Translational Medicine: Tools and Techniques provides a standardized path from basic research to the clinic and brings together various policy and practice issues to simplify the broad interdisciplinary field. With discussions from academic and industry leaders at international institutions who have successfully implemented translational medicine techniques and tools in various settings, readers will be guided through implementation strategies relevant to their own needs and institutions. The book also addresses regulatory processes in USA, EU, Japan and China. By providing details on omics sciences techniques, biomarkers, data mining and management approaches, case reports from industry, and tools to assess the value of different technologies and techniques, this book is the first to provide a user-friendly go-to guide for key opinion leaders (KOLs), industry administrators, faculty members, clinicians, researchers, and students interested in translational medicine.

There has been an explosion of interest in recent years regarding the origin and of intellectual property law. The study of copyright history, in particular, has grown remarkably in the last twenty years, with a flurry of activity in the last ten. This Handbook takes stock of the field of copyright history as it stands today, as well as examining potential developments in the future. The contributions feature copyright and history experts from across the UK, Australia, the United States, France, Spain and Italy. Covering European, US and international copyright history and traversing from the 16th Century to the early 20th century, this book offers a broad survey of the field and a solid foundation for future research. Students and scholars of copyright law, authorship, art, and the book and music trades will find this book to be an invaluable resource. It will also be of use to practising lawyers and judges with an interest in the doctrinal history of copyright law. Contributors: I. Alexander, J. Bellido, C. Bond, K. Bowrey, O. Bracha, E. Cooper, I. Gadd, J.C. Ginsburg, H.T. Gomez-Arostegui, B. Lauriat, N.A. Mace, H. MacQueen, A.J. Mann, S. Ricketson, F. Rideau, C. Seville, M. Woodmansee

Since previously published intellectual property law and business research discusses institutional analyses without interdisciplinary insights by technical experts, and technical references tend to concern engineering solutions without considering the social impact of institutional protection of multimedia digital information, there is a growing demand for a resource that bridges the gap between multimedia intellectual property protection law and technology. Intellectual Property Protection for Multimedia Information Technology provides scholars, management professionals, researchers, and lawyers in the field of multimedia information technology and its institutional practice with thorough coverage of the full range of issues surrounding multimedia intellectual property protection and its proper solutions from institutional, technical, and legal perspectives.

Over much of the past century, the law governing third-party importation of non-counterfeit, genuine goods has been obscured by conceptual uncertainty. In recent years, the debate over the gray market has centered on the fundamental reasons for trademark protection, and has raised the possibility of conflict between the two traditionally recognized purposes of trademark law--protecting consumers from deception and protecting trademark owners from lost sales. Hiebert discusses the evolution of the universality and territoriality principles of trademark law, and develops a new understanding of the role of goodwill in resolving trademark infringement issues. Beginning with a review of the earliest days of trademark law, Hiebert traces the development of the twofold purpose and territoriality doctrines in the United States, and examines in detail the cases, statutes, and regulations governing parallel imports. Unlike other recent treatments of the subject, this work benefits from the availability of important archival materials, and devotes considerable attention to the nineteenth-century antecedents of modern parallel importation doctrine, and to the evolution of trademark doctrine within the broader context of American legal realism.

The primary purpose of a patent law system should be to enhance economic efficiency, in particular by providing incentives for making inventions. The conventional wisdom is that patents should therefore be strictly exclusive rights. Moreover, in practice patent owners are almost never forced to give up their right to exclude others and receive only a certain amount of remuneration with, for instance, compulsory licensing. Other economically interesting patent-law objectives, however, include the transfer and dissemination of knowledge. Mechanisms exist by which the patent owner decides if he or she would prefer exclusive or non-exclusive rights, for instance the opportunity to declare the willingness to license and create patent pools. But it is questionable whether these mechanisms are sufficient and efficient enough in view of the existence of patent trolls and other problems. This work challenges the conventional wisdom to a certain extent and makes proposals for improvements.

The United States Supreme Court famously labeled copyright "the engine of free expression" because it provides a vital economic incentive for much of the literature, commentary, music, art, and film that makes up our public discourse. Yet today's copyright law also does the opposite--it is often used to quash news reporting, political commentary, church dissent, historical scholarship, cultural critique, and artistic expression.
In Copyright's Paradox, Neil Weinstock Netanel explores the tensions between copyright law and free speech, revealing how copyright can impose unacceptable burdens on expression. Netanel provides concrete illustrations of how copyright often prevents speakers from effectively conveying their message, tracing this conflict across both traditional and digital media and considering current controversies such as the remix and copying culture rampant on YouTube and MySpace, hip-hop music and digital sampling, and the Google Book Search litigation. The author juxtaposes the dramatic expansion of copyright holders' proprietary control against the individual's newly found ability to digitally cut, paste, edit, remix, and distribute sound recordings, movies, TV programs, graphics, and texts the world over. He tests whether, in light of these developments and others, copyright still serves as a vital engine of free expression and he assesses how copyright does--and does not--burden speech. Taking First Amendment values as his lodestar, Netanel argues that copyright should be limited to how it can best promote robust debate and expressive diversity, and he presents a blueprint for how that can be accomplished.
Copyright and free speech will always stand in sometension. But there are ways in which copyright can continue to serve as an engine of free expression while leaving ample room for speakers to build on copyrighted works to convey their message, express their personal commitments, and create new art. This book shows us how.

Called the business crime wave of the 21st century, trademark counterfeiting and product piracy are worldwide in scope and cost the U.S. economy billions of dollars every year. High technology and the globalization of business have made it possible to counterfeit and pirate a seemingly limitless number of products, from t-shirts, designer jeans, films and books to auto and airplane parts, and prescription drugs. The 1995-1996 trade dispute between the U.S. and China shows how serious the problem has become for American business and for U.S. diplomatic relations. Paradise explores the history of counterfeiting and piracy, shows how they are done, and the strategies that U.S. businesses are using to combat them. With interviews, commentary, and anecdotes by corporate attorneys, business leaders, and private investigators, this well-written book is essential for anyone interested in the damage that violations of intellectual property law are inflicting on world trade and what is being done to stop it. Called the business crime wave of the 21st century, trademark counterfeiting and product piracy are worldwide in scope and cost the U.S. economy billions of dollars every year. High technology and the globalization of business have made it possible to counterfeit and pirate a seemingly limitless number of products, from t-shirts, designer jeans, films and books to auto and airplane parts, and prescription drugs. The 1995-1996 trade dispute between the U.S. and China shows how serious the problem has become for American business and for U.S. diplomatic relations. Paradise explores the history of counterfeiting and piracy, shows how they are done, and the strategies that U.S. businesses are using to combat them. With interviews, commentary, and anecdotes by corporate attorneys, business leaders, and private investigators, this well-written book is essential for anyone interested in the damage that violations of intellectual property law are inflicting on world trade and what is being done to stop it. Paradise lays out the problem in Chapter 1 with a clear explanation of the differences between trademarks, copyrights, and patents, and the laws covering each. In Chapter 2 he looks at the role played by organized crime, gray market goods, the lack of intellectual property laws, and ultimately the threat to U.S. business. He discusses the recent investigations and disputes with China, and its aftermath throughout Southeast Asia. Chapter 4 focuses on the knockoff, chapter 5 on street peddlers and flea markets (and how merchants are retaliating), and chapter 6 on the tracking of counterfeiters. The entertainment industries and the pharmaceutical industries are then closely examined. He follows with equally comprehensive (and chilling) studies of automobile and aircraft parts counterfeiting and piracy in cyberspace. Paradise ends with a look at what is being done to counteract the inroads that piracy and counterfeiting have made into the global economy, and offers a provocative call for more and better efforts in the future.

This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.

Although the European harmonisation of trademark law started more than two decades ago and is now quite robust, heretofore practitioners have had no easily accessible and comprehensive description and analysis of this regime to rely upon in their work, despite the existence of commentaries of the Directive and Regulation on trademarks. Now, European Trademark Law describes all relevant developments in both legislation and case law, in particular of the Court of Justice, offering not only a succinct introduction to the theory, structure and nature of trademark law, but also insightful suggestions for resolving and answering a host of practical problems. As the authors note, their book provides an 'overview of trademark law rather than an overview of trademark legislation.' The authors view the law from different perspectives; they take both the European perspective and the perspective from harmonised national trademark law, in particular as it is in the Benelux countries. Paying particular attention to the implications of the considerable stream of case law that has followed from partially new doctrines set in place by the harmonization process, the book greatly clarifies the workings and interrelations of such factors as the following: * situations that did not constitute infringement under former trademark law but do constitute infringement today and vice versa; * different types of marks and their particularities; * registration and opposition procedures; * relevant international treaties; * requirements for the mark; * grounds for refusal and invalidity; * scope of and limitations to trademark protection; * use of trademarks in comparative advertising; * referential use of trademarks; * use of trademarks on the internet; * exhaustion of rights, parallel trade; * concepts of well known trademarks and trademarks with a reputation; * procedural aspects of enforcing trademark rights; * how trademark rights are lost. The analysis also covers specific aspects of the trademark right that are related to other legal areas, such as property law, trade name law, the law regarding geographical indications of origin, copyright law, competition law, and product liability. An especially valuable part of the book's presentation follows the 'life' of a trademark from filing the application up to and including its cancellation, revocation or invalidity. Intellectual property lawyers, judges, academics and in-house counsel will greatly appreciate this very useful guide to the current state of trademark law practice in Europe.

The three-step test--by which limitations on exclusive copyrights are confined to certain special cases' which do not conflict with a 'normal exploitation of the work' and do not 'unreasonably prejudice the legitimate interests of the author'--is among the most enduring of standards affecting limitations on intellectual property rights. Its field of application is the delicate balance between exclusive rights and sufficient breathing space for the free flow of ideas and information. However, the emerging information society has thrown numerous unforeseen obstacles in the once-clear path of its implementation. Can the traditional balance between grants and reservations of copyright law be recalibrated along the lines of the three-step test in order to meet current and future needs? Controversies over this crucial question--in Europe, the U.S., Australia, and elsewhere, as well as in two significant WTO panels in 2002--have brought the three-step test into focus, the essential principle governing copyright limitations in the information society. Investigating the development, structure, and function of the three-step test in international copyright law with thoroughness and precision, Copyright, Limitations and the Three-Step Test offers a close and insightful analysis of its continuing utility for the twenty-first century. The book includes: viable restatements of the rationales of copyright protection for the emerging IP environment; new insights into the relationship between copyright protection and copyright limitations; in-depth explanation of the structure and functioning of the three-step test; detailed interpretations of each criterion of the test; discussion of the two WTO panelreports dealing with the test; a proposal for the further improvement of the copyright system and the international rules governing copyright law; detailed information about international conference material concerning the test; and discussion of potential future trends in copyright law. The author provides many examples that demonstrate the test's impact on different types of limitations, such as private use privileges and the U.S. fair use doctrine. He explains the test's role in the European Copyright Directive. The detailed examination and explanation of the three-step test will be of extraordinary value to policymakers, judges, and lawyers in the field of intellectual property law seeking to react adequately to the challenges of the digital environment.

Protection of intellectual property rights (IPRs) has become a global issue. The Trade-Related Aspects of Intellectual Property (TRIPS) Agreement outlines the minimum standards for IPR protection for WTO members and offers a global regime for IPR protection. However, the benefits of TRIPS are more questionable in poorer countries where national infrastructure for research and development (R&D) and social protection are inadequate, whereas the cost of innovation is high. Today, after more than a decade of intense debate over global IPR protection, the problems remain acute, although there is also evidence of progress and cooperation. This book examines various views of the role of IPRs as incentives for innovation against the backdrop of development and the transfer of technology between globalised, knowledge-based, high technology economies. The book retraces the origins, content and interpretations of the TRIPS Agreement, including its interpretations by WTO dispute settlement organs. It also analyses sources of controversy over IPRs, examining pharmaceutical industry strategies of emerging countries with different IPR policies. The continuing international debate over IPRs is examined in depth, as are TRIPS rules and the controversy about implementing the 'flexibilities' of the Agreement in the light of national policy objectives. The author concludes that for governments in developing countries, as well as for their business and scientific communities, a great deal depends on domestic policy objectives and their implementation. IPR protection should be supporting domestic policies for innovation and investment. This, in turn requires a re-casting of the debate about TRIPS, to place cooperation in global and efficient R&D at the heart of concerns over IPR protection.

Although there is intellectual property protection in China, many companies, wary of China's much-publicized reputation for counterfeiting and piracy, fail to enter the largest developing market in the world because of an excess of caution. By detailing protection procedures that work, this practical handbook aims to open the door to a secure presence in the Chinese marketplace. "Chinese Intellectual Property Law and Practice" covers every step a company's counsel or patent agent needs to take, from registration of rights to invoking the effective enforcement methods now in place under Chinese law, in order to ensure effective protection of copyrights, patents, trademarks, trade names, trade secrets, and licensing arrangements in China. Written by a panel of active Chinese trade authorities - including practicing lawyers, academic specialists, and even a private investigator - the book shows how to: transfer intellectual property when investing in China; license products and services successfully in China; challenge unfair trade activities successfully via the US International Trade Commission and other non-Chinese authorities; use Chinese media and communications to undermine piracy and foster good will; secure strong judicial enforcement against copyright infringement; combat creative theft of IP rights, especially on the Internet; and evaluate the efficacy of a factory raid. Also included are numerous case studies from specific industries (including software, sporting goods, publishing, and luxury goods), a model contract, a bibliography, and a list of web sites.

The effort to win federal copyright protection for dance choreography in the United States was a simultaneously racialized and gendered contest. Copyright and choreography, particularly as tied with whiteness, have a refractory history. This book examines the evolution of choreographic works from being federally non-copyrightable, unless they partook of dramatic or narrative structures, to becoming a category of works potentially copyrightable under the 1976 Copyright Act. Crucial to this evolution is the development of whiteness as status property, both as an aesthetic and cultural force and a legally accepted and protected form of property. The choreographic inheritances of Loie Fuller, George Balanchine, and Martha Graham are particularly important to map because these constitute crucial sites upon which negotiations on how to package bodies of both choreographers and dancers - as racialized, sexualized, nationalized, and classed - are staged, reflective of larger social, political, and cultural tensions.

Traditional copyright law strikes a delicate balance between an author's control of original material and society's interest in the free flow of ideas, information, and commerce. In today's digitally networked environment, this balance has shifted dramatically to one side, as powerful rights holders contractually impose terms and conditions of use far beyond the bounds set by copyright law. This vitally significant book explores this conflict from its gestation through its current manifestations to its future lineaments and potential consequences. Focusing on statutory copyright limitations that enshrine constitutional rights such as freedom of expression and privacy, foster dissemination of knowledge, safeguard competition, and protect authors from market failure, Copyright Limitations and Contracts clearly explains the rationale for these limitations and questions the legality of overriding them by contractual means. The author finds a complex array of factors clouding the emergence of coherent rules in the matter, among them the nature of the contract (e.g. fully negotiated vs. "shrinkwrap"), the respective interests of the parties involved, and the legislated policy of particular regimes. She points out that the United States' new Uniform Computer Information Transactions Act (UCITA), which is likely to be adopted be many U.S. States and influence similar legislation in many other countries, leaves this crucial issue essentially unresolved. Among the author's many startling insights is that, contrary to the commonly held notion that the Internet is a bastion of free speech, in fact it is now possible (via encryption technology) for the first time in human history to exerciseabsolute control over copyrighted material, even under circumstances of global mass distribution. As we become more and more aware that the intersection of copyright and contract reveals one of the deepest and most far-reaching contradictions of our time, this illuminating analysis will be of extraordinary value to jurists in every area of public and private law.

This book comprises chapters by leading international authors analysing the interface between intellectual property and foreign direct investment, development, and free trade. The authors search for a balance between the conflicting interests that inherently coexist in intellectual property law. The chapters dig deep into the subjects and notions that have become central in international intellectual property legal developments: i) flexibility, public interest and policy-space for implementation; ii) interfaces between the intellectual property regime and other legal regimes; and iii) the development of international intellectual property law and its influence on national legal orders, which includes the implementation of intellectual property undertakings.

Are IQ tests racially and culturally biased? That was the controversial question in two landmark lawsuits: the California case of Larry P. v. Riles (1979) and the Chicago case of PASE v. Hannon (1980). Litigating Intelligence is a detailed analysis and comparison of these complex cases--the background, evidence, testimony, arguments, and surprising outcomes. It is also an important case study of the role of social science testimony in the courtroom and the role of the courts in setting social policy.

It has often been said that information is power. This is more true in the information age than ever. The book profiles the tools used by criminal law to protect confidential information. It deals with the essence of information, the varieties of confidential information, and the basic models for its protection within the context of the Internet and social networks. Eli Lederman examines the key prohibitions against collecting protected information, and against using, disclosing, and disseminating it without authorization. The investigation cuts across a broad subject matter to discuss and analyze key topics such as trespassing and peeping, the human body as a source of information, computer trespassing, tracking and collecting personal information in the public space, surveillance, privileged communications, espionage and state secrets, trade secrets, personal information held by others, and profiling and sexting. Infocrime will appeal to graduate and undergraduate scholars and academics in the legal arena, in law schools and schools of communication, and to practicing lawyers with an interest in legal theory and a concern for the protection of the personal realm in a world of increasingly invasive technologies.

This volume provides thorough coverage of some troublesome and seldom clarified issues that affect scholars who deal with nonprint media. When is it legitimate in teaching or publishing to "quote" a visual image from television, film or printed graphics? To quote the lines from a musical lyric? Why has the long tradition of fair use for printed material, which sanctions quoting without permission, been so slow in its extension to other media? How can scholars and publishers prudently behave in an area where media corporations are uncooperative or belligerent in dealing with requests to document arguments through the inclusion of copyrighted materials? This book offers a forum where scholars, lawyers, archivists, and federal administrators of copyright law express informed viewpoints about these issues.

Intellectual property scholars often argue that a European Copyright Code is unnecessary, undesirable, and perhaps impossible. It is certainly true that drafting rules for the European copyright law of the future is a sensitive and risky task. However, the intersection between the present and the future, the delicate point where it is felt that one era is fading away and a new dawn is breaking, has arrived for European copyright law; and moreover, the Lisbon Treaty has provided an explicit legal basis for an EU copyright policy. At this moment, all views, interests, concerns, and expectations should be weighed in order to establish the next step forward from this critical stage. Such a wide-ranging evaluation was the objective of an international conference held in Nicosia, Cyprus, in April 2011. This book reprints the papers presented at that conference, touching on such issues as the following: rules of copyright ownership and allocation of rights; codification techniques; copyright exceptions and limitations; copyright as a public interest question; claims of culture and human rights; economic rights of the author; enforcement of copyright; EU harmonization of copyright; interoperability; media as tangible objects; moral rights; the duration of copyright; the notion of the "public"; the role of fundamental rights; the concept of work; employment relationships, commission contracts, and collective works; copyright licensing; and the concept of "fair use". Several authors offer insightful comments on the ways in which the Wittem Group's draft European Copyright Code propounds some of these issues. Recognizing that the existing steps towards harmonized copyright protection in Europe have gone little farther than a patchwork of eight directives and a set of case law interpretation rules, the authors take important steps towards decrypting the gaps and inconsistencies in the existing common legal framework. In their reexamination of the sources and justifications of copyright law and its crucial role in balancing the right to information with requirements of data protection and privacy, they have created in this book an in-depth resource for forward-looking policymakers, academics, and practitioners in the field of copyright law throughout the European Union.