The European Court of Justice has ruled that it is not necessary to include the name of a repackager on repackaged pharmaceuticals. The preliminary ruling was delivered in joined trade mark infringement proceedings referred to the European Court by the Danish courts.

The pharmaceuticals at issue in the main proceedings were manufactured by Merck Sharp & Dohme, which also held the trade marks rights in the goods. The pharmaceuticals were imported into Denmark by two parallel importers authorised to market and sell the goods there. These “marketing authorisation holders” then outsourced the repackaging of the pharmaceuticals to group companies. However, the repackaging was stated to have been carried out by the marketing authorisation holders. Merck challenged, before the Danish courts, the practice of not naming the repackager on the packaging of the pharmaceuticals, alleging that it infringed its trade mark rights. The Danish courts then asked the European Court for guidance on the correct interpretation of the relevant provisions of the EU Trade Mark Directive.

The Directive provides that trade mark rights are exhausted when a trade marked product is put on the market in the EU with the trade mark owner’s consent. However, such rights are not exhausted where there are legitimate reasons for a trade mark owner to oppose further commercialisation of the goods in question.

The Court found that the lack of the name of the repackager on pharmaceuticals is not a legitimate basis to oppose further commercialisation. It stated that as the marketing authorisation holder is the entity with ultimate responsibility for repackaging, it is sufficient, from a consumer protection perspective, that the name of this entity be provided. The interests of the trade mark owner are safeguarded as he/she can enforce his/her rights directly against the marketing authorisation holder. Further, the use of the name of the marketing authorisation holder avoids giving consumers the impression that the goods have been repackaged by the trade mark owner.

While the decision provides clarity on the rights of trade mark owners as regards repackaged pharmaceutical goods, it was not an unexpected or surprising ruling. It is in line with the industry norm that a marketing authorisation holder is ultimately responsible for the actions of the repackager it authorises to repackage imported goods.

Contributed by David Cullen and John Magee.