EU trade mark law reform – important changes for brand owners in the pharmaceutical industry Robert Guthrie, Osborne Clarke Trade mark law and practice in the European Union will be revamped over the next few years as final compromise texts have been agreed for: (a) a new replacement Trade Mark Directive (the TMD), which partially harmonises trade mark law and practice across the EU's member states; and (b) revisions to the Community Trade Mark Regulation (the CTMR), which governs the law and practice of the EU wide Community trade mark. The new TMD and the revisions to the CTMR are an evolution, rather than a revolution, of the EU's trade mark system. However, there are still a number of substantive changes to EU trade mark law and practice that will have a significant impact on trade mark owners, including those in the pharmaceutical sector. easier for counterfeit goods to be diverted to the EU market. The compromise texts provide that goods in transit will infringe trade mark rights where they bear without authorisation a trade mark which is identical to a trade mark registered for the goods concerned (Article 9(5) of the revised CTMR and Article 10(5) of the new TMD). However, the trade mark owners' right to take action will lapse if the holder of the goods provides evidence that the trade mark owner cannot prevent the sale of the goods in the intended final destination. These new provisions proved to be somewhat controversial. In particular, there was a concern that these provisions could be used to inhibit the transit of generic medicines through the EU. To deal with these concerns, a number of recitals have been added that make it clear that these new provisions are intended to be compatible with the EU's GATT obligations and, as regards generic medicines, the 'Declaration on the TRIPS Agreement and Public Heath' adopted by the Doha WTO Ministerial Conference on 14 November 2001 – which provides that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Furthermore, what is currently Recital 19e of the revised CTMR and Recital 22d of the new TMD states that: "Appropriate measures should be taken with a view to ensuring the smooth transit of generic medicines. With respect to international nonproprietary names (INN) as globally recognized generic names for active substances in pharmaceutical preparations, it is vital to take due account of the existing limitations on the effect of [European Union] trade mark rights. Consequently, the proprietor of a [European Union] trade mark should not have the right to prevent any third party from bringing goods into the [Member State/Union] without being released for free circulation there based upon similarities between the INN for the active ingredient in the medicines and the trade mark." It is not entirely clear how the new provisions on goods in transit could inhibit the transit of generic medicines based on similarities between the INN and the trade mark, as they only apply when the goods bear a trade mark which is identical to the registered trade mark. However, the recitals are clearly designed to inhibit this new right being used against the transit of generic medicines. Use of mark on packaging and other means Pharmaceutical brand owners will also be pleased that trade mark owners have been given a new right to prohibit use of the same or similar trade marks on “packaging, labels, tags, security authenticity features or devices or any other means on which the mark may be fixed" where there is a risk that such packaging, labels or other means will be used to infringe the trade mark owner's rights (Article 9a of the revised CTMR and Article 11 of the new TMD). This new provision should make it easier for customs authorities to take action when such materials are imported into the EU with the intention of affixing them to counterfeit products within the EU. Name changes The Community trade mark or CTM will be renamed the European Union trade mark. The Office for Harmonization in the Internal Market or OHIM (the European Union's trade mark and design registry) is also being renamed and will in the future go by the rather more prosaic moniker of the European Union Intellectual Property Office. Substantive law changes Key changes to note, particular for brand owners in the pharmaceutical sector, are: Graphic representation The requirement that trade marks must be capable of graphic representation will be removed. This will remove some of the practical obstacles to the registration of non-traditional marks, such as sound, smell and dynamic marks. However, the removal of the graphic representation requirement does not mean that such marks will be any more likely to avoid an objection on the grounds that they are non-distinctive. Counterfeit goods in transit At the moment EU trade mark rights are not infringed by goods that are merely transiting through the EU, even if those goods are counterfeits. This means brand owners and customs authorities can find it difficult to seize counterfeit goods in transit and stop them from entering other jurisdictions (where they may not be identified and detained). It also makes it 4