Source: EURLEX
Language: en
Format: md

Case C‑681/16

Pfizer Ireland Pharmaceuticals, Operations Support Group

v

Orifarm GmbH

(Request for a preliminary ruling from the Landgericht Düsseldorf)

(Reference for a preliminary ruling — Intellectual and industrial property — Patent law — Acts of Accession to the European Union of 2003, 2005 and 2012 — Specific Mechanism — Whether applicable to parallel imports — Regulation (EC) No 469/2009 — Product protected by a supplementary protection certificate in a Member State and marketed by the holder of the basic patent in another Member State — Exhaustion of intellectual and industrial property rights — No basic patent in the new Member States — Regulation (EC) No 1901/2006 — Extension of the protection period)

Summary — Judgment of the Court (Second Chamber), 21 June 2018

1. Accession of new Member States—Acts of Accession of 2003, 2005 and 2012—Intellectual property—Specific mechanism authorising the holder of a patent or supplementary protection certificate to prevent the importation of medicinal products from the new Member States—Conditions under which applicable—Impossibility of obtaining an equivalent patent and a supplementary protection certificate in the those States at the time when the application for the patent was published or the application for a certificate was filed

   (Act of Accession of 2003, Annex IV, Chapter 2; Act of Accession of 2005, Annex V, Chapter 1; Act of Accession of 2012, Annex IV, Chapter 1)
2. Accession of new Member States—Acts of Accession of 2003, 2005 and 2012—Intellectual property—Specific mechanism authorising the holder of a patent or supplementary protection certificate to prevent the importation of medicinal products from the new Member States—Applicable to supplementary protection certificates with a paediatric extension under Regulation No 1901/2006

   (Act of Accession of 2003, Annex IV, Chapter 2; Act of Accession of 2005, Annex V, Chapter 1; Act of Accession of 2012, Annex IV, Chapter 1; European Parliament and Council Regulation No 1901/2006, Art. 36(1))

1. The Specific Mechanisms laid down 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, in Chapter 1 of Annex V to the Act concerning the conditions of accession of the Republic of Bulgaria and Romania and the adjustments to the Treaties on which the European Union is founded, and in Chapter 1 of Annex IV to the Act concerning the conditions of accession of the Republic of Croatia and the adjustments to the Treaty on European Union, the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community, must be interpreted as authorising the holder of a supplementary protection certificate issued in a Member State other than the new Member States referred to in those Acts of Accession to oppose the parallel importation of a medicinal product from those new Member States in a situation where the legal systems of those States provided for the possibility of obtaining equivalent protection at the time when the application for the basic patent was published and/or the application for a supplementary protection certificate in the importing Member State was filed, but did not yet provide for such a possibility at the time when the application for a basic patent was filed, with the result that it was impossible for the patent holder to obtain an equivalent patent and a supplementary protection certificate in the exporting States.

   As regards the exact date on which the level of protection in the importing Member State and that in the exporting States must be compared, it follows from the use of the word ‘filed’ in the provisions cited in paragraph 42 of this judgment that that date is the date on which the application for protection was lodged.

   (See paras 43, 57, operative part 1)
2. The Specific Mechanisms laid down 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, in Chapter 1 of Annex V to the Act concerning the conditions of accession of the Republic of Bulgaria and Romania and the adjustments to the Treaties on which the European Union is founded, and in Chapter 1 of Annex IV to the Act concerning the conditions of accession of the Republic of Croatia and the adjustments to the Treaty on European Union, the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community, must be interpreted as applying to the extension provided for in Article 36(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004.

   (see para. 73, operative part 2)

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