Pharmaceutical Patent Law, 2nd Edition

A comprehensive review of the critical issues at the intersection of patent law and food and drug law, with a new chapter on Follow-on Biologics. 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. Pharmaceutical Patent Law, Second Edition 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; 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 the food and drug laws. Pharmaceutical Patent Law, Second Edition also provides complete coverage of advanced topics, including the antitrust implications of patent settlements, the experimental use privilege, and international aspects of the field.