Reference for a preliminary ruling from High Court of Justice (Chancery Division) (United Kingdom) made on 10 November 2016 – Merck Sharp v Comptroller-General of Patents, Designs and Trade Marks
(Case C-567/16)
Language of the case: English
Referring court
High Court of Justice (Chancery Division)
Parties to the main proceedings
Applicant: Merck Sharp
Defendant: Comptroller-General of Patents, Designs and Trade Marks
Questions referred
Is an End of Procedure Notice issued by the reference member state under Article 28(4) of European Parliament and Council Directive 2001/83/EC1 of 6 November 2001 on the Community code relating to medicinal products for human use before expiry of the basic patent to be treated as equivalent to a granted marketing authorisation for the purposes of Article 3(b) of European Parliament and Council Regulation 469/2009/EC2 of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (the "SPC Regulation"), such that an applicant for an SPC in the Member State in question is entitled to apply for and be granted an SPC on the basis of the End of Procedure Notice?
If the answer to question (1) is no; in the circumstances in question 1, is the absence of a granted marketing authorisation in the Member State in question at the date of the application for an SPC in that member state an irregularity that can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?
____________1 OJ L 311, p. 67
2 OJ L 152, p. 1