1984

Hatch-Waxman amendment to Food, Drug, and Cosmetics Act (viz, “Drug Price Competition and Patent Term Restoration Act”) sought to clarify length of patent protection for drug makers, as well as offering makers of generic drugs financial incentives to bring cheaper version of brand name drugs onto the market as soon as the patents expired = abbreviated application process for generic makers, whereby they no longer had to include fresh clinical trials in their applications. But the intent was undercut by concessions to brand manufacturers via “a host of new ways to extend their patents . . . allow[ing] up to a five-year extension for claims of ‘time lost in regulatory review’ during which makers of generic drugs could not even submit an application.” In sum, the amendment instead ushered in an era in which multimillion-dollar court battles over patents now precede (and delay) each generic entry, driving prices up in the process” (Rosenthal, 94-95).