The US FTC issues a policy statement warning pharmaceuticals off improperly listing their drugs on the FDA’s "Orange Book" in order to delay the entry of generic rivals

Key Takeaways The FTC is focusing its attention on the listing of pharmaceutical patents in the FDA’s Orange Book. Patent listing may be the subject of FTC inquiry even absent infringement litigation enforcing the relevant patents. Companies should review existing Orange Book listings to confirm that the listed patents satisfy the statutory criteria. On September 14, 2023, the Federal Trade Commission (“FTC”) and Food and Drug Administration (“FDA”) issued a “Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book,” with the stated goal of putting pharmaceutical companies “on notice” that the FTC would be scrutinizing patent listing practices. [1] The Policy Statement reflects the FTC’s continued focus on patent enforcement in the pharmaceutical