05 January 2017 - Authored by:Birgit Kramer
Last December the Regional Court Düsseldorf referred questions for a preliminary ruling to the CJEU (docket number C-681/16) concerning the applicability of the Specific Mechanism during the term of an SPC extended in accordance with the Paediatric Regulation.
Factual background is that the plaintiff owning an SPC for a pharmaceutical product wanted to prevent parallel imports of this pharmaceutical product from the European member states that joined the European Union in 2004, 2007 and 2013 into Germany by invoking its SPC. The term of the SPC had been extended in accordance with the Paediatric Regulation due to the conduct of paediatric studies in line with an approved paediatric investigation plan. (Also) for the time of the extended term of the SPC, the plaintiff referred to the Specific Mechanism which is a transitional regulation in the Acts of Accession of 2003, 2005 and 2012 establishing an exemption to the basic principle of exhaustion in the European Union. The Specific Mechanism basically says that the owner of a patent or SPC may within the European Union prevent parallel imports from the accession states based on his patent or SPC provided that at the time the owner of the patent or SPC had applied for the right in Germany, “such protection” could not have been obtained in the concerned accession state. In case of the concerned SPC, substance protection for the pharmaceutical compound could have been obtained in none of the accession states at the time the German patent forming the basic patent for the SPC had been applied for in Germany. At the time the SPC had been applied for in Germany, some of the accession states provided regulations basically allowing SPC protection. However, as the basic patent that could not have been obtained is a necessary requirement for obtaining the SPC, also in these states actually obtaining SPC protection for the product was impossible.
The Regional Court Düsseldorf referred in total four questions to the CJEU, most relevant being (1) whether “such protection” as required by the Specific Mechanism can be assumed in cases where at the time of the application for the SPC in Germany regulations providing for SPC protection were existent in the accession state but an SPC could not have been obtained factually due to the lack of a basic patent and (2) whether the Specific Mechanism can be applied during the extended term of the SPC. In our opinion the first of these two questions must be answered with no and the second with yes.
As to the first question, the purpose of the Specific Mechanism must be considered. This is to protect the holder of the patent or SPC from disadvantages from the accession of new member states to the European Union that do not provide for an equivalent protection for pharmaceutical products as the existing member states. This makes it necessary that “such protection” as required under the Specific Mechanism can only be assumed if the right holder factually had the chance to obtain a right in the accession state for the concerned product giving him the same rights as the invoked right in Germany. In case of an SPC, this is only possible if the same basic patent as the German one was also given in the accession state. The basic patent is mandatory requirement for the granting of the SPC which excludes assuming “such protection” in cases where this could not have been obtained.
As regards the second question, it must be taken into account that the SPC is also during its extended term a uniform right granting continuous protection. There is neither an indication nor a justification to limit the rights conveyed by the SPC during the extension of the term. Additionally, answering the second question with yes is the only interpretation that allows the holder of the SPC the bonus provided for in the Paediatric Regulation when the required paediatric studies have been conducted. Thus, it is the only interpretation doing justice to the effet utile of the Paediatric Regulation.