The ANDA Patent Certification Requirement and Thirty-Month Stay Provision: Is it Necessary?

Abstract

Patent law and the Federal drug approval laws are both rather arcane and complex. The intersection of these two areas in the Hatch-Waxman Act is particularly complicated, and this perhaps explains the failure of the Act to consistently comply with core philosophical principles for supporting the modern intellectual property regime. 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.