New ECJ-judgment on the requirements for obtaining a SPC
The ECJ has recently found in the case C-527/17 that an SPC for a medicinal product cannot be issued on the basis of a CE certificate of conformity for a medical device, as such a certification procedure does not equate to a marketing authorisation for a medicinal product.
In the case Boston Scientifics Ltd. had applied for an SPC for the medicinal product paclitaxel on the basis of the patent and the CE certificate of conformity for the medical device TAXUS, in which paclitaxel constituted the supporting medical device. However, the SPC application was denied on the grounds that the medicinal product (paclitaxel), which was the subject of the application, was not covered by a marketing authorisation.
Boston Scientifics Ltd. challenged the decision on the grounds that the safety and effect of paclitaxel had already been reviewed in the course of the certification procedure for the TAXUS medical device. In their opinion, an authorisation for the use of the medicinal product in a medical device should equate to a marketing authorisation for the medicinal product itself.
The ECJ concluded that Article 2 of the SPC Regulation shall be interpreted in such a way that a CE certificate of conformity for a medical device, incorporating as an integral part a medicinal product, does not equate to a market authorisation for the medicinal product itself. Moreover, the ECJ held that an SPC can only protect a product that is used as a medicinal product and thus not a substance as the one in dispute, which is used as a supporting part of a medical device and performs an action ancillary to that which is performed by the device.
Under the current SPC-regime, the issuance of an SPC therefore requires a separate marketing authorisation for the medicinal product in question, regardless of whether the medicinal product has been used in an authorised medical device, and regardless of whether the safety and effect of the medicinal product have already been reviewed during the certification procedure for the medical device.
Read ECJ's decision