On a reference from the Austrian Supreme Court concerning Article 7 of the Trade Marks Directive (89/104/EEC) and the parallel importation of pharmaceuticals, the European Court of Justice (ECJ) has followed the lead of Advocate General Sharpston and concluded that the lawfulness of the new packaging, in which drugs are marketed in another European Economic Area (EEA) State by a parallel importer, is to be measured solely against whether it is capable of damaging the reputation of the trade mark and its proprietor. There is no presumption that the adverse effect on the trade mark holder’s rights should be the minimum possible. As such, the trade mark holder’s power to control such trade appears to be diminished. The case in question is The Wellcome Foundation Ltd v Paranova Pharmazeutica Handels GmbH [2008] C- 276/05 (unreported).

FORMAL CONCLUSION

The ECJ’s formal response to the Austrian court was

  1. Article 7(2) of [the Trade Marks Directive as amended] is to be interpreted as meaning that, where it is established that repackaging of the pharmaceutical product is necessary for further marketing in the Member State of importation, the presentation of the packaging should be assessed only against the condition that it should not be such as to be liable to damage the reputation of the trade mark or that of its proprietor.
  2. Article 7(2) is to be interpreted as meaning that it is for the parallel importer to furnish to the proprietor of the trade mark the information which is necessary and sufficient to enable the latter to determine whether the repackaging of the product under that trade mark is necessary in order to market it in the Member State of importation.

COMMENT

In following the Advocate General’s opinion the ECJ has brought some clarity to the extent of a parallel importer’s obligations in relation to the repackaging and notification requirements under the BMS criteria. Some uncertainties remain, however and these may continue to be explored by major pharmaceutical companies that are likely to continue opposing parallel importers unabated and on several fronts. In particular, Paranova’s central concerns were that extensive disclosure of a proposed repackaging regimen by a parallel importer to a trade mark owner could result in splitting the market with the same drug, or in over-complicated demands that could impede competition within the EEA. The ECJ’s ruling may not have allayed those concerns completely.