Hikma Pharmaceuticals v. Amarin Pharmaceuticals
In the Hatch Waxman Amendments of 1984, Congress created a framework for accelerated approval of generic versions of brand-name drugs, spurring competition in the pharmaceutical industry and saving consumers and government health-care programs trillions of dollars. One of the key provisions of the Hatch-Waxman Amendments allows a generic drug to be approved for marketing even if some uses of the brand-name drug are still under patent, as long as the patented uses are omitted from the generic drug’s labeling. Introduction of generics using such “skinny labels” is vitally important to the success of the Hatch-Waxman Amendments because brand-name drug manufacturers typically seek to extend their monopolies by repeatedly patenting new uses of their drugs. Hatch-Waxman permits generic versions of such drugs to be introduced as long as they are not marketed for the patented uses.
Brand-name manufacturers have nonetheless sued generic manufacturers who use skinny labels for “inducing” patent infringement when, as inevitably happens, prescriptions for patented uses of the drug are filled with the generic version. The brand-name manufacturers point to little more than the FDA-authorized label itself and the generic manufacturers’ accurate descriptions of their drugs as “generic versions” or “generic equivalents” of the brand-name drug. In recent years, the U.S. Court of Appeals for the Federal Circuit has allowed such cases to proceed, although they strike directly at the heart of the Hatch-Waxman Amendments.
Amarin Pharmaceuticals brought such a case against Hikma Pharmaceuticals. After the Federal Circuit’s ruling in the case, the Supreme Court granted certiorari to consider the Federal Circuit’s permissive stance toward suits against generic manufacturers. Public Citizen filed a brief supporting the generic manufacturer in the case, explaining that the Federal Circuit’s decisions cannot be squared with the Hatch-Waxman Amendments and that they threaten to undermine the Amendments’ unparalleled record of success in reducing health-care costs for Americans.