STAT+: FTC warns drugmakers they can face legal action over improper patent listings
The FTC warned pharmaceutical companies they could face legal action if they improperly list patents for brand-name medicines in an FDA registry.
The Federal Trade Commission warned pharmaceutical companies they could face legal action if they improperly list patents for brand-name medicines in a Food and Drug Administration registry, the latest effort by the federal government to scrutinize patent moves by drugmakers.
In explaining its new policy statement, the FTC noted that some drug companies have failed to follow requirements for listing patents in the so-called Orange Book in hopes of thwarting competition from lower-cost generic medicines. The FDA’s Orange Book is used to put generic companies on notice about certain types of patents that a brand-name company claims covers its medicine.
The stipulation is part of a complex legal process that is used to sort out patent infringement and, ultimately, make it possible for generic companies to market their versions of brand-name medicines in the U.S. But the FTC has found that some brand-name drug companies submitted patents to the Orange Book without properly claiming certain patents, such as a drug substance or method for using a drug.
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