Non-patent protection of pharmaceuticals in the USA

Abstract

The Obama administration’s recent health care reform legislation resulted from intense and divisive deliberations over public health policy in the USA. The existence of a fundamental right to health care, the role of the government in health care commerce, and the fiscal sustainability of existing service models were among the issues that were subject to spirited discussion. Widespread recognition that a significant number of individuals in the USA cannot readily afford the medications they require played a central role in the debate. 1 Manyofthe concernsthatpromptedhealth care reformlegislationin 2010hadearlier motivatedthe enactmentof the DrugPrice Competitionand Patent TermRestoration Act of 1984. 2 Congress intended that this legislation, commonly known as the Hatch-WaxmanAct,wouldbalancethe needforinnovativenewpharmaceuticalswith the availability of less expensive generic drugs. The statute includes elaborate provisions governing the mechanisms through which a potential generic manufacturer may obtain marketing approval on a drug that was originally sponsored by another. Among these measures were an exemption from patent infringement for activities associated with regulatory marketing approval, 3 unique litigation mechanisms for managing patent disputes, 4 and a government-sponsored clearing house of pharmaceutical patents. 5 This contribution focuses upon two additional aspects of the Hatch-Waxman Act and related legislation.In Part II, this essay considers patent term extension provisions – at first blush an odd choice given its title. The patent term extension rules