CJEU confirms that prior authorisation for a drug-incorporating device is not an MA under the SPC Regulation

The Court of Justice of the European Union (CJEU) has ruled that a supplementary protection certificate (SPC) cannot be granted for a medical device comprising an active ingredient because the EU authorisation procedure for devices does not result in a marketing authorisation (MA).

The request was made in proceedings brought by Boston Scientific Ltd. and concerned the refusal by the German Patent and Trade Mark Office to issue a SPC. The relevant patent related to the use of medicinal substances to reduce restenosis following angioplasty. The preliminary refusal was on the ground that the product forming the subject of that application did not have a MA for the purposes of Regulation No 469/2009 (the SPC Regulation).

Article 2 of the Regulation states that a product may be the subject of a SPC only if it has been subject, as a medicinal product, to an MA procedure as laid down in Directive 2001/83 (the 2001 Directive). The terms ‘medicinal product’ and ‘medical device’ are mutually exclusive so that a product that falls within the definition of a ‘medicinal product’ within the meaning of the 2001 Directive may not be classified as a ‘medical device’ within the meaning of Directive 93/42 (the Medical Devices Directive).

To determine whether a product falls under one or other of the relevant definitions, Article 1(5) (c) of the Medical Devices Directive requires the competent authorities to take particular account of the principal mode of action of the product. A product which does not achieve its principal mode of action by pharmacological, immunological or metabolic means falls under the definition of a ‘medical device’.

The Court concluded that Article 2 of the Regulation must be interpreted as meaning that a prior authorisation procedure under the Medical Devices Directive for a device incorporating a substance cannot be treated in the same way as an MA procedure for that substance, even if that substance was the subject of the assessment provided for in the Medical Devices Directive.

This article was co-authored by Mark Pugh.