Filing of ANDA is infringement only when drug or use of drug for which FDA approval is sought is claimed in patent

The Patent Act provides an artificial act of infringement that allows resolution of potential patent infringement disputes before a generic drug manufacturer actually makes or markets a proposed generic drug. Under 35 U.S.C. section 271(e)(2)(A), it is an act of infringement to submit an Abbreviated...

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Bibliographic Details
Published inIntellectual property & technology law journal Vol. 15; no. 4; pp. 11 - 12
Main Authors Gutterman, Jennifer, Harley, Patricia, Ezring, Bernadette McCann, Shin, Adrian S
Format Journal Article
LanguageEnglish
Published Clifton Aspen Publishers, Inc 01.04.2003
Subjects
Alzheimer's disease
Disease
Drugs
Epilepsy
FDA approval
Generic drugs
Intellectual property
Laws, regulations and rules
Manufacturers
Patent infringement
Pharmaceutical industry
State court decisions
United States > US
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Summary:The Patent Act provides an artificial act of infringement that allows resolution of potential patent infringement disputes before a generic drug manufacturer actually makes or markets a proposed generic drug. Under 35 U.S.C. section 271(e)(2)(A), it is an act of infringement to submit an Abbreviated New Drug Application to the FDA for a drug claimed in a patent or the use of which is claimed in a patenti if the purpose of such submission is to obtain approval, to engage in the commercial manufacture, use, or sale of a drug claimed in a patent or the use of which is claimed in a patent before the expiration of such a patent.
ISSN:1534-3618