Browsing Harvard Law School by Keyword "ANDA"
Now showing items 1-2 of 2
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The ANDA Patent Certification Requirement and Thirty-Month Stay Provision: Is it Necessary?
(2001)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 ... -
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)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 ...