New referral to the CJEU

In Merck Sharp & Dohme v Comptroller-General of Patents [2016] EWHC 1896 (an appeal to BL O/117/16), Mr Justice Arnold has referred the following questions to the CJEU for a preliminary ruling:

(1) Is an end of procedure notice issued by the reference member state under Article 28(4) of the Medicinal Products Directive equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation?

(2) If the answer to question (1) is no, is the absence of a granted marketing authorisation at the date of the application for a certificate an irregularity which can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?

This case arose because Merck Sharp & Dohme filed an SPC application one day before patent expiry but only had the "End of Procedure Communication" but not a marketing authorisation.