Brussels Commercial Court: Parallel Imported Pharmaceuticals Must Comply With Latest Packaging

On 27 April 2017, the President of the Dutch-language Commercial Court of Brussels (Nederlandstalige Rechtbank van Koophandel/Tribunal de commerce néerlandophone)decided a case concerning the repackaging of parallel imported pharmaceuticals, in which it applied the so-called "BMS"-criteria which the Court of Justice of the European Union ("ECJ") developed in Bristol-Myers-Squibb (Case C-427/93).

The ECJ held in Bristol-Myers-Squibb that parallel imported products can be repackaged: (i) if repackaging is objectively necessary to market the product in the country of importation; (ii) if the repackaging does not affect the original condition of the product inside the packaging; (iii) if the new packaging clearly states who repackaged the product and indicates the name of the manufacturer; (iv) if the presentation of the repackaged product is not liable to damage the reputation of the trade mark or of its owner; and (v) if the importer gives notice to the trade mark owner before the repackaged product is put on sale, and, on demand, supplies him with a specimen of the repackaged product. If these five conditions are satisfied, the trade mark owner cannot legitimately object to the further marketing of a repackaged pharmaceutical.

The dispute before the Commercial Court of Brussels related to the parallel import and repackaging by Pi Pharma NV ("Pi Pharma") of pharmaceuticals of Merck Sharp & Dohme Corp. and MSD Belgium BVBA (together, "MSD"). MSD is the marketing authorisation holder of a pharmaceutical with the active ingredient montelukast which it markets under the trade mark "Singulair" in various presentations, including formats of 28 and 98 tablets. After the Federal Agency for Medicines and Health Products (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/Agence Fédérale des Médicaments et des Produits de Santé, the "FAMHP") had objected to the use by MSD of two shades of the colour blue for its logo as this could hamper the legibility of the labelling, MSD changed the logo to a single dark blue colour. On 16 January 2015, Pi Pharma notified MSD that it had received a licence from the FAMHP to distribute parallel imported "Singulair" products on the Belgian market. Pi Pharma imported the products from Poland where MSD also markets Singulair in packaging formats of 28 tablets. Subsequently, Pi Pharma repackaged the product into a new packaging of 98 tablets.

MSD claimed that Pi Pharma infringed its trade marks and copyright...