Since 1984, generic pharmaceuticals have continued to grow, and are an important element in our national struggle to increase affordable health care options in the United States. The Hatch-Waxman Act has played a pivotal role in helping to create a regulatory environment that fosters the development of generic pharmaceuticals, thereby increasing access to lower-cost alternatives to more expensive drugs. An important part of balancing the interests of the generic manufacturers against those of the primary pharmaceutical makers is the thirty-month stay provision of the Hatch-Waxman Act. This comment begins by taking a look at the history of the Hatch-Waxman Act and recent reforms to the Hatch-Waxman Act. The comment explores the policy goals of the Act, and some of the abuses that developed once the Act was passed, with a particular focus on the evolution of the thirty-month stay provision of the Hatch-Waxman Act. The comment analyzes recent cases, paying particular attention to the equitable approach taken by the court when lengthening or shortening the stay in response to the various interests the court is seeking to protect. Next, this comment analysis whether or not the Hatch-Waxman Act has met the policy goals it was intended to meet. The comment evaluates the effect the Hatch-Waxman Act had in its general form as contrasted to the current state of affairs in the court, framed within the regulatory duties of the FDA to determine the appropriate direction for future legislation. Additionally, the comment proposes reforms to reestablish balance so that the thirty-month stay provision of the Hatch-Waxman Act is used to maintain patent rights without abusing the rights of others.
Christopher R. Walker, Deadly Delay / Postponed Pills, 10 J. Marshall Rev. Intell. Prop. L. 254 (2010)