On April 26, 2007, the ECJ issued a judgment regarding the extent to which importers may change the original packaging of brandname pharmaceuticals traded in EU. The case focused on whether the conditions set out by the ECJ, on July 11, 1996, in Bristol-Myers Squibb (“BMS”) and relative to when pharmaceutical manufacturers are entitled to prevent parallel imports of re-boxed pharmaceutical products, also apply to overstickered products.
Parallel importers argued that those conditions should not apply to overstickered products.The ECJ held that overstickering might create real risks for the guarantee of origin. Furthermore, the specific market access condition concerning the absence of damage to reputation is not limited to cases where the repackaging is defective, of poor quality, or untidy, but it may also include damage resulting simply from practices such as de-branding and cobranding.
However, this is a question of fact for the national court to decide in each case. The ECJ further stated that it belongs to the parallel importer to prove that the market access conditions are satisfied while the conditions relating to the absence of damages to the original packaging of the product and the absence of damage to reputation is in charge of the proprietor. The Court also rules that the right of pharmaceutical companies to prevent parallel imports where no notice has been provided is the same as in the case of counterfeit goods and that national courts can allow damages to pharmaceutical companies on the same basis.
Therefore, the ECJ has determined that the BMS conditions must be mechanically applied to overstickered products as well as to re-boxed ones. In addition, the ECJ has pointed out that all imported products for which the parallel importer has not given any notice must be regarded as infringements.
While his judgment shall be welcome by the Drugs industry, it is to be noted that the Court leave many points to be decided by National Courts.