MONTH-IN-BRIEF (Oct 2023)
FTC Issues Policy Statement Confirming Its Position That Improperly Listing Patents in the Orange Book May Be Considered a Violation of the FTC Act
The Federal Trade Commission (FTC) has released a new Policy Statement addressing one of its long-standing concerns in the pharmaceutical industry: the improper listing of patents in the Orange Book. In an open meeting of the Commissioners in September, the FTC voted unanimously to approve the issuance of the new statement, which directly addresses the improper listing of patents in the Food and Drug Administration’s (FDA) publication of Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the “Orange Book” (Policy Statement). The Policy Statement is a forceful warning to companies and individuals that may thwart competition in pharmaceutical markets through improperly listed patents.