On Access and Accountability — Two Supreme Court Rulings on Generic Drugs

Abstract

In June, the U.S. Supreme Court issued two rulings regarding the marketing of generic drugs that may alter the pharmaceutical business landscape. First, in Federal Trade Commission v. Actavis, the Court confronted the law governing a controversial pharmaceutical marketing practice known as reverse payment agreements, or pay for delay.1 This practice occurs when a generic drug company identifies a vulnerable patent held by a brand-name drug manufacturer and seeks approval from the Food and Drug Administration (FDA) for a generic version before the patent expires, provoking a lawsuit for infringement. The two companies then forge a settlement whereby the brand-name . . .