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. Core topics covered include:
- 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 patent infringement
- Remedies for patent infringement
- The experimental use privilege
- Antitrust treatment of pharmaceutical patent settlements
- International aspects of pharmaceutical patent practice
The Second Edition of Pharmaceutical Patent Law includes the following new information:
- Extensive coverage of the new follow-on biologics legislation
- The impact of Bilski v. Kappos on diagnostic method claims
- New judicial guidance on patent term extensions under the Hatch-Waxman Act
- Significant case law regarding forfeiture of the 180-day generic exclusivity
- The developing law of “obvious to try” in the post-KSR era
Pharmaceutical Patent Law, Second Edition not only reviews current issues of importance, but identifies topics—such as parallel importation and authorized generics—that are likely to be of growing significance. The treatise is invaluable to the busy practitioner who is determined to keep on track in this evolving area of the law.
The all-new 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 v. Prometheus and Caraco v. Novo Nordisk
- The FDA’s new approval pathway for biosimilars
The new 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.