmaceutical product - Prior notification requirement))

(2015/C 118/10)

Language of the case: English

Referring court

Parties to the main proceedings

Applicants: Merck Canada Inc., Merck Sharp & Dohme Ltd

Defendant: Sigma Pharmaceuticals plc

Operative part of the judgment

1)The second paragraph of the Specific Mechanism provided for in Chapter 2 of Annex IV to 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 must be interpreted as not requiring the holder, or beneficiary, of a patent or supplementary protection certificate to give notification of his intention to oppose a proposed importation before invoking his rights under the first paragraph of that mechanism. However, if such a holder or beneficiary does not indicate such an intention during the one-month waiting period laid down in the second paragraph of the mechanism, the person proposing to import the pharmaceutical product in question may legitimately apply to the competent authorities for authorisation to import the product and, where appropriate, import and market it. The Specific Mechanism thus denies that holder or his beneficiary the possibility of relying on his rights under the first paragraph of the mechanism with regard to any importation and marketing of the pharmaceutical product carried out before such an intention was indicated.

2)The second paragraph of the Specific Mechanism must be interpreted as meaning that the notification must be given to the holder, or beneficiary, of the patent or the supplementary protection certificate, the latter term designating any person enjoying the rights conferred by law on the holder of the patent or the supplementary protection certificate.

3)The second paragraph of the Specific Mechanism is to be interpreted as not requiring the person intending to import or market the pharmaceutical product in question to give notification himself, provided that it is possible from the notification to identify that person clearly.

(<span class="super">1</span>) OJ C 9, 11.1.2014.