Publication Date

2021

Document Type

Article

Abstract

This article reports the results of a study analyzing every Federal Circuit decision the author could find dating back to 2005 that applies the doctrine equivalents (DOE) in the context of pharmaceutical patent litigation, and in particular infringement lawsuits brought against Abbreviated New Drug Application (ANDA) applicants by branded drug companies under the Hatch-Waxman Act. The results of this study show that pharmaceutical innovators were prevailing against would-be generic competitors under the DOE both prior to, and subsequent to, a 2007 article by Professors Lemley and Allison describing the demise of the doctrine equivalents, but that patentees’ success rate has improved markedly in recent years. This article is a follow-up to another Holman Report I published last year that focused on application of the DOE to biomolecule claim limitation, Ajinomoto v. ITC, the Doctrine of Equivalents, and Biomolecule Claim Limitations at the Federal Circuit.

Publication Title

Biotechnology Law Report

Volume

40

Issue

2

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