The EU Court of Justice recently gave a detailed judgment in a series of cases referred from Denmark concerning the repackaging of parallel imports of medicinal products.
The Danish court had referred seven questions (including several sub-questions) in disputes between pharmaceutical companies and parallel importers. They concerned cases where the medicinal products from other EU Member States were repackaged in new outer packaging, the package leaflet replaced and a new unique identifier and anti-tampering device attached.
The court essentially asked whether the trade mark owners (i.e. pharmaceutical companies) can oppose the repackaging in these circumstances or, as the defendants argued, whether the repackaging is necessary and lawful.
A balanced approach
The Court took a balanced approach in its judgment. On the main question, it said that the relevant EU legislation must be interpreted as meaning:
that the proprietor of a trade mark is 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 carried out in accordance with Article 47a(1) of Directive 2001/83 would leave visible or tangible traces of that original outer packaging having been opened, provided that:
– there is no doubt that those traces of opening are attributable to the repackaging of that medicinal product by that parallel importer, and
– 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 (emphasis added).
It also addressed supplementary points raised by the referral, namely:
Member States are precluded from requiring that medicinal products imported in parallel must, in principle, be repackaged in new packaging and that recourse may be had to relabelling and to the affixing of new safety features to the original outer packaging of those medicinal products only on application and in exceptional circumstances, such as a risk of disruption to the supply of the medicinal product concerned.
Where a Member State requires repackaging, that does prevent a trade mark proprietor from opposing the parallel import of a medicinal product repackaged in new outer packaging to which that mark is affixed.
The BMS condition under which a trade mark owner can oppose further marketing of repackaged products where it is not necessary is satisfied “where the trade mark which appeared on the original outer packaging of the medicinal product concerned has been replaced by a different product name on the new outer packaging of that medicinal product, provided that the immediate packaging of that product bears that trade mark and/or that new outer packaging refers to that mark”.
Trade mark owners may oppose the marketing of repackaging products where not all the trade marks/distinctive signs have been replaced where the presentation is “liable to damage the reputation of the trade mark or where that presentation does not enable normally informed and reasonably attentive consumers, or enables them only with difficulty, to ascertain whether that medicinal product originates from the proprietor of the trade mark or an undertaking economically linked to him or her or, on the contrary, originates from a third party, thus adversely affecting the function of indicating the origin of the mark.”
Sensible and practical
This comprehensive ruling is the CJEU’s latest contribution to the extensive jurisprudence on repackaging in the EU. By taking a sensible and practical approach, it should be reassuring for trade mark owners in the pharmaceutical industry.
However, this complex area may yet throw up further questions. Companies that are active in this sector – both trade mark proprietors and parallel importers – will want to study the ruling carefully as well as any subsequent decisions in this area. It is unlikely to be the last word.