On 25 October 2018 the ECJ handed down decision (C-527/17) responding to a preliminary ruling request from the German Federal Patents Court regarding the availability of a supplementary protection certificate (SPC) for a medical device which incorporated a pharmaceutical drug.
The medical device at the centre of the case — the TAXUS device — was a drug-eluting coronary stent coated in Paclitaxel (a drug which has an inhibiting effect on the further narrowing of a blood vessel for which Boston Scientific had held a European Patent since 1994). The question referred to the ECJ concerned an application for an SPC for Paclitaxel which was grounded on the CE conformity certificate obtained for the TAXUS device in 2003, in accordance with the provisions of EU Directive 93/42/EEC (the 'Medical Devices Directive').
The granting of SPCs is governed by Regulation (EC) 469/2009 (the 'SPC Regulation') which seeks to reward holders of pharmaceutical patents for the time invested in costly research and development. One of the preconditions to obtaining SPC protection for a medicinal product for human use is that at the date of application a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with EU Directive 2001/83/EC (the 'Medicinal Products Directive').
The Court held that the wording of the SPC Regulation was clear and that a human medicinal product may be the subject of an SPC, only if it has been subject to a marketing authorisation procedure as provided for in the Medicinal Products Directive.
It further held that the terms 'medicinal product' and 'medical device' are mutually exclusive, and that a product which does not achieve its principal mode of action by pharmacological, immunological or metabolic means falls under the definition of medical device, and any substance which is integral to that device but performs an ancillary function, cannot be classified independently from that device.
Although Boston Scientific's TAXUS device had undergone a comparable authorisation procedure as part of its CE authorisation, it could not be argued that Paclitaxel had undergone an equivalent authorisation procedure to that required for SPC protection.
It is clear from this decision that SPC protection will not be extended to cover a medical device/drug combination product which is classified and regulated as a medical device under the Medical Devices Directive. Although the decision will come as a disappointment to medical device owners, it is not a surprising one and provides much awaited legal certainty.