This comprehensive Handbook provides an in-depth analysis of the origin and main substantive provisions of the TRIPS Agreement, the most influential international treaty on intellectual property currently in force. A uniquely qualified set of academics and experts from around the world discuss the historical context in which the Agreement was negotiated, its basic principles and the nature of the obligations it creates for WTO members. Together with the second volume ? Research Handbook on the Interpretation and Enforcement of Intellectual Property under WTO Rules ? it examines the minimum standards that must be implemented with regard to patents, trademarks, geographical indications, copyright and related rights, integrated circuits and test data. This Handbook is an essential tool for scholars, researchers and advanced students in the field of intellectual property. It also provides materials of direct relevance for policymakers and legal practitioners.

Systemic Bias: Algorithms and Society looks at issues of computational bias in the contexts of cultural works, metaphors of magic and mathematics in tech culture, and workplace psychometrics. The output of computational models is directly tied not only to their inputs but to the relationships and assumptions embedded in their model design, many of which are of a social and cultural, rather than physical and mathematical, nature. How do human biases make their way into these data models, and what new strategies have been proposed to overcome bias in computed products? Scholars and students from many backgrounds, as well as policy makers, journalists, and the general reading public will find a multidisciplinary approach to inquiry into algorithmic bias encompassing research from Communication, Art, and New Media.

This book focuses on the fraught relationship between cultural heritage and intellectual property, in their common concern with the creative arts. The competing discourses in international legal instruments around copyright and intangible cultural heritage are the most obvious manifestation of this troubled encounter. However, this characterization of the relationship between intellectual and cultural property is in itself problematic, not least because it reflects a fossilized concept of heritage, divided between things that are fixed and moveable, tangible and intangible. Instead the book maintains that heritage should be conceived as part of a dynamic and mutually constitutive process of community formation. It argues, therefore, for a critically important distinction between the fundamentally different concepts of not only intellectual and cultural heritage/property, but also of the market and the community. For while copyright as a private property right locates all relationships in the context of the market, the context of cultural heritage relationships is the community, of which the market forms a part but does not - and, indeed, should not - control the whole. The concept of cultural property/heritage, then, is a way of resisting the reduction of everything to its value in the market, a way of resisting the commodification, and creeping propertization, of everything. And, as such, the book proposes an alternative basis for expressing and controlling value according to the norms and identity of a community, and not according to the market value of private property rights. An important and original intervention, this book will appeal to academics and practitioners in both intellectual property and the arts, as well as legal and cultural theorists with interests in this area.

This collection considers the future of climate innovation after the Paris Agreement. It analyses the debate over intellectual property and climate change in a range of forums - including the climate talks, the World Trade Organization, and the World Intellectual Property Organization, as well as multilateral institutions dealing with food, health, and biodiversity. The book investigates the critical role patent law plays in providing incentives for renewable energy and access to critical inventions for the greater public good, as well as plant breeders' rights and their impact upon food security and climate change. Also considered is how access to genetic resources raises questions about biodiversity and climate change. This collection also explores the significant impact of trademark law in terms of green trademarks, eco labels, and greenwashing. The key role played by copyright law in respect of access to environmental information is also considered. The book also looks at deadlocks in the debate over intellectual property and climate change, and provides theoretical, policy, and practical solutions to overcome such impasses.

This book contains the most current information on how to implement, develop and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a 9-step closed-loop process approach for medical device, pharmaceutical and biologic manufacturers, as well as any company or institution, which has to maintain a quality system. CAPA violations along with ineffective complaint investigations continue to be the number one cited violation of device warning letters for the past four years, leading the US Food and Drug Administration or FDA to remind firms to fully investigate complaints, find the root cause of nonconforming products and document their CAPA activities. A review of FDA warning letters issued to pharmaceutical companies reveals that most of these warning letters resulted from recurring failures, ineffective investigations found, and missing or inappropriate corrective and preventive actions. Companies often make the mistake of fixing problems in their processes by revising procedures or more commonly by 'retraining' employees that may or may not have caused the problem. This is typically event-focused. Companies then will make the false assumption that the errors have been eradicated. In many cases they will also consider the steps taken as their Preventive Action. The reality is that the causes of the failure were never actually determined; therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. CAPA is not just a quick-fix, simple approach. It is a process and has to be understood throughout organizations. This book addresses all of the above issues, in a pragmatic, down- to-earth manner.

This book deals comprehensively with the question of the scope of copyright protection for computer programs. Offering a unique blend of scholarship, technical rigor, and readability, it dispels the confusion and controversy that surround the application of copyright law to computer programs. Through an orderly development of facts and analysis it shows why the copyright law is the appropriate regime for software protection and explains the nature of copyright protection for software. Alternating between essay format and case study, the book provides expert counsel to those interested in this interface between technology and law. "Software, Copyright, and Competition: The Look and Feel' of the LaW," is undoubtedly one of the best pieces of legal scholarship in any subject this editor has ever had the pleasure to read. As to its subject matter, it is the best analysis of look and feel' written to date. . . . The book is very readable. Not only does the author explain' the law for the non-lawyer, but he explains the zen' of computer programming to the non-programmer. With wit and insight he puts to rest the many old wives tales the legal community believes about programmers. . . . In the best of all possible worlds, this book would be mandatory reading for any judge or arbitrator faced with a look and feel' case. "The Software Law Bulletin," January 1990

Two forces, innovation and imitation, fuel the intense competition that underlies the dramatic technological progress taking place in the computer industry. As the competitive battleground shifts increasingly to the software sector, a vigorous debate has arisen over whether the principal legal regime for protecting the asset value of computer programs--the copyright law--encourages or inhibits that competition. Industry executives, computer lawyers, law professors and lawmakers alike are participating in the debate, the outcome of which will quite literally shape the future of the computer industry.

This book deals comprehensively with the question of the scope of copyright protection for computer programs. Offering a unique blend of scholarship, technical rigor, and readability, it dispels the confusion and controversy that surround the application of copyright law to computer programs. Through an orderly development of facts and analysis it shows why the copyright law is the appropriate regime for software protection and explains the nature of copyright protection for software. Alternating between essay format and case study, the book provides expert counsel to those interested in this interface between technology and law.

This book provides an overview of disability exceptions to copyright infringement and the international and human rights legal framework for disability rights and exceptions. The focus is on those exceptions as they apply to visual art, while the book presents a comprehensive study of copyright's disability exceptions per se and the international and human rights law framework in which they are situated. 3D printing now allows people with a visual impairment to experience 3D reproductions of paintings, drawings and photographs through touch. At the same time, the uncertain application of existing disability exceptions to these reproductions may generate concerns about legal risk, hampering sensory art projects and reducing inclusivity and equity in cultural engagement by people with a visual impairment. The work adopts an interdisciplinary approach, with contributions from diverse stakeholders, including persons with disabilities, cultural institutions and the 3D printing industry. The book sketches the scene relating to sensory art projects. Experts in intellectual property, human rights, disability and art law then critically analyse the current legal landscape relating to disability access to works of visual art at both international and regional levels, as well as across a broad representative sample of national jurisdictions, and identify where legal reform is required. This comparative analysis of the laws aims to better inform stakeholders of the applicable legal landscape, the legal risks and opportunities associated with sensory art and the opportunities for reform and best practice guidelines, with the overarching goal of facilitating international harmonisation of the law and enhanced inclusivity.

This book radically rethinks the philosophical basis of copyright in the arts. The author reflects on the ontology of art to argue that current copyright laws cannot be justified. The book begins by identifying two problems that result from current copyright laws: (1) creativity is restricted and (2) they primarily serve the interests of large corporations over those of the artists and general public. Against this background, the author presents an account of the ontology of artworks and explains what metaphysics can tell us about ownership in the arts. Next, he makes a moral argument that copyright terms should be shorter and that corporations should not own copyrights. The remaining chapters tackle questions regarding the appropriation of tokens of artworks, pattern types, and artistic elements. The result is a sweeping reinterpretation of copyright in the arts that rests on sound ontological and moral foundations. Radically Rethinking Copyright in the Arts will be of interest to scholars and advanced students working in aesthetics and philosophy of art, metaphysics, philosophy of law, and intellectual property law.

Technological change has transformed the ways knowledge is developed and shared internationally. Accordingly, in the quarter-century since the WTO was established, and since its Agreement on Trade-Related Aspects of Intellectual Property Rights came into force, both the knowledge dimension of trade and the functioning of the IP system have been radically transformed. The need to understand and respond to this change has placed knowledge at the centre of policy debates about economic and social development. Recognizing the need for modern analytical tools to support policymakers and analysts, this publication draws together contributions from a diverse range of scholars and analysts. Together, they offer a fresh understanding of what it means to trade in knowledge in today's technological and commercial environment. The publication offers insights into the prospects for knowledge-based development and ideas for updated systems of governance that promote the creation and sharing of the benefits of knowledge.

International copyright law is a complex and evolving field, of manifest and increasing economic significance. Its intellectual challenges derive from the interlocking relationships of multiple international instruments and national or regional laws and judgments.This ground-breaking casebook provides a comprehensive and comprehensible account of international copyright and neighboring rights law, from the cornerstone of the 1886 Berne Convention and the Rome Convention of 1961, through to the 1994 TRIPS Agreement and the 1996 and later WIPO Copyright Treaties. It examines how national laws have implemented the international norms, and explores the issues these sources have left ambiguous or unresolved. Ginsburg and Treppoz, two of the leading lights in international copyright law, bring their expert commentary and provocative questions to judiciously selected extracts from cases, analytical texts, and the texts of the treaties themselves, to develop a deeply nuanced understanding of this field. The approach centers on comprehending the international law and international treaties and, rather than analyzing the treaties in turn and in abstract, offers a concrete issue-by-issue treatment of the subject. Key features of the casebook: - Written by two leading authorities in the field - Carefully selected extracts from primary and secondary sources - Build a clear picture of the field - Expert analytical commentary and questions set the extracts in context - U.S. and E.U. perspectives integrated throughout the text to ensure maximum relevance and encourage students to make comparative assessments - An issue-based approach that synthesizes the treaties and facilitates a nuanced understanding - Exposition of lacunae in the treaties, and extensive consideration of how private international law fills the gaps - Leads students through the field from beginning to end.

This book considers a new approach to online copyright infringement. Rather than looking at the subject within a purely technological context, it provides legal analysis from a human perspective. This book highlights that there are three key instances in which the capacity of a human mind intersects with the development of copyright regulation: (1) the development of copyright statutory law; (2) the interpretation of the copyright statutory law the judiciary; and (3) human interaction with new technology. Using a novel framework for constructing digital perspectives, the author, Dr Hayleigh Bosher, analyses the laws relating to online copyright infringement. She provides insights into why the law appears as it does, shedding light on the circumstances of how it came to pass and demonstrates a clear malfunction in the interpretation and application of copyright law to online activities that derives from the disconnect between the technological and the human perspectives. The book proposes putting the human element back into copyright analysis to enable the return of reason where it has been lost, and provide a clearer, more consistent and fair legal regulation of online copyright infringement. Law, Technology and Cognition: The Human Element in Online Copyright Infringement will be of interest to students, academics, researchers, as well as practitioners.

Despite the apparent advantages of the internet, there is little debate that it facilitates intellectual property infringements, including infringements of trade mark rights. Infringers not only remain hidden by the anonymity the internet provides but also take advantage of its increasing reach and the associated challenges with regard to cross-border enforcement of rights. These factors, among others, have rendered the internet a growing source of counterfeit and other infringing products. It has, therefore, become necessary for right holders to shift their focus from individual infringers to internet intermediaries, such as Internet Service Providers (ISPs), hosts and navigation providers, which are responsible in numerous ways for making content promoting infringements available to internet users. In light of these developments, this book conducts a comprehensive analysis of the liability of such intermediaries for trade mark infringements and considers the associated issues and challenges in the diverging approaches under which liability may be imposed. At present, however, neither UK trade mark law nor English common-law principles relating to accessorial liability provide a basis to hold internet intermediaries liable for trade mark infringements. As such, this book considers approaches adopted in some of the Continental European countries and the US in order to propose reforms aimed at addressing gaps in the existing legal framework. This book also examines alternative remedies, such as notice and takedown and injunctions, and discusses the associated shortcomings of each of these remedies.

A major target of Goal 3 of the Sustainable Development Goals adopted by the United Nations in 2015 is the elimination of 'the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases' and combating 'hepatitis, water-borne diseases and other communicable diseases'. Intellectual property (IP) has been identified as one of the factors impeding access to affordable medicines in developing countries, especially in relation to the HIV pandemic. This book examines the scope of the existing flexibilities in international IP law for promoting access to medicines. It analyses the factors accounting for the underutilisation of the flexibilities in Africa and the measures that African countries may adopt to address the IP barriers to access to medicines. It explores the regional strategies that Africa can adopt to resolve the tension between IP regimes and access to medicines. It also highlights how trade liberalisation and regional integration can play crucial roles in enhancing the use of TRIPS flexibilities, local pharmaceutical manufacturing and access to medicines in Africa. By adopting qualitative research methods to investigate how African countries may effectively use IP to serve public health purposes through the stratagem of regional integration, this book will be a valuable contribution to the existing literature on IP.

Protecting the Brand, Volume II: Busting the Bootlegs follows Volume I which provides a unique combination of legal and business best practices related to intellectual property protection. This second volume showcases U.S. states specific legal statues and examples related to legal approach to counterfeiting and grey market issues. The primary emphasis is to prove advice to U.S. companies navigating the complex domestic legislation and provide a single source of reference for both law practitioners and those tasked with intellectual property rights enforcement and compliance who need to understand the applicable state legislation. Both volumes of this book are focused on leveraging trademark enforcement while also commenting on copyright and patent enforcement, establishing a framework for successful brand protection in the future.

Intellectual Property and Health Technologies

Balancing Innovation and the Public's Health

Joanna T. Brougher, Esq., MPH

At first glance, ownership of intellectual property seems straightforward: the control over an invention or idea. But with the recent explosion of new scientific discoveries poised to transform public health and healthcare systems, costly and lengthy patent disputes threaten both to undermine the attempts to develop new medical technologies and to keep potentially life-saving treatments from patients who need them.

"Intellectual Property and Health Technologies" grounds readers in patent law and explores how scientific research and enterprise are evolving in response. Geared specifically to the medical disciplines, it differentiates among forms of legal protection for inventors such as copyrights and patents, explains their limits, and argues for balance between competing forces of exclusivity and availability. Chapters delve into the major legal controversies concerning medical and biotechnologies in terms of pricing, markets, and especially the tension between innovation and access, including:

The patent-eligibility of genesThe patent-eligibility of medical process patentsThe rights and roles of universities and inventorsThe balancing of access, innovation, and profit in drug developmentThe tension between biologics, small-molecule drugs, and their generic counterpartsInternational patent law and access to medicine in the developing world

As these issues continue to shape and define the debate, "Intellectual Property and Health Technologies" enables professionals and graduate students in public health, health policy, healthcare administration, and medicine to understand patent law and how it affects the development of medical technology and the delivery of medicine. "

This book reflects on the development of Nigeria's intellectual property law and outlines the urgent need for reform. Bringing together expert contributors from around the world, the book identifies and discusses the inadequacies and lacunas in current intellectual property law, and how it is practiced and applied in Nigeria. The book argues that the revision and reform of Nigeria's intellectual property law will be vital for the country's development and national interests, whilst also recognising that Nigeria's legal provisions must sit within a broader global context. Divided into three parts, the book discusses patents, trademarks, and copyright in the context of broad overarching themes affecting all aspects of intellectual property law. Honouring Professor Adebambo Adewopo SAN, the pioneering thinker in Nigerian intellectual property law, this book will be an important resource for researchers working on African Law.

This book offers a critical examination of the jurisprudence of the World Trade Organization (WTO) as an emancipatory international social contract on trade. The book suggests that the WTO is an international organization built and operating on member states' attribution of authority through consent with legislative, administrative, and adjudicative functions - three functions in one triune personality. With a solid constitutional continuity building on GATT experiences, the WTO has successfully made governments accountable to foreign individuals in various capacities either as traders of goods, providers of services, or holders of intellectual property rights within the global marketplace. With a triune personality, the WTO operates within the reign of state primacy - the force - ultimately for the benefits of individuals - the ends - in the global marketplace, and gains a soul of its own in the institutional evolution - the means - of the global trading regime. Although the tripartite dynamics between states, international institutions, and individuals in the global marketplace are unprecedentedly complex, the WTO's ends of benefiting individuals in the global marketplace has no end. Beyond the critical analysis of WTO's decision-making by consensus, the book critically examines GATT's "common intention" treaty interpretation, Antidumping's NME methodology, TRIPS' public health concerns, and IP-competition trade policy dynamics. A unified WTO jurisprudence looking at the WTO as an international social contract on trade is therefore proposed to allow a fresh look at the force, the means, and the ends of the constitutional evolution of the global trading regime.

This book is the first to analyze the compliance of different types of a breeder's exception to patent rights with article 30 of the Agreement on Trade-Related Aspects of Intellectual Property Rights. This type of exception allows using protected biological matter for breeding new varieties of plants. The breeder's exception is widely accepted under plant variety legislation, but it is not common under patent laws despite the fact that patent rights often cover plant varieties. Only few European countries have adopted such an exception. After the entry into force of the Agreement on a Unified Patent Court, the exception will be mandatory for all European Union Member states. Based on a legal and economic approach, this book offers guidance to those countries that need to incorporate a breeder's exception into their national patent systems and suggests the importance of the exception for promoting plant breeding activities.

This book covers cross-border strategies to understand and profit from intellectual property. It starts with a basic overview of IP before focusing specifically on international business contexts. The book then explores factors that affect IP-related business activities in different countries. Next, follows a discussion of the importance of managing IP valuation, people, and products, which leads into an examination of strategies for obtaining value from IP-related activities, including licensing. This edition updates the contents and adds new contemporary cases, such as internet-based crimes and trademarked sport brands. Readers will gain an understanding of the significance of IP to corporate success in the increasingly globalized world. With updated knowledge on deriving value from IP, this book will provide insights for practitioners to deal with cross-border issues of IP, and for scholars across disciplines to advance studies of cross-border issues and conflicts in IP.

This book is the first to provide a detailed and critical account of the emergence, development, and implementation of plant variety protection laws in Asian countries. Each chapter undertakes a critical socio-legal analysis of one or more legal frameworks to understand, evaluate, and explore the concerns of diverse national stakeholders, the histories and dynamics of law-making, and the ways in which plant variety protection and seed certification laws interact with local agricultural systems. The book also assesses how Asian countries can capitalise on the 'unused policy space' in international agreements such as the Agreement on Trade-Related Aspects of Intellectual Property Rights and the International Convention for the Protection of New Varieties of Plants, as well as international obligations beyond these, such as those contained in the Convention on Biological Diversity and the Plant Treaty. It also highlights the many ways in which Asian experiences can offer new insights into the relationship between intellectual property and plants, and how relevant laws might be re-imagined in other regions, including Africa, Europe, and the Americas. By adding an important new perspective to the ongoing debate on intellectual property and plants, this book will appeal to academics, practitioners, and policy-makers engaged in work surrounding intellectual property laws, agricultural biodiversity, and plant breeding.

This book critiques the decision-making process in Article 53(a) of the European Patent Convention. To date, such decisions have been taken at high levels of expertise without much public involvement. The book eschews traditional solutions, such as those found within legislative, judicial and patent office realms and instead develops a radical blueprint for how these decisions can be put to the public. By examining wide-scale models of participatory democracy and deliberation, this book fills a significant gap in the literature. It will be invaluable for patent lawyers, academics, practitioners and intellectual property and patent officials.

1) The book provides an understanding of GI from legal and policy perspectives. 2) It focuses on the handloom industry in India. 3) The book will be of interest to departments of development studies, IPR studies, policy studies and South Asian studies across UK and USA.

Behind the scenes of the many artists and innovators flourishing beyond the bounds of intellectual property laws Intellectual property law, or IP law, is based on certain assumptions about creative behavior. The case for regulation assumes that creators have a fundamental legal right to prevent copying, and without this right they will under-invest in new work. But this premise fails to fully capture the reality of creative production. It ignores the range of powerful non-economic motivations that compel creativity, and it overlooks the capacity of creative industries for self-governance and innovative social and market responses to appropriation. This book reveals the on-the-ground practices of a range of creators and innovators. In doing so, it challenges intellectual property orthodoxy by showing that incentives for creative production often exist in the absence of, or in disregard for, formal legal protections. Instead, these communities rely on evolving social norms and market responses-sensitive to their particular cultural, competitive, and technological circumstances-to ensure creative incentives. From tattoo artists to medical researchers, Nigerian filmmakers to roller derby players, the communities illustrated in this book demonstrate that creativity can thrive without legal incentives, and perhaps more strikingly, that some creative communities prefer, and thrive, in environments defined by self-regulation rather than legal rules. Beyond their value as descriptions of specific industries and communities, the accounts collected here help to ground debates over IP policy in the empirical realities of the creative process. Their parallels and divergences also highlight the value of rules that are sensitive to the unique mix of conditions and motivations of particular industries and communities, rather than the monoculture of uniform regulation of the current IP system.

This book explores the question of whether software should be patented. It analyses the ways in which the courts of the US, the EU, and Australia have attempted to deal with the problems surrounding the patentability of software and describes why it is that the software patent issue should be dealt with as a patentable subject matter issue, rather than as an issue of novelty or nonobviousness. Anton Hughes demonstrates that the current approach has failed and that a fresh approach to the software patent problem is needed. The book goes on to argue against the patentability of software based on its close relationship to mathematics. Drawing on historical and philosophical accounts of mathematics in pursuit of a better understanding of its nature and focusing the debate on the conditions necessary for mathematical advancement, the author puts forward an analytical framework centred around the concept of the useful arts. This analysis both explains mathematics', and therefore software's, nonpatentability and offers a theory of patentable subject matter consistent with Australian, American, and European patent law.

Using the UK as a case study the book aims to provide a detailed rationale for the tension between a policy perspective that tries to provide protection for victims of such practices through legislation and the need to better understand a phenomenon that constantly evolves as a result of new technology, disruptive adoption and social norms.