A Look at The Drug Price Competition and Patent Term Restoration Act of 1984

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A Look at The Drug Price Competition and Patent Term Restoration Act of 1984

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Lee, David D. en_US
dc.date.accessioned 2012-12-07T20:09:28Z
dc.date.issued 2002 en_US
dc.identifier.citation A Look at The Drug Price Competition and Patent Term Restoration Act of 1984 (2002 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:10018983
dc.description.abstract The DPC-PTR Act was a piece of legislation that was fought over bitterly by the generic and research-based industries, and passed only when a tenuous balance was reached through last-minute negotiations. "One indication of the controversial nature and sensitivity of the coalition was that there is almost none of the usual legislative history to this bill. There are no Senate reports, for example, and floor statements were extremely limited and dealt with only a small number of technical points. To really understand the intent of this legislation, one almost had to be there as it was negotiated." The passage of the legislation did not stop the two sides from feuding with each another. This naturally led to litigation. But due to the incomplete legislative history, ambiguous language of the Act, and the imaginative theories of the lawyers for the opposing drug companies, the courts have had to wrestle with the conflicting language and principles of the Act. With many millions of dollars often at stake, the outcomes of these cases were important to both innovators, copiers, and consumers. However, in spite of the seriousness of the matters that the DPC-PTR Act influenced, some of the opinions that resulted from litigation on the Act are perplexing. This paper will provide a general history of the passage and the first few years of the Drug Price Competition and Patent Term Restoration Act of 1984, and will examine the contrast between the serious nature of the Act and some of the humorous judicial opinions that resulted from it. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject DPC-PTR en
dc.subject Hatch-Waxman en
dc.subject drugs en
dc.subject legislation en
dc.title A Look at The Drug Price Competition and Patent Term Restoration Act of 1984 en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-12-07T20:09:28Z

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