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Book Review: Generic Pharmaceutical Patent and FDA Law

By Aaron Barkoff

Shashank Upadhye has written a new text, Generic Pharmaceutical Patent and FDA Law, that anyone reading Orange Book Blog will certainly find useful.  Mr. Upadhye is Vice President & Global Head of Intellectual Property for Apotex.

The book provides a nice overview of patent law--especially as applied to pharmaceuticals--and the drug approval process.  In addition, it includes detailed chapters on issues that arise from the Hatch-Waxman Act, including Orange Book patent certifications and notice letters, the 30-month stay, 180-day exclusivity and forfeiture, and declaratory judgment.  A complete list of the book's chapters appears below.

Generic Pharmaceutical Patent and FDA Law is incredibly current, citing not only cases that were decided this year, but also FDA decisions made this year and even numerous pending cases.  The book also excels by offering countless practice tips.  It is not simply a legal treatise.  Moreover, despite its focus on generic drugs, those who work with brand-name drug companies will also find the book helpful because it describes the issues facing generic drug companies.

Generic Pharmaceutical Patent and FDA Law is published by Thomson/West and is available to purchase from their website.  To receive a 10% discount on the book, use promo code 571793 or click here.

Chapter Listing:

1. Basics of Patent Law
2. Patent Infringement Rules and Procedures
3. Foundations of Patent Invalidity
4. Inequitable Conduct and Unenforceability
5. Equitable Defenses to Patent Infringement
6. Basics of Brand Drug Approval Process and Orange Book Listings
7. Abbreviated New Drug Application (ANDA) Approval Process
8. "Paper NDA" and 505(b)(2) Applications
9. Patent Infringement Safe Harbor Exemptions
10. Mechanics of Orange Book Patent Certifications and Notice Letters
11. The 30-Month Injunction/Stay
12. Brand Side Exclusivities
13. The 180-Day Exclusivity
14. Forfeiture of the 180-Day Exclusivity
15. Declaratory Judgment
16. Patent Infringement Damages and Remedies

Full post as published by Orange Book Blog: At the Intersection of Patent Law and FDA Law on July 08, 2008 (boomark / email).