A Formalistic Approach to Competition Law and Its Risks: The Curious Case of Roche/Novartis

The Roche/Novartis case raised an issue of European competition law so complex that it called upon the intervention of the most important and authoritative judicial body of the European Union, i.e. the Grand Chamber of the Court of Justice. Some of the outcomes of this case are, however, particularly worth analysing because they show to the highest degree the potential logical shortcomings that can be created by combining a too rigid and sterile application of competition law principles with complex factual circumstances. More specifically, in this case the legal questions of the definition of the relevant product market, of the competitive relationship between the parties and of the implications of a licensing agreement between them needed to be adjudicated with reference to the unlawfulness of the creation and marketing of the relevant product, of the marketing of such product by third-parties (and not by one of the infringers) and of the weight of regulatory issues within the competition law assessment. Despite the arguably unique set of facts of the case, the problematic – even contradictory – nature of its findings cautions us against a formalistic application of competition law and shows instead the preference of adopting a substantive approach within the competition law assessment. Hoffmann-La Roche, Novartis, Avastin, Lucentis, competition law, Article 101 Treaty on the functioning of the European Union (TFEU), off-label, pharmaceuticals, formalism, regulation.