The Hatch-Waxman (Im)Balancing Act

Abstract

The Hatch-Waxman Act was intended to establish a balance between the competing interests of brand name and generic drug companies, fostering innovation while giving the public access to a wider selection of affordable drugs. However, abuses of certain provisions of the Act threaten this balance, and broad judicial interpretations ascribed to other provisions of the Act may have the unintended consequence of injuring the fledgling research tools industry. In Chapter I, this paper will navigate through the maze of the Hatch-Waxman Act’s statutory amendments, describing the Abbreviated New Drug Application (ANDA) and the Patent Term Extension procedures created by the Act, the functions that Congress probably intended these features of the Act to serve, and how successful the Act has been at meeting these goals. In Chapter II, this paper will focus on those provisions of the Act that have had the unintended consequence of prolonging brand name drug companies’ market exclusivity, and incentivizing collusion between brand name and generic drug companies, to the detriment of the public. Special emphasis will be placed on Congress' attempts at legislative reforms that involve either closing these loopholes or increasing the Federal Trade Commission's (FTC) and Justice Department's enforcement power, in response to recent criticisms by the FTC. In Chapter III, this paper will follow the gradual expansion in scope of the Bolar amendment, one of the provisions of the Act, through progressive iterations in judicial precedent, as it evolved from its originally intended role, as a balancing factor between the interests of brand name and generic drug companies, to its current role, as a potential threat to the legitimacy of the research tools industry. Other threats that certain patent law doctrines pose to this fledgling industry will also be discussed, and possible solutions will also be suggested.