CJEU Rules On Roche/Novartis Agreement Restricting Off Label Use Of Avastin

On 23 January 2018, the European Court of Justice (CJEU) handed down its judgment in Case C-179/16 relating to an on-going saga concerning Hoffman-La Roche Ltd (Roche) and Novartis AG (Novartis) and their attempts to restrict the off-label of Avastin.

The CJEU's decision emphasises the increasingly wide application of competition law to the pharmaceutical sector. It should be welcome news, in particular to other developers of biosimilars who frequently face similar challenges and issues with regard to questions and concerns raised about the safety and efficacy of their products, even when they have been through extensive comparability studies and received marketing authorisations.

It is clear that originator companies will need to take greater care in the future to ensure any issues or safety concerns are raised in the context of a legitimate safety concern/pharmacoviligence monitoring only, and not with a view to reducing the competitive pressure of a rival's product.

Background

Avastin is a monoclonal antibody originally developed by a US subsidiary of Roche, Genentech, and granted an MA for oncological indications. At the same time as developing Avastin, Genentech also developed another monoclonal antibody (mAb), which also received an MA and was marketed as Lucentis.

Lucentis is authorised for the treatment of eye diseases (aged-related macular degeneration). Genetech licensed the commercialisation of Lucentis to Novartis, as it was already active in the field of ophthalmology, whereas Roche was not. While Avastin is authorised for treatment for oncological conditions, it is also frequently used "off-label" for the treatment of eye diseases, because it has a much lower price than Lucentis.

Fines by the Italian competition authority

In 2014, the Italian competition authority imposed two fines, each amounting to over €90 million, on both Roche and Novartis, on the grounds that they had put in place an arrangement designed to achieve an artificial differentiation between Avastin and Lucentis in breach of Article 101(1) of the TFEU (the EU's prohibition against anti-competitive agreements). Essentially, the arrangements were viewed as a form of collusive market sharing, as Avastin and Lucentis were equivalent in all respects for the treatment of eye diseases, and the arrangement was designed to achieve an artificial differentiation between them by manipulating the perception of the risks of using Avastin in the field of ophthalmology.

As a...