In response to a reference from the Austrian Supreme Court, the European Court of Justice (ECJ) has decided on two issues relating to the repackaging of Zovirax.

The Trade Marks Directive (89/104/EEC) provides that a trade mark owner may not prohibit the use of a trade mark in relation to goods which have been put on the market within the European Economic Area under that mark, either by the owner of the mark or with its consent. The sole exception to this is where there are legitimate reasons for opposing further commercialisation of the goods, particularly where the condition of the goods is altered or impaired once the goods are out in the relevant market.

In an earlier case, Bristol-Myers Squibb v Paranova AS [1996] ECR I-3457, the ECJ ruled that in cases of parallel imports of repackaged or relabelled pharmaceuticals, to avoid a trade mark infringement, a parallel importer must be able to show the following:

  • that the opposition of the trade mark owner contributed to the artificial partitioning of the markets between member states (this would apply where the repackaging of the product was "necessary" to allow the product to enter the market in the importing state);
  • that the original condition of the product remained unaffected by its repackaging;
  • that the identity of both the original manufacturer and the repackager was clear following the repackaging;
  • that the presentation of the repackaged product did not, or was not likely to, damage the reputation of the trade mark or its owner; and
  • that the repackager gave notice of his intentions to the trade mark owner before the repackaged product entered the market, and provided a sample on request.  

In the current case, Wellcome Foundation Ltd v Paranova Pharmazeutika Handels GmbH, 22 December 2008, Wellcome owned the Zovirax trade mark and licensed GlaxoSmithKline Pharma GmbH as the Austrian importer. Paranova was the licensed importer for Greece, and in order to comply with Austrian regulations, they repackaged the goods from packs of 70 to packs of 60. Wellcome was sent parts of the repackaged goods as samples, and requested that in future cases, Paranova supply a fully dressed sample together with reasons as to why it was repackaging. Paranova failed to comply fully with Wellcome's requirements and Wellcome sought an injunction to prevent further repackaging.

The ECJ decision set out that where it is established that the repackaging of a pharmaceutical product is necessary in order to market the product in a specific Member State, the presentation of the packaging should be assessed only in terms of whether it is liable to damage the reputation of the trade mark or its owner. Further, the parallel importer must give the trade mark owner such information as was both necessary and sufficient in nature, for the trade mark owner to be able to determine whether such repackaging was necessary in order for the paralleled product to enter the market in the Member State of importation. As to the nature of the information which must be provided, this could vary depending on the facts of each case, and, in exceptional circumstances, this may include the requirements of the Member State of export, including a declaration as to the Member State of export.

In effect, the ECJ agreed with the parallel importer's interpretation of the scope of the criteria used to assess the presentation offered by the repackager, and with its interpretation of the requirements for notification to be offered to the trade mark owner, as required under Article 7.

The ECJ upheld the principle of minimum intervention in cases of this type and did not impose a duty on the repackager to state the country of export as a matter of course.