Customer Reviews

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

5 star:		(6)
4 star:		(0)
3 star:		(1)
2 star:		(1)
1 star:		(0)

 

 

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.

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.

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.

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

This is a fairly well written overview of generic gaming. While intellectual property and regulatory affairs are central themes of this industry, the author keeps the reader interested with relevant illustrations and a light writting style. All aspects of pIVs, litigations, and LCM are covered in a way that is accessible to the neophyte while preserving details and nuances for the pharma professional. As far as I remember, this was the only book available on the topic that I was able to find. However I would recommend it for both its content and conciseness.
Good for students/policy makers researching the topic, portfolio managers at innovator pharmas, job seekers in the generic industry, and the general audience.

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...

I agree completely with B. Vendsel's review. The horrible formatting in the Kindle edition is very distracting.

This might be an excellent book but I can only wade through a few screens before having to set it aside out of sheer aggravation.

I hope the publishers would see fit to re-format this book and give those of us who purchased it a copy that is actually readable.

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.