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Pharmaceutical Patent Law, Second Edition, with 2013 Cumulative Supplement

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Main Volume Information

In recent years, pharmaceutical patent laws have been subjected to significant legislative reforms, controversial amendments to FDA regulations, numerous investigations by antitrust enforcement authorities, judicial precedent from the Supreme Court, and far-reaching pronouncements from the World Trade Organization (WTO). Pharmaceutical Patent Law, Second Edition takes on the complicated tasks of tracking legal developments within the PTO, the FDA, Congress, the courts, the FTC, the Department of Justice, and the WTO; 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 of pharmaceutical patent law from the perspectives 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 
  • Defenses to, and remedies for, patent infringement 
The treatise not only reviews current issues of importance, but also reflects the impact of the new patent reform law on pharmaceutical patents and identifies topics, such as parallel importation and authorized generics, that are becoming increasingly significant. Pharmaceutical Patent Law, Second Edition is the ideal reference for practitioners looking for detailed guidance on pharmaceutical patent law in an easy-to-use format.

Supplement Information

The  2013 Cumulative Supplement highlights significant events that occurred since that text was published. This Supplement is current through July 2013, and includes discussion of the 2011 Leahy-Smith America Invents Act (AIA) and analysis of the Supreme Court’s recent groundbreaking decision in Federal Trade Commission v. Actavis, Inc., as well as in Association for Molecular Pathology v. Myriad, Inc. It discusses the impact of the Food and Drug Administration Safety and Innovation Act (FDASIA), which also extended the term of marketing exclusivities for certain infectious disease products; the availability of the experimental use exception for clinical trials; and judicial analysis of the MMA triggers for forfeiture of the 180-day generic exclusivity.

The 2013 Cumulative Supplement examines notable decisions issued by the Federal Circuit concerning the “safe harbor” exception introduced by the Hatch-Waxman Act; the status of clinical trials as patent-defeating “public uses” under the Patent Act; and the requirements for an enabling disclosure for pharmaceutical patents. It also discusses decisions from the D.C. Circuit that address the requirements to obtain three-year new clinical study exclusivity as well as the generic exclusivity forfeiture events introduced by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. 

Main Volume Information

2010/856 pp. Hardcover with 2013 Supplement/Order #9324P  


Supplement Information

2013/Softcover/ISBN 9781617463242/Order #2324

Main Volume Information

About the Author
John R. Thomas is Professor of Law at Georgetown University in Washington, DC. He has served as law clerk to Chief Judge Helen W. Nies of the U.S. Court of Appeals for the Federal Circuit, Instructor at the U.S. Patent and Trademark Office, and Visiting Researcher for the Congressional Research Service of the Library of Congress. 


Supplement Information

John R. Thomas, Author