FTC Employs New Tactic in Effort Against Drug Makers Alleged to Have Improperly Listed Patents in the FDA’s Orange Book

On Nov. 7, 2023, the Federal Trade Commission (FTC) announced it is disputing the listing of more than 100 patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,” known as the “Orange Book.” The FTC’s announcement follows its Sept. 14 release of a policy statement outlining the Commission’s views the ways in which allegedly improper Orange Book patent listings may constitute violations of the antitrust laws, and committing the FTC to…
By: Fenwick & West LLP