IP case law Court of Justice

Referral C-527/17 (LN, 5 Sep 2017)

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?

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