Pharmaceutical Patents: Issues and Considerations

Florian Aerts (Editor)

Series: Laws and Legislation, Pharmacology – Research, Safety Testing and Regulation
BISAC: LAW046000

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Volume 10

Issue 1

Volume 2

Volume 3

Special issue: Resilience in breaking the cycle of children’s environmental health disparities
Edited by I Leslie Rubin, Robert J Geller, Abby Mutic, Benjamin A Gitterman, Nathan Mutic, Wayne Garfinkel, Claire D Coles, Kurt Martinuzzi, and Joav Merrick

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Although brand-name pharmaceutical companies routinely procure patents on their innovative medications, such rights are not self-enforcing. Brand-name firms that wish to enforce their patents against generic competitors must therefore commence litigation in the federal courts. Such litigation ordinarily terminates in either a judgment of infringement, which typically blocks generic competition until such time as the patent expires, or a judgment that the patent is invalid or not infringed, which typically opens the market to generic entry. This book introduces and analyzes innovation and competition policy issues associated with pharmaceutical patent litigation settlements. It begins with a review of pharmaceutical patent litigation procedures under the Hatch-Waxman Act, then introduces the concept of reverse payment settlements, and analyzes the status of reverse payment settlements under antitrust laws, and discusses congressional issues and possible alternatives. (Imprint: Novinka )

Preface

Pharmaceutical Patent Settlements: Issues in Innovation and Competitiveness
(John R. Thomas, CRS)

The Role of Patents and Regulatory Exclusivities in Pharmaceutical Innovation
(John R. Thomas, CRS)

Patent Infringement and Experimental Use Under the Hatch-Waxman Act: Current Issues
(John R. Thomas, CRS)

The Hatch-Waxman Act: Over a Quarter Century Later
(Wendy H. Schacht, John R. Thomas, CRS)

Index

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