Merck v Sigma Pharmaceuticals, European Court of Justice
The European Court of Justice has ruled on questions referred by the Court of Appeal on the interpretation of the “Specific Mechanism” with regard to the importation of pharmaceutical products from Poland. The Specific Mechanism allows for certain UK patents to be used to prevent parallel imports from certain eastern European countries. The intended importer must give one month’s notice to the patentee or their beneficiary of its intention to import the goods subject to the patent.
In this case, Merck owned a patent for a pharmaceutical product which was the active ingredient in its product, “Singulair”. Sigma imported Singulair into the UK from Poland. Sigma applied for, and was granted, UK regulatory parallel licences for Singulair. Sigma then began to sell Singulair. In response, Merck sued Sigma for patent infringement. Sigma did not seek to challenge the validity of the patent, but maintained that it had given notice of the intention to import Singulair from Poland in June 2009 and Merck had not objected to Sigma’s activity until December 2010. Sigma argued that if Merck had wanted to rely on its patent rights, the Specific Mechanism legislation required Merck to have responded to its notification and it had failed to do so. Merck’s argument was that it was Sigma’s sister company that had given the notice of intention and it had gone to another company in Merck’s group.
At a first hearing of this claim in the Patents County Court, the judge concluded that Sigma had infringed Merck’s patent rights and damages were awarded. Sigma appealed the decision and the Court of Appeal made a reference to the ECJ for interpretation of certain provisions of the Specific Mechanism.
The ECJ has now confirmed that the owner of the patent was required to respond to a notice of intention to import by an importer, but that the notice must have been given to the owner of the patent and not another company in its group. If the owner does not respond to that notice, the distributor can ask the regulator to approve the importation. The ECJ added that the notice of intention to import does not have to be sent by the company engaged in the parallel importing as long as it is possible to identify the importer clearly.
