BOOK

Pharmaceutical Patent Law, Third Edition

This treatise is the only reference available with a detailed, practitioner-oriented treatment of pharmaceutical patent law from the perspective of both patent law and food and drug laws. 

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DESCRIPTION

Pharmaceutical Patent Law, Third Edition takes on the complicated tasks of tracking legal developments within the Patent and Trademark Office, the Federal Drug Administration (FDA), Congress, the courts, the Federal Trade Commission (FTC), the Department of Justice, and the World Trade Organization; examining how these agencies and organizations interact with each other; and determining how they impact strategies within a practitioner’s core area of expertise. This treatise is the only reference available with a detailed, practitioner-oriented treatment from the perspective of both patent law and food and drug laws.
Pharmaceutical Patent Law provides complete coverage of advanced topics, including the antitrust implications of patent settlements, the experimental use privilege, and international aspects of the field. Core topics covered include follow-on biologics; the substance and procedure of pharmaceutical patent acquisition; FDA marketing approval procedures for innovative and generic drugs, as well as FDA marketing exclusivities; the FDA’s Orange Book; and patent term extension standards.
The Third Edition covers the following significant developments:

  • Caraco Pharmaceutical v. Novo Nordisk and its implications for Hatch-Waxman counterclaims
  • Is the Biologics “Patent Dance” Optional? Ramifications of Amgen v. Sandoz
  • 2015 FDA regulations implementing the MMA
  • Increasing scrutiny of patent use codes
  • The Actavis antitrust revolution
  • The growing role of citizen petitions in FDA regulatory practice
  • The 15 FDA regulatory exclusivities
  • Dramatic patent law developments in the Supreme Court
  • Implementation of the America Invents Act
  • Antitrust implications of “product hopping”
  • And more

 


AUTHOR

Bloomberg BNA authors and editors are practicing professionals with insider perspectives and real-life experience. Learn more about this book’s authors and editors.

John R. Thomas is a member of the faculty of Georgetown University Law Center, Washington, D.C., and a widely published author in the field of pharmaceutical patent law. He frequently serves as a Special Master in patent litigation before the federal courts.

 


CONTENTS

View full table of contents and preface.