The matter at hand

Lohman & Rauscher is the proprietor of the EU trade mark ‘DEBRISOFT’ under which it manufactures and markets a dressing used for the superficial treatment of wounds. Junek Europ-Vertrieb is a company established in Austria and markets in Germany, by way of parallel importation, the dressings as manufactured and exported to Austria by Lohman & Rauscher.

Junek Europ-Vertrieb reimported and sold the dressings in Germany. Before the sale, the company had affixed on the box a label featuring the name of Europ-Vertrieb, its contact details, a barcode and a central pharmaceutical number. The label was applied neatly to an unprinted part of the box and did not conceal the ‘DEBRISOFT’ mark. Junek Europ-Vertrieb had not given prior notice to Lohmann & Rauscher of the reimportation of the dressings and also had not supplied it with the modified packaging of the product with the additional label affixed to it.

Lohmann & Rauscher International considered that the conduct of Junek Europ-Vertrieb was an infringement of the DEBRISOFT mark, which position was confirmed by both the Landgericht Düsseldorf and, in appeal, by the Oberlandesgericht Düsseldorf. Junek Europ-Vertrieb then lodged an appeal before the Bundesgerichtshof.

The exhaustion of a trade mark right, as stipulated in Article 13(1) of Trade Mark Regulation 207/2009Council Regulation [EC] No 207/2009 of 26 February 2009 on the Community trade mark, implies that a trade mark proprietor cannot prohibit the use of its trade marks in relation to goods which have been put on the market in the European Union under that trade mark by the proprietor or with its consent. Article 13(2) of that Regulation stipulates that this does not apply where there exist legitimate reasons for the proprietor to oppose further commercialisation of the goods, especially where the condition of the goods is changed or impaired after they have been put on the market.

The referring court asks, in essence, whether the exhaustion provision must be interpreted as meaning that the proprietor of a mark may oppose the further commercialisation, by a parallel importer, of a medical device in its original internal and external packaging when an additional label has been added by the importer. More specifically, it wishes to know whether the principles developed by the ECJ in its judgments in Bristol-Myers Squibb and Others (C‑427/93, C‑429/93 and C‑436/93) and Boehringer Ingelheim and Others (C‑348/04) apply in such a situation.

The judgment of the ECJ

First of all, the ECJ recalls its earlier findings in the aforementioned case law that the proprietor of a mark may legitimately oppose the further commercialisation of a pharmaceutical product imported from another Member State if the importer has repacked or relabelled the product, unless the following five conditions are all satisfied (paragraphs 22 through 30):

• it is established that the use of the trade mark rights by the proprietor thereof to oppose the marketing of the relabelled products under that trade mark would contribute to the artificial partitioning of the markets between Member States;

• it is shown that the repackaging cannot affect the original condition of the product inside the packaging;

• the new packaging states clearly who repackaged the product and the name of the manufacturer;

• the presentation of the repackaged product is not such as to be liable to damage the reputation of the trade mark and of its owner; thus, the packaging must not be defective, of poor quality, or untidy;

• the importer gives notice to the trade mark proprietor before the repackaged product is put on sale, and, on demand, supplies him with a specimen of the repackaged product.

In the present judgment, the ECJ clarifies that the facts that gave rise to the above case law, differ from the facts in the present case. In those earlier cases, an intervention by the parallel importer was at issue that involved not only affixing an additional external label to the packaging of the pharmaceutical products concerned or its repackaging, but also the opening of the original packaging in order to insert an information leaflet in a language different from that of the country of origin of the product which bore the mark in question (paragraphs 31 through 33). In the present case, Junek Europ-Vertrieb has merely affixed an additional label to the unprinted part of the original packaging of the medical device in question, which, moreover, had not been opened. Second, the label is small in size and only includes the name, contact details, a barcode and a pharmacological number (paragraph 34).

According to the ECJ, the attachment of such a label does not constitute “repackaging” within the meaning of the its earlier judgments, “given that the packaging of the medical device concerned has not been modified and the original presentation of the packaging has not been affected other than by the attachment of a small label, which does not conceal the mark and which designates the parallel importer as responsible for placing it on the market by setting out his details, a barcode and a central pharmacological number” (paragraph 35). As a consequence, “it cannot, in any event, be held that the attachment of such a label affects the specific purpose of the mark, which is to guarantee the origin of the product that it identifies” (paragraph 36).

The ECJ therefore answers to the referring question by stating that the exception of Article 13(2) of Trade Mark Regulation 207/2009Council Regulation [EC] No 207/2009 of 26 February 2009 on the Community trade mark to the exhaustion rule of Article 13(1) of Trade Mark Regulation 207/2009Council Regulation [EC] No 207/2009 of 26 February 2009 on the Community trade mark  “must be interpreted as meaning that the proprietor of a mark cannot oppose the further commercialisation, by a parallel importer, of a medical device in its original internal and external packaging where an additional label, such as that at issue in the case in the main proceedings, has been added by the importer, which, by its content, function, size, presentation and placement, does not give rise to a risk to the guarantee of origin of the medical device bearing the mark“ (paragraph 39).