Hatch-Waxman in the Federal Courts: from 1994--2004

Decisions of the federal courts play a crucial role in drug development. Litigation related to drug development and approval under the abbreviated new drug application ("ANDA") process over the past 10 years was evaluated, examining over 300 written decisions from 22 U.S. District Courts a...

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Bibliographic Details
Published inDrug development and industrial pharmacy Vol. 31; no. 2; p. 215
Main Authors Ludwig, S Peter, Kosinski, Kristin Behrendt, Harris, Jonathan
Format Journal Article
LanguageEnglish
Published England 01.01.2005
Subjects
Drug Approval - legislation & jurisprudence
Drug Design
Drug Industry
Drugs, Generic - economics
Federal Government
Humans
Marketing of Health Services
Patents as Topic - legislation & jurisprudence
United States
United States Food and Drug Administration
United States
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Summary:Decisions of the federal courts play a crucial role in drug development. Litigation related to drug development and approval under the abbreviated new drug application ("ANDA") process over the past 10 years was evaluated, examining over 300 written decisions from 22 U.S. District Courts and the U.S. Court of Appeals for the Federal Circuit. These written decisions represent the majority of patent litigation between brand and generic drug manufacturers. The reported data set provides critical information for the drug development and litigation strategies of both brand and generic manufacturers. The examination also provides a realistic portrayal of the anticipated outcome if a legal action is initiated.
ISSN:0363-9045
DOI:10.1081/DDC-200047811