Book

Pharmaceutical Patent Law, Third Edition, with 2018 Cumulative Supplement

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. 


Meet The Author

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. 


SUMMARY OF CONTENTS

New in the 2018 Cumulative Supplement:   

  • The new competitive generic therapy exclusivity
  • The biologics patent dance and federal preemption
  • Pharmaceutical patent term extensions in overseas markets
  • Personalized medicine patent upheld under Section 101
  • Subject matter jurisdiction under the Hatch-Waxman Act

 

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.