On 14 September 2015, the Court of Appeal of Mons permitted parallel imported pharmaceutical products to be repackaged and sold in package sizes that are predominant on the Belgian market.

The case pitted Merck Sharp & Dohme ("MSD") against parallel importer Impexeco. MSD makes and sells pharmaceutical products based on the active ingredient losartan. These products are sold in Belgium under the trade marks Cozaar® and Loortan®. Impexeco bought Cozaar® boxes of 28 tablets in Poland and repackaged the products for sale on the Belgian market in boxes of 98 tablets, which is the most common packaging format for this product in Belgium.

MSD objected to the importation of the repackaged products and requested the Mons Commercial Court to prohibit Impexeco from importing the products.

The Mons Commercial Court imposed on 8 February 2013 a penalty on Impexeco for its failure to provide a final packaging sample to MSD prior to the importation and its failure to mention on the packaging that the goods had been imported by Impexeco. However, Impexeco was allowed to carry on importing the medicines.

Following the decision at first instance, Impexeco sent a sample of its final packaging for the imported products to MSD on 15 May 2013.

MSD further appealed against the decision of the Mons Commercial Court claiming that Impexeco should not be allowed to repackage the imported products.

The Court of Appeal recalled that the rules on parallel importation of pharmaceutical products seek to establish a balance between trade mark law and competition law. In particular, trade mark law provides that exclusive rights of goods sold in the EU/EEA are exhausted unless legitimate reasons exist to object to a further sale, such as the fact that the goods have been altered or reconditioned. On the other hand, competition law precludes the artificial partitioning of the single EU market.

The balance is supposed to be struck by the application of the so-called BMS criteria (Case C-427/93, judgment of the Court of Justice of the European Union, 11 July 1996), which were summarised by the Court of Appeal of Mons as follows. Repackaging is permitted only if:

  • the use by the trade mark proprietor of the rights granted by the trade mark to object to the sale of reconditioned goods would result in the artificial partitioning of the single market. The reconditioning must thus be objectively necessary to enter the market in the country of destination;
  • the reconditioning must not negatively affect the original state of the product;
  • the party responsible for the reconditioning as well as the manufacturer are clearly mentioned on the packaging;
  • the presentation of the reconditioned product does not impair the reputation of the trade mark or its proprietor; in other words, the reconditioning cannot be defective, of poor quality, etc.; and
  • the importer must give prior notice to the trade mark proprietor before the sale of the reconditioned product.

MSD argued that there was no objective necessity to repackage the products as a mere relabelling would have been sufficient. MSD thereby referred to the BMS case which held that repackaging is not objectively necessary if a mere relabelling is sufficient. However, the Court of Appeal sided with Impexeco in finding the repackaging objectively necessary in the case at hand. The Court of Appeal considered that the Belgian market consisted almost exclusively of packages of 98 tablets. Moreover, the Federal Agency for Medicines and Health Products (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Agence fédérale des médicaments et des produits de santé) had objected to a relabelling of the products. Finally, based on surveys submitted by Impexeco, the Court of Appeal found that the reluctance on the market to accept relabelled products further showed the necessity for repackaging. 

As a result, MDS's action to prohibit the repackaging was rejected.

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