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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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
Author:	Halstead, David P.
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)
Full Text & Related Files:	Halstead.pdf (201.0Kb; PDF) Halstead.rtf (77.76Kb; RTF file) Halstead.html (86.22Kb; HTML)
Abstract:	The 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.
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