For the second volume of The Legal Industry Reviews France, Christophe Hénin and Marine Zoroddu, associate from Intuity Law Firm explain the details of the turn that took place in the Lucentis Case in France in February.
On February 16, 2023, the French Court of Appeal fully overturned the French Competition authority’s decision (Decision No. 20-D-11 dated 9 September 2020) which imposed to Novartis and Roche a € 444 million fine for abuse of collective dominant position aimed at maintaining Lucentis’ position and price (€ 1161 by injection) by curbing the off-label use of Avastin (€ 40 by injection) for the treatment of age-related macular degeneration (AMD) between 2008 and 2013 (French Court of Appeal, 16 February 2023, No. 20/14632).
As regards cross-holdings and contractual ties between Novartis and Roche including license agreements with Genetech, which has developed both Avastin and Lucentis, they were considered as a single collective entity.
In this case, Novartis and Roche were alleged to have implemented two types of abusive measures:
- denigration’s statements addressed to the healthcare practitioners and the public by exaggerating the risks associated with the use of Avastin in the treatment of AMD;
- use of alarmist/misleading language regarding the risks associated with the use of Avastin as well as administrative obstruction with the French public authorities aimed at hindering the authorization for using Avastin in the treatment of AMD.
Unsurprisingly, the French Court of Appeal arguments were less guided by economic than legal considerations, but it could barely be foreseen that its interpretation would lead to overturn all grounds for the French Competition Authority’s decision.
The Court first considered that as the law n°2011-12 dated 29th of December 2011 lessened the possibilities of off-label use so that Avastin could no longer be legally prescribed and had to be considered as off-market and not substitutable with Lucentis.
Then, the Court considered that statements which points out differences between two medicinal products, where only one of which had a marketing authorisation for a given indication, could not be assessed in the same way as to that of a generic and an originator product, since they were presumed to be equally effective and safe. It was not the case for Lucentis and Avastin, and the context of the widespread of the off-label use of Avastin, at the time of the Mediator scandal contributed to legitimate Novartis and Roche statements, according to the Court. Therefore, the statements addressed to healthcare professionals and the public were found not to be disparaging or exceeding the limit of freedom of speech.
Regarding the practices undertaken with public authorities, the Court held, in particular, that Roche could not be reproached for refusing to file an application for an extension of a marketing authorisation and that on the basis of scientific studies available at that time, Novartis statements were neither alarming nor misleading. The Court finally reminded that the French Authority for Health Products Safety was fully able to conduct a critical reading of the scientific studies under discussion and publicly available.
Beyond the discrepancies of interpretation between the French Competition Authority and French Courts, this decision stands in contrast to previous decisions ruled in our European neighbouring countries on this case, in the context of the growing sanctions in the pharmaceutical sector:
- on October 5, 2021, the Italian Supreme Court upheld the Italian Competition Authority decision to fine Novartis and Roche approximately € 180 million for anti-competitive agreements;
- on January 23, 2023, the Belgian Competition Authority imposed a € 2 million fine on both companies on the same grounds as the French Competition Authority.
However, in France, Novartis and Roche are not out of the woods yet, as this decision can still be appealed to the French Supreme Court.
Christophe Hénin and Marine Zoroddu, are associate lawyers at Intuity Law Firm in France.