The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management

The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management
by Martin, A. Voet

The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management
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Book Summary Information

Author: Martin, A. Voet
Edition: Paperback
Audio: English (Original Language); English (Unknown); English (Published)
Published: 2005-01-15
ISBN: 1581124309
Number of pages: 144
Publisher: Brown Walker Press

Book Reviews of The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management

Book Review: An Introduction for Everyone in the Pharmaceutical Business
Summary: 5 Stars

I read the Generic Challenge in one evening. It is easy to read, anecdotal and short (100 pages). My favorite portions of the book were Chapter 2 (pharmaceutical patenting strategy) and Chapter 7 (drug life-cycle management). It is hard to believe that so much information and seasoned advice is packed into this little book.

Generic Challenge is not written as a reference for experts. Rather, the book is written as an introduction for readers who are new to the field and interested in the topic. Because patents are now so fundamental to the business of pharmaceuticals and biotechnology, I would recommend this book to virtually everyone working in those industries regardless of whether you will deal directly with patents.
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Summary of The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management

The Generic Challenge is a must read for pharmaceutical executives and managers, and regulatory, legal, business development, R&D and strategic marketing professionals and anyone who has an interest in the future of the leading American pharmaceutical and biotechnology industries and the high value jobs they provide. It explains clearly and understandably the role of patents, FDA regulation of generic drugs and the Hatch Waxman Act on drug development today and how improvements in innovative drug products provide enhanced benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind available on this important subject. Chapters 1-2 cover patents generally and patent enforcement and infringement Chapter 3 covers pharmaceutical, biological and medical device patents Chapters 4-5 cover FDA and drug product exclusivities Chapter 6 covers the Hatch Waxman Act and recent Medicare Act Amendments Chapter 7 puts it all together with Pharmaceutical Life-Cycle Management

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