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Pharmaceutical Patent Law, Third Edition, with 2016 Supplement

Published by Bloomberg BNA
By John R. Thomas
Publication Date: 2016
1,140 pages

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Price: $540 + S&H
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Pharmaceutical Patent LawA comprehensive review of the critical issues at the intersection of patent law and food and drug law.

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

 The 2016 Supplement adds discussion of the following:

  • The on-sale bar and pharmaceutical suppliers

  • Personal jurisdiction in Hatch-Waxman Cases

  • Equivalent infringement for pharmaceutical patents

  • Rolling review NDAs and patent term extension

  • How to avoid filing Paragraph IV certifications

About the Publisher

Technology Transfer Tactics is proud to partner with Bloomberg BNA Books to bring our customers access to this comprehensive and authoritative resource. All Bloomberg BNA Books are written by respected experts with extensive experience in patent law and IP licensing. These renowned authors draw from their wealth of professional expertise and in-depth research to deliver the most highly regarded editorial quality in the industry.

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