Improper Orange Book Patent Listings Are Subject of FTC Brief in Viatris-Sanofi Dispute

The FTC has filed an amicus brief amid the ongoing dispute between Viatris’ Mylan and Sanofi over the latter’s patents for Lantus insulin, assailing the use of improperly listed Orange Book patents to delay generic competition.

In May, Mylan filed a lawsuit in the U.S. District Court for the Western District of Pennsylvania arguing that Sanofi engaged in anticompetitive practices by improperly listing patents in the FDA’s Orange Book to delay approval of Mylan’s Lantus biosimilar, Semglee.

While the FTC said it “takes no position on Mylan’s specific factual allegations” in its Monday amicus curiae filing, the federal regulator nevertheless noted that “improper Orange Book listings like those alleged here can cause significant harm to competition, and that harm can extend beyond the delay caused directly by the improper listing.”

Read the FTC’s brief here.

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