German Federal Court of Justice clarifies conditions for the lawfulness of pharmaceutical advertising Dr. Ralf Möller, Esche Schümann Commichau, Hamburg, Germany Standing jurisprudence has placed strict requirements on the accuracy, unambiguousness, and clarity of information provided in healthcare-related advertising to ensure a high level of protection for human health. Any advertisement citing scientific studies that do not bear out the advertised claim is deemed misleading even in cases wherein the information itself is accurate and capable of being verified in some other manner (so-called ‘truth in citation’ principle). that the advertisement was misleading, due to the lack of sufficient scientific evidence for any such weight-related benefits and, in particular, that no such benefit had been evidenced by the referenced studies. statements made in the advertisements citing certain scientific studies as being misleading because they violated the ‘truth in citation’ principle. However, as regards those claims which were made without referencing any study the German Federal High Court of Justice believed that the specific statements were covered by the marketing authorization and/or the product characteristics and therefore decided that these statements were not misleading. In an important decision dated 6 February 2013 (I ZR 62/11 – Basisinsulin mit Gewichtsvorteil), the German Federal High Court of Justice has fundamentally summarized the conditions established by the German jurisprudence for the lawfulness of pharmaceutical advertising and ruled on the significance of the marketing authorization and the product characteristics. The subject of scrutiny were several statements made in advertisements claiming – in part with express citations of scientific studies, in part without any supporting evidence at all – that the use of certain diabetes medications would cause weight loss. The plaintiff objected on the basis International Update Sharabh Shrivastava, CHADHA & CHADHA The customs officials in the Czech Republic have recently seized a total of 194,300 counterfeit Viagra and Cialis pills at Prague’s Vaclav Havel airport. The fake anti-impotence pills originated in south Asia. The investigation is ongoing and it is not yet known whether they were intended for the Czech Republic market. India In the specific case, the German Federal High Court of Justice deemed the The German Federal High Court of Justice decided that for statements made in an advertisement which accurately reflect, either literally or logically, the content of the marketing authorization or the product characteristics, respectively, without citing any specific scientific studies, it has to be presumed that these statements generally comply with the applicable proven state of the art as of the date of the marketing authorization and that they are, for said reason, lawful. Such statements may then, however, be considered misleading, if the plaintiff presents and, if required, demonstrates that more recent scientific evidence exists that contradicts the sustainability of the statements evidenced during the approval process. This scientific evidence has to have become known after the approval date or has to have not been accessible to the approving authorities at the time they made their decision. Thanks to the clear words of the German Federal High Court of Justice regarding the evidentiary value of the marketing authorization and/or the product characteristics, pharmaceutical companies should in the future even more thoroughly review to what extent healthcare-related advertising information can, as a matter of law, be evidenced in specific contexts with the marketing authorization and/or the product characteristics alone. By doing so, both the imponderables in connection with legal interpretations of scientific studies (a common issue in legal proceedings) and a possible prohibition of the advertising on account of its being misleading could be avoided. Comment The provisions concerning well-known trademarks and trademarks with reputation have been aligned with the corresponding provisions of the Directive 2008/95/EZ. The amended law clearly outlines the conditions, the authorized persons and the procedure related to the invalidation of trade marks and collective trade marks. If sold as originals, the estimated value of the pills would have been EUR € 3.4 million (USD $ 4.6 million). Montenegro PETOSEVIC Montenegro has recently drafted amendments to its trade mark law in order to harmonize it with the European Union trade mark legislation. It is expected that the amendments will be adopted soon. The amended law more precisely regulates the trade mark registration process and trade mark infringement court proceedings. Finally, the amended law stipulates monetary fines in case of trademark infringement. The fine in the amount 3 The amended law further strengthens civil protection in case of trade mark infringement. To that end, the law includes additional provisions on the seizure and destruction of goods, compensation of damages, usual compensation, unjust enrichment, preliminary injunctions, securing evidence and the publication of court decisions. The provisions regulating the procedure for cancellation of a trade mark due to non-use have been amended as well. The new law also permits canceling trade marks that have become generic as well as trade marks that are likely to cause confusion with existing marks, in line with Directive 2008/95/EZ. of EUR €1,500 – 20,000 (USD $2,100-28,000) may be imposed against a legal entity in case of the unauthorized use of a trademark. The amendments stipulate fines in the amount of EUR €500-2,000 (USD $700-2,800) for physical persons and the responsible person within a legal entity, and the fines in the amount of EUR €1,300-6,000 (USD $1,8008,300) for entrepreneurs. Russia has recently adopted a set of Civil Code amendments, which will enter into force on 1 October 2014. Below is the summary of main IPrelated amendments: A request for the state registration of an assignment, license or pledge substitutes the registration of an assignment/license/pledge agreement. In this sense, the Russian legislation will be brought in line with the Singapore Treaty on the Law of Trade marks. It will be possible to file a request and supplement it with either a notification signed by both parties or a copy/extract of the agreement (Art. 1232). If the exclusive license is granted, the PETOSEVIC Russia