The EU Court of Justice clarifies the application of competition law to the pharmaceutical sector concerning off-label use of medicine and the dissemination of misleading information about product characteristics (Hoffman-La Roche / Novartis)

On 23 January 2018, the CJEU rendered its judgment in the case Hoffman-La Roche and Others v AGCM, providing clarification on important aspects of competition law in the pharmaceutical sector. The CJEU rendered its judgment pursuant to a request for a preliminary ruling by the Italian Council of State on the interpretation of Article 101 TFEU. Background Genentech, a US subsidiary of Hoffman-La Roche (Roche) developed Avastin and Lucentis, two biotech medicines derived from the same active substance. Avastin was designated for oncologic applications, while Lucentis was designed to treat ophthalmological diseases. Genentech, which was only active in the United States, granted licenses to Roche for the commercialisation of Avastin outside the United States, and to Novartis for the