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Biotechnology and Pharmaceutical Patents: Law and Practice by Marc S. Gross, S. Peter Ludwig, Robert C. Sullivan, Jr.

Protect and Increase the Value of Biotechnology and Pharmaceutical Patents!
Biotechnology and Pharmaceutical Patents: Law and Practice
by Marc S. Gross, S. Peter Ludwig, Julie R. O'Sullivan
List Price: $420.00  
Eligible for Free Standard Shipping on U.S. Prepaid Orders
Imprint: Aspen Publishers
ISBN: 9780735562660
Looseleaf: 1,132 pages
Last Updated: 11/17/2009
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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, trade secrets, know-how, databases, data collection, and business plans.

Biotechnology and Pharmaceutical Patents: Law and Practice....

  • Clearly enumerates the requirements for a BioPharma patent application, e.g., compliance with the utility, enablement, and written description 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 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!


  1. BioPharma Intellectual Property That Is Patentable Subject Matter
  2. The Novelty Requirement
  3. Nonobviousness
  4. Formal Standards of Patentability for BioPharma Inventions
  5. Restriction and Double Patenting
  6. Inequitable Conduct: What It Is and How to Avoid It
  7. How to Write a BioPharma Patent Application
  8. How and When to File BioPharma Patent Applications
  9. Identifying the Inventors
  10. Protecting IP Rights of Nonprofit Institutions
  11. How to Prosecute a BioPharma Patent Application
  12. Post-Grant Procedures
  13. Extending the Life of a BioPharma Patent
  14. Licensing BioPharma Patents
  15. Patent Infringement
  16. Statutory Infringement of Pharmaceutical Patents Under the Hatch-Waxman Act
  17. Approval of Biologics and the Prospect of Follow-On Biologics
  18. Assertion of Patent Infringement in the International Trade Commission
  19. Regulatory Exclusivities for Pharmaceutical Products
  20. Trademark Issues Relating To Pharmaceuticals
  21. Protection of IP Rights by Trade Secrets
  22. How to Obtain BioPharma Patents in Canada, China, The European Union, India And Japan
  23. BioPharma Patent-Related Regulatory Approval Provisions In Canada, China, the European Union, India and Japan
  24. How to Enforce BioPharma Patents in Canada, China, the European Union, India and Japan

 Guide To EU Pharmaceutical Regulatory Law
Sally Shorthose, Bird & Bird LLP
Also available online at : www.kluwerlawonline.com In the European Union and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny of the urgent and essential role su more...
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| Price: $300.00 | ISBN: 9789041128454 | Format: Paperback 
Imprint: Kluwer Law International