In 2020, when Novartis and Roche were fined 444 million euros ($475 million) by France’s Autorite de la Concurrence, it was the largest ever penalty levied by the country’s anti-competition watchdog.
But three years later, the Swiss pharma giants are off the hook. A Paris appeals court has overturned (PDF) the verdict, ruling that Novartis and Roche did not abuse their market dominance to protect use of their shared macular degeneration treatment, Lucentis, when a much cheaper off-label alternative was available.
Roche had been accused of refusing for months to provide samples of its cancer medicine Avastin to regulators in France to review in comparison to Lucentis. But the appeals court ruled that this action could not have had anti-competitive effects, AFP reports.
The court also said that Novartis had been “measured in tone” and not denigrating toward Avastin, according to the news service. And there was no attempt by either of the companies to be misleading or alarmist in their marketing of the drugs the court found.
Novartis and Roche confirmed the victory and their being cleared all of anti-competition charges.
"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 reiterated its opposition to use of off-label products before they've been properly vetted.
"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," the company said.
After officials at the French Competition Authority raided local offices of Novartis and Roche way back in 2014, the agency filed its verdict against the drugmakers in 2020.
The authority alleged Novartis waged a public relations campaign against Roche's Avastin, which is often used off-label in macular degeneration. In its review, the authority considered the two pharma giants as one entity because Novartis owned a significant but non-controlling stake in its cross-town Swiss rival. Novartis has since sold that Roche stake.
In addition, Roche's subsidiary Genentech developed Lucentis and licensed its sales outside of the United States to Novartis.
When France's antitrust authority originally levied the fine, it estimated that Lucentis cost 1,161 euros per injection while Avastin was 40 euros or less.
At the time of the original ruling, Novartis said it was "very disappointed" in the verdict and would appeal. Roche said it believed it was in compliance with local regulations.
"Roche is pleased that no anti-competitive practice has been found," the company said in a statement. "In addition, the Court of Appeal recognizes the legitimacy of the health concerns defended by Roche in answer to the request of the French health authorities, between 2008 and 2013, concerning the off-label use of its drug Avastin."
Novartis bore the brunt of the original fine at 385 million euros while Roche was hit with a levy of 59 million euros.
Before the case in France, officials in Italy fined the companies a combined 180 million euros.