On 25 October 2018 the Court of Justice of the EU (CJEU) issued its decision in C-527/17 Boston Scientific. The Court held that award of a CE-mark for a medical device comprising an active ingredient as an integral part (a medical device/drug combination) is not considered to be a marketing authorisation which can support an application for an SPC (Supplementary Protection Certificate). This applies irrespective of whether or not the active ingredient was assessed by a national medicines authority or the EMA during the consultation process for award of the CE-mark.
Article 2 of the SPC Regulation states that a product is eligible for SPC protection only if it has been granted marketing authorisation in accordance with the Medicinal Products Directive (2001/83/EC). Medical devices are not subject to assessment under the Medicinal Products Directive and so the decision of the CJEU is in some respects not surprising.
However, there was some uncertainty in that a medical device/drug combination is subject to a more rigorous approval procedure in which the quality, safety and efficacy of the drug component is assessed in a manner analogous to that required by the Medicinal Products Directive. Some national patent offices therefore took the view that a CE-mark for such a device/drug combination could be treated as a marketing authorisation which can support an SPC application, whereas others took the opposite view. The question was referred to the CJEU by the German Federal Patent Court in the context of Boston Scientific’s application for an SPC for paclitaxel, which relied upon the award of a CE-mark for a paclitaxel-eluting stent and a patent covering paclitaxel for the prevention of restenosis.
The CJEU noted in particular that the effects of the active ingredient component and the device component in a drug/device combination cannot be classified separately. Thus, if the device as a whole has a principal mode of action that cannot be categorised as that of a medicinal product within the meaning of the Medicinal Products Directive, then the device cannot be considered to be an authorised product within the meaning of that Directive. It is irrelevant that the drug component may have an ancillary action (an anti-proliferative effect in this case) that could be so-categorised if assessed independently. Although the quality, safety and efficacy of the drug component of a drug/device combination may be assessed as part of the CE-mark process, this is not an independent assessment of the drug as a medicinal product. It is only carried out in the context of the intended purpose of the device and the incorporation of the drug into the device, and thus is not an assessment covered by the Medicinal Products Directive.
Although this decision is specifically concerned with drug/device combinations, the conclusions will likely be applicable to all medical devices. Effectively therefore, the CJEU have confirmed that, under the current legislation, SPCs are not available for medical devices irrespective of the level of regulatory assessment (and corresponding delay) that may be required in order to market such devices. It remains to be seen whether separate legislation analogous to the SPC Regulation will be introduced to encourage research into medical devices. Such legislation is likely to be increasingly desirable, as the complexity of medical devices and the corresponding regulatory burden continues to increase.