• European Perspectives

    Pharmaceuticals in the European Union

    Three recent cases before the European Court have considered matters of interest to pharmaceutical trade mark owners.

    The first case (Dr. Karl Thomae and EFPIA v European Commission and Council) dealt with applications for marketing authorisation at a Community level and the right to include two or more trade marks or pack designs in a single application. Under Council Regulation No. 2309/93, it is possible to obtain a single authorisation to market a pharmaceutical product throughout the EU via an application made to the European Agency for the Evaluation of Medicinal Products (EMEA). Under Commission Regulation No. 542/95, it is possible for the owner of such a centralised authorisation to vary its terms in certain respects. Minor amendments, such as a change in the name or address of the holder, can be made to the original authorisation.

    In the case in point, Dr. Karl Thomae obtained a Community authorisation for a product to be used in the treatment of Parkinson’s disease. The authorisation contained the single trade mark Daquiran. Because of trade mark conflicts in Denmark, Germany, Finland and Sweden, Dr. Karl Thomae sought to vary its authorisation as follows:

    • Amend the mark to be used in Denmark, Finland and Sweden to Sipnok,
    • Amend the mark to be used in Germany to Firol, and
    • Amend the package design in Germany to one that was different to the pack to be used elsewhere in the EU.

    The EMEA refused to accept these variations. Their position was that any variation of this type (mark and/or pack) had to apply to the whole EU. Dr. Karl Thomae, together with the pharmaceutical pressure group EFPIA, appealed this refusal to the Court of First Instance. The Court ruled as follows:

    • There are no grounds for concluding that the mark in a Community marketing authorisation (Community MA) cannot be varied by the addition of other marks where

    i) The holder of the Community MA demonstrates that the variation is rendered necessary by exceptional circumstances which may adversely affect public health, and

    ii) The Commission has ascertained that the variation applied for satisfies the criteria of the quality, safety and efficacy of the medicinal product.

    • Such a variation (to the mark) could be justified if the authorisation holder lost a trade mark infringement action in a Member State and therefore had to change its mark in that country. If, in these circumstances, the variation were refused, the pharmaceutical product would have to be taken off the market in the country of infringement pending the acceptance of a new Community MA containing a new mark. This could prejudice public safety in the country from which the product was withdrawn.
    • For similar reasons, it should also be possible to vary the package design for part only of the EU in a Community MA provided the criteria of exceptional circumstances and quality/safety/efficacy are met.

    The second case (A. Menarini and EFPIA v European Commission) involved a centralised marketing authorisation for Optruma, a treatment of osteoporosis. The authorisation holder, Eli Lilly, had licensed Menarini to sell the product in Italy and consequently had sought the EMEA’s approval for the use of an Italian pack which not only featured details of Menarini at the appropriate place on the pack (the so called “blue box”), but also included Menarini’s company logo (a stylised letter M). The EMEA refused to accept the pack design because of the presence of the logo. Menarini appealed to the CFI against this refusal. The Court concluded that the logo could feature on the pack. They noted that it was already acceptable for the holder of the Community MA (in this case, Eli Lilly) to include its logo. If that were the case for Eli Lilly, it should also apply to their local Italian representative (Menarini).

    The final case (Aventis Pharma Deutschland v Kohlpharma and MTK Pharma) involved the parallel importation of Insuman cartridges. Aventis owned two centralised marketing authorisations, one for packs containing ten cartridges, the other for packs containing five cartridges. In France, Aventis sold five packs, whilst in Germany they sold ten packs.

    Kohlpharma and MTK are parallel importers. They purchased Insuman in France, imported the product to Germany, repackaged it into a single pack containing ten cartridges and sold the resulting product in Germany. Aventis sued for trade mark infringement claiming that Kohlpharma’s/MTK’s repackaging was not necessary. It was open to them simply to bundle two French packs together, oversticker them in the traditional fashion and sell this in Germany. The German Court put the following (paraphrased) question to the ECJ, “Does Regulation 2309/93 (establishing a centralised authorisation procedure) preclude a medicinal product, which is the subject of two separate Community MA’s one for a pack of five cartridges and the other for a ten pack, from being marketed in a package consisting of two packs of five items which have been joined (bundled) together and relabelled?”

    The ECJ ruled that Kohlpharma and MTK could not simply bundle two French packs together for sale in Germany because such a product would not be covered by the Community MA for ten Insuman cartridges, the specific requirements of which were intended to prevent consumers from being misled and to protect public health. The Court left it to the German Court to decide whether, in the light of their ruling, it was objectively necessary for Kohlpharma/MTK to create a new pack containing ten cartridges for sale in Germany.

     

    Comment

    The research based pharmaceutical community will welcome the ECJ ruling that, in exceptional circumstances, they can vary a centralised marketing authorisation by the addition of a second trade mark. This is a sensible decision and reflects the difficulty of identifying and protecting a trade mark for Class 5 goods on an EU wide basis. The decision is also timely given that, with the enlargement of the EU to twenty five countries in May 2004, the level of difficulty of finding an “EU wide” mark is set to increase significantly. It remains to be seen, however, whether the EMEA and the Commission, who both appear to believe that the pharmaceutical research industry finds such “trade mark difficulties” too easily and too regularly, primarily because they are a means of inhibiting parallel importation, will accept the ECJ’s ruling gracefully. In the author’s view, it is more likely that they will continue to reject attempts to vary the original trade mark in an EMEA centralised marketing authorisation, because the circumstances are not exceptional enough.