European Union: ECJ Again Rules In Favour Of Repackaging Of Parallel-Traded Pharmaceuticals

On 28 July 2011, the Court of Justice of the European Union (the "ECJ") handed down a judgment addressing questions referred to it by the Danish Supreme Court (the "Referring Court") with respect to the rules governing the repackaging of parallel-traded pharmaceuticals.

The proceedings before the Referring Court had been initiated by Merck against Orifarm and Paranova, two Danish parallel importers, on the basis of Article 7(2) of the First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to trade marks. In Bristol-Myers Squibb, a judgment of 1996, the ECJ set forth 5 conditions which, when met by parallel importers, preclude trade mark owners from objecting to the marketing of a repackaged pharmaceutical product pursuant to this provision. Under one of these conditions, the new packaging should clearly indicate the repackager of the product. Merck felt it was entitled to act against Orifarm and Paranova given that they had mentioned their own names on the new packages of parallel imported Merck products, rather than the names of the actual repackaging companies which had acted as their subcontractors.

On 12 May 2011, Advocate General Bot already gave his opinion in this case and rejected Merck's position. The ECJ has now sided with the Advocate General.

The ECJ first stated that the objective of the requirement at issue is to avoid that the consumer is led to believe that the trade mark owner is responsible for the repackaging. The ECJ then held that this objective is achieved if parallel traders clearly mention the name of the firm that oversees and assumes responsibility for the repackaging. According to the ECJ, this also adequately protects the trade mark owner in the event that the original condition of the product within the packaging was affected by the repackaging or the presentation of the repackaged product is liable to damage the repute of the trade mark.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.