Under EU case law, agreements with an anti-competitive object are those which, by their very nature, can be regarded as being harmful to the proper functioning of normal competition. Thus, where the anticompetitive object of the agreement is established, it is not necessary to examine its actual effects on competition. In order to determine whether an agreement reveals in itself a sufficient degree of harm to competition for it to be considered a restriction of competition by object, regard must be had to the content of its provisions, its objectives and the economic and legal context of which it forms part.

The underlying case was referred to the Court of Justice of the European Union ("ECJ") by the Italian Supreme Court which requested guidance on the appeal lodged by Roche and Novartis of a fine imposed by the Italian Competition Authority ("ICA") for an infringement of Article 101 TFEU. The ICA had found that Roche and Novartis had colluded in the dissemination of misleading information to prevent the off-label use of the lower-priced product Avastin (commercialised by Roche) in order to favour the commercialisation of the higher-priced product Lucentis (commercialised by Novartis). Both products were licensed by the same company, Genentech.

In its judgment, following Advocate General Saugmandsgaard Øe's opinion, the ECJ took the view that the communication, in the context of scientific uncertainty, of misleading information on adverse effects resulting from the off-label use of one product (i.e., Avastin) with a view to reducing the competitive pressure on the other product (i.e., Lucentis) constitutes a restriction of competition "by object".

To reach this conclusion, the ECJ examined the conduct concerned in its legal and economic context. The ECJ found that the fact that two companies, which marketed competing products, disseminated misleading information relating to a product marketed by one of them (i.e., Avastin) may constitute evidence that the information was not disseminated for legitimate pharmacovigilance purposes. The ECJ noted that, given the characteristics of the medicinal product market, the dissemination of misleading information was likely to deter doctors from prescribing the medicinal product in question. The ECJ thus concluded that an arrangement pursuing the objectives described above must be regarded as sufficiently harmful to competition to render an examination of its effects superfluous.

The judgment is of great practical interest as the concerted practice of Roche and Novartis did not fall within any traditional type of infringement "by object". Notably, the ECJ once again declined to limit restrictions "by object" to certain forms of concerted practice and emphasised the need to assess the nature of the agreement, its content, and the economic and legal context of which it is part.

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