Prerequisite for the admissibility of an advertisement for a remedy

The parties market medicinal products for the treatment of diabetes mellitus which are based on different active substances. The plaintiff's preparation contains the active ingredient insulin largin, the defendant's preparation the active ingredient insulindetemir. The plaintiff essentially contests the advertising statement contained in a leaflet of the defendant, according to which the product marketed by the defendant leads to a lower weight gain compared to the product containing the active ingredient used by the plaintiff. In this context, one part of the claims is directed against the fact that the defendant specifically relied on a study to substantiate its advertising claim. Another part of the claims is directed against the advertising statement without reference to a study.

The plaintiff's position is that the study results on which the defendant relies are not sufficiently scientifically substantiated. The advertising is therefore misleading.

The Berlin Regional Court dismissed the action. The appeal filed against this decision was unsuccessful. According to the Court of Appeal, the advertising did not violate competition law because the study results on which the defendant's advertising claims were based had been included in the expert information examined during the authorisation procedure. Therefore, it could be assumed that the weight advantage advertised by the defendant corresponded to the scientifically proven state of the art. The plaintiff had not refuted this assumption. With the appeal admitted by the senate, the plaintiff wants to achieve the conviction of the defendant.

In response to the plaintiff's appeal, the Federal Court of Justice (BGH) partially set aside the appeal judgement and referred the case back to the Court of Appeal for a new hearing and decision. Affected by the annulment are those claims that are directed against the advertising with a weight advantage, as evidenced by reference to a study.

The Federal Court of Justice assumed that in this respect misleading statements could be considered from the point of view of a violation of the principle of "truth in quotation". According to this principle, study results that are cited in advertising or in legal proceedings as evidence of a health-related claim are in principle only sufficiently meaningful if they were conducted and evaluated according to the recognised rules and principles of scientific research. As a rule, this requires that a randomised, placebo-controlled double-blind study with an adequate statistical evaluation is available, which has been included in the discussion process of the scientific community through publication. Whether studies - as in the case in dispute - that were subsequently prepared on the basis of available study data within the framework of a so-called subgroup analysis or by way of a summary of several scientific studies (meta-analysis) can also carry an advertising claim depends on the circumstances of the individual case. In addition to compliance with the scientific rules applicable to these studies, the question of whether the advertising is misleading depends above all on whether the public is sufficiently clearly informed of the special features of the type, conduct or evaluation of this study and, if applicable, of the limitations made in the study itself with regard to the validity and significance of the results found and thus made aware of the only limited scientific significance of the study. The advertising in question does not contain such informative references, although the study referred to has given reason to do so.

On the other hand, the claim of a weight advantage in the case in dispute, which was made without any specific reference to the study, is not legally objectionable because such an advantage - more precisely: a lower weight gain - can be inferred from the marketing authorisation for medicinal products and the expert information in the case in dispute according to the findings of the Kammergericht which are free of legal errors. It is true that, according to the principle of strictness governing the law on advertising of medicinal products, claims with technical statements in the field of health-related advertising are generally only permissible if they correspond to established scientific knowledge. In principle, however - according to the Federal Supreme Court - an advertiser can refer to the content of the marketing authorisation and the expert information as scientific proof of the correctness of his advertising claim, because these documents are the subject of the review by the marketing authorisation authority. However, misleading statements can be considered if the plaintiff demonstrates and, if necessary, proves that there are newer scientific findings that became known only after the date of authorisation or that were otherwise not available to the authorisation authority at the time of the authorisation decision, which speak against the scientific validity of the statements substantiated by the authorisation. Since the plaintiff had not submitted any such findings, the action was rightly dismissed in this respect.

 

Judgment of the BGH of 6 February 2013 - I ZR 62/11 - Basic insulin with weight advantage

Lower courts:

LG Berlin - Judgment of 9 June 2009 - 15 O 704/07

KG Berlin - Judgment of 22 February 2011 - 5 U 87/09

 

Source: Press release of the BGH

 

Goldberg Attorneys at Law 2013

Attorney at Law Michael Ullrich, LL.M. (Information Law)

Specialist lawyer for information technology law (IT law)

E-mail: info@goldberg.de

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