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EU – MSD v. Comptroller-General / SPC referral to CJEU

17 Jan 2017

Merck Sharp and Dohme v. The Comptroller-General of Patents, Designs and Trade Marks, referral to CJEU, 10 November 2016, Case No. C-567/16, 10 Nov 2016

The questions referred are:

(1) Is an End of Procedure Notice issued by the reference member state under Article 28(4) of European Parliament and Council Directive 2001l83/EC 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/EC 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?

(2) 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?

The case can be followed here.

A copy of the referral decision (in Dutch) can be accessed here.