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Practising Law Institute (PLI), the nation's leading provider of continuing legal education, and international law firm, Kaye Scholer LLP, announce the release of Pharmaceutical and Biotech Patent Law— a timely new treatise that fills a crucial information need for patent practitioners by focusing on the many significant changes to patent law that uniquely affect the vast pharmaceutical and biotechnology industries and on how Congress and the courts are responding to the subsequent growth in patent litigation.
Organized to present patent law issues that arise from the earliest stages of drug discovery through final regulatory approval and marketing, Pharmaceutical and Biotech Patent Law features the expert contributions of attorneys of the Patent Group of Kaye Scholer LLP, who examine:
- The all-important utility requirement as it pertains to pharmaceutical patents, clarifying the types of inventions that do (and do not) pass the test for specific and substantial utility.
- The pivotal issue of inventorship, with coverage of the tests used to identify the inventor and the types of priority disputes and originality contests that can arise.
- Several commercially significant categories of patentable subject matter and the recurring legal issues associated with these categories, to help practitioners consider the problems and opportunities presented by different types of patents.
- Claims construction as it applies to pharmaceutical and biotech inventions, with in-depth insight into how the courts determine the validity of claims and how to ensure their validity through sound drafting.
- Patent infringement as it relates to pharmaceutical and biotech inventions, including the tests used to prove infringement and several available defenses, with extensive coverage of the experimental use defense and related decisional law.
Pharmaceutical and Biotech Patent Law also discusses antitrust suits launched by generic competitors, distributors, and patients against pharmaceutical manufacturers, with a focus on what constitutes "unreasonable restraint of trade." It also explains the purpose, components, impact, and future implications of such major patent legislation as the Hatch-Waxman Act and the Bayh-Dole Act.
Summary of Contents
- Introduction to the United States Patent System
- An Overview of Research & Development, Product Launch, and Patent Enforcement
- Utility Requirement
- Patentability: Obtaining and Challenging Patents
- Biological Deposits
- Types of Biological and Pharmaceutical Patents
- The Hatch-Waxman Act
- Claim Construction
- Patent Infringement
- Experimental Use Defense to Patent Infringement
- Government Funded Research: Bayh-Dole and Other Acts
- Antitrust, FTC, and State Competition Law
- Appendices: Glossary of Biotechnology Terminology from Case Law
- Primer on Basic Biotechnology Concepts
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