Case C-681/16: Pfizer Ireland Pharmaceuticals v Orifarm, Opinion AG E. Tanchev
Patent Law. SPC.The plaintiff was the registered holder of an SPC protecting the protein Etanercept. Etanercept is an active substance of the drug Enbrel® that the plaintiff produces and markets in Germany. The German Patent and Trade Mark Office granted to the plaintiff a ‘paediatric extension’ of the SPC by which the protection was extended and expired on 1 August 2015. Since 2012, the defendant had informed the plaintiff of its intention to carry out parallel imports from Estonia and Latvia and – from February 2015 - also from Bulgaria, the Czech Republic, Hungary, Poland, Rumania, Slovakia and Slovenia. The plaintiff repeatedly objected to this. In April 2015, the plaintiff discovered that packages of Enbrel, which had been produced for Poland, Slovenia and Lithuania and Croatia, all of which identified the defendant as the parallel importer, were available on the German market. Therefore, the plaintiff filed suit with the referring court, the Landgericht Düsseldorf, for infringement of its SPC. The defendant argued that he lawfully acquired Enbrel in the new member states, so that the SPC rights were exhausted. The plaintiff, however, pleads that the SPC rights weren’t exhausted, because of the exception in the Act of Accession of the new member States, referred to under the term of ‘Specific Mechanism’. The referring court asks the Court to clarify the scope of application of the Specific Mechanism in the present case where an SPC as such was available in the Accession State at the relevant time but the requisite basic patent did not exist (first question) and whether it makes a difference if the basic patent could have been obtained in the Accession State by the time of publication of the German patent application (second question). With its third and fourth questions, the Landgericht Düsseldorf queries whether and to what extent the Specific Mechanism applies to the paediatric extension, which is not expressly mentioned in the wording of the Acts of Accession.
AG E. Tanchev proposes that the Court asnswer the questions to the following effect:
“(1) The holder of a supplementary protection certificate that was issued to it for the Federal Republic of Germany can rely on the Specific Mechanism to prevent the importation of products into the Federal Republic of Germany from the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania and Croatia (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; Part I 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; 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) if the supplementary protection certificate was applied for in the Federal Republic of Germany at a time at which the laws for obtaining such a supplementary protection certificate already existed in the respective Accession States but could not be applied for by, or issued to, the holder of the supplementary protection certificate issued for the Federal Republic of Germany because the basic patent required for the issuing of the supplementary protection certificate did not exist in the abovementioned Accession State.
(2) It does not make any difference to the answer to Question 1 if it was merely at the time of the filing of the application for the basic patent issued for the Federal Republic of Germany that such protection through a basic patent could not be obtained in the Accession State but, by the time of publication of the application on which the basic patent issued for the Federal Republic of Germany was based, it could be so obtained.
(3) The holder of a supplementary protection certificate that was issued to it for the Federal Republic of Germany can rely on the Specific Mechanism to prevent the importation of products into the Federal Republic of Germany from the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania and Croatia if those products are imported after the expiry of the term of the supplementary protection certificate stipulated in the original decision to grant the patent but before the expiry of the six-month extension of the term of the supplementary protection certificate that was granted to it on the basis 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.
(4) It does not make any difference to the answer to Question 3, in the case of Croatia, that, on account of the accession of Croatia in 2013, the Specific Mechanism did not come into force until after the entry into force of Regulation No 1901/2006 on 26 January 2007 – unlike in the other Member States which acceded prior to 26 January 2007, namely the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria and Romania.”
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