The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management (second edition) [Paperback]

Martin A. Voet (Author)

Book Description

ISBN-10: 1599424444 | ISBN-13: 978-1599424446 | Publication Date: May 1, 2008 | Edition: 2

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.

Editorial Reviews

Review

I read The Generic Challenge in one evening. It is easy to read, anecdotal and short. It is hard to believe that so much information and seasoned advice is packed into this little book. Patents and FDA Exclusivity form the bedrock foundation of today's pharmaceutical and biotechnology industries. I would recommend this book to virtually everyone working in those industries -- from the CEO down to the drug reps and lab techs -- regardless of whether they will deal directly with patents.
DENNIS CROUCH, Associate Professor of Law, University of Missouri, Editor of Patently-O.com

An extraordinary book full of practical, strategic information on the interaction of drug creation, law and regulatory approval. Provides a perceptive and insightful analysis of patent and regulatory laws affecting drug development. A must-read for anyone associated with a pharmaceutical company, from mangers and CEOs to CFOs and regulatory professionals, The Generic Challenge will guide readers thro --This text refers to the Kindle Edition edition.

Product Details

• Paperback: 184 pages
• Publisher: Brown Walker Press; 2 edition (May 1, 2008)
• Language: English
• ISBN-10: 1599424444
• ISBN-13: 978-1599424446
• Product Dimensions: 8.3 x 5.4 x 0.6 inches
• Shipping Weight: 8 ounces (View shipping rates and policies)
• Average Customer Review: 4.4 out of 5 stars  See all reviews (8 customer reviews)
• Amazon Best Sellers Rank: #874,670 in Books (See Top 100 in Books)

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Customer Reviews

Most Helpful Customer Reviews

6 of 7 people found the following review helpful:

5.0 out of 5 stars Accessible Primer on Patents & Exclusivity in the Pharma Industry, July 6, 2008

By 

Jeffrey Seguritan - See all my reviews
(REAL NAME)   

This review is from: The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management (second edition) (Kindle Edition)

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.

2 of 2 people found the following review helpful:

5.0 out of 5 stars Required reading for anyone in the biotech/pharma industry, May 22, 2008

By 

Ligeia - See all my reviews

This review is from: The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management (second edition) (Paperback)

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.

1 of 1 people found the following review helpful:

5.0 out of 5 stars Great little book, May 5, 2011

By 

Aaron F. Barkoff - See all my reviews

This review is from: The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (third edition) (Paperback)

Like the first two editions, this book is short, easy to read, and packed with information about patent law and FDA regulations relating to innovator and generic pharmaceuticals. With the third edition, the book has been updated to include discussions of the Biologics Price Competition and Innovation Act, which established a pathway for the approval of biosimilars; the pending patent reform legislation; and recent court decisions such as Novo Nordisk v. Caraco, concerning Patent Use Codes, and Ortho-McNeil v. Lupin, concerning patent term extensions.

I highly recommend this book to anyone working in the legal, regulatory, business development and R&D groups at pharmaceutical companies--both innovator and generic. Outside counsel working in this field will also find the book helpful, as it concisely ties together many disparate legal and regulatory considerations that are critically important to pharmaceutical companies.