FTC Warns Drugmakers Against Improper Patent Filings

The FTC issued a statement Thursday saying that brand drug manufacturers could be harming competition in the generic market by improperly listing patents in the Food and Drug Administration’s “Orange Book” — a list of certain patents on products that a brand name says would cover its product.

“Brand drug manufacturers are responsible for ensuring their patents are properly listed. Yet certain manufacturers have submitted patents for listing in the Orange Book that claim neither the reference listed drug nor a method of using it,” the FTC wrote.

“When brand drug manufacturers abuse the regulatory processes set up by Congress to promote generic drug competition, the result may be to increase the cost of and reduce access to prescription drugs,” the commission added.

The commission said it put out its notice to warn companies that it will be looking into whether these improper listings “constitute unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act.”

The FTC said that these improper listings could “disincentivize” investments in competing products and reduce patient access to more affordable drugs. It warned that it will use its “full legal authority” against those who continue to improperly list patents.

“Patents improperly listed in the Orange Book can significantly undermine fair competition and harm the American public. The FTC will continue to use all its tools to halt unlawful business practices that contribute to high drug prices,” the FTC wrote.