The matter at hand

Bayer is the proprietor of the German trade mark Androcur. Kohlpharma, a parallel importer, informed Bayer that for the distribution of parallel-imported medicinal product Androcur, it intended to repackage the product. Bayer argued that the use of new packaging would go beyond what was necessary in order to distribute the product in Germany.

The referring court, Landgericht Hamburg (Regional Court, Hamburg) raised the question whether the exhaustion provision must be interpreted as meaning that the proprietor of a mark may oppose the marketing, by a parallel importer, of a medicinal product repackaged in new outer packaging to which that trade mark is affixed, where relabelling of that product would also allow the medicinal product to be marketed in that Member State and whether the presence of traces on the outer packaging influences this assessment.

The judgment of the ECJ

In answering this question, the ECJ first reiterates several of its earlier findings, to conclude that it “has thus held that the trade mark proprietor may oppose replacement packaging where the parallel importer is able to reuse the original packaging for the purpose of marketing in the Member State of importation by affixing labels to that packaging”, but that “the trade mark proprietor is entitled to oppose the parallel importer’s use of that replacement packaging only on condition that the relabelled medicinal product is able to have effective access to the market concerned” (paragraph 66). 

Ion light of these criteria, the ECJ concludes that the trade mark proprietor is entitled to oppose the repackaging where it is “objectively possible to relabel the medicinal product concerned”. This entails that the relabelling is in compliance with the applicable labelling requirements and must actually access the market of the Member State of importation (paragraph 68).

Regarding the presence on the outer packaging of visible traces of prior opening, the ECJ holds that this is not sufficient for the view that relabeling is not equivalent, where there is no doubt that those traces of opening are attributable to the repackaging by the parallel importer (paragraph 78).