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

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.

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...

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.

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 statement is false.

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." 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 author got it all wrong. The test was NOT overturned. The U.S.Supreme Court merely held that the test was optional and not required.

Recent cases from the Federal Circuit, e.g., in 2008, emphasize the fact that the teaching-suggestion-motivation test is still a valid test. According to an opinion from July 2008 (Eisai v. Reddy's (Fed. Cir. 2008): "In keeping with the flexible nature of the obviousness inquiry, KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1739 (2007), the requisite motivation can come from any number of sources and need not necessarily be explicit in the art." To repeat, it is not correct to state or imply that the motivation test has been overturned.

See also, Takeda v. Alphapharm (Fed. Cir. 2007), which held that the motivation test to be valid:

"While the KSR Court rejected a rigid application of the teaching, suggestion, or motivation ("TSM") test in an obviousness inquiry, the Court acknowledged the importance of identifying "a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does" in an obviousness determination. KSR, 127 S. Ct. at 1731. Moreover, the Court indicated that there is "no necessary inconsistency between the idea underlying the TSM test and the Graham analysis." Id. A s l o n g a s the test is not applied as a "rigid and mandatory" formula, that test can provide "helpful insight" to an obviousness inquiry. "

Furthermore, KSR v. Teleflex is just a speed-bump in the history of the obviousness requirement. Graham v. John Deere is the most important U.S.Supreme Court on the obviousness requirement. But this book fails to mention or describe Graham v. John Deere. This is like writing a book about the 20th century that discloses the Korean War, but fails to mention World War II.

The second edition of GENERIC CHALLENGE, 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 arguably false.

First of all, please note that in Europe (PCT patent application), claims to methods for medical treatment are not permitted. Thus, where you want a claim for a method of medical treatment in a PCT patent application, what is used instead is a type of a methods of manufacture claim. Second, a methods of medical treatment claim is not so powerful, since it only enables you to sue doctors (an impractical task). Third, a method of medical treatment claim is not of highest priority, since might be better and more powerful is a claim to a method for manufacturing the drug (here you can sue the manufacturer).

On page 49, the author states that "claims tend to be long-winded because the regulations require each claim to consist of one sentence. The broadest patents have the shortest claims."

This is false.

This statement is wrong for three reasons. First, the regulations do NOT set forth this requirement. Please see 37 CFR 1.75. There is nothing here about 1-sentence claims. Instead, the requirement is in MPEP 608.01(m). The statement is also wrong because adding extra words to a claim is commonly used to achieve claims of greater breadth. 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. The author's writing is wrong for a third reason. 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 35, 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 competitors from gaining allowed claims. Moreover, as soon as a patent application is published, it also becomes a shield, both in the U.S. and in Europe. (By "sword," what is meant of course is using the patent for litigation against an infringer. By "shield" what is meant is something more passive, for example, use as prior art against a competitor's patent or patent application.)

A book on patent law is not the same as a book on home gardening. If the book on home gardening is filled with errors, it will not have any adverse effects on your company or business. In contrast, if a book on patent law is filled with errors, and if you following the mis-teachings of those errors, it could adversely effect your company.

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.

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 statement is false.

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." 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 author got it all wrong. The test was NOT overturned. The U.S.Supreme Court merely held that the test was optional and not required.

Recent cases from the Federal Circuit, e.g., in 2008, emphasize the fact that the teaching-suggestion-motivation test is still a valid test. According to an opinion from July 2008 (Eisai v. Reddy's (Fed. Cir. 2008): "In keeping with the flexible nature of the obviousness inquiry, KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1739 (2007), the requisite motivation can come from any number of sources and need not necessarily be explicit in the art." To repeat, it is not correct to state or imply that the motivation test has been overturned.

See also, Takeda v. Alphapharm (Fed. Cir. 2007), which held that the motivation test to be valid:

"While the KSR Court rejected a rigid application of the teaching, suggestion, or motivation ("TSM") test in an obviousness inquiry, the Court acknowledged the importance of identifying "a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does" in an obviousness determination. KSR, 127 S. Ct. at 1731. Moreover, the Court indicated that there is "no necessary inconsistency between the idea underlying the TSM test and the Graham analysis." Id. A s l o n g a s the test is not applied as a "rigid and mandatory" formula, that test can provide "helpful insight" to an obviousness inquiry. "

Furthermore, KSR v. Teleflex is just a speed-bump in the history of the obviousness requirement. Graham v. John Deere is the most important U.S.Supreme Court on the obviousness requirement. But this book fails to mention or describe Graham v. John Deere. This is like writing a book about the 20th century that discloses the Korean War, but fails to mention World War II.

The second edition of GENERIC CHALLENGE, 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 arguably false.

First of all, please note that in Europe (PCT patent application), claims to methods for medical treatment are not permitted. Thus, where you want a claim for a method of medical treatment in a PCT patent application, what is used instead is a type of a methods of manufacture claim. Second, a methods of medical treatment claim is not so powerful, since it only enables you to sue doctors (an impractical task). Third, a method of medical treatment claim is not of highest priority, since might be better and more powerful is a claim to a method for manufacturing the drug (here you can sue the manufacturer).

On page 49, the author states that "claims tend to be long-winded because the regulations require each claim to consist of one sentence. The broadest patents have the shortest claims."

This is false.

This statement is wrong for three reasons. First, the regulations do NOT set forth this requirement. Please see 37 CFR 1.75. There is nothing here about 1-sentence claims. Instead, the requirement is in MPEP 608.01(m). The statement is also wrong because adding extra words to a claim is commonly used to achieve claims of greater breadth. 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. The author's writing is wrong for a third reason. 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 35, 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 competitors from gaining allowed claims. Moreover, as soon as a patent application is published, it also becomes a shield, both in the U.S. and in Europe. (By "sword," what is meant of course is using the patent for litigation against an infringer. By "shield" what is meant is something more passive, for example, use as prior art against a competitor's patent or patent application.)

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.

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 statement is false.

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." 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 author got it all wrong. The test was NOT overturned. The U.S.Supreme Court merely held that the test was optional and not required.

Recent cases from the Federal Circuit, e.g., in 2008, emphasize the fact that the teaching-suggestion-motivation test is still a valid test. According to an opinion from July 2008 (Eisai v. Reddy's (Fed. Cir. 2008): "In keeping with the flexible nature of the obviousness inquiry, KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1739 (2007), the requisite motivation can come from any number of sources and need not necessarily be explicit in the art." To repeat, it is not correct to state or imply that the motivation test has been overturned.

See also, Takeda v. Alphapharm (Fed. Cir. 2007), which held that the motivation test to be valid:

"While the KSR Court rejected a rigid application of the teaching, suggestion, or motivation ("TSM") test in an obviousness inquiry, the Court acknowledged the importance of identifying "a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does" in an obviousness determination. KSR, 127 S. Ct. at 1731. Moreover, the Court indicated that there is "no necessary inconsistency between the idea underlying the TSM test and the Graham analysis." Id. A s l o n g a s the test is not applied as a "rigid and mandatory" formula, that test can provide "helpful insight" to an obviousness inquiry. "

Furthermore, KSR v. Teleflex is just a speed-bump in the history of the obviousness requirement. Graham v. John Deere is the most important U.S.Supreme Court on the obviousness requirement. But this book fails to mention or describe Graham v. John Deere. This is like writing a book about the 20th century that discloses the Korean War, but fails to mention World War II.

The second edition of GENERIC CHALLENGE, 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 arguably false.

First of all, please note that in Europe (PCT patent application), claims to methods for medical treatment are not permitted. Thus, where you want a claim for a method of medical treatment in a PCT patent application, what is used instead is a type of a methods of manufacture claim. Second, a methods of medical treatment claim is not so powerful, since it only enables you to sue doctors (an impractical task). Third, a method of medical treatment claim is not of highest priority, since might be better and more powerful is a claim to a method for manufacturing the drug (here you can sue the manufacturer).

On page 49, the author states that "claims tend to be long-winded because the regulations require each claim to consist of one sentence. The broadest patents have the shortest claims."

This is false.

This statement is wrong for three reasons. First, the regulations do NOT set forth this requirement. Please see 37 CFR 1.75. There is nothing here about 1-sentence claims. Instead, the requirement is in MPEP 608.01(m). The statement is also wrong because adding extra words to a claim is commonly used to achieve claims of greater breadth. 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. The author's writing is wrong for a third reason. 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 35, 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 competitors from gaining allowed claims. Morever, as soon as a patent application is published, it also becomes a shield, both in the U.S. and in Europe. (By "sword," what is meant of course is using the patent for litigation against an infringer. By "shield" what is meant is something more passive, for example, use as prior art against a competitor's patent or patent application.)

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.

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 statement 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." 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." To repeat, the author Martin Voet got it all wrong. The test was NOT overturned. The U.S.Supreme Court merely held that the test was optional and not required.

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.

On page 49, the author states that "claims tend to be long-winded because the regulations require each claim to consist of one sentence. The broadest patents have the shortest claims."

This statement is false.

This statement is wrong for three reasons. First, the regulations do NOT set forth this requirement. Please see 37 CFR 1.75. There is nothing here about 1-sentence claims. Instead, the requirement is in MPEP 608.01(m). The statement is also wrong because adding extra words to a claim is commonly used to achieve claims of greater breadth. 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. The author's writing is wrong for a third reason. 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 35, 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 competitors from gaining allowed claims. Morever, as soon as a patent application is published, it also becomes a shield, both in the U.S. and in Europe. (By "sword," what is meant of course is using the patent for litigation against an infringer. By "shield" what is meant is something more passive, for example, use as prior art against a competitor's patent or patent application.)

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. What a mess this "book" is.

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.

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 statement 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." 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." To repeat, the author Martin Voet got it all wrong. The test was NOT overturned. The U.S.Supreme Court merely held that the test was optional and not required.

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.

On page 49, the author states that "claims tend to be long-winded because the regulations require each claim to consist of one sentence. The broadest patents have the shortest claims."

This statement is false.

This statement is wrong for three reasons. First, the regulations do NOT set forth this requirement. Please see 37 CFR 1.75. There is nothing here about 1-sentence claims. Instead, the requirement is in MPEP 608.01(m). The statement is also wrong because adding extra words to a claim is commonly used to achieve claims of greater breadth. 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. The author's writing is wrong for a third reason. 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 35, 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 competitors from gaining allowed claims. Morever, as soon as a patent application is published, it also becomes a shield, both in the U.S. and in Europe.

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. What a mess this "book" is.

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.

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 statement is not really 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.

On page 49, the author states that "claims tend to be long-winded because the regulations require each claim to consist of one sentence. The broadest patents have the shortest claims."

This statement is false.

This statement is wrong for three reasons. First, the regulations do NOT set forth this requirement. Please see 37 CFR 1.75. There is nothing here about 1-sentence claims. Instead, the requirement is in MPEP 608.01(m). The statement is also wrong because adding extra words to a claim is commonly used to achieve claims of greater breadth. 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. The author's writing is wrong for a third reason. 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 35, 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 competitors from gaining allowed claims. Morever, as soon as a patent application is published, it also becomes a shield, both in the U.S. and in Europe.

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.

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.

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 statement is not really 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.

On page 49, the author states that "claims tend to be long-winded because the regulations require each claim to consist of one sentence. The broadest patents have the shortest claims."

This statement is false.

This statement is wrong for three reasons. First, the regulations do NOT set forth this requirement. Please see 37 CFR 1.75. There is nothing here about 1-sentence claims. Instead, the requirement is in MPEP 608.01(m). The statement is also wrong because adding extra words to a claim is commonly used to achieve claims of greater breadth. 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. The author's writing is wrong for a third reason. 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 35, 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 competitors from gaining allowed claims. Morever, as soon as a patent application is published, it also becomes a shield, both in the U.S. and in Europe.

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.

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.

If you buy a book on making paper dolls, but the instructions are in error, it will not likely have adverse effects on your company. However, if you apply the quantities of misinformation found in this "book" it could harm your company's patent portfolio.

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 statement is not really 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.

On page 49, the author states that "claims tend to be long-winded because the regulations require each claim to consist of one sentence. The broadest patents have the shortest claims."

This statement is false.

This statement is wrong for three reasons. First, the regulations do NOT set forth this requirement. Please see 37 CFR 1.75. There is nothing here about 1-sentence claims. Instead, the requirement is in MPEP 608.01(m). The statement is also wrong because adding extra words to a claim is commonly used to achieve claims of greater breadth. 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. The author's writing is wrong for a third reason. 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 35, 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 competitors from gaining allowed claims. Morever, as soon as a patent application is published, it also becomes a shield, both in the U.S. and in Europe.

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.

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.

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 statement is not really 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.

On page 49, the author states that "claims tend to be long-winded because the regulations require each claim to consist of one sentence. The broadest patents have the shortest claims."

This statement is false.

This statement is wrong for three reasons. First, the regulations do NOT set forth this requirement. Please see 37 CFR 1.75. There is nothing here about 1-sentence claims. Instead, the requirement is in MPEP 608.01(m). The statement is also wrong because adding extra words to a claim is commonly used to achieve claims of greater breadth. 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. The author's writing is wrong for a third reason. 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 35, 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 competitors from gaining allowed claims. Morever, as soon as a patent application is published, it also becomes a shield, both in the U.S. and in Europe.

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.

Please see my review of the first edition of this "book" for documentation of more mistakes.

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. This "book" is dog-doo.

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 statement is not really 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.

On page 49, the author states that "claims tend to be long-winded because the regulations require each claim to consist of one sentence. The broadest patents have the shortest claims."

This statement is false.

This statement is wrong for three reasons. First, the regulations do NOT set forth this requirement. Please see 37 CFR 1.75. There is nothing here about 1-sentence claims. Instead, the requirement is in MPEP 608.01(m). The statement is also wrong because adding extra words to a claim is commonly used to achieve claims of greater breadth. 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. The author's writing is wrong for a third reason. 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 35, 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 competitors from gaining allowed claims. Morever, as soon as a patent application is published, it also becomes a shield, both in the U.S. and in Europe.

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.

Please see my review of the first edition of this "book" for documentation of more mistakes.

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.

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.

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 a review of the first edition, annotated 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 $25.00, this tiny "book" is no bargain.

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.

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 a review of the first edition, annotated 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 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. (THIS MISTAKE STILL OCCURS on page 35 of second edition.)

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. (This mistake appears to be corrected in the second edition.)

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. (FORTUNATELY, THIS RUDE COMMENT is not in the second edition.)

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 mistake appears to be corrected in the second edition.)

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 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.

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.