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
Recommended Citation
Christopher M. Holman,
Branded Drug Companies Are Successfully Asserting the Doctrine of Equivalents in Hatch-Waxman Litigation,
40
Biotechnology Law Report
72
(2021).
Available at:
https://irlaw.umkc.edu/faculty_works/222