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Portolano Cavallo Studio Legale was founded in 2001 by partners Manuela Cavallo and Francesco Portolano. The firm’s activity is mainly focused on the corporate/M&A sector and the media industry.
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Eng / Ita
Jul 18

The European Court of Justice addresses parallel Imports of pharmaceuticals under the Specific Mechanism established in the Accession Treaties for new Member States

The reference for a preliminary ruling made by the District Court of Düsseldorf (Landgericht) followed a heated dispute between Pfizer Ireland Pharmaceuticals, Operations Support Group (Pfizer) and Orifarm GmbH (Orifarm) concerning parallel imports of Enbrel, a genetically engineered protein for the treatment of arthritis. The appellant – proprietor of a supplementary protection certificate (SPC) for biologic drug Etanercept – demanded an injunction against Orifarm for the parallel importation of medicinal products from low-pricing countries into Germany.

SPCs are patent extensions valid in EU member countries, Iceland, Liechtenstein and Norway that grant additional intellectual property rights to patent holders on a wide range of biologically active compounds such as medicaments, veterinary drugs, herbicides and insecticides. Their purpose is to offset part of the financial and time costs associated with research and development activities prior to gaining authorization for market entry. Given that developing new drugs can be a long and costly process, supplementary protection certificates guarantee appropriate levels of patent assurance.

The first marketing authorization for Enbrel was granted to Wyeth Pharma on 1 February 2000 for Switzerland, with validity in many European jurisdictions. In 2006, the German Patent and Trade Mark Office granted Wyeth an SPC on top of the basic patent. In October 2009, Pfizer acquired Wyeth, among whose assets was the SPC at issue. In 2010, the basic patent expired, and the annexed certificate entered into force for a period of five years.

In April 2015, Pfizer learned of the existence of parallelly imported packages of Enbrel available for sale on German territory. The Danish group Orifarm was subsequently identified as responsible for importing the drug from Poland, Slovenia, Croatia and Lithuania, despite being repeatedly denied permission to do so by Pfizer. Alleging breach of the Specific Mechanisms laid out in the Acts of Accession of 2003, 2005 and 2012, Pfizer filed a complaint with the Regional Court for infringement of the SPC, seeking injunctive relief to prevent the further importation, possession and sale of the product; order the immediate disclosure of the information related to those activities for the period from 1 September 2010 to 1 August 2015, and the recall and destruction of all imported products; obtain reparation for the damages incurred.

The Landgericht Düsseldorf stayed the proceedings and referred to the Court of Justice the question of whether the Specific Mechanisms allow the holder of a supplementary protection certificate issued for Germany to prohibit the importation of medicinal products from the Accession States (the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania and Croatia) into Germany if the SPC application was submitted at a time when the Accession States had laws providing for equivalent protection, but the patent required for the issuing of the certificate did not yet exist in the Accession State.

According to the exhaustion doctrine, an intellectual property right owner who has filed for a patent in a Member State cannot oppose the importation of a product sold in a different Member State by themselves or by others with their explicit consent. However, the Accession Treaties of 2003, 2005 and 2012 establish Specific Mechanisms designed to strike a balance between the free movement of goods and the effective protection of intellectual and industrial property rights granted under a basic patent. They enable patent holders to enforce exclusive rights against importers in cases where those rights would otherwise be exhausted.

In the decision, the European Court of Justice stressed the indissoluble link between the existence of an SPC and that of a basic patent: indeed, a product cannot be protected by a supplementary protection certificate in the absence of a basic patent underlying it. In light of this notion, the Court noted that at the time the patent application for Enbrel was filed in Germany, back in 1990, the patent holder was unable to obtain an equivalent patent and SPC in the exporting States. In fact, while “the legal systems of [the exporting] States provided for the possibility of [securing] equivalent protection at the time when the application for the basic patent was published and/or the application for an SPC in the importing Member State was filed, they did not yet provide for such a possibility at the time when the application for a basic patent was filed”. Ruling in favor of Orifarm, the Court concluded, would amount to imposing on the patent holder the burden of keeping track of the laws of any potential Accession State.

Therefore, the Curt of Justice concluded that the Specific Mechanisms must be interpreted as authorizing 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.