Martin Howe QC and Isabel Jamal acted for the appellants in successfully persuading the Court of Appeal to make a preliminary reference on the interpretation of the so-called ‘Specific Mechanism’, which relates to the parallel importation of pharmaceuticals from Poland and other EU Accession States. The case was decided at first instance ([2012] EWPCC 18, HHJ Birss QC) without a reference.
Sigma notified Merck of its intention to import a Merck drug called Singulair from Poland asking whether Merck had any objection. Merck did not reply as a result of an administrative oversight. Sigma went ahead and imported and sold large quantities of Singulair until Merck objected at which point it stopped. The Specific Mechanism in Poland’s Act of Accession to the EU creates an exception to the normal EU free movement rules. It allows drug patent or SPC holders in the existing Member States to enforce them against parallel imports when they could not have obtained corresponding protection under Polish law. It also requires the patent holder or his beneficiary to be notified at least one month before the import licence is applied for. The Court of Appeal’s questions to the ECJ will ask whether there has to be a prior demonstration by the patent holder of its intention to invoke the Specific Mechanism before parallel importations are to be treated as infringing acts; and also by whom and to whom the notification should be given, since in this case it was given by another company in Sigma’s group, and was sent to Merck’s operating subsidiary in the UK rather than to its Canadian subsidiary which was the registered proprietor of the patent.