We wrote in 2020 about the hefty fines levied against Novartis and Roche for allegedly engaging in anti-competitive practices with respect to its age-related macular degeneration (AMD) drug, Lucentis. The French Competition Authority found that Novartis and Roche promoted Lucentis over Roche’s less expensive cancer drug, Avastin, which can be used off-label to treat AMD.
According to the French Competition Authority, Novartis tried to stop ophthalmologists from prescribing Avastin off-label for AMD cases by exaggerating the risks involved with the off-label use of Avastin for AMD, when compared to the safety and tolerance of Lucentis. This practice allegedly limited the number of off-label Avastin prescriptions for AMD and helped to keep Lucentis at a higher price point.
Novartis was appalled by the findings and the fine and promised to appeal, “strongly refut[ing]” the anti-competitive practice allegations. At that time, the company noted that “this decision relies on a gross misinterpretation of the facts and a distortion of previous case law that is not intended to cover the situation in this case.”
Now, it looks like it was well worth the appeal as the Paris Court of Appeal has overturned the fine, saying that Novartis and Roche did not engage in anti-competitive practices when promoting Lucentis as compared to the off-label use of Avastin. The appeals court noted that Novartis was “measured in tone” and did not dinigrate Avastin, nor did either company act in a “misleading” or “alarmist” fashion in their marketing of the drugs. This was, at least in part, because the Court of Appeal distinguished the use of a drug on an off-label basis versus a generic competitor, with off-label usage not having the same “presumption of safety” as a generic.
The Court of Appeal also noted that the “Bertrand Law” restricted the use of off-label prescriptions, and therefore, that Novartis and Roche could not engage in exclusionary behavior during a time when Avastin and Lucentis were not valid competition for the treatment of AMD.
“Novartis strongly contested these allegations from the outset and firmly believes the company has acted appropriately and in compliance with competition law and the interests of patients at all times,” the company said. “It is satisfied that this has now been recognized by the Court of Appeal, which has annulled the French Competition Authority’s decision in its entirety.”
Novartis also reiterated its opinion that off-label products should not be promoted until they have been properly vetted, saying, “Novartis firmly believes that measures encouraging widespread off-label use and reimbursement of a medicine in an unlicensed indication, despite the presence of licensed medicines on the market, are a threat to the established legal, medical and regulatory system that is in place to guarantee the approval and use of effective and safe medicines in patients.”
However, this may not be the end of this case, as the French Competition Authority has indicated that it plans to appeal the ruling.