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

1. Accession of new Member States — 2003 Act of Accession — Company law — Specific mechanism — Medicinal product protected by a patent or a supplementary protection certificate — Proposed parallel importation from a new Member State — Requirement for the holder to notify the importer of his intention to oppose the importation — None

   (2003 Act of Accession, Annex IV, Chapter 2, second para.)

2. Accession of new Member States — 2003 Act of Accession — Company law — Specific mechanism — Medicinal product protected by a patent or a supplementary protection certificate — Requirement for a potential importer to notify the holder or his beneficiary of his intention to import such a medicinal product — Notification given to persons linked to the holder by company or undertaking connections — Not permissible

   (2003 Act of Accession, Annex IV, Chapter 2, second para.)

3. Accession of new Member States — 2003 Act of Accession — Company law — Specific mechanism — Medicinal product protected by a patent or a supplementary protection certificate — Requirement for a potential importer to notify the holder or his beneficiary of his intention to import such a medicinal product — Person responsible for giving such notification

   (2003 Act of Accession, Annex IV, Chapter 2, second para.)

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.

   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)

2.  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)

3.  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 is to be interpreted as not requiring the person intending to import or market in a Member State from another Member State which acceded to the EU in 2003 a pharmaceutical 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 to give one month’s prior notification himself, provided that it is possible from the notification to identify that person clearly.

   In order for the holder, or beneficiary, of the patent or supplementary protection certificate to be able to make an informed decision as to whether to oppose the importation, where necessary by commencing infringement proceedings, it is essential that the notification should identify clearly the person proposing to carry out the importation. The interests of the person enjoying the protection conferred by the patent or supplementary protection certificate, or his beneficiary, would not be adequately protected if the notification did not contain that information.

   On the other hand, it would be too formalistic to interpret the terms of the Specific Mechanism as going so far as to require that the person who is to carry out the notification must be the person intending to import or market the product in question, bearing in mind that the Specific Mechanism does not expressly lay down such a requirement.

   (see paras 48-50, operative part 3)

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

1. Accession of new Member States — 2003 Act of Accession — Company law — Specific mechanism — Medicinal product protected by a patent or a supplementary protection certificate — Proposed parallel importation from a new Member State — Requirement for the holder to notify the importer of his intention to oppose the importation — None

   (2003 Act of Accession, Annex IV, Chapter 2, second para.)

2. Accession of new Member States — 2003 Act of Accession — Company law — Specific mechanism — Medicinal product protected by a patent or a supplementary protection certificate — Requirement for a potential importer to notify the holder or his beneficiary of his intention to import such a medicinal product — Notification given to persons linked to the holder by company or undertaking connections — Not permissible

   (2003 Act of Accession, Annex IV, Chapter 2, second para.)

3. Accession of new Member States — 2003 Act of Accession — Company law — Specific mechanism — Medicinal product protected by a patent or a supplementary protection certificate — Requirement for a potential importer to notify the holder or his beneficiary of his intention to import such a medicinal product — Person responsible for giving such notification

   (2003 Act of Accession, Annex IV, Chapter 2, second para.)

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.

   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)

2.  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)

3.  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 is to be interpreted as not requiring the person intending to import or market in a Member State from another Member State which acceded to the EU in 2003 a pharmaceutical 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 to give one month’s prior notification himself, provided that it is possible from the notification to identify that person clearly.

   In order for the holder, or beneficiary, of the patent or supplementary protection certificate to be able to make an informed decision as to whether to oppose the importation, where necessary by commencing infringement proceedings, it is essential that the notification should identify clearly the person proposing to carry out the importation. The interests of the person enjoying the protection conferred by the patent or supplementary protection certificate, or his beneficiary, would not be adequately protected if the notification did not contain that information.

   On the other hand, it would be too formalistic to interpret the terms of the Specific Mechanism as going so far as to require that the person who is to carry out the notification must be the person intending to import or market the product in question, bearing in mind that the Specific Mechanism does not expressly lay down such a requirement.

   (see paras 48-50, operative part 3)