Brussels Court Of Appeal Applies And Clarifies Criteria For Parallel Importation Of Medicines

 
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On 20 November 2012, the Court of Appeal of Brussels (the "Court") issued an interesting judgment discussing the obligations imposed on parallel importers of medicines. The Court clarified when parallel importers are allowed to repackage (as opposed to re-label or over-sticker) parallel imported medicines and how the parallel importer must inform the brand owner of the parallel importation.

Trade marks are, in principle, 'exhausted' after the first marketing of the product in the EU/EEA with the consent of the trade mark owner, and the trade mark proprietor can no longer rely on his exclusive rights unless there are legitimate reasons for the proprietor to oppose further commercialisation of the goods (Article 7 of Directive 2008/95/EC to approximate the laws of the Member States relating to trade marks - the "Trade Mark Directive"). The Court of Justice of the European Union (the "ECJ") accepts that repackaging (or re-labelling) can constitute a 'legitimate reason' within the meaning of Article 7(2) of the Trade Mark Directive for the trade mark proprietor to oppose the further commercialisation of parallel imported medicines.

However, the ECJ also determined criteria permitting the repackaging of parallel imported medicines. In particular, the ECJ set out five cumulative criteria in the BMS case (joined cases C-427/93, C-429/93 and C-436/93, judgment of 11 July 1996) (the "BMS criteria").

The BMS criteria for repackaging are as follows: (i) the trade mark holder's use of its trade mark results in the artificial partitioning of the market of Member States. This implies that the trade mark objects to the repackaging of medicines while the new package is necessary to market the product in the country of destination; (ii) the repackaging does not affect the original condition of the product; (iii) the new packaging clearly states who repackaged the product and the name of the manufacturer; (iv) the presentation of the repackaged product is not liable to harm the reputation of the trade mark holder (i.e., the packaging must not be defective, of poor quality, or untidy); and (v) the parallel importer gives notice to the trade mark holder before the repackaged product is put on sale, and, on demand, supplies him with a specimen of that product.

If all five conditions are satisfied, the parallel importer must be allowed to repackage the product. In contrast, if any of these five conditions is not met, the trade mark holder can claim that the...

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