European Union Court of Justice rules on SPCs for medical devices
On October 25, 2018, decision C-527/17 of the Court of Justice of the European Union was published. The ruling excludes medical devices that comprise an active ingredient from protection by Supplementary Protection Certificates (SPC). In short, the CJEU decision confirmed that a Marketing Authorization for a medical device that includes an active ingredient cannot be considered equivalent to a Marketing Authorization of a medicine, issued according to the Medicinal Products Directive (Directive 2001/83 / EC).
Decision C-527/17 originates from an appeal filed by Boston Scientific, holder of European patent EP 0 681 475, against the decision to refuse to grant a CCP in Germany for its TAXUS ™ medical device.
On January 21, 2003, Boston Scientific obtained a CE certificate of conformity to market its paclitaxel-coated stent (TAXUS ™ medical device), in which the active agent paclitaxel acts as an adjuvant product of said medical device. The certificate of conformity was issued according to directive 93/42/EEC, concerning medical devices. Based on this authorization, Boston Scientific Ltd applied to the German Patent and Trademark Office for an SPC that was rejected by that office. As a result of the appeal filed by Boston Scientific before the Federal Patent Court, the latter decided to refer the question to the CJEU whether Article 2 of Regulation No. 469/2009 (any active ingredient or combination of active ingredients protected by a patent may be covered by an SPC) should be interpreted as meaning that a prior authorisation procedure, in accordance with Directive 93/42, for a device incorporating as an integral part a substance, within the meaning of Article 1(4) of that directive, can be treated in the same way as a Marketing Authorisation for that substance under Directive 2001/83, given that the same substance was the subject of the assessment provided for in the first and second paragraphs of section 7.4 of Annex I to Directive 93/42.
Article 1(4) of the cited directive 93/42/CEE defines:
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, that device shall be assessed and authorized in accordance with this Directive.
Decision C-527/17 therefore confirmed the interpretation that a medical device according to article 1(4) of directive 93/42/EEC is not the same as a medicinal product and therefore there is no legal provision to grant an SCP to a medical device.