With filing in Sanofi and Mylan insulin lawsuit, FTC amps up scrutiny on pharma's patent tactics

The U.S. Federal Trade Commission (FTC) isn’t letting up in its effort to crack down on pharma’s alleged misuse of a patent mechanism in the FDA’s regulatory process. And it’s Sanofi’s turn to land in the crosshairs.

The FTC is weighing in on an antitrust lawsuit that Viatris’ Mylan brought against Sanofi in May centered on the French pharma’s popular insulin product Lantus. Although the agency didn’t pick sides in the case, it’s using the lawsuit as an opportunity to criticize the type of behavior accused of Sanofi.

Specifically, the FTC argues “improper” listings in the FDA’s Orange Book can “cause significant harm to competition, and that harm can extend beyond the delay” in access to a competing drug, the FTC said in an amicus brief filed in the case.

In the lawsuit, Mylan accused Sanofi of running a “multifaceted monopolization scheme” to protect Lantus. One of the alleged illegal practices involves entering in the Orange Book a “thicket of invalid and/or uninfringed patents” to delay the approval of biosimilars, according to Mylan’s complaint.

Mylan and its then-partner Biocon Biologics in late 2020 launched Semglee, a copycat of Lantus. Viatris has since sold its biosimilars business to Biocon. But by Mylan’s account, Lantus should have faced biosimilar competition in 2015 when its core patent expired. In 2014 alone, Lantus’ U.S. sales were $7.9 billion.

The Orange Book documents patents protecting branded drugs, providing a chance for drugmakers to list out the intellectual property that might be infringed by a proposed generic. The FDA isn’t responsible for verifying the listed patents, but it instead takes a ministerial role in keeping records.

Once a generic manufacturer notifies the FDA of its intent to market a generic, the brand-name maker may respond within a specified time frame and trigger a 30-month stay, which bars the FDA from allowing the generic entry.

That 30-month delay can carry big stakes in the commercial market, potentially incentivizing branded companies to list ineligible patents in the Orange Book, the FTC argued. Exploiting this stay with an unqualified patent “merely delays consumer access to a competing product that might reduce prices, improve quality and access, or both,” the agency said.

In the Sanofi lawsuit, Mylan said the allegedly invalid patents in the Orange Book provided Sanofi a platform for “baseless litigation” against potential competitors.

Of the challenges to more than 50 Sanofi patent claims through the Patent and Trademark Office’s inter partes review process, only two claims have survived, and neither of them could have affected Mylan, according to the complaint.

Sanofi knew these patents were weak but still listed them “with the specific intent to monopolize” the market for Lantus, Mylan argued.

For its part, the FTC said it’s not commenting on whether the Sanofi patents were improperly listed or whether the company broke the law. But, “as a general matter, improper listings can cause significant harm to competition and consumers,” the FTC said.

The FTC said it’s long been concerned about abuses of the Orange Book. But it was only recently that the antitrust watchdog launched a more publicized crackdown on those improper listings.

Following a meeting in September, the FTC issued a policy statement warning pharma companies of potential legal actions if they list sham patents in the Orange Book. Then in November, the agency sent letters to 10 companies notifying them of its challenge against more than 100 patents in the FDA’s database. The drugmakers, including AbbVie, AstraZeneca, Boehringer Ingelheim, GSK and others, were given 30 days to withdraw or amend their listings.