Health Affairs December 13, 2023
On September 14, 2023, the Federal Trade Commission (FTC) issued a statement condemning pharmaceutical manufacturers’ improper inclusion of patents in the Food and Drug Administration’s (FDA’s) Approved Drug Products with Therapeutic Equivalence Evaluations, or “Orange Book” as it is more commonly known. As explained more fully below, the Orange Book lists all drugs that the FDA has deemed to be safe and effective; for each drug, it also lists all patents that the manufacturer (the branded firm) claims cover the drug compound, formulation, or method of use. These patent listings put potential generic drug manufacturers on notice of claimed intellectual property rights and potentially delay the availability of cheaper generic versions of branded drugs.
Through its statement, the FTC put...
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