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
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
*   Harvard University Law  School, J.D. candidate, June 2004. He can be contacted at
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 An abbreviated, unpublished version of this article won first place in the Boston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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