The Generic Challenge: Understanding Patents, FDA & Pharmaceutical Life-Cycle Management (second edition) | 
 enlarge | Author: Martin A. Voet
Publisher: Brown Walker Press
Category: Book
List Price: $28.95
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Avg. Customer Rating:  3 reviews
Sales Rank: 178525
Media: Paperback
Edition: 2
Number Of Items: 1
Pages: 184
Shipping Weight (lbs): 0.4
Dimensions (in): 8.3 x 5.4 x 0.6
ISBN: 1599424444
Dewey Decimal Number: 342
EAN: 9781599424446
ASIN: 1599424444
Publication Date: May 1, 2008
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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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 Still contains mistakes from the first edition. The newly written material contains new mistakes. August 2, 2008
2 out of 4 found this review helpful
The second edition is substantially re-written, when compared to the first. Some of the errors and oversights from the first edition can be found in the second edition. Plus, there are some newly inputted errors and confusing things.
For example, in a discussion of the recent KSR v. Teleflex case, the author states that "The KSR case overturned an important line of cases . . ." from the Federal Circuit (page 58). But this is not true. The U.S. Supreme Court merely held that the case law relating to the teaching-suggestion-motivation test was still valid, but that this test should not be applied rigidly. The best commentary on this test is in Federal Register Oct. 10, 2007, vol. 72, pages 57526-57535. The Federal Register discloses that, "The Federal Circuit erred by applying the teaching-suggestion-motivation test in an overly rigid and formalistic way." In my opinion, the author should have used the second edition to describe this optional test, and how to apply this optional test, and not merely to dismiss it as being "overturned."
The second edition, in commentary about pharmacology patents and claims, states that the most important claim to a drug is a claim to a compound (page 82 of second edition). This much is true. But the author then states that the next best claim, covering the drug, is a claim covering a method for using the drug in medical treatment. This is false. First of all, please note that in Europe, claims to methods for medical treatment are not permitted. Second, this type of claim is not so powerful, since it only enables you to sue doctors. Third, this type of claim is not of highest priority, since what is better and more powerful is a claim to a method for manufacturing the drug (here you can sue the manufacturer). The writing in the second edition is still as careless as that in the first edition.
The following is from a review of the first edition, annotated here to reflect changes in the second edition:
Pages 1-40 disclose some background information relating to patents. Here, the author is plainly uncomfortable with the topic. Pages 41-107 describe various regulations relating to FDA submissions. Here, the writing is somewhat more assured.
On page 14, the author states that "claims tend to get long winded because for some reason lost in the mists of time, there can only be one sentence in each claim, so that [sic] sentence sometimes gets very long." This is false. A basis for single sentence claims is the Patent Act of 1836, but also in a publication from July 1836 called "Information to Persons Having Business to Transact at the Patent Office." (IN THE SECOND EDITION, THE AUTHOR DELETED THE STATEMENT ABOUT "LOST IN THE MISTS OF TIME," HOWEVER THERE IS NO MENTION OF THE PATENT ACT OF 1836 AS THE ORIGIN OF 1-SENTENCE CLAIMS.)
On page 15, the author states that the Seaborg claim is a broad claim. This is false. The Seaborg claim is a species claim (a narrow claim). The Seaborg claim is NOT a genus claim (genus claims are broad claims). On page 15, the author states that "the broadest patents have the shortest claims." This is not really true. The author forgets that certain extra words, such as "comprising" or "or", are universally used to broaden claims. Again, the author might have described how "comprising language" is used to broaden claims. The author also might have explained how "or language" is used to broaden claims. But nothing is said about these techniques for broadening claims. Note also that what can be broad is a CLAIM in a patent, not the patent itself. From the writing, the reader might infer that the SPECIFICATION determines whether a patent's coverage is broad or narrow. But this is not the case. An author writing for a novice audience should not be using careless phraseology in referring to established, clearly defined concepts. (THIS MISTAKE STILL OCCURS in the second edition. See page 49.)
On page 16, the author tries to describe the Doctrine of Inherency, giving the example of a mechanism of action of a drug. This is a confusing example, because there are really two issues going on in this example: (1) Inherency; and (2) Failure to satisfy the utility requirement (35 USC 101). This is also a bad example because often, when faced with a discovery relating only to mechanisms, the patent attorney might draft a claim reading, "A method to detect this mechanism" or "A method to stimulate this mechanism." For the claim given by the author, when written by an attorney to read "A method to detect this mechanism" or "A method to stimulate this mechanism," only utility is an issue (inherency would no longer be an issue). The author should have used the much better example found in a case from the Federal Circuit, In re Cruciferous Sprouts. (THE SECOND EDITION FAILS TO TALK ABOUT CRUCIFEROUS SPROUTS. THIS OPINION IS THE EASIEST PATENT CASE TO UNDERSTAND, WHERE THE GOAL IS TO UNDERSTAND INHERENCY.)
On page 23, the author states that "A patent is a sword, not a shield. . ." This is false. As soon as a patent is filed, it becomes a powerful shield, as it can become prior art under 35 USC 102(e), preventing the allowance of U.S. patents, e.g., of competitors. Morever, as soon as a patent application is published, it also becomes a shield, preventing the allowance European patents, e.g., of a competitor. (THIS MISTAKE STILL OCCURS on page 35 of second edition.)
This "book" contains only about 30,000 words. This is the length of a typical law review article. At $26.00, this tiny "book" is no bargain. I would suggest, instead, using the same money to buy these two compact discs: Schumann, Works for Oboe and Piano (Holliger and Brendel) plus The Ventures play the Greatest Surfin' Hits of All-Time.
The author prides himself in the use of informal, inviting language. However, the author makes the same mistake as that made by Robert Preston (Harold Hill) in the classic musical, THE MUSIC MAN. This mistake is believing that a teacher who succeeds in making his or her students feel happy, can somehow compensate for the teacher's own shortcomings.
 Accessible Primer on Patents & Exclusivity in the Pharma Industry July 7, 2008
2 out of 3 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.
Required reading for anyone in the biotech/pharma industry May 22, 2008
2 out of 3 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.
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