Pharmaceutical Patent Law, Third Edition, with 2017 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


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 2017 Cumulative Supplement adds discussion of the following:

  • The Patent Dance After Sandoz v. Amgen
  • The new rules of patent venue
  • The 2016 Final FDA Rules
  • Divided infringement and pharmaceutical patents
  • The post-AIA on-sale bar
Summary of Contents

I. IntroductionChapter 1. Introduction to Pharmaceutical Patents

II. Patent AcquisitionChapter 2. Patent Eligibility

Chapter 3. Utility

Chapter 4. Novelty

Chapter 5. Nonobviousness

Chapter 6. The Patent Instrument

Chapter 7. Patent Acquisition Procedures

Chapter 8. Duration of Rights

III. Marketing Approval Procedures

Chapter 9. The FDA Drug Approval Process

Chapter 10. The Orange Book

Chapter 11. Regulatory Exclusivities

IV. Infringement

Chapter 12. Scope of Patent Rights

Chapter 13. Claim Interpretation and the Doctrine of Equivalents

Chapter 14. Parallel Importation

Chapter 15. The Experimental Use Privilege

Chapter 16. Antitrust Considerations

V. International and Comparative Aspects

Chapter 17. International and Comparative Patent Law

Chapter 18. International and Comparative Data Protection Law

VI. Biologics

Chapter 19. Follow-on Biologics


Table of Cases



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.



View full table of contents and preface.