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BNA Books Announces the Publication of the 2011 Supplement to "Pharmaceutical Patent Law, Second Edition"

ARLINGTON, Va., Dec. 27, 2011 /PRNewswire-USNewswire/ -- BNA Books, a division of specialized news and information publisher BNA, today announces the publication of the 2011 Supplement to Pharmaceutical Patent Law, Second Edition, discussing domestic and international developments in pharmaceutical patent law.


Pharmaceutical Patent Law, Second Edition tracks legal developments within the PTO, the FDA, Congress, the courts, the FTC, the Department of Justice, and the WTO; examines how these agencies and organizations interact with each other; and determines how developments impact strategies within a practitioner's core area of expertise. 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.

Pharmaceutical Patent Law also 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, a relatively new field; 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; and defenses to and remedies for patent infringement.

The all-new 2011 Supplement includes: 

  • A brand-new section on post-marketing activity
  • A new section amplifying international and comparative data protection law, discussing and comparing European supplementary protection certificates and other data protection efforts around the world
  • Discussion of implications for pharmaceutical patent practice of the Leahy-Smith America Invents Act
  • Discussion of the experimental use privilege and postapproval activities
  • Analysis of the multiple 30-month stays under the MMA
  • Discussion of the new FTC report on authorized generics
  • Discussion of patent eligibility following In re Bilski 
  • Analysis of the FDA labeling practice and induced infringement

Pharmaceutical Patent Law, Second Edition, 2011 Supplement is authored by John R. Thomas, 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, a wholly-owned subsidiary of Bloomberg L.P., is a leading source of legal, regulatory, and business information for professionals. In addition to Pharmaceutical Patent Law, BNA's Book Division publishes: Patents and the Federal Circuit; Patent, Trademark, and Copyright Laws; Patent Litigation Strategies Handbook; Patent Prosecution: Law, Practice, and Procedure; and other titles in intellectual property law. For a free BNA Books catalog, call 1.800.960.1220, send an e-mail request to, or visit us online at

Pharmaceutical Patent Law, Second Edition, 2011 Supplement may be purchased alone (Order #1984-PR11/$235.00 plus tax, shipping, and handling) or with the main volume (860 pp. Hardcover/Order #9984-PR11/$525.00 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. A 10% discount is available on print copies of books when ordering from the website at Please note that discounts cannot be combined.

Editors: Review copy available upon request.
Please e-mail Matt Greene at, or call 703.341.5767.


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