The parties market pharmaceuticals for the treatment of diabetes mellitus, which are based on different active ingredients. The plaintiff's preparation contains the active ingredient insulin glargine, while the defendant's preparation contains insulin detemir. The plaintiff primarily objects to the advertising claim contained in a leaflet by the defendant, stating that the product marketed by the defendant leads to less weight gain compared to the product containing the active ingredient used by the plaintiff. One part of the claims challenges the defendant's specific reliance on a study to substantiate its advertising claim. Another part of the claims targets the advertising statement without reference to a study.
The plaintiff asserts that the study results relied upon by the defendant are not sufficiently scientifically substantiated. The advertisement is therefore misleading.
The Berlin Regional Court dismissed the action. The appeal filed against it was unsuccessful. According to the Higher Regional Court, the advertisement did not violate competition law because the study results, on which the defendant's advertising claims were based, had been incorporated into the product information reviewed during the approval process. It was therefore to be presumed that the weight advantage advertised by the defendant corresponded to the scientifically established standard. The plaintiff had not refuted this presumption. With the appeal on points of law permitted by the Senate, the plaintiff seeks to secure the defendant's conviction.
Upon the plaintiff's appeal on points of law, the Federal Court of Justice partially overturned the appellate judgment and referred the matter back to the Higher Regional Court for a new hearing and decision regarding those aspects. The reversal affects those claims directed against advertising a weight advantage substantiated by reference to a study.
The Federal Court of Justice held that, in this respect, misleading advertising could be considered under the principle of 'citation truthfulness'. According to this, study results cited in advertising or in legal proceedings as evidence for a health-related claim are generally only sufficiently conclusive if they have been conducted and evaluated according to recognized rules and principles of scientific research. This typically requires a randomized, placebo-controlled, double-blind study with adequate statistical evaluation, which has been integrated into the scientific community's discourse through publication. Whether advertising claims can also be supported by studies subsequently generated from existing study data through a so-called subgroup analysis or by summarizing several scientific investigations (meta-analysis) – as in the present case – depends on the specific circumstances of the individual case. For the question of misleading advertising, in addition to compliance with the scientific rules applicable to these studies, it is particularly important whether the public is sufficiently clearly informed in the advertisement about the specific characteristics of the type, conduct, or evaluation of this study and, if applicable, the limitations made in the study itself regarding the validity and significance of the findings, thereby making the limited scientific validity of the study apparent to them. The contested advertisement does not contain such clarifying information, even though the referenced study provided grounds for it.
In contrast, the claim of a weight advantage made without specific reference to the study is legally unobjectionable in the present case, because such an advantage – more precisely: less weight gain – can be inferred from the drug regulatory approval and the product information, according to the Higher Regional Court's legally sound findings. While it is generally true for statements with expert claims in the field of health-related advertising, according to the strict principle applicable in pharmaceutical advertising law, that advertising is only permissible if it corresponds to established scientific knowledge. However, in principle – as stated by the Federal Court of Justice – an advertiser can rely on the content of the approval and the product information as scientific proof of the correctness of their advertising claim, because these documents are subject to review by the approval authority. However, misleading advertising may be considered if the plaintiff demonstrates and, if necessary, proves that newer scientific findings, which became known only after the approval date or were otherwise inaccessible to the approval authority during the approval decision, exist and contradict the scientific validity of the statements substantiated by the approval. Since the plaintiff had not presented any such findings, the dismissal of the action in this regard was justified.
Judgment of the Federal Court of Justice of February 6, 2013 – I ZR 62/11 – Basal Insulin with Weight Advantage
Lower Courts:
Berlin Regional Court – Judgment of June 9, 2009 – 15 O 704/07
Berlin Higher Regional Court – Judgment of February 22, 2011 – 5 U 87/09
Source: Press release of the Federal Court of Justice
Goldberg Attorneys at Law 2013
Attorney Michael Ullrich, LL.M. (Information Law)
Specialist Lawyer for Information Technology Law (IT Law)
Email: info@goldberg.de
