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 on the body in a manner ancillary to that device had to be dealt with under Article 1(4) and might not be regarded as a medicinal product capable of being the subject of this marketing authorisation procedure.
The term "medicinal product" had to be distinguished from the term "medical device". The terms were mutually exclusive so that a product falling within the definition of a medicinal product within the meaning of the 2001 Directive could not be classified as a medical device within the meaning of the 1993 Directive.
In order to determine whether a product fell under one or other of those definitions, Article 1(5)(c) of the 1993 Directive required the authorities to take account of the principal mode of action of the product. A product which did not achieve its principal mode of action by pharmacological, immunological or metabolic means fell under the definition of a "medical device". Conversely, a product which achieved its principal intended action in the human body by such means was a medicinal product. Where a substance, such as that in this case, acted on the body with action ancillary to that of the device in which it was incorporated, it could not be classified independently from that device and was not a "medicinal product", even if it could have been classified as such if it were used separately. Such a substance could not therefore fall within the scope of the 2009 Regulation.
The prior authorisation procedure for a substance which formed an integral part of a medical device under the 1993 Directive was not equivalent or comparable to the procedure provided for under the 2001 Directive. The two regulations were mutually exclusive.
The 1993 Directive required that, where a medical device incorporated as an integral part such a substance, the quality, safety and usefulness of the substance had to be verified by analogy with the methods specified in the 2001 Directive. Those verifications were not in relation to a use of the substance independent of the device but, instead, taking into account the intended purpose of the medical device and of the incorporation of the substance into that device. So, such a substance did not fulfil any of the conditions laid down in Article 2 in order to be eligible for an SPC, even if the quality, safety and usefulness of that substance were verified by analogy with the methods specified in the 2001 Directive.
The EU legislation intended to reserve the grant of SPCs to medicinal products alone, to the exclusion of both medical devices and substances used as adjuvant products of a medical device. The extension of the scope of that regulation to such substances would have the practical effect of enabling SPCs covering medical devices which incorporated those substances to be granted, contrary to that objective.
This decision follows the recent trend for the ECJ to give more straightforward interpretations of the SPC Regulation, providing certainty for users of the system. Although concerned with a specific type of combined medical device/ medicinal product combination, the reasoning should be generally applicable. SPC protection is therefore not possible for active ingredients which are ancillary to the overall effect of a medical device on the basis of a CE approval of a medical device/ medicinal product combination.
Case: Boston Scientific Ltd v Deutsches Patent- und Markenamt C 527/17.
First published in the December 2018 issue of PLC Magazine and reproduced with the kind permission of the publishers. Subscription enquiries 020 7202 1200.
