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Dechert has successfully represented the Roche group before the Paris Court of Appeal in its appeal of the French Competition Authority’s decision n° 20-D-11 of 9 September 2020, which had penalized several entities of the Roche and Novartis groups with a fine totaling EUR 444 million for an alleged abuse of a collective dominant position in the French market for the treatment of wet AMD. In a judgment rendered on 16 February 2023, the Court of Appeal embraced Roche's arguments, finding that there was no infringement of competition law and, consequently, entirely annulling the French Competition Authority's decision.
After more than eight years of legal battle, the court finally recognized the merits of the arguments made by Roche both before the French Competition Authority and on appeal. First, it confirmed that, since the Bertrand law of December 2011, which aimed to reinforce the safeguards relating to the off-label use of drugs (i.e., without authorization) following the Mediator scandal, Lucentis® – authorized for the treatment of wet AMD and marketed in France by Novartis – on the one hand, and Avastin® – authorized for the treatment of certain cancers unrelated to the eye and marketed in France by Roche – on the other hand, could not legally be regarded as competing products.
Second, and above all, the Court of Appeal rightfully ruled that Roche's responses to the health authorities' inquiries about the potential risks associated with the off-label intravitreal use of Avastin® for the treatment of wet AMD, a use for which this product had neither been developed nor authorized, were neither alarmist nor misleading, particularly in a context of great scientific uncertainty and worrying reports coming at the time of the alleged practices from both the French regional health authorities and foreign health authorities.
The judgment sets an important limit on the increasing interference of the French Competition Authority in cases relating to the marketing of health products, and notably recalls that the action of public authorities in the pharmaceutical sector must be guided first and foremost by the need to ensure patient safety and safeguard public health, and not by purely mercantile considerations.
Dechert’s team included partners Mélanie Thill-Tayara and Laurence Bary, national partner Marion Provost and associate Pénélope Agosta for the antitrust aspects as well as partner Sophie Pelé and associate Margaux Lasseigne for the pharma regulatory aspects.
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Dechert’s life sciences team in France represents companies ranging from multinational giants to emerging companies involving all aspects of the life sciences industry, including pharmaceuticals, biotechnology, drug discovery, genomics, biopharmaceuticals, diagnostics, medical devices and health care. We also assist investment funds with life sciences investments. Read more »