Following the referral from the German Bundespatentgericht in September 2017 in LN (now Boston Scientific) (Case C-527/17), the CJEU today delivered its decision (without any intervening Advocate General opinion).
The question referred (in September 2017) concerned the availability of supplemental protection certificates (SPCs) for medical devices:
“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?”
In its decision, the CJEU has held that an SPC is not available for a medical device authorised under the Medical Devices Directive 93/42/EEC, even if the device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product and the quality, safety and usefulness of that substance has been verified by analogy with the methods specified in the Medicinal Products Directive 2001/83/EC.
Pending a fuller analysis of the decision (to follow), this appears to be more of a prohibition for medical device SPCs, and if so would be an adverse decision in terms of the availability of SPCs for any products (in a human therapeutic context) not authorised directly pursuant to the Medicinal Products Directive 2001/83/EC.
The emphasis on extending protection for medical devices may now shift to whether a new form of protection should be provided (for example following the European Commission’s recent studies into the legal and economic aspects of SPCs). Pending the advent of any such system, drug-device combination products on the regulatory borderline between medicinal products and medical devices may be at a key junction as to whether or not an SPC will be available.
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