Hatch-Waxman Game-Playing from a Generic Manufacturer Perspective: From Ticlid~(R) to Pravachol~(R), Apotex Has Difficulty Telling Who's on First

摘要

SINCE THE INCEPTION of the Hatch-Waxman Act more than two decades ago, branded pharmaceutical companies and their generic competitors have battled each other constantly with a variety of legal game-playing strategies, seeking to wrest advantages fromthe complex and conflicting wording of the legislation. A more recent phenomenon is generic rivals using creative legal strategies to fight among themselves in court skirmishes over the highly valuable exclusive marketing period normally granted to the first company to file for approval to market a generic version of a branded drug. A recent decision by the Circuit Court of Appeals for the District of Columbia has limited the scope for some of these inter-generic skirmishes and so restored some certainty to the process, but other attempts by generics to "game" the system through new legal strategies are surely inevitable.