CJEU reference concerning SPCs and the 'specific mechanism'

The Düsseldorf Regional Court has referred questions to the CJEU for a preliminary ruling, which concern the impact of the so-called 'specific mechanism' on Supplementary Protection Certificates (SPCs) (case C-681/16). The CJEU has been asked questions which include whether the holder of an SPC issued for the Federal Republic of Germany can rely on the specific mechanism to prevent the importation of products into Germany from the accession States: the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania and Croatia; if the SPC was applied for in Germany at a time when the laws for obtaining an SPC already existed in these countries, but an SPC could not be obtained in them because the basic patent required for the SPC did not exist.

We will report on this reference in more detail in the March edition of Synapse.

Latest ruling in the PIP scandal: Elisabeth Schmitt

In the latest development in the PIP scandal the CJEU has ruled in Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH that a notified body is not under a general obligation to carry out unannounced inspections, to examine devices and/or to examine the manufacturer’s business records. However, in the face of evidence indicating that a medical device may not comply with the requirements laid down in Directive 93/42, as amended by Regulation No 1882/2003, the notified body must take all the steps necessary to ensure that it fulfils its obligations under Article 16(6) and Annex II of that Directive. The court further states that the purpose of the notified body’s involvement is to protect the end users of medical devices. Culpable failure by that body to fulfil its obligations under the Directive may give rise to liability under national law.

We will report on this reference in more detail in the March edition of Synapse.