The Hatch-Waxman Act of 1984 increases patient access to lower-cost generic drugs. The Hatch-Waxman framework creates an automatic stay that blocks the Food and Drug Administration (FDA) from approving a new generic drug for thirty months. The America Invents Act (AIA) of 2011 created new administrative proceedings at the U.S. Patent and Trademark Office (USPTO) that replace certain aspects of district court patent litigation. This Comment examines the relevant statutory provisions of the Hatch-Waxman Act and AIA and explores the scenarios that give rise to uncertainty about the thirty-month stay. It argues that the thirty-month stay should terminate when the Federal Circuit affirms the USPTO¿s unpatentability determination and issues the formal mandate. Because neither the FDA nor courts are likely to construe the relevant statutory provisions to this effect, this Comment proposes an amendment to incorporate AIA proceedings into the Hatch-Watchman framework.
AIA Proceedings: A Prescription for Accelerating the Availability of Generic Drugs,
Emory L. J.
Available at: https://scholarlycommons.law.emory.edu/elj/vol66/iss4/6