The ANDA Patent Certification Requirement and Thirty-Month Stay Provision: Is it Necessary?

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The ANDA Patent Certification Requirement and Thirty-Month Stay Provision: Is it Necessary?

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Range, Brian en_US
dc.date.accessioned 2012-06-07T20:34:05Z
dc.date.issued 2001 en_US
dc.identifier.citation The ANDA Patent Certification Requirement and Thirty-Month Stay Provision: Is it Necessary? (2001 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852164
dc.description.abstract Patent law and the Federal drug approval laws are both rather arcane and complex. The intersection of these two areas in the Hatch-Waxman Act is particularly complicated, and this perhaps explains the failure of the Act to consistently comply with core philosophical principles for supporting the modern intellectual property regime. The following paper addresses the problems arising from the thirty-month stay provision of the Hatch-Waxman Act, evaluates the legitimacy of the provision under accepted philosophical justifications for intellectual property, and suggests possible alternatives for addressing the failures of this provision. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject ANDA en
dc.subject thirty-month stay en
dc.subject hatch-waxman en
dc.subject FDA en
dc.subject drug approval en
dc.title The ANDA Patent Certification Requirement and Thirty-Month Stay Provision: Is it Necessary? en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T20:34:05Z

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