Intellectual Property Books

An excellent source for pharmaceutical scientists to gain a good working knowledge of the NDA/ANDA approval process. Significant discussion on the historic basis for most of today's regulations. Especially useful for those working for generic firms- comprehensive discussion on the legal issues related to Hatch-Waxman amendments and patent certification. Recommend waiting for the updated version which should be ready for distribution from Aspen in May 2008.

Generic and Innovator Drugs provides a complete reference to significant developments in FDA approval requirements, including extensive coverage of innovator drugs, the drug approval process and patent term extension.

The Fifth Edition includes expanded coverage of relevant issues, including:

A chapter on FDA regulation of biologic drugs
An explanation of the interpretation by the FDA and the courts of the market exclusivity provisions FDA administers
An explanation of the new user fee legislation and FDA commitments in response to that legislation
A chapter reflecting new FDA requirements on drug exports
Plus, the full text of relevant statutes, regulations, FDA guidelines, memoranda, correspondence, and more.
This one-volume guide contains exhaustive discussions and analyses of all the major regulatory and legal actions from the 1938 FDCA grandfather clause through the latest amendments to the Federal Food, Drug, and Cosmetic Act.
Generic and Innovator Drugs is an invaluable reference for drug company officials, regulatory affairs staffs, and legal counsel.

Table of Contents

FDA Approval Requirements
Full New Drug Applications
Abbreviated New Drug Applications and "Paper NDAs"
Delaying Approval of Competitive Products
Public Availability of NDA Data
Potential for Government Compensation for Innovators
The Orphan Drug Amendments
Debarment
FDA Fraud Policy
Accelerated Approvals
Export and Import Requirements
Prescription Drug User Fees

This book makes complicated issues and statutes easier to understand. The book clarifies, using case citations, the FDA statutes. A very handy resource.

All those on the Right on the censorship issue should read this book. Perhaps a few minds would be changed. The story of the two women that brought out in this country is especially interesting.

---- Al Hromjak

This is an amazing book. In Girls Lean Back Everywhere, de Grazia gives a good history of censorship in the United States. James Joyce, Henry Miller, William Burroughs, Radclyffe Hall et al, have faced the blade of the censor. Lenny Bruce, The Swedish film I Am Curious, Robert Mapplethorpe and 2 Live Crew are also discussed in this book. This book packs a lot of information about the great (and not so great) literature and art that has been banned in the United States. While some of the work might be mediocre it still most be protected. 2 Live Crew may not deserve to be mentioned in the same breath as James Joyce but one should at least have the choice to do so. That is one of the basic arguments of the book. Unless a book or artwork can be shown to be utterly without socially redeeming value, it must be protected by the First Amendment. Some of the court transcription of various trials are fascinating. I came to revere great men such as Barney Rossett and Judge William Brennan (who I paraphrased earlier in the review) for their efforts in making free expression just that: free. It is a book that should be read by lovers of literature and art. It should be read by anyone hesitant to have their First Amendment Rights get Borked. America would be the richer if this book sat on coffee tables all across the country. It strengthened my faith in the First Amendment and strengthened my resolve to fight for its preservation. A book like this should be read in colleges so kids can learn about the Comstockian fools that occasionally muster up steam enough to run amok over the Constitutional liberties the rest of us would like to enjoy.

I encountered this book in my researches on the first amendment. It provides hard to find information and intriguing details and the rarely heard backgrounds to the many cases which it discusses. As such, it is a very useful research tool, and a captivating read for those who are interested in Domestic Obscenity or similar fields. Despite this, I found the organization difficult to follow, and the information somewhat densely presented.

While it may sound evanescent, intellectual property is the bedrock of many contemporary companies. Some analysts believe that intellectual property (called "IP" by the initiated) represents 76% of the Fortune 100s' market cap. Similarly, some 80% of the S&P 500s' value comes from IP and other intangibles. What is this exotic, but valuable, commodity? IP is made up of four main kinds of government-granted property rights: patents (for inventions like a better mousetrap), copyrights (for works of expression like books), trademarks (such as "Coke" and "Pepsi") and trade secrets (such as the Coca-Cola recipe). In this slim, lively book, Paul Goldstein, a leading expert on IP, brings this ethereal topic down to earth. Best of all, he describes the principles behind the legal rules, allowing you to understand where IP laws might be going and why. Whatever industry you are in, getAbstract suggests that it could be wise to learn about IP, particularly given this painless introduction.

I wish I had a dollar for every time I've heard a C-level executive say something to the effect that her or his organization's "most valuable assets walk out the door at the end of each day." Indeed they do. How effectively are they managed? In turn, how effectively do they manage the intellectual property entrusted to their care, especially now when organizations have become so "transparent" as they struggle to "navigate the tricky passages where the law and business of intellect assets converge? What we have in this volume is a wealth of information, observations, insights, and suggestions that can be of incalculable value to decision-makers as they make their way during that perilous journey.

Paul Goldstein carefully organizes and then presents his material within seven chapters, followed by a "Sources" section (Pages 209-231) for those who wish to obtain additional information about one or more issues addressed in a given chapter. As Goldstein points out, "In this book I will examine the most important forms of intellectual property, using legal studies to illustrate routes to success and failure in managing legal risk and extracting value from these assets. I will also shine a light on the underlying forces of change that make intellectual property so challenging as a business asset."

Goldstein is a professor at Stanford Law School and counsel to the Morrison & Foerster firm for which he works on intellectual property litigation and transactions for corporate clients throughout the world. Of special interest to me is his explanation of how and why technological change as well as shifting social and economic currents regularly disrupt the patent, copyright, trademark, and trade secrets that protect intellectual assets. Therein lies what he perceives to be a paradox: "without property rights these assets will be underproduced, but with property rights they will be underused" and thus deprive legislators and judges of "steady compass points" to guide their lawmaking.

He addresses questions such as these:

What are the most important forms of intellectual property?

Which "routes to success and failure in managing legal risk" should be carefully considered?

How to extract value from IP assets?

What are the underlying forces of change that make IP so challenging as a business asset?

Why are the risks and rewards of intellectual assets no less manageable than those of other business activities?

Which management tools can be most helpful to managing intellectual assets?

As Goldstein explains in his Introduction, "The central lesson of this book is that every decision involving intellectual assets is ultimately a legal decision, and that every legal decision is at bottom a business decision. If intellectual property is economically too important to be left to lawyers, it is also too legally charged to be left to managers." They must work effectively together to ensure that all business decisions are legally sound and that all legal decisions support the given enterprise in terms of its objectives, strategy, and performance.

In February of 1859 in Jacksonville, Illinois, Abraham Lincoln delivered a "Lecture on Discoveries and Inventions" in which he noted that the U.S. Constitution includes a clause guaranteeing the "right" of inventors and authors to royalties for patents and copyrights. "Before then, any man might instantly use what another had invented; so that the inventor had no special advantage from his own invention." Lincoln then made a critically important point: "The patent system changed this; secured to the inventor, for a limited time, the exclusive use of his invention; and thereby added the fuel of interest to the fire of genius, in the discovery and protection of new and useful things." These thoughts were expressed almost 150 years ago.

I recalled Lincoln's lecture as I worked my way through Chapters 2-7 in which Goldstein rigorously examines issues concerning patents, copyrights, trademarks, trade secrets, intellectual assets on the Internet, and intellectual assets in international markets. What he offers in this volume (especially to C-level executives without formal training in law) is a remarkably thorough briefing on legal fundamentals (i.e. parameters, perils, relative advantages and disadvantages, and possible implications) at a time when there are so many trends in progress or emerging, notably increasing exploitation abroad of all forms of intellectual property as well as the decline of the ratio of U.S. receipts to payments. From Goldstein's perspective, these and other trends point to a single fact: " although the United States may not soon revert to its nineteenth-century status as a net importer of intellectual assets, the intellectual trade margins it enjoyed during the latter part of the twentieth-century will probably continue to decline in the twenty-first century. Thomas Friedman's shrewd generalization that `the world is flat' applies as directly to the production of intellectual goods as it does to other goods and services." For decision-makers who are now struggling to understand the "tough new realities" that could make or break their organizations, Paul Goldstein's brilliant book is a "must read."

Those who share my high regard for this volume are urged to check out Friedman's aforementioned book, The World Is Flat and Competing in a Flat World: Building Enterprises for a Borderless World co-authored by Victor K. Fung, William K. Fung, and Yoram (Jerry) Wind as well as Business Power: Creating New Wealth from IP Assets co-authored by Robert Shearer and other members of the National Knowledge & Intellectual Property Management Taskforce and Essential of Intellectual Property co-authored by Alexander Poltorak and Paul Lerner.

I liked this book. I thought it was very informative. I've been familiar with intellectual property law since my days at law school. And I've known and understood much of what was presented in this book. I believe that just about any entrepreneur will get something out of this book. And I certainly recommend that entrepreneurs, and upper level executives at mid to large companies, set a little time aside to read this book to help them in income earning endeavors.

The book has an introduction and 7 chapters:

0. Introduction
1. The intellectual property paradox
2. Patents
3. Copyrights
4. Trademarks
5. Trade secrets
6. Intellectual assets on the Internet
7. Intellectual assets in International Markets

I think I would have liked the book better if there had been a chapter inserted after the introduction that gave an overview of intellectual property law. An explanation of intellectual property in general terms would have been good. And an explanation how the law of patents, copyrights, trademarks and trade secrets all interrelated would have been great! Unfortunately, we had to read about this in piecemeal as we read chapters 2-5.

I also would have liked the book better if there had been a chapter on IP licensing. Apparently few IP cases go to trial, or at least litigation doesn't conclude in a judgment by court or jury. Settlement involves some sort of licensing agreement or agreements. The book mentions licensing quite a bit, but never really explains it. I think the subject is important enough to warrant a chapter being devoted to it.

The intended audience for this book is business people - not lawyers. As such, I think the author wrote the text using too much "lawyer talk." For example, What is discovery? I doubt your average businessperson knows. And why are specific court cases important to mention? Also, I think the book would have been so much better if chapters had been more structured and better outlined. The way they were written I got the feeling while I was reading them that I was a law school professor reading final exam essays submitted by law students. The content is certainly there. But it could have been laid out more clearly. Stick to the points rather than get caught up in the intricacies of a court matter. 4 stars!

It is a comprehensive but thorough book. I recommend it as a starting point in this field.

... you've found your IP hornbook.

This is an essential buy for any law student taking IP. IP is a tough course with a lot of uncertainty, but this volume does a great job of simplifying the material. It was easy to digest and an enjoyable read during finals period.

The book is laid-out in a similar pattern as my course was, dividing trademark, patent, trade secret, copyright, as well as providing a short treatment on international IP and federal preemption of state IP law.

Be warned: this edition was published in 2003 and there's been a lot of change in the law of IP since then. You'll want to study the KSR case, TM Dilution Revision Act of 2006, and the latest from the Fed. Cir. in addition to this excellent treatment.

I plan on keeping this book by my side when I begin practicing, and look forward to the 2nd edition.

Intellectual property is now very different from 1997, when the comparable work of the eminent Paul Godstein was published.
The present work is a service for European lawyers, who must know rather much about the American legal tradition and be able to discern the similarities behind different concepts and the differences where one would not expect to find them.
The book is written in a lucid way avoiding extreme "legalese" and avoiding partisan tones. Readers might remember that here they are presented an outline for not very advanced lawyers - who naturally use Nimmer - Nimmer and the other vast works about IP.

The sub-title for "Let's Talk Patents" tells us it's a patent primer for "Busy Corporate Managers and Entrepreneurs." What it does not say is that it is also a primer for any inventor who would throw off the cloak of ignorance.

Why? Because ignorance of patent law [ignorance: not having knowledge of a certain thing] may lead to unintended forfeiture of patent rights, or worse, being scammed out of money the inventor cannot afford.

Anyone who might be put off by the word "primer" must consider -- where do you get your knowledge of patents now? In High School or College? Not likely. Only a couple conventional colleges in the U.S. even have courses on inventing and patenting. So how does one learn about this vital subject? From TV ads? Advice from a brother-in-law? Some business article or column you read years ago? Unfortunately, the answer is too often, yes. That's a pretty meager education on a subject that may change one's life... Now perhaps a "patent primer" is starting to make more sense? Especially if you would rather not appear too stupid when you do reach that point where you need to talk to a patent attorney.

Let's assume you are a fairly typical problem solver, manager, or free thinker, and maybe even a grasp of the concept of invention -- patent -- money. Most everyone does. But if words or phrases like "intellectual property rights", "prior art", "doctrine of equivalents", "disclosure", or "infringement" are not a part of your vocabulary, you can offer a big Thank You to Ms. Etherton for writing and publishing "Let's Talk Patents." She is a registered patent attorney, but because she avoided writing it in "lawyer-ease," your ignorance is about to dissipate.

Upon opening her book and looking at the list of contents, "WOW" would be an automatic response. You may not have ever pondered questions about "Statutory Invention Registration" or "Direct and Indirect Infringement" but now, all of a sudden, you realize you are holding in your hands not just a book about patent education, but a real reference jewel. "Let's Talk Patents" suddenly becomes a valuable resource for information -- for you!

Before even finishing the first chapter, there's another revelation: "Let's Talk Patents" could easily have created a high intimidation response by being another compendium of dry, factual pages. But oh no, it's not... In fact, Ms. Etheron's style is so direct --so clear -- that her teaching examples make it very easy for us to relate to things we already know. Who could not relate to: "walking into a dark alley unarmed" and "red flat" or "...it's usually the money, who has it and who gets it."

Her straight talk, easy language and understandable examples, such as the problems of two competing bicycle manufactures, pull the reader along so smoothly they may not be aware of how much they're learning. That's talent.

After Etherton's book, when someone says "Let's Talk Patents" you will be armed and ready.

Sandra has done a very good job of presenting a complex subject in a very approachable manner. While not exhaustive, this book will give you a good basic understanding of patents and how they can help a business reach its goals.

This little book tells you: what patents can and cannot do for you; how and whether to apply for a patent; how long a patent can protect your idea; the cost and time required to get a patent; etc. The writing is informal with clear examples and minimum jargon. It can be read quickly to provide good advice before deciding on whether to try to get a patent.

This book is heavy on the legal information (it's from Nolo Press) but light on what to do to get an invention licensed. Has good legal advice which would be a use to any invcentor who has a deal ready to go, but not much help on evaluating the proct for license or how to get a licenseing deal to come about. Would recommend this book only for those who have already made prototypes, contacted licensees, and are ready to start writing contracts - then get this useful book.

I felt that this book provided a firm clear basis to write a contract to license your invention. I have to agree that it did little but rehash the usual ways of marketing your invention. Perhaps the book should have be titled: Write a good contract for licensing your invention.

I thought this book took you nicely through each step in the licensing process explain your legal rights and the legal rights of others in detail. I enjoyed the book and thought it was easy to read despite covering alot of legalese.

"Take Your Great Idea to Market With a Solid Legal Agreement" promises this new book. The promise is fulfilled with plenty of solid details about the licensing process. This is not about venturing or bringing your own invention to market, but about protecting your property rights while licensing the invention. This would include inventors who work for companies that may want to license their work.

I generally like the NOLO series because the books are well-written and easy to understand for beginners. I received this book as a gift and it was valuable in learning the basics. However, I needed to learn more, so I later discovered other related books in the NOLO series. So I guess it all depends on how much you want to know as a beginner. If just the basics, then "Patents for Beginners" is adequate. If you need a deeper understanding, then I would recommend "Patent, Copyright & Trademark".

An impressive and "reader friendly" compendium of information and instruction Nolo's Patents For Beginners is the ideal introduction to the patenting process for novice inventors and entrepreneurs. Written in plain English, the reader is provided with up-to-date principles of patent law; shown how to properly "read" a patent application; shown the nuts and bolts of patent ownership; informed what the inventor's social or economic status is irrelevant; learn how to analyze and resolve patent disputes; what patents don't inherently provide "defensive" protection; and what the fundamentals of international patent law are. Nolo's Patents For Beginners is a highly recommended addition to personal, professional, academic, corporate, and community library reference patent law collections.

This is an excellent book to get a fast and accurate overview of patents -- what they are, how they are created and defended, etc. Although some books have more detail (e.g., "Patent, Copyright & Trademark: An Intellectual Property Desk Reference") have more detail, this book condenses it into the necessary parts which are excellent for beginning jurists, expert witnesses, or someone contemplating creating a patent.

Great book detailing the ins and outs of entertainment scriptwriting contracts and negotiations. Recommend this highly!

As a budding screenwriter, I find this book helpful in a way that I can enrich myself with the knowledge that otherwise has to be earned through hours of lawyer's consulting fees. the

How do you know if you're getting a fair deal? How do you protect your original creation? And what does it mean when they tell you you're going to get a share of "Net Profits?" This is an invaluable resource for screenwriters. Stephen Breimer is an entertainment lawyer who really knows his stuff. It's great that he took the time to make this information available (for a lot less money than he'd charge for an hour of his time!). Screenwriters, don't be taken! Check it out (or better, buy it!).

You need to understand that information and knowledge are the key to overcoming or finding the most efficient way to solve a problem. Humanity's infrastructure has created a tremendous amount of infrastructure. It is critical, for the person who would be effective, to take a perspective of where the information may lie and how to best access it.

This book is not the most focused response to approaching this very fundamental problem - it is more a technical study for a subquestion in information science and policy. But it IS something that will begin to steer one in the right direction of developing a perspective of how to map knowledge in society - who owns it, where it is in society, and how to begin accessing it. The necessary skills are that this helps with is in developing a nascent understanding of the economics of information and knowledge sharing.

This is a unique book by a very respected scholar. It methodically goes, chapter by chapter, over who owns your name and address (the U.S. Postal Service does), your telephone number, your medical history, your image, your electronic messages, video entertainment, religious information, computer software, and government information. The answers are not always obvious. A real benchmark.

Information privacy is a dynamic field. This is a good introductory book to key concepts. It is also a nice guide to key legal decisions that have influenced current information privacy policy in the United States. The legal cases are presented in an approachable, narrative form -- not a lot of legal mumbo-jumbo. The only shortcoming of this book is that it was published in 1994. A lot has changed since then. Even so, I recommend it as a starting point for those just stepping into the realm of information privacy.

In reading this review, keep in mind that I am a lay person in the truest sense of the word, and so I brought no prior understanding to the subject of "cultural ownership" in reading this book. With that caveat, my review:

In Who Owns Native Culture? Brown successfully combines two philosophical perspectives to the subject: the legal view, and the social/anthropological view. In the legal view, he covers applicable law, and emerging international conventions in several different countries. In the social view, he turns away from the formal rationalism of the law, to the formal irrationality of numerous social views, such as "emotivism". Throughout numerous case studies, he relates the opinion that entirely legal constructs will not work in preserving Native Culture. He thoroughly rejects the idea that a single legal framework can cover all situations, as a result, he promotes the case by case approach of negotiations.

One small problem I had was that in the chapter on Ethnobotany, some sections read like a press release directly from Shaman Pharmaceuticals, touting the superiority of the drug Provir, whose efficacy was in fact minimal. Beyond this, my lack of knowledge of the subject precludes a more comprehensive review.

How much we need a book that looks with unjaundiced eyes on the issue of cultural ownership and cultural appropriation. This is that book, but with a caveat: there is something slightly out of balance here, with the overbalance being in the form of a bias toward an intellectual definition of ownership. Brown is a scholar, and a worthy one. As such, his virtue is a healthy skepticism toward all points of view, rather than an unreflective sympathy toward each. In a sense, he is a debunker, not a sequential believer, and this places him in a distinct relationship to his material that seems to this reader to militate against a sympathy toward that which cannot be explicated or analyzed by rational means. I know I am getting murky here. But the simple fact is that you cannot do justice to non-analytical traditions and points of view by the application of analysis. This is perhaps better explained by demonstration in a wonderfully subtle treatise by Kent Nerburn called Neither Wolf nor Dog. Here, in the guise of a novel or some sort of fictionalized non-fiction, a man who has lived with native people takes on the subject from a different angle. He, too, comes up a bit short by using a device that is perhaps too clever by half. But he gets me closer to an understanding by embodying conflicting points of view and expressing them with the conviction of different systems of belief. I suggest that the reader consider both these books as distinct halfs to a very difficult whole. Though the distance between them is great, it is in the space in the center that some true understanding of the problem of cultural appropriation and ownership will be found.

In this book, Michael Brown discusses a wide range of cases in which indigenous cultures and cultural artifacts are used or appropriated by majority (or foreign) cultures. The kinds of issues that he discusses include folk tales, folk music, native art, traditional ecological knowledge (including medicinals), crop varieties used primarily by Native peoples, and religious beliefs and objects that have been borrowed by others.

His strategy is to avoid establishing hard-and-fast rules but to explore, sympathetically, middle-ground solutions that respect Native beliefs and rights. He argues that general rules often cause more harm, introducing elements of policing and control that cause Native peoples to lose control over their own culture. According to Brown, negotiated solutions among well-meaning people can lead to better resolutions in individual cases, while also developing new principles that may prove to be useful in future disputes.

Brown explores these issues through a series of cases and anecdotes, which he seems to have chosen in a completely haphazard way. He tells the stories journalistically, providing his own commentary and the opinions of both sides of each issues. This approach makes the book very readable but not fully satisfactory to people looking for systematic treatment of these issues.

Hardliners will be offended because Brown does not give Natives exclusive control over their own heritage. He would argue that all culture includes shared (social) elements as well as individual elements (artistry for example), and that both features are routinely shared. Cultures borrow from one another all the time - - New Age beliefs borrow from Native religious, Native cultures have borrowed from Christianity and Islam. Exclusive rights ignore these elements of sharing, exchange, and new syntheses.

Brown is likely to satisfy most well-meaning people from majority cultures, such as liberal whites in the United States, Canada or Australia. Those people who regularly end up on the short end of the stick will be suspicious of consensus solutions, which reflect power imbalances in more subtle ways. This book awaits a response from them, but nonetheless represents a respectful attempt at reasonable solutions to these various problems.