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 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
- 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 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
Main Volume Information
2010/856 pp. Hardcover/Order #9984
Supplement Information
2011/Softcover/ISBN 9781570189845/Order #1984