Court of Justice of European Union Denies Hoffmann-La Roche and Novartis Chance to Re-litigate Safety Claims Regarding Off-label Use of Avastin

• 08/07/2022
• Articles

In a judgment delivered yesterday, the Court of Justice of the European Union (CJEU) thwarted an attempt by Hoffmann-La Roche (Roche) and Novartis to re-open their case against the Italian competition authority regarding the off-label use of Avastin®, that medicine’s interchangeability with Lucentis®, another, more expensive, medicine that was specifically authorised for that use, and the safety claims which the parties made regarding the off-label use.

Prompted by questions raised by the Italian Council of State (the CS), the CJEU held in an earlier judgment back in 2018 that the coordinated dissemination by competing firms of misleading safety claims with regard to a medicine’s off-label use may constitute a serious violation of the competition rules that qualifies as a “by object” infringement and therefore allows the European Commission to dispense with the requirement to show the arrangement’s anticompetitive effects (see, Van Bael & Bellis Life Sciences News and Insights, 24 January 2018).
 
Armed with this response, the CS then dismissed an appeal brought by Roche and Novartis against a decision of 2014 of the Italian competition authority which had imposed fines of EUR 182.5 million on Roche and Novartis because these firms had implemented a market-sharing agreement to discourage the off-label use of Roche’s Avastin® in favour of a more expensive competing product (Lucentis®, whose marketing authorisation is held by Novartis).
 
Even though, barring unusual circumstances, the judgment of the CS was final, Roche and Novartis mounted a challenge against that judgment before the same CS arguing that the CS had misapplied the 2018 judgment of the CJEU. The parties contended that the position adopted by the Italian health authorities in relation to the unlawfulness of the off-label prescription of Avastin® should have prevented the CS from classifying both Lucentis® and the off-label use of Avastin® in the same product market. They also maintained that the CS had failed to determine whether the information which they disseminated was actually misleading. In their view, the CJEU held in 2018 that a restriction by object could only be found to exist if the information that was spread was deceptive. According to the parties, this requires an assessment of the nature of that information, but the CS had failed to carry out such an evaluation.
 
Rather than rejecting this challenge out of hand because of a lack of procedural avenue, the CS referred fresh questions to the CJEU which in essence sought to determine whether Articles 4(3) and 19(1) of the Treaty on European Union, Articles 2(1)-(2) and 267 of the Treaty on the Functioning of the European Union, and Article 47 of the Charter of Fundamental Rights of the European Union require the Italian legal system, which under the circumstances does not allow for the challenge of a judgment delivered by the CS, nonetheless to permit such a challenge on the grounds that the judgment at issue is not in conformity with an earlier pronouncement in the same case by the CJEU (see, Van Bael & Bellis Life Sciences News and Insights, 31 March 2021).  The CS also sought to learn whether it is for the national judge to review the correct implementation of principles enunciated by the CJEU in the same judicial proceedings when national law does not permit a further challenge, or whether it is the CJEU’s responsibility to carry out such an assessment.
 
The CJEU made short shrift of this request and in the process endorsed the approach followed by the CS. The CJEU held that it is in accordance with EU law for the CS to dispose of a case in which it had solicited a preliminary ruling form the CJEU even if the parties do not have the opportunity to challenge the resulting judgment once more on the grounds that this judgment would have misapplied the guidance given earlier by the CJEU. The CJEU specified that this principle, which defers to national procedural law, is valid as long as the lack of further recourse under national law applies equally to challenges under Italian law and challenges based on EU law.
 
In its latest judgment, the CJEU made it also clear that while its guidance on points of law is binding on a national court, it is for the national court to apply the facts to the legal principles established by the CJEU. Finally, the CJEU pointed out that if the CS were ultimately found to have made a mistake, this would open the possibility for Roche and Novartis to claim damages. However, the parties would still have to show that the breach of law made by CS was of a sufficiently serious nature and that there is a direct causal link between that significant breach and the loss or damage which the injured parties claim to have sustained.