Review: DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT, 1984 AND THIRTY-MONTH STAY PROVISION

The Hatch-Waxman act of 1984 has been quite successful in increasing the availability of generic drugs, but closer analysis reveals that the Act’s provisions relating to patent certification actually delay approval of generic drugs. The following paper addresses the problems arising from the thirty-month stay provision of the Hatch-Waxman Act, evaluates the legitimacy of the provision under accepted philosophical justifications for intellectual property, and suggests possible alternatives for addressing the failures of this provision. This article interprets the complicated Act and examines it with respect to the different theories of intellectual property. The numerous problems caused by the thirty month stay provision, ‘evergreening’ and ‘trip-wire’ patenting are also discussed at length. The legal implications of litigation including ethics and anti-trust law are examined. In conclusion, we authors recommend various remedial steps to be taken to exploit the Act to its fullest such that generic drug approval is not unnecessarily delayed.