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The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management (second edition) |  | Author: Martin A. Voet
Publisher: Brown Walker Press
Category: Book
List Price: $28.95
Buy New: $25.79
as of 7/30/2010 02:12 CDT details
You Save: $3.16 (11%)
New (11) Used (7) from $25.75
Seller: Amazon.com
Rating:  6 reviews
Sales Rank: 227128
Media: Paperback
Edition: 2
Pages: 184
Number Of Items: 1
Shipping Weight (lbs): 0.5
Dimensions (in): 8.3 x 5.4 x 0.6
ISBN: 1599424444
Dewey Decimal Number: 346.730486
EAN: 9781599424446
ASIN: 1599424444
Publication Date: May 1, 2008
Availability: Usually ships in 24 hours
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Product Description
Explains clearly and understandably the role of patents, FDA regulations of generic drugs and the Hatch Waxman Act on conventional and biological drug product development today and how directed innovation can result in enhanced care for patients while extending the commercial lives of the drugs. 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.
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| Customer Reviews:
Showing reviews 1-5 of 6
 Accessible Primer on Patents & Exclusivity in the Pharma Industry July 7, 2008
Jeffrey Seguritan
5 out of 6 found this review helpful
As a consultant in the pharmaceutical/biotech industry, I found this reading to be pleasantly illuminating and gently absorbing (took only 2 leisurely days to read). Although having some exposure to law school pedagogy and lingo myself, Mr. Voet explains the legal underpinnings of patent law with a simplistic and logical exposition interlaced with sufficient detail, precision and nuance (as is expected in any effective discussion on law). He begins his tour from the basic definition of a patent, and guides the reader through important matters like patent claims, interference, "doctrine of equivalents", and some noteworthy legal precedents that guide current interpretations of patent law (for example, how the Merck v. Integra decision provides "safe harbor exemption" for infringements that pertain to preclinical and clinical research pursuant to FDA submission). Not lost in Voet's description is the distinctive legal environments and dynamics in other key pharmaceutical markets like the E.U., Canada and Japan, and those variations are aptly examined. While there is indeed a distinction between patent rights and market exclusivities, Voet describes the interplay between the two in the ever critical task of product life-cycle management. His own pharma industry experience enriches his exposition by revealing industry-specific patterns (like the propensity for innovator companies to file broad drug compound patents and padding with narrow patents on formulation, new indications, etc.), and walking through illustrative examples and case studies (like Syntex's life-cycle strategy on Acular 0.5% against generic threats by the notorious Apotex). Despite the admittedly dynamic nature of patent law and market exclusivities, Voet's material is refreshingly up-to-date (referring to events/considerations as recent as 2007-08). Key takeaways are neatly summed up at the end of each chapter, and an exhaustive glossary is available to keep the reader reminded of key terminology. Overall, an easy and necessary read for anyone wanting to delve in the complex arena of pharmaceutical product life-cycle management.
Review of the Kindle version January 22, 2010
Martin A. Voet (Mission Viejo, California)
1 out of 1 found this review helpful
As pointed out by other reviewers, the KINDLE version has numerous typography errors and i have asked the publisher to withdraw the Kindle version until Amazon fixes it. I apologize to prior purchasers of the Kindle version of my book as neither I nor my publisher had any opportunity to review it before it was made available by Amazon.
Martin Voet
Author, The Generic Challenge
Required reading for anyone in the biotech/pharma industry May 22, 2008
Ligeia
3 out of 4 found this review helpful
This book is all about exclusivity: how the patent and FDA laws interact to give only one biotech or pharma company the exclusive rights to sell a drug. Exclusivity matters more than just about anything else in the drug industry - there's safety, efficacy, and exclusivity, in that order - yet I can't think of a single book which addresses the subject the author does here. Every executive in the biotech/pharma industry should be required to read it; anyone wanting to understand the patent system and how the industry uses it should read this book, as well. The author writes clearly and engagingly, and makes the most complicated subjects interesting and easy to understand. I consulted the first edition regularly in my work in biotech, and look forward to using this revised edition, as well, which has many more examples and illustrations.
very helpful overview of current issues February 22, 2009
T. Um (DC)
0 out of 1 found this review helpful
this is a great overview of the pharm industry. the author concisely introduces readers to the current issues. i think everyone should read this book because drug concerns everyone. although author says he intentioanlly omitted citations, very brief citation as endnote would have been helpful.
 Content is great. formatting isn't August 20, 2009
B. Vendsel (AZ)
The title says it all. The content is wonderful but reading it can be troublesome and occasionally downright aggravating due to a completely inept formatting job. Not just the usual issues with oddly placed page breaks or poor embedded images but long strings of words with no spacing and odd patterns of capitalization. It's so bad at some points I have begun to wonder if this is even a legitimate copy...
Showing reviews 1-5 of 6
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