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9 Va. J.L. & Tech. 1 (2004)

handle is hein.journals/vjolt9 and id is 1 raw text is: VIRGINIAJOURNAL OF LAW& TECHNOLOGY WINTER 2004 UNIVERSITY OF VIRGINIA VOL. 9, No. 1 Consumer Protection, Patents and Procedure: Generic Drug Market Entry and the Need To Reform the Hatch- Waxman Act ANDREW A. CAFFREY, III, & JONATHAN M. ROTTERt ABSTRACT As the importance of prescription drugs in our health care system and national economy has increased, there has been a concomitant increase in attention to the issue of access to these phamiaceuticals. Congress has sought to facilitate the entry of generic drugs into the market, beginning with the passage of the Hatch-Waxman Act of 1984, which provided a mechanism for faster generic drug entry. But abuse of the procedures established by Hatch-Waxman has led to effects that are contrary to the act's intent. The automatic stays granted to patent holders that postpone market entry by generics, along with the strategic use of statutory windovs of exclusivity, have allovwd patent holders to extend illicitly their hold on monopoly prices. These effects have been well documented by the FTC and have spurred procedural change at the FDA Consumer suits show that consumers are also real parties in interest in controversies regarding generic drug entry. FTC recommendations and the recent Gregg-Schumer Amendments would repair major gaps in the original statutory framework but not completely eliminate opportunities for misuse. Together with the FTC's suggestions, changes w propose - the duty to litigate, not settle, infringement suits; changes in Orange Book listing practice; and a real market-based disgorgement of excess profits accrued during an automatic stay - wuld ensure that brand-name pharmaceutical companies receive their due patent protection, but nothing more. D 2004 Virginia Journal of Law & Technology Association, at http://www.vjolt.net. Use paragraph numbers for pinpoint citations. t Harvard University Law School, J.D. candidate, June 2004. He can be contacted at acaffrey@law.harvard.edu. * Harvard University Law School, J.D. candidate, June 2004. He can be contacted at jrotter@law.harvard.edu. For assistance with this paper, the authors acknowledge Laurie Allen, Havi Glaser, James Laur, and Professor Joseph Singer. An abbreviated, unpublished version of this article won first place in the Boston Patent Law Association's 2003 Writing Competition

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