The Court of Justice of the European Union (CJEU) has issued a ruling clarifying what you can, and cannot, do if you wish to import goods from one Member State of the EU to another.

In summary, it has ruled that the trademark owner cannot oppose the further commercialisation of a medical device in its original internal and external packaging even where an additional label has been added by a parallel importer in certain circumstances. These are where, by its content, function, size, presentation and placement, the added label does not give rise to a risk to the guarantee of origin of the medical device bearing the trademark.

The CJEU's judgment in Junek Europ-Vertrieb GmbH v Lohmann & Rauscher International GmbH & Co. KG case C-642/16 (17 May 2018) seemingly smooths the way for parallel importers of trademarked products to bypass the conditions laid down in the BMS and Boehringer authorities. The case gives guidance on what constitutes repackaging, and therefore when the BMS/Boehringer conditions are relevant, in the context of trademarks for medical devices.

As reiterated by the CJEU, the BMS/Boehringer conditions are as follows:

"the proprietor of a mark may legitimately oppose the further commercialisation of a pharmaceutical product imported from another Member State in its original internal and external packaging with an additional external label applied by the importer, unless:

  1. it is established that the use of the trademark rights by the proprietor thereof to oppose the marketing of the relabelled products under that trademark would contribute to the artificial partitioning of the markets between Member States;
  2. it is shown that the repackaging cannot affect the original condition of the product inside the packaging;
  3. the new packaging states clearly who repackaged the product and the name of the manufacturer;
  4. the presentation of the repackaged product is not such as to be liable to damage the reputation of the trademark and of its owner; thus, the packaging must not be defective, of poor quality, or untidy; and
  5. the importer gives notice to the trademark proprietor before the repackaged product is put on sale, and, on demand, supplies him with a specimen of the repackaged product."

The CJEU identified the issue in the earlier cases as being not the addition of an external label to the packaging, but the opening of the original packaging in order to insert an information leaflet in a different language from that of the country of origin of the product. What is more, the earlier BMS/Boehringer decisions were made in circumstances where, for example, the product concerned had been repackaged in boxes which had been designed by the parallel importer and on which the proprietor's mark had (in some cases) been reproduced.

In this case, the CJEU acknowledged that the parallel importer had merely affixed an additional label to the unprinted part of the original packaging of the medical device, but that the product remained as originally packaged and unopened. The label itself was small and only included information regarding the name, address and telephone number of the parallel importer along with a barcode and a central pharmacological number.

The CJEU held that as the packaging of the medical device concerned had not been modified and so the original presentation had not been affected other than by the attachment of a small label, the BMS/Boehringer conditions did not apply. In reaching that conclusion, the Court noted that the label did not conceal the mark and only designated the parallel importer as responsible for placing the product on the market, so this did not constitute repackaging. This is an interesting development of the case-law, showing that the Court will look at each case on its facts rather than applying blanket rules. In this case, it found that the content, function, size, presentation and placement of the label did not affect the function of the trademark to guarantee the origin of the medical device and so it was permissible.