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.
SUMMARY OF CONTENTS
The 2017 Cumulative Supplement adds discussion of the following:
I. IntroductionChapter 1. Introduction to Pharmaceutical PatentsII. 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
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
Chapter 19. Follow-on Biologics
Table of Cases
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