BOOK DETAILS:
Biotechnology and Pharmaceutical Patents: Law and Practice
by Marc S. Gross, S. Peter Ludwig, Robert C. Sullivan, Jr.
Description
Biotechnology and Pharmaceutical Patents: Law and Practice is a comprehensive, how-to guide for protecting BioPharma inventions. This practice-based resource applies the law in the context of BioPharma patents as business assets, helping you to maximize their value and ensure their protection.
The material is designed to be easily accessible and immediately applicable to any BioPharma patent issue you may be facing. Biotechnology and Pharmaceutical Patents is arranged topically so that you can go straight to a specific section to answer a particular question. And this practical resource provides specific strategies for protecting proprietary intellectual property, including patentable inventions, data exclusivity, and trademarks.
Biotechnology and Pharmaceutical Patents: Law and Practice....
- Clearly enumerates the requirements for a BioPharma patent application, e.g., compliance with the novelty utility, obviousness, enablement, written description, and definiteness requirements
- Addresses issues arising during prosecution of a patent application, including discovery of prior art and inequitable conduct pitfalls
- Explains the regulatory and approval process for drugs and biologics, including Hatch-Waxman issues and regulatory exclusivities
The only practice-focused reference in the field, Biotechnology and Pharmaceutical Patents: Law and Practice approaches the topic from the perspective of problems faced by patent practitioners and patent decisionmakers on a daily basis. This brand-new resource helps you focus on the proper business and legal solution and saves you time in your research. In addition, Biotechnology and Pharmaceutical Patents: Law and Practice comes with a BONUS CD-ROM, containing over 40 practice-proven forms that you can edit and adapt to your immediate needs!
Table of Contents
- BioPharma Intellectual Property That Is Patentable Subject Matter
- The Novelty Requirement
- Nonobviousness
- Formal Standards of Patentability for BioPharma Inventions
- Restriction and Double Patenting
- Inequitable Conduct: What It Is and How to Avoid It
- How to Write a BioPharma Patent Application
- How and When to File BioPharma Patent Applications
- Identifying the Inventors
- Protecting IP Rights of Nonprofit Institutions
- How to Prosecute a BioPharma Patent Application
- Post-Grant Procedures
- Extending the Life of a BioPharma Patent
- Licensing BioPharma Patents
- Patent Infringement
- Statutory Infringement of Pharmaceutical Patents Under the Hatch-Waxman Act
- Approval of Biologics and the Prospect of Follow-On Biologics
- Assertion of Patent Infringement in the International Trade Commission
- Regulatory Exclusivities for Pharmaceutical Products
- Trademark Issues Relating To Pharmaceuticals
- Protection of IP Rights by Trade Secrets
- How to Obtain BioPharma Patents in Canada, China, The European Union, India And Japan
- BioPharma Patent-Related Regulatory Approval Provisions In Canada, China, the European Union, India and Japan
- How to Enforce BioPharma Patents in Canada, China, the European Union, India and Japan
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