Customer Reviews

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

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

 

 

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."

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.

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.

On pages 18-19, the author attempts to explain novelty, utility, and non-obviousness. However, the author only mentions the statute 35 USC 103, and fails to mention 35 USC 102 (novelty) or 35 USC 101 (utility). At this point, it is becoming clear that the "book" is unusually disorganized and inaccurate.

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.

On page 28, the author tries to explain the "Function, Way, Result" test. But what a mess the author has made. The author writes, ". . . it might infringe under the doctrine of equivalents because your gizmo has an element that performs a similar function by similar means in a similar way . . ." What happened to "Result"? Where is "Result"? Where? The author is further confused here, because he uses the term "means." In patent law, the term "means" is used to invoke 35 USC 112, paragraph six. The term "means" should not be used when initiating an explanation of the Doctine of Equivalents. Another mess.

On page 31, the author writes, "This is called prosecution history estoppel if you really wanted to know." This type of comment is excessively informal, and is not appropriate for a "book" on patent law.

On page 89, the author states that "The FDA recently approved a combination of two well-known cholesterol lowering statins giving new life to Merck's Zocor by combining it with a newer statin sold by Schering-Plough." This is false. The compound of Schering-Plough is Zetia. But Zetia (Ezetimibe) is not a statin.

This "book" contains only about 30,000 words. This is the length of a typical law review article. At $25.00, this tiny "book" is no bargain. The production could be better. While the quality of the glossy cover is excellent, the ink in my copy of the book is smeared on pages 34, 49, 88, 105, and 108. Citations for cases, and the names of cases, are missing (pages 51, 66, 71, 74).

This "book" contains way too many errors in its attempts to describe various issues in patent law. For this reason, this "book" deserves zero 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.

The book is concise, witty, understandable by lay and law people alike, and helpful in understanding the difficulties that innovative drug companies face as well as how generics keep the innovators on their toes. Not designed as a treatise (thankfully), it is helpful for someone who wants a quick and readable overview of patents and drug laws and regulations in the U.S. and elsewhere, and how they affect the incentives to develop new drugs. This is well-suited for people who work at drug companies (whether innovator or generic) and among the professionals that serve those companies, not to mention politicians and others who make or influence policy, or anyone who wants to be informed about the facts and policies that underlie the "generic" debate that plays out in the press.

The Generic Challenge should be required reading for every pharmaceutical executive. It is a long overdue prescription for an information gap that many in the pharmaceutical industry suffer from, whether they realize it or not. The book provides a clear and concise explanation of the most significant concepts of patent law and FDA regulatory law and the important ways interact to influence product life-cycle management. It also provides a "big picture" view of the current challenging legal and regulatory environment for the development and commercialization of innovative drugs. It is written in an easy-to-read style and does not overwhelm the reader with endless citations to case law or Federal regulations. The Generic Challenge succeeds in being a basic but extraordinarily useful primer on the interface between pharmaceutical patent law and regulatory issues. It is well worth the price.