The matter at hand

Under EU law, medicinal products may not be placed on the market within the Union unless and until a marketing authorisation has been granted. In order to obtain such authorisation, pharmaceutical companies have to carry out clinical trials to verify the effects of the medicinal product, and submit the results thereof as part of their application for authorisation. This process can take quite some time, with the (from a trade mark law perspective: unpleasant) side effect that it can take a long time before the trade mark intended for the pharmaceutical product can be used to advertise or market the product.

In this case, Viridis Pharmaceutical was still in the middle of this process with respect to a medicinal product it intended to market under the trade mark BOSWELAN, when the five year period expired within which it should have made genuine use of this mark. At that point, Hecht-Pharma filed an application for revocation of the trade mark BOSWELAN on the basis of Article 51(1)(a) of Trade Mark Regulation 207/2009Council Regulation [EC] No 207/2009 of 26 February 2009 on the Community trade mark.

The application was granted by the Cancellation Division and this decision was upheld by the Fifth Board of Appeal and the General Court. All held that the use of the trade mark BOSWELAN, which had been limited to the use thereof in the context of a clinical trial, had been insufficient to constitute genuine use, and that there were no proper reasons for non-use. Viridis appealed to the ECJ, arguing that the use of the trade mark in the context of the clinical trial did constitute genuine use, and, alternatively, that there were proper reasons for non-use, considering that the marketing authorisation required to place the products on the market had not been granted yet.

The judgment of the ECJ

The ECJ recalls that it follows from Ansul/Ajax (C-40/01) that ''genuine use of the mark thus entails use of the mark on the market for the goods and services protected by that mark and not just internal use by the undertaking concerned. Use of the mark must relate to goods or services already marketed or which are about to be marketed and for which preparations by the undertaking to secure customers are under way, particularly in the form of advertising campaigns.'' (paragraph 39).

The ECJ rules that the General Court correctly applied this case law by considering “a medicinal product for which marketing authorisation has not yet been granted cannot even form the subject of advertising intended to obtain or preserve a market share. It is therefore impossible to use a mark covering such a medicinal product on the market concerned, contrary to the requirement laid down in the case-law cited in paragraph 39 of the present judgment.'' (paragraph 47).

As to the use Viridis had made of the trade mark in the context of the clinical trial, the ECJ holds that while it is true that there can also be genuine use if the relevant goods have not been marketed yet “that a mark can be found to be put to such use only if the marketing of the goods at issue is imminent” (paragraph 51). In the (factual) assessment of the General Court, this was not the case here, because there was no evidence that the clinical trial was nearly concluded. Moreover, the General Court correctly applied the ECJ’s case law by considering that the use in the context of the clinical trial was of an internal nature, since it had taken place outside of competition, within a limited circle of participants, and without the aim of creating or maintaining a market share.

The ECJ summarises that “inasmuch as the genuine use of an EU trade mark cannot be established by acts of use related to a stage prior to the marketing of the goods or services covered unless the marketing is imminent, the acts of use capable of establishing such genuine use must be external in nature and produce effects for the future public of those goods or services, even in such a pre-marketing phase.” (paragraph 53).

The ECJ then goes into the question of whether the fact that medicinal products may not be marketed without a marketing authorisation constitutes a proper reason for non-use, considering that the process for obtaining a marketing authorisation can be lengthy. In this regard, the ECJ recalls that it follows from Häupl (C‑246/05) that “only obstacles having a sufficiently direct relationship with a trade mark making its use impossible or unreasonable, and which arise independently of the will of the proprietor of that mark, may be described as ‘proper reasons for non-use’ of that mark” (paragraph 65). The ECJ continues that although government requirements for goods or services protected by the trade mark may constitute proper reasons for non-use, in this case the long period of non-use was not caused by the requirement of a marketing authorisation, but, according to the General Court’s assessment, by acts and events within Viridis’ sphere of influence and falling within its responsibility. In this regard, the General Court had pointed out that Viridis had applied for the trade mark on the basis of its own choice in 2003, while at that time there was considerable uncertainty as to whether and when the product, which was still at the clinical testing stage, could be marketed. In addition, the General Court took account of the fact that the difficulties encountered during the clinical trial resulted from insufficient funding by Viridis and that Viridis submitted the application for a clinical trial more than three years after the registration of the mark at issue.

On this basis, the ECJ rules that the General Court did not err in law by holding that the duration of the non-use was not a result of obstacles that occurred independently of the will of the trade mark owner.