The European Court of Justice (ECJ) has ruled that a supplementary protection certificate (SPC) could not be granted for a substance which was an integral and active part of a patented medical device because the EU authorisation procedure for devices did not result in a marketing authorisation under the EU legislation covering medicinal products.
Article 2 of the SPC Regulation (469/2009/EC) (2009 Regulation) (Article 2) provides that any medicinal product for human use protected by a patent in an EU member state and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure set out in the Medicinal Products Directive (2001/83/EC) (2001 Directive) may, under the terms and conditions provided for in the 2009 Regulation, be the subject of an SPC.
Article 1(2)(b) of the 2001 Directive defines "medicinal product". Article 1(2)(a) of the Medical Devices Directive 93/42/EEC (1993 Directive) defines "medical device".
Where a device incorporates as an integral part a medicinal product which is liable to act on the body with action ancillary to that of the device, that device shall be assessed and authorized in accordance with the 1993 Directive (Article 1(4), 1993 Directive) (Article 1(4)).
B owns a European patent relating to the use of medicinal substances which claimed the use of taxol. Although taxol had already been the subject of a marketing authorisation as a medicinal product for the treatment of certain cancers, it was not subject, as a medicinal product intended for the claimed use in this patent, to any formal authorisation procedure under the 2001 Directive.
B obtained a CE certificate of conformity in relation to the medical device, a taxol-coated stent. In the context of the mandatory certification procedure taxol, an adjuvant product of that medical device, was the subject of a prior assessment, under the 1993 Directive.
B filed an SPC application on the basis of the patent and of the CE conformity certificate issued for the medical device.
The German Patent Office rejected the application on the ground that the product forming the subject of that application did not have a marketing authorisation as required by the 2009 Regulation.
B appealed, arguing that taxol had undergone an administrative authorisation procedure in accordance with the 1993 Directive. B argued that, during that procedure, an in-depth review of the safety and usefulness of taxol in relation to its use in the medical device had been carried out, so mandatory certification procedure should be regarded as an authorisation procedure equivalent to the marketing authorisation procedure laid down in the 2001 Directive.
The German court referred to the ECJ on the question whether Article 2 should be interpreted as meaning that an authorisation under the 1993 Directive for a combined medical device and medicinal product within the meaning of Article 1(4) is to be treated as a valid marketing authorisation under the 2001 Directive, where the quality, safety and usefulness of the medicinal product component has been verified under that 2001 Directive.
The ECJ ruled that the wording of Article 2 made it clear that a product might be the subject of an SPC only if it had been subject, as a medicinal product, to an marketing authorisation procedure as laid down in the 2001 Directive. So a substance which, as here, formed an integral part of a medical device and acted