The matter at hand

Merck Sharp & Dohme and other applicants in the main proceedings are manufacturers of medicinal products and proprietors of the trade marks under which the medicinal products are sold. The defendants in these proceedings import products into Denmark, which were placed on the market in other Member States.

In the main proceedings, two scenarios came into play: In some of the disputes leading to the main proceedings, the trade mark was replaced by a new product name with reference to the original trade mark, (both the blister packs inside that new outer packaging and the new leaflet accompanying the medicinal products indicate that, that product corresponds the product sold under the proprietor’s trade mark). In other of those disputes, the trade mark of those manufacturers was affixed to new outer packaging, but without other distinguishing marks on the new outer packaging.

The manufacturers argued that the repackaging in new outer packaging in the two scenarios mentioned above conferred them the right to oppose the repackaging as this was not ‘necessary’, (as is required by the first of the five principles from cases C-427/93, C-429/93 and C-436/93 (Bristol-Myers Squibb and others). The parallel importers disagreed and claimed that, given the circumstances of the case, repackaging is ‘necessary’ and therefore lawful.

The referring court, the Sø- og Handelsretten (Maritime and Commercial Court), raised preliminary questions regarding the interpretation of Article 15(2) of Trade Mark Directive 2015, asking (in short) whether and under which circumstances a proprietor may oppose further commercialisation of a medicinal product that a parallel importer has repackaged in new external packaging to which the trade mark has been reaffixed.

The judgment of the ECJ

Upon addressing the questions raised, the ECJ recalls that “the rights conferred by a trade mark are not to entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the European Union under that trade mark by the proprietor or with his or her consent” (paragraph 47). That provision seeks the balance between, on the one hand, the fundamental interests of trade mark protection, and on the other hand, those of free movement of goods in the internal market.

The ECJ further reiterates that the repackaging in new packaging constitutes a greater interference on the rights of the proprietor than relabelling the original packaging (paragraph 56).

Further, the ECJ refers to various regulations aimed at preventing the entry of falsified medicinal products in the legal supply chain. More specifically, the ECJ refers to Article 54 of Directive 2001/83 and considers that pursuant to this regulation the packaging “must be equipped with safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to verify the authenticity of the medicinal product concerned” (paragraph 59), such as an ‘anti-tampering device’ (paragraph 67). 

In light of the above considerations, the ECJ rules that the proprietor of a trade mark is in principle “entitled to oppose the marketing, by a parallel importer, of a medicinal product repackaged in new outer packaging to which that trade mark is affixed where the replacement of the anti-tampering device of the original outer packaging, […] , would leave visible or tangible traces of that original outer packaging having been opened.” However, two requirements apply, namely that (i) “there is no doubt that those traces of opening are attributable to the repackaging of that medicinal product by that parallel importer”; and (ii) “those traces do not cause, on the market of the Member State of importation or on a substantial part of it, such strong resistance from a significant proportion of consumers to the medicinal products repackaged in that way that it would constitute a barrier to effective access to that market” (paragraph 79).

As for the first scenario described above (trade mark is replaced by a new product name, with reference to the original trade mark), the ECJ holds that the proprietor has a legitimate interest in opposing the further marketing of this product “where such repackaging of that medicinal product in new outer packaging is not objectively necessary for the purposes of its being marketed in the Member State of importation” (paragraph 118). In case of the second scenario (trade mark is affixed to new outer packaging without any other distinguishing signs) the proprietor may only oppose the marketing, when the presentation of that new outer packaging is in fact liable to “damage the reputation of the trade mark” or when said use “adversely affects the function of indicating the origin of the mark” (paragraph 130).