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.

Conventional wisdom holds that robust enforcement of intellectual property (IP) right suppress competition and innovation by shielding incumbents against the entry threats posed by smaller innovators. That assumption has driven mostly successful efforts to weaken US patent protections for over a decade. This book challenges that assumption. In Innovators, Firms, and Markets, Jonathan M. Barnett confronts the reigning policy consensus by analyzing the relationship between IP rights, firm organization, and market structure. Integrating tools and concepts from IP and antitrust law, institutional economics, and political science, real-world understandings of technology markets, and empirical insights from the economic history of the US patent system, Barnett provides a novel framework for IP policy analysis. His cohesive framework explains how robust enforcement of IP rights enables entrepreneurial firms, which are rich in ideas but poor in capital, to secure outside investment and form the cooperative relationships needed to transform a breakthrough innovation into a marketable product. The history of the US patent system and firms' lobbying tendencies show that weakening patent protections removes a critical tool for entrants to challenge incumbents that enjoy difficult-to-match commercialization and financing capacities. Counterintuitively, the book demonstrates that weak IP rights are often the best entry barrier the state can provide to protect entrenched incumbents against disruptive innovators. By challenging common assumptions and offering a powerful integrated framework for understanding how innovation happens and the law's role in that process, Barnett's Innovators, Firms, and Markets provides important insights into how IP law shapes our economy.

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.

Africa is known for its multi-faceted immaterial culture, manifested in highly original music, oral texts, artistic performances and sporting events. These cultural expressions are increasingly regulated by intellectual property rights, as orally transmitted stories are written down, traditional songs broadcast and ownership claimed, and sporting activities once part of village life become national media events. This volume brings together an interdisciplinary team of legal experts, anthropologists and literary scholars to explore, from an African point of view, what happens to intangible cultural goods when they are confronted with large-scale commodification and distribution through media technologies, and globalized and divergent judicial systems, institutions and cultural norms. These transformations are observed in contexts that range from Senegalese wrestling contests to beauty pageants in Mali, from Kenyan hip-hop to the Nigerian novel, from the vuvuzela horn to Cameroonian masks. Contributors address the role of the state and the legacy of the European origination of IP laws, as well as the forms of ownership, technologies of mediation and degrees of commercialization that existed pre-colonially in different African societies. Resisting a single narrative of the imposition of a Western legal regime displacing older African modes, a more complex picture is revealed of the intricate interconnections between pirates, artists, communities, governments and international organizations. It is only when local actors embrace technologies and regulations in a specific historical situation that these become influential forces for change. The question raised is not whether international IP norms conform to African practices, nor whether media impose Western styles, but rather what local actors do with these regulations and how both local and Western practices and technologies impact on each other and co-exist. 'Intellectual property (IP) has become central to global governance but we have little idea of how this international legislation plays out on the ground. This pioneering book shows how local actors use IP rather than the other way around. A must-read for anyone interested in intellectual property.' Isabel Hofmeyr, Visiting Global Distinguished Professor, New York University; Professor of African Literature, University of the Witwatersrand 'A deeply engaging and evidence-rich analysis of the worlds into which intellectual property law, specifically copyright law, has entered in Africa and its effect on these worlds. This collection illustrates the best of what edited volumes can do: create a diverse, informed, and compelling conversation about a specific yet complex topic.' Dr. Hauke Dorsch, AMA African Music Archives, Johannes Gutenberg Universitat Mainz

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.

Academics and practitioners are currently divided on the issues involved in permitting and regulating the commercial exploitation of publicity. 'Publicity' is the practice of using an individual's name, image and reputation to promote products or to provide media coverage, often in gossip magazines and the tabloid press. This book provides a theoretical and multi-jurisdictional review of the nature of publicity practice and its appropriate legal regulation. The book includes a detailed exploration of the justifications advanced in favour of publicity rights and those that are advanced against. Removing the analysis from any one jurisdiction the book examines current academic and judicial perspectives on publicity rights in a range of jurisdictions, drawing out similarities and differences, and revealing a picture of current thinking and practice which is intellectually incoherent. By then clearly defining the practice of publicity and examining justifications for and against, the author is able to bring the nature and shape of the right of publicity into much sharper focus. The book includes a careful consideration of possible limits to any right of publicity, the potential for assigning publicity rights or transferring them post mortem, and whether defences can be offered. The author concludes by arguing for a publicity right which provides a degree of protection for the individual but which is significantly curtailed to recognise valid competing interests. This is a work which will be of interest to academics and practitioners working in the field of publicity, privacy and intellectual property.

Stefan Larsson's Conceptions in the Code makes a significant contribution to sociolegal analysis, representing a valuable contribution to conceptual metaphor theory. By utilising the case of copyright in a digital context it explains the role that metaphor plays when the law is dealing with technological change, displaying both conceptual path-dependence as well as what is called non-legislative developments in the law. The overall analysis draws from conceptual studies of "property" in intellectual property. By using Karl Renner's account of property, Larsson demonstrates how the property regime of copyright is the projection of an older regime of control onto a new set of digital social relations. Further, through an analysis of the concept of "copy" in copyright as well as the metaphorical battle of defining the BitTorrent site "The Pirate Bay" in the Swedish court case with its founders, Larsson shows the historical and embodied dependence of digital phenomena in law, and thereby how normative aspects of the source concept also stains the target domain. The book also draws from empirical studies on file sharing and historical expressions of the conceptualisation of law, revealing both the cultural bias of both file sharing and law. Also law is thereby shown to be largely depending on metaphors and embodiment to be reified and understood. The contribution is relevant for the conceptual and regulatory struggles of a multitude of contemporary socio-digital phenomena in addition to copyright and file sharing, including big data and the oft-praised "openness" of digital innovation.

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 enforcement of patent rights raises complex, and, from a private international law perspective, unique difficulties. Since intellectual property practitioners started to seek the consolidation of cross-border patent disputes, the interplay of private international rules has led to drastic changes in patent litigation across Europe. This book analyses in detail both the European rules on jurisdiction (the Brussels Convention and its successors) and the choice of law rules as they apply to cross-border patent disputes, and will be essential reading for both intellectual property lawyers and international commercial litigation specialists.

There is an inherent tension between the push to harmonize international intellectual property norms and the need to remain flexible and adaptive in domestic policy-setting. In trademark law, global brands protection must be balanced against the interests of consumers, who, though they may be aware of the global realm, are ultimately local actors. This is the key issue explored in this well-crafted and timely book.' - Daniel J. Gervais, Vanderbilt University Law School, US 'Trademark law is territorial but trademarks, like trade, are increasingly global. Trademark owners often operate in worldwide markets where they are confronted with varying territorial legal rules about registration and even use of their trademarks. This apparent dichotomy between trade without borders and trademark laws with borders creates many challenging legal and practical issues which this volume tackles. This outstanding collection offers both specialists and novices insights into this complex topic. The editors are to be commended for their foresight in bringing this collection together.' - Susy Frankel Victoria, University of Wellington, New Zealand 'The growing globalization of trade increases the challenges faced by trademark owners in the territories where they operate or plan to expand. Trademark owners thus have to find ways to solve the tension between global markets and territorial regimes of protection, which is precisely what this book explores from different angles and what makes it an essential work in today's borderless and brand-based economy. The result is a remarkable collection of original and thought-provoking chapters, which masterfully discuss the challenges and opportunities that the global economy presents, and will continue to present, for the territorial acquisition and enforcement of trademark rights.' - Jacques de Werra, University of Geneva, Switzerland As the modern business world becomes increasingly decentralized and globally focused, traditional interpretations and applications of trademark protection law are facing greater and greater challenges. This is particularly true regarding the principle of trademark territoriality, which holds that trademark rights are bound by the laws of individual nations. This timely volume offers expert analyses of the challenges facing crucial aspects of trademark law from some of the most prominent scholars in the field. The contributors explore how the rise of international trade and globalization has changed the way trademark law functions in a number of important areas, including protection of well-known marks, parallel imports, enforcement of trademark rights against counterfeiting, remedies, protection of certification marks, and domain names. A detailed discussion of the history of trademarks and territoriality along with a comprehensive breakdown of current issues make this a complete and well-rounded resource for the study of trademark law in a contemporary context. Students, professors and practitioners working in international law, trade law and intellectual property law will find this book to be a valuable resource. Contributors include: G.W. Austin, I. Calboli, L. Chan Grinvald, M. Chon, D.C.K. Chow, G.B. Dinwoodie, C.H. Farley, L.C. Grinvald, M. LaFrance, M.A. Leaffer, E. Lee, J. Lipton, L.A.W. Lockridge, D.E. Long, P.-E. Moyse, M. Wong, P.K. Yu, D. Zografos Johnsson

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 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.

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.

Intended for both business people and legal practitioners, this book offers a practical conceptual framework for the analysis and implementation of cross-border technology transactions, as well as alerting potential parties to technology transfers to the salient issues they should systematically confront and resolve as they seek to structure and implement their transaction. Particular attention is devoted to the identification of traps in the path of successful international-technology transfer. The term "technology" is used in the book in its broadest possible sense, including what in some countries is referred to as "industrial property" and encompassing all legal categories of intellectual property, such as copyrights, trademarks, patents, know-how and trade secrets. The book applies an interdisciplinary approach to a complex and interdisciplinary subject and seeks to harmonize the frequently divergent perspectives that business people and lawyers bring to technology transactions. The topics covered include intellectual-property regimes and how to safeguard one's proprietary rights in technology; contractual provisions; tax structures and tax implications of technology-transfer transactions; and conflicts of law, choice of law and dispute resolution in the international technology-transfer context.

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.

How has the legal system used its traditional body of copyright and patent law to protect rights in computer software? The last 15 years have changed the entire landscape with regard to the creation and protection of software as intellectual property. Written by a computer expert with extensive participation in some of the most important software trials of the period, this book invites you to think critically about significant software issues and learn about the legal pitfalls surrounding software development in the industry today. The book is organized around various legal issues raised by both plaintiffs and defendants in copyright litigation, and the problems of the U.S. Patent & Trademark Office in dealing with the rapid proliferation of applications for software-related patents. The author explains important terms and concepts in software litigation such as infringement, substantial similarity, reverse engineering, the merger defense, and "look and feel". Galler's book is a succinct, readable survey for computer professionals, nonlegal academics, and lawyers who need a fast summary of the critical issues and cases in software and intellectual property matters.

This work, perhaps for the first time, provides a description of the great variety of proposals at EEC level for the reform and harmonisation of intellectual property law. It addresses patents, copyright and neighbouring rights, trade marks, biotechnology, semiconductor chips, topography right, industrial designs and plant breeders' rights. Save as required for the purpose of shedding light on the EEC proposals, it does not attempt to examine member states' national laws. In the case of industrial designs, where no harmonisation has yet been proposed, a very brief survey of national jurisdictions is presented. There is a useful appendix of documents, a bibliography and index. This practical handbook will prove invaluable to practitioners, both in the IP field and non-specialists, seeking up-to-date information on European developments, including solicitors, barristers, patent agents and trade mark agents in private practice, commerce and industry throughout the EEC and in Member States' major trading partners.