Supplementary Protection Certificates (SPCs) are available for certain medicinal or plant protection products, as explained here. However, it remains unclear whether certain types of medical devices are also eligible for SPC protection. A new referral to the Court of Justice of the EU (CJEU) seeks clarification.
The SPC Regulation sets out that SPCs are available for products that have undergone a specific marketing authorization procedure (1), but it remains unclear whether a product must undergo that specific procedure (which typically applies to medicinal products), or whether an equivalent procedure (2) (which typically applies to medical devices) makes a device eligible for an SPC.
To date, this issue has been dealt with in a non-uniform manner across the EU, so whilst there are a few instances where SPCs have been granted for certain medical devices (on the basis of authorisations granted under the Medical Devices Directive), e.g. in the Netherlands, Italy, and France, the UK has taken a stricter approach.
A new referral to the CJEU (C-527/17) has now been made to try to seek more clarity and potential harmonization in this regard.
The following question has been referred:
Must Article 2 of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products be interpreted as meaning that, for the purposes of that regulation, an authorisation under Directive 93/42/EEC for a combined medical device and medicinal product within the meaning of Article 1(4) of Directive 93/42/EEC is to be treated as a valid marketing authorisation under Directive 2001/83/EC, where, as part of the authorisation procedure laid down in Annex I, Section 7.4, first paragraph, to Directive 93/42/EEC, the quality, safety and usefulness of the medicinal product component has been verified by the medicinal products authority of a Member State in accordance with Directive 2001/83/EC?
The question seems to be limited to certain devices that are in combination with a medicinal product, e.g. stents coated with a drug, so, as usual, any answers by the CJEU are unlikely to provide clarity across the whole field.
(1) an "administrative procedure as laid down in Directive 2001/83/EC” (the Medicinal Product Directive”) according to Article 2 of the SPC Regulation
(2) For example, the route prescribed for Class III Medical Devices in Directive 93/42/EEC
the quality, safety and usefulness of the medicinal product component has been verified by the medicinal products authority