On September 14, 2023, the Federal Trade Commission (FTC) issued a policy statement in collaboration with the U.S. Food and Drug Administration (FDA), cautioning pharmaceutical companies that manufacture and market brand-name drugs. The statement serves as a warning, indicating that legal repercussions may follow if these companies engage in the improper listing of patents in the FDA’s publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations,” aka the “Orange Book.”
The policy statement highlights the potential negative consequences of inaccurately listing patents in the Orange Book, suggesting that such actions can have adverse effects on competition by hindering the entry of more affordable generic alternatives into the market. Moreover, it emphasizes the likelihood of maintaining artificially elevated prices as a result of such practices.
As outlined in the policy statement, the FTC will closely examine instances of improper patent listings in the Orange Book, considering them potential violations of Section 5 of the FTC Act, addressing unjust competitive practices.
A link to the FTC’s policy statement is available here.