Merck Sharp & Dohme Corp v Comptroller-General of Patents, Designs and Trade Marks, Ch Div (Arnold J), 29/7/16

The court referred to the CJEU for a preliminary ruling a number of questions on the interpretation of Regulation 469/2009 concerning the supplementary protection certificate. M had a patent for a pharmaceutical supplied as “Atozet”. A day before the patent expired, M applied for an SPC, without having a UK marketing authorisation but relying on an “end of procedure” notice indicating approval for marketing in Germany. The Comptroller refused the SPC because there was no valid UK marketing authorisation and on appeal the Court referred questions as to (1) whether an end of procedure notice in Germany was equivalent to a granted marketing authorisation; (2) if not, whether the irregularity could be cured under art10(3) of the Regulation once the marketing authorisation had been granted.