One of These Things Is Not Quite the Same: A Comparison of the Patent Doctrine of Equivalents with Suitability for Filing an Abbreviated New Drug Application

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One of These Things Is Not Quite the Same: A Comparison of the Patent Doctrine of Equivalents with Suitability for Filing an Abbreviated New Drug Application

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Halstead, David P. en_US
dc.date.accessioned 2012-06-07T20:38:09Z
dc.date.issued 2002 en_US
dc.identifier.citation One of These Things Is Not Quite the Same: A Comparison of the Patent Doctrine of Equivalents with Suitability for Filing an Abbreviated New Drug Application (2002 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852178
dc.description.abstract The doctrine of equivalents as applied to chemical patents is compared to the FDA’s findings of bioequivalence in reviewing suitability petitions for filing Abbreviated New Drug Applications (ANDAs). The doctrine of equivalents provides the greatest flexibility early in the drug-development process, gradually diminishing as the product refinements become increasingly minor. Determinations of bioequivalence, however, exhibit the reverse trend as applied to analogous situations in the context of suitability petitions. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject doctrine of equivalents en
dc.subject suitability petition en
dc.subject ANDA en
dc.title One of These Things Is Not Quite the Same: A Comparison of the Patent Doctrine of Equivalents with Suitability for Filing an Abbreviated New Drug Application en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T20:38:09Z

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