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New Second Edition of Pharmaceutical Patent Law Examines Critical Intersection of Patent Law and Food and Drug Law

ARLINGTON, Va., Jan. 3, 2011 /PRNewswire-USNewswire/ -- BNA Books, a division of BNA, announces the publication of the Second Edition of Pharmaceutical Patent Law, the most relied upon reference available with a detailed, practitioner-oriented treatment of pharmaceutical patent law from the perspective of both patent law and the food and drug laws.


This revised treatise takes on the complicated tasks of tracking legal developments within the PTO, FDA, Congress, the courts, the FTC, the Department of Justice, and the WTO. This treatise examines how these agencies and organizations interact with each other and analyzes how they will impact strategies within a practitioner's core area of expertise.

Pharmaceutical Patent Law, Second Edition 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:

  • The substance and procedure of pharmaceutical patent acquisition
  • FDA marketing approval procedures for innovative and generic drugs
  • The FDA's Orange Book
  • Patent term extension standards
  • FDA marketing exclusivities
  • The scope of patent rights
  • Patent infringement procedures under the Hatch-Waxman Act
  • Defenses to patent infringement
  • Remedies for patent infringement
  • The experimental use privilege
  • Antitrust treatment of pharmaceutical patent settlements
  • International aspects of pharmaceutical patent practice

The Second Edition includes the following new information:

  • Extensive coverage of the new follow-on biologics statute
  • The impact of Bilski v. Kappos on diagnostic method claims
  • New judicial guidance on patent term extensions under the Hatch-Waxman Act
  • Significant case law regarding forfeiture of the 180-day generic exclusivity
  • The developing law of "obvious to try" in the post-KSR era

Pharmaceutical Patent Law, Second Edition not only reviews current issues of importance, but identifies topics such as parallel importation and authorized generics that are likely to be of growing significance. The author, Professor John R. Thomas, is a member of the faculty of Georgetown University Law Center, Washington, DC, where he teaches courses in both patent and food and drug law.

BNA is a leading private publisher of news and information products for professionals in law and business. In addition to Pharmaceutical Patent Law, BNA's Book Division publishes Anatomy of a Patent Case;  Biotechnology and the Federal Circuit; Constructing and Deconstructing Patents; Drafting Patent License Agreements; Electronic and Software Patents: Law and Practice; Intellectual Property Taxation: Transaction and Litigation Issues; International Patent Litigation: A Country-by-Country Analysis; Patent Infringement Remedies; Patent Law and Practice; Patent Prosecution: Law, Practice, and Procedure; Patent, Trademark, and Copyright Laws; Patent, Trademark, and Copyright Regulations; Patents and the Federal Circuit; Trademark Litigation Practice; Harmon on Patents: Black-Letter Law and Commentary; and other titles in legal specialties. The BNA Books website, including an online catalog, can be found at

The new Second Edition of Pharmaceutical Patent Law may be purchased (860 pp. Hardcover/Order #1898-PREL10/$445.00 plus tax, shipping, and handling) from BNA Books, PO Box 7814, Edison, NJ 08818-7814. Telephone orders: 1-800-960-1220. Fax orders: 1-732-346-1624. For a free BNA Books catalog, call 1-800-960-1220 or send an e-mail request to A 10% discount is available on print copies of books when ordered from the website at (Please note that discounts cannot be combined).

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