U.S. Sup. Ct.
12-416
The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act or Act) creates special procedures for identifying and resolving patent disputes between brand-name and generic drug manufacturers, one of which requires a prospective generic manufacturer to assure the Food and Drug Administration (FDA) that it will not infringe the brand-name’s patents. One way to provide such assurance (the “paragraph IV” route) is by certifying that any listed, relevant patent “is invalid or will not be infringed by the manufacture, use, or sale” of the generic drug. 21 U. S. C. §355(j)(2)(A)(vii)(IV).
