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
Halstead, David P.
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CitationOne 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)
AbstractThe doctrine of equivalents as applied to chemical patents is compared to the FDAâ€™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.
Citable link to this pagehttp://nrs.harvard.edu/urn-3:HUL.InstRepos:8852178
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