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 

Supplement Information

The 2012 Cumulative Supplement advises practitioners of recent significant developments, including: 

• Extensive changes brought about by the Leahy-Smith America Invents Act
• The Supreme Court's decisions in Mayo Collaborative Services v. Prometheus Laboratories and Caraco v. Novo Nordisk
• The FDA's new approval pathway for biosimilars

The supplement also includes a section amplifying international and comparative data protection law, discussion of the experimental use privilege and post-approval activities, and analysis of the multiple 30-month stays under the MMA.

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2010/856 pp. Hardcover/Order #9984

Supplement Information

2012/Softcover/ISBN 9781617460883/Order #2088

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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 

Main Volume Information

• Summary Table of Contents
• Detailed Table of Contents
• Preface

Supplement Information

• Summary Table of Contents
• Detailed Table of Contents
• Preface