In its judgment dated 2 February 2013 (I ZR 62/11) the German Federal Court of Justice (Bundesgerichtshof/BGH) extended the advertising options for the pharmaceutical industry. According to this decision, pharmaceutical companies may advertise their medicinal products with properties that are expressly mentioned in the marketing authorisation or in the SMPC, even if the promoted product claim is not supported by a referenced clinical study.
The defendant promoted its medicinal product with a claim that it lead to less weight gain than the plaintiff's diabetes product and made reference to a clinical study. This clinical study was created retrospectively on the basis of already existing study data in the way of a combination of several scientific studies (“meta-analysis”). However, the defendant did not sufficiently point out this particularity of the study’s evaluation. In other words, the defendant did not emphasise that the study had limited scientific validity. The plaintiff alleged that the results of the study were not sufficiently supported by the clinical trial and that the advertising was therefore misleading. However, the weight advantage property was expressly covered by the marketing authorisation and SMPC for the defendant's product.
The Court referred the question of whether the reference to the clinical study was misleading back to the court of previous instance. According to the Court, the advertising is likely to be misleading because of a possible violation of the "quotation truth" principle. This principle states that study results that are mentioned in advertising are only sufficient to support a product claim if the study results were generated in accordance with the “rules of scientific research”. In principle, these rules of scientific research require a randomised placebo-controlled double-blind study. According to the Court, it depends on the circumstances of each case if a clinical trial created in the way of a meta-analysis is sufficient to support an advertising claim. In the case of a meta-analysis, the advertising company must clearly indicate that the study has only limited scientific validity.
The Court held that, irrespective of the foregoing, the “weight advantage” claim could legally be used as long as the defendant did not refer to the meta-analysis in its promotional material. This follows from the fact that the advertising message "weight advantage" is expressly mentioned in the marketing authorisation and the SMPC that were subject of review by the approval authority. As a result, a promotional claim cannot be considered misleading if the claim is covered by the marketing authorisation.
The reasoning of the Court’s decision has not yet been published.