Orange Book Concerns Pick Up as Yet Another Issue for Pharmaceutical Manufacturers

Pharmaceutical manufacturers are increasingly finding themselves defending decisions to list in the U.S. Food and Drug Administration’s (FDA) Orange Book patents that they assert are associated with their products. The Federal Trade Commission (FTC) issued a policy statement in September 2023 announcing an evaluation of whether improper Orange Book listings “may constitute an unfair method of competition in violation of Section 5 of the FTC Act.”……
By: Holland & Knight LLP