Federal Circuit panel disagrees with Warner-Lambert decision

In Warner-Lambert Co. v. Apotex Corp., a panel of the Federal Circuit held that submission of an Abbreviated New Drug Application (ANDA) to the FDA can be an act of infringement under 35 U.S.C. sec 271(e)(2) only if the drug or the use of the drug for which FDA approval is sought is claimed by the p...

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Bibliographic Details
Published inIntellectual property & technology law journal Vol. 15; no. 6; pp. 13 - 14
Main Authors Goldstein, Lori, Ezring, Bernadette McCann, Shin, Adrian S
Format Journal Article
LanguageEnglish
Published Clifton Aspen Publishers, Inc 01.06.2003
Subjects
Analysis
District courts
FDA approval
Federal court decisions
Generic drugs
Infringement
Patent infringement
Pharmaceutical industry
State court decisions
Summary judgment
United States > US
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Summary:In Warner-Lambert Co. v. Apotex Corp., a panel of the Federal Circuit held that submission of an Abbreviated New Drug Application (ANDA) to the FDA can be an act of infringement under 35 U.S.C. sec 271(e)(2) only if the drug or the use of the drug for which FDA approval is sought is claimed by the patent at issue. In a recent decision, the Federal Circuit affirmed a grant of summary judgment of no infringement based on the holding of Warner-Lambert. All three members of the Allergan panel joined separate concurring opinions criticizing the Federal Circuit's decision in Warner-Lambert.
ISSN:1534-3618