Case C‑539/13

Merck Canada Inc.

and

Merck Sharp & Dohme Ltd

v

Sigma Pharmaceuticals plc

(Request for a preliminary ruling from the Court of Appeal (England and Wales) (Civil Division)

‛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’

Summary — Judgment of the Court (Third Chamber), 12 February 2015

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. Nevertheless, in such a situation, the holder, or beneficiary, of the patent or supplementary protection certificate cannot be regarded as having forfeited the right to rely on the Specific Mechanism. Although he may not obtain compensation for the loss suffered as a result of the parallel imports which he failed to oppose in good time, such a holder or beneficiary remains, in principle, free to oppose future importation and marketing of the pharmaceutical product protected by the patent or supplementary protection certificate. (see paras 32, 33, operative part 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 meaning that the one month’s prior notification, required of any person intending to import or market in a Member State from another Member State that acceded to the EU in 2003 a medicinal product covered by a patent or supplementary protection certificate registered in a Member State at a time when such protection could not be obtained in one of the new Member States for that product, must be given to the holder, or beneficiary, of the patent or 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. The purpose of the notification requirement is to enable the holder, or beneficiary, of a patent or supplementary protection certificate to prevent the import and marketing of a protected product by being informed, in advance, of any proposed parallel importation from one of the new Member States in which it was not possible to obtain such protection before its accession to the EU. By imposing that notification requirement, the EU legislature made clear its intention to strike a balance between the risk of imposing too many formal requirements on the parallel importer and the risk of placing the person enjoying the protection conferred by a patent or supplementary protection certificate, or his beneficiary, in a position of legal uncertainty. To accept that notification may be given to other persons linked to the holder of the patent or supplementary protection certificate, or his beneficiary, by company or undertaking connections would be liable to undermine the effectiveness of the Specific Mechanism and might place the holder in a position of legal uncertainty, at odds with the objective pursued by the Specific Mechanism. (see paras 39, 41, 43, operative part 2)