This case refers to the parallel import into Germany, by Junek, of medical devices that Lohman had previously placed in the Austrian market. In order to do so, Junek had affixed a small label on the box of the product. This label included only the following information: the name of the company responsible for the importation, its address and telephone number, a barcode, and a central pharmaceutical number which serves to organise the movement of products with the pharmacies. According to the Court, the label was attached neatly to an unprinted part of the box and did not conceal the trademark of Lohmann.

Junek, prior to importing the product into Germany, did not give notice to Lohman, nor did it supply Lohman with the modified packaging of the product with the label affixed. Lohman claimed that, because of this, Junek had infringed Lohman’s trademark since it had not respected the criteria that the jurisprudence of the CJUE had established for parallel imports of repackaged medicinal products.

Relabelling and repackaging

In Europe, when discussing parallel trade of medicines, the relabeling and repackaging of such medicines have been a hot topic for years. In 1996, the CJUE established that repackaging the product should only be accepted by the trademark owner if the parallel importer could show that relabeling it was not enough to place the product in the destination market. In 2007, in the Boehringer case, the CJUE ruled that repackaging would not be a trademark infringement provided that 5 conditions were met. Among these, the parallel trader had to notify the trade mark owner before the repackaged product was put on sale and, upon request, provide such owner with a sample of the repackaged product. The Court, in 2007 further said that affixing a label to the packaging of a medicinal product was not just relabeling but also repackaging when the package of the product is altered. In the 2007 cases, the packaging was altered because the parallel importer, in addition to affixing an external label, opened the original packaging in order to insert an information leaflet in a language different from that of the country of origin of the product.

In this case, the Court notes that the packaging of Lohman’s product had not been modified, and that the only alteration from the original presentation was the attachment of a small label that did not conceal the trademark of Lohman, and that included the information that we have mentioned above. This, according to the Court, could not be considered to be repackaging, but just as a mere relabeling and, therefore, Junek did not need to give notice to Lohman nor provide it with a sample of the relabeled product. Thus, considering the circumstances, Lohman could not oppose to the parallel trade.

The Court shows once more sympathy to those who wish to take full advantage of the EU rules on free movement, but the ruling is very much influenced by the fact that Junek’s label was a neat and small one, that did not affect neither the quality nor the image of the product. Furthermore, the Court gives a lot of value to the fact that Junek’s label did not generate confusion as to the origin of the product.

La entrada Parallel imports of relabelled medical devices will be easier in the future aparece primero en Faus & Moliner Abogados.

Roche Diagnostics markets in vitro diagnostic medical devices in Germany. Servoprax purchased said devices in the United Kingdom, where they were also marketed, and then added a label and instructions in German and sold them in Germany. The product’s label in Germany made reference to two units of measurement (“mmol/l” and “mg/dl”), whilst in the United Kingdom, the label only featured one unit (“mmol/l”). Given that the units that Servoprax distributed in Germany only made reference to the latter unit (“mmol/l”), Roche Diagnostics believed that Servoprax could not sell them in such country without previously submitting them to an additional compliance assessment. Servoprax submitted the products to said assessment in December 2010 but, nevertheless, Roche Diagnostics brought suit for alleged damages caused theretofore. The local court, believing that the case was dependent on the interpretation of Directive 98/79/EC, suspended the main proceedings and raised the issue before the CJEU.

Freedom of movement covers the actions of Servoprax

Given that Directive 98/79/EC establishes that in vitro diagnostic medical devices that have been assessed and have obtained the CE marking must be able to enjoy free movement within the EU and given that German laws do not prohibit their distribution when the product information included is solely provided in the “mmol/l” unit of measurement, the CJEU ruled that there was no reason to demand that Servoprax submit the units resold in Germany to a new compliance assessment. In this regard, it asserted that the product compliance assessment is an obligation of the manufacturer who places the product onto the Community market for the first time, and not of the parallel importers purchasing a product in a Member State before subsequently reselling it in another. The foregoing applies, according to the Court, even if the information on the product has to be translated into the official language of the country to which the product is imported to, as established in Directive 98/79/EC.

Inclusion of a label and instructions in German does not involve reconditioning

The Court’s comments on the position of the European Commission are worth noting, given that the latter sustained that the parallel importer was obliged to communicate operations to the manufacturer, by way of analogy with the criteria set out in European case law in connection with medicinal products. The CJEU, on the other hand, concluded that the mere fact that a label and instructions translated into the official language of the importing country were included on the product, without changing its packaging or presentation, does not mean it was reconditioned. As a result, it asserted that in such cases, there is no legal basis that calls for the manufacturer to be informed of such operations.

La entrada Parallel import of in vitro diagnostic medical devices aparece primero en Faus & Moliner Abogados.