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.

Exploring the debate over the benefits of legal protection for fashion design, this book focuses on how a combination of minimal legal protections for design, evolving social norms, digital technology, and market forces can promote innovation and creativity in a business known for its fast-paced remixing and borrowing. Focusing on the advantages and disadvantages of the main US and EU IP laws that protect fashion design in the world's biggest fashion markets, it describes how recent US case law in copyright and trademark cases has led to misaligned incentives for the industry and a lack of clear protection, while in the EU, the CJEU's interpretation of the pan-European design rights system has created significant overlap with copyright law and risks leading to the overprotection of design. The book proposes that creativity and innovation in fashion derive some benefit from a limited unregistered design right protection and that cumulation with copyright protection is unhelpful. It also proposes that there is a larger role for developing social norms relating to sustainability, the ethics of cultural appropriation, and the online shaming of counterfeiters, that can also help create a fair equilibrium between protection and borrowing in fashion design.

This collection comprises eighteen contemporary articles on an often overlooked, but important, field of intellectual property law: trade secrets and undisclosed information. Divided into five parts, the selected articles examine various aspects of trade secret law, including its historical development and the range of theories and justifications for trade secret protection. The material also provides a detailed exploration of the scope and limits of trade secret protection, and addresses how trade secret issues arise in a number of contexts, including employment, governmental relations, and the internet. Including an original introduction by the editors, Trade Secrets and Undisclosed Information brings this significant subject into the forefront of discussion, and will be an invaluable resource to students, scholars and practitioners alike.

Succession, Wills and Probate is an ideal textbook for those taking an undergraduate course in this surprisingly vibrant subject, and also provides a clear and comprehensive introduction for professionals. Against an account of the main social and political themes of succession law, the book gives detailed explanations of core topics such as alternatives to wills and the making, altering and revocation of wills. It also explains personal representatives and how they should deal with a deceased person's estate and interpret and implement the will. Gifts may fail, estates may be insolvent or a person may die intestate, without a will at all. Increasingly relatives and others seek to challenge the will, for example on the grounds of the testator's capacity or under the law of family provision. This third edition is edited, updated and revised to take account of new legislation and case law across all the relevant issues, including a new final chapter dealing with the potentially contentious issues that are becoming more central to professional work in the field of succession.

First published in 1992, Authorship and Copyright traces the history of constructions of authorship as a legal reality. It offers an alternative to the two mainstream interpretations that have traditionally been assigned to authorship: the Romantic dialectical 'birth of the author' or the language-based post-structuralist 'death of the author.' Saunders examines the shortcomings of both schemes by arguing that they impose an arbitrary philosophical direction on the history of authorship and the law of copyright. Saunders addresses the issues relating to copyright and the construction of authorship as a legal status. Combining information and polemic, the author explores such matters as the historical and theoretical relations of copyright and the droit moral, the aestheticization of the law and the juridification of aesthetics, and the argument that authorship as a legal reality is a historically contingent and variable arrangement that cannot be separated from its cultural and juridical context. This book will be of interest to students of law, literature and philosophy.

Intellectual property law is currently exploding, as demonstrated by the growth of technology transfer offices in universities. More and more scientists, companies, and institutions are rushing to secure intellectual property rights for their ideas and inventions. This process frustrates many people; patent laws are constantly changing, and most books about them are either overly technical or boring.
Protecting Your Ideas: The Inventor's Guide to Patents is a succinct, straightforward guide to the system. This guide presents the steps involved in obtaining patent protection for inventions. It is easy to read and brimming with essential information and advice compounded from FAQs posed by the author's academic and industrial clientele. The text includes tips, warnings, and examples that guide the reader through the invention process so patent rights are not jeopardized. Checklists and other helpful information are provided to assist the inventor preparing to enter the patent process. The book includes valuable resource information and business guidance to protect the inventor from consumer fraud that is sometimes associated with the patent process. Protecting and Idea is a must read for every engineer, scientist, or amateur inventor.
Key Features
* Simple, easy-to-read format demystifies the patent process
* Numerous example patents help to illustrate the issues involved
* Provides an overview of the types of intellectual property protection
* Incorporates up-to-date information about U.S. patent laws
* Advises inventors about the do's and don'ts of patenting
* Includes useful resources for helping inventors safeguard their ideas

The fields of intellectual property have broadened and deepened in so many ways that commentators struggle to keep up with the ceaseless rush of developments and hot topics. Kritika: Essays on Intellectual Property is a series that is designed to help authors escape this rush. It creates a forum for authors who wish to more deeply question, investigate and reflect upon the evolving themes and principles of the discipline. Bringing together leading experts in intellectual property, this fourth volume of Kritika tackles head on the most pressing legal issues that lie at the heart of the contemporary marketplace. The topics in this volume include the possible futures of IP; the challenges that the information age poses for rational code design and the protection of social interests; the changing purpose of unfair competition law; the Durkheimian basis for a more socially inclusive form of IP; the reality of IP on the legal streets of Brazil; the shortfalls of intellectual property as dominium and the issue of rights to machine-generated and automated data. With contributions from: Pedro Marcos Nunes Barbosa, Rochelle C. Dreyfuss, Severine Dusollier, Valeria Falce, Mark Findlay, Frake Hennine-Bodewig and Hans-Wolfgang Micklitz

This global primer surveys international initiatives on traditional knowledge, folklore, cultural heritage and genetic resources, and describes in a comprehensive manner regional and national principles of protection in Asia, Europe, Africa, Oceania, the Middle East, the United States and the Americas. The most innovative parts of the book discuss three key approaches. First, the book highlights the relevance of customary law, describes how it is recognized and applied in legal systems and assesses its effectiveness as an enforcement mechanism. Second, through selected cases, the book illustrates the problem of biopiracy to which the disclosure requirement has been proposed as a policy response. It traces the origins of the disclosure requirement to instruments developed jointly by WIPO and UNESCO. Third, the book proposes a novel approach to protecting traditional knowledge premised on the principle of reciprocity and the use of mutual recognition agreements (MRAs) and assesses the scope of such MRAs. Libraries and universities will find this work is an invaluable resource for scholars and researchers. The material will also be important for government officials and organizations developing policy. Furthermore, the information available in these pages can empower indigenous peoples and local communities looking to promote awareness and protect traditional knowledge.

The book deals with (unfortunately) a highly relevant question of extraordinary measures adopted in many countries in connection with the recent pandemic, and the impact of such measures on ownership rights and constitutional freedoms as a whole. Using the methods of synthesis, analysis and historical comparison, the researchers address this issue from different perspectives, starting with the origins of state-governed crisis management, through the theoretical status of such measures and their role in the legal system, to the question of liability for damages arising from their imposition and application. Based on a critical analysis of existing measures, the book provides feedback on their compliance with basic legal principles and suggests possible solutions of encountered problems.

This innovative Research Handbook explores the complex and controversial interactions between intellectual property (IP) and investment law. In light of recent developments at national, European and international levels, the chapters critically examine the legitimacy of current practices with regard to the social function of IP rights and the regulatory autonomy of States to undertake measures in the public interest. Internationally renowned contributors analyse high profile cases in the framework of global legal forums and agreements, such as the Global Agreement on Tariffs and Trade and the WTO. Exploring the significance of fundamental human rights and ethical concerns, this Research Handbook will provide critical insight into intellectual property law, particularly with respect to the protection of IP as an investment, and its adjudication in the context of investor-state dispute settlement (ISDS) mechanisms. Comprehensive and engaging, academics and higher-level students working on intellectual property, investment law, European law and international law, will benefit from this Research Handbook. Specialized lawyers and practitioners, as well as organizations or governments involved in IP regulation, will also take advantage from its insight. Contributors include: E. Bonadio, G. Cook, C. Correa, T. Cottier, R.C. Dreyfuss, S. Frankel, S. Gaspar-Szilagyi, C. Geiger, R. Geiger, D. Gervais, H. Grosse Ruse-Khan, C.M. Ho, M. Husovec, S. Klopschinski, A. Marsoof, B. Mercurio, T. Mylly, R.L. Okediji, P. Roffe, D. Segoin, X. Seuba, P.N. Upreti, L. Vanhonnaeker, H. Wager, P.K. Yu

Intellectual property rights are essential for a firm's competitive edge and success and form the significant assets for many firms. The authors of this book argue that intellectual property is a complex phenomenon, which inevitably requires a combination of both economic and legal considerations, because the lack of understanding of the mechanisms for the protection and preservation of IP can serve to undermine any of the potential economic benefits. The book outlines the opportunities that can be derived from the use of IP in business and also identifies the rules necessary for their implementation. It offers a comprehensive, systemic research of intellectual property based on the most up-to-date legislation and cases of IP use in Russia. Such an approach will allow readers to fully understand the peculiarities of IP as a special phenomenon of the Russian market. There is a good balance between theoretical knowledge and practical implementation, and the plain language and unique approach to structuring information make the book accessible and easy to understand. It contains a special glossary of terms to facilitate the understanding of the material presented in the book. Although the book looks specifically at the Russian case, it will have international appeal, since intellectual property, by its very nature, has become a transnational phenomenon. Moreover, the international regulatory framework provides for the similarity of legal regulation of IP. The book will find an audience among researchers concerned with the economics and law of intellectual property, as well as, policymakers and practitioners involved in business IP.

This book focuses on the economic aspects of intellectual property (IP). It includes considerations of the wider category of intangible assets. However, the primary focus is devoted to patents which the author argues are the most vivid example of the Tragedy of Intangible Abundance (TIA). TIA touches upon a key issue in the contemporary economy. On the one hand, there is an enormous supply of IP, yet, on the other hand, such an abundance does not necessarily solve existing issues but rather creates new ones as well. This book elaborates on the reasons for the emergence of TIA and its consequences. The author uses clear metaphors to explain very complex issues. The book provides a valuable and interdisciplinary analysis of the field and offers practical solutions. It is based on the data collected by the author during the qualitative research he conducted among a group of start-ups. It presents guidance on determining which instrument is the most efficient for a particular situation. It also provides arguments for decision-makers and their advisors as to why a more open approach towards intellectual property would be more beneficial under many circumstances in the contemporary economy. While universal issues are addressed, the author distinguishes the European perspective too. The book is written in a clear and concise style and covers all of the crucial aspects of IP management. It will find an audience among scholars of economics and business.

This book focuses on analysing how legal systems set the terms for interactions between human beings and plants. The story that the book recounts is one of experimental lawmaking in Ecuador, a country where over the past decade, governmental officials and civil society advocates have attempted to reconfigure how human individuals and institutions relate to nature, by following an "eco-centric" approach to lawmaking. In doing so, Ecuadorian legislators, administrators, and judges have taken seriously the ontologies of non-human entities, including plants, through a process that has required the continuous navigation of tensions with certain "logics" that pervade conventional legal regimes. The book endeavours to disrupt these conventional assumptions and approaches to lawmaking by taking seriously alternative strategies to reconstitute interactions between people and plants. In doing so, the book argues in favour of an "ecological turn" in laws that govern vegetal life. The analysis is based on a close examination of the experiences that lawmakers in Ecuador have had when experimenting with innovative approaches to re-form relationships between human and non-human beings. Concretely, these experiments have yielded constitutional, legislative, and regulatory changes that inform the inquiry of how intellectual property and plant genetic resources laws - both in Ecuador and worldwide - could become more "ecological" in nature. The argument that the book develops is based on extensive ethnographic fieldwork and empirical research in Ecuador, complemented by archival and doctrinal legal analysis. The contents of the book will be of interest to an academic audience of legal scholars and postgraduate students in law, in addition to scholars and students in the fields of anthropology, sociology, socio-legal studies, and science and technology studies.

The Supreme Court of the United States in Feist v. Rural (1991) required that databases must have a minimal degree of creativity for copyright. The judgment was highly significant and the subsequent period is understood as the post-Feist era. It has been globally influential. However, the decision is extremely complex and remains unsatisfactorily interpreted. In particular, it has been impossible to illuminate the creativity requirement. The book gives an account of the decision's conceptual structure, focusing on its full delineation of the opposite to creativity. In a radical and unprecedented innovation, it is correlated with an automatic computational process. Creativity itself is understood as non-computational or directly human activity concerned with meaning. Determining the presence of creativity is reduced to a four-stage test. This work then has acute practical current relevance to property in data in the digital age; it will also be of theoretical interest to, and is aimed at, researchers in, practitioners, and students of intellectual property worldwide.

Contemporary copyright was born in a heroic era of human history when technologies facilitated idea dissemination through the book trade reaching out mass readership. This book provides insights on the copyright evolution and how proprietary individual expression's copyright protection forms an integral part of our knowing in being, driven by the advances of technology through the proliferating trading frameworks. The book captures what is central in the process of copyright evolution which is an "onto-epistemological offset". It goes on to explain that copyright's protection of knowing in originality's delineation of expression and fair use/dealing's legitimization of unauthorized use and being are not isolatable, but rather mutually implicated. While the classic strict determinism has been subject to an onto-epistemological challenge, the book looks at the proliferation of global trade and advent of information technology and how they show us the beauty and possibility of intra-dependence between copyright authorship, entrepreneurship, and readership, which calls for a fresh copyright onto-epistemology. Building on its onto-epistemological critiques on the stakeholder, force, and mechanism of copyright evolution, the book helps readers understand why, not only copyright, but also law in general, and justice too, need to be onto-epistemologically balanced, as this is categorically imperative for being, the fundamental law of nature.

Arguing that the translation of scientific and technical learning materials, and the publication of these translations in a timely and affordable manner, is crucially important in promoting access to scientific and technical knowledge in the developing world, this book examines the relationship between copyright law, translation and access to knowledge. Taking Sri Lanka as a case study in comparison with India and Bangladesh, it identifies factors that have contributed to the unfavourable relationship between copyright law and the timely and affordable translation of scientific and technical learning materials, such as colonisation, international copyright law, the trade interests of the developing economies and a lack of expertise and general lack of awareness surrounding copyright law in the developing world. Highlighting the need to reform international copyright law to promote the needs and interests of developing countries such as Sri Lanka, the book points to a possible way forward for developing countries to achieve this and to address the problem of striking a proper and delicate balance in their copyright laws between the protection of translation rights and the ability of people to access translations of copyright protected scientific and technical learning materials.

New innovations are created every day, but today's business leaders are focused on finding disruptive innovations which are cheaper and lower performing than upmarket technologies. They create new markets, and challenge the status quo of existing technological thinking creating uncertainty both in the future of the innovation and the outcome of the market upheaval. Disruptive innovation is an influential innovation theory in business, but how does it affect the law? Several of these technologies have brought new ways for individuals to deal with copyright works while disrupting existing market expectations, while their ability to spawn social norms has presented challenges for legislation. Considering disruptive innovation as a class, this book examines innovations that have impacted copyright in the past, what lessons can be learned from how the law interacted with them, and how the law can successfully deal with them going forward. Creating comprehensive guidance that can be used when faced with disruptive innovations with the aim of more successful legislation, it considers whether copyright law itself has been disrupted through these innovations. Exploring whether disruptive innovations as a class have unique properties that necessitate action by legislators and whether these properties have the possibility to disrupt the law itself, this book theorises how the law should deal with disruptive innovations in general, going beyond a discussion of the regulation of specific innovations to develop a framework for how law makers should deal with disruptive innovations when faced by one.

Ideas are the fuel of industry and the entertainment business. Likewise, manufacturers receive suggestions for new products or improvements to existing products, and retailers frequently receive ideas for new marketing campaigns. Many ideas are not new and may be used by anyone without the risk of incurring any legal liability, but some ideas are novel and valuable. If the originator of a potentially useful idea does not have the financial resources to exploit the idea, he or she may submit it to another, with the expectation of receiving compensation if the idea is used. Although an extensive body of intellectual property law exists to protect the rights of inventors, authors, and businesses that own valuable brands or confidential proprietary information, raw ideas receive no protection. Nevertheless, the originator of a potentially useful and marketable idea is not without legal recourse. The courts have developed, through a long line of common law precedents, legal protection for novel and concrete ideas under certain circumstances. The originator of an idea can rely on contract law, whereby the recipient may expressly or impliedly agree to pay for the idea. Alternatively, if the idea is disclosed in confidence, its unauthorized use by the recipient allows the originator of the idea to recover compensation. Finally, some courts have treated the ownership of ideas as quasi-property rights.

This book builds an empirical basis towards creating broader prevention and intervention programs in curbing digital piracy. It addresses the psychosocial, cultural and criminological factors associated with digital piracy to construct more efficient problem-solving mechanisms. Digital piracy including online piracy involves illegal copying of copyrighted materials. This practice costs the software industry, entertainment industry, and governments billions of dollars every year. Reports of the World Intellectual Property Organization (WIPO) and Business Software Alliance (BSA) view piracy largely in the light of economic factors; the assumption being that only those who cannot afford legitimate copies of software, music, and movies indulge in it. Drawing on research and theories from various disciplines like psychology, sociology, criminology, and law, the authors have designed an empirical study to understand the contribution of psychological, cultural and criminological factors to digital piracy. The chapters include data from India and China, which continue to be on the Special 301 report priority watch list of the WIPO, and Serbia, which has been on the watch list 4 times. They examine the role of self-control, self-efficacy, perceived punishment severity, awareness about digital piracy, peer influence, neutralization techniques, novelty seeking, pro-industry factors and other socio-demographic factors in predicting digital piracy. This book addresses a large readership, comprising academics and researchers in psychology, criminology and criminal justice, law and intellectual property rights, social sciences, and IT, as well as policymakers, to better understand and deal with the phenomenon of digital piracy.

The legal protection of geographical indications (GIs) is characterised by a variety of approaches which translates the many objectives attached to them. These range from protection of the consumers and producers' interests against unfair competition practices, to territorial development, to preservation of cultural heritage and natural resources. Looking beyond formal legal protection for GIs, this book seeks to re-draw attention to what happens in the real world by exploring the opportunities and constraints which influence whether regional product branding initiatives are successful. It asks: what makes GIs work in practice and does the type of legal protection matter? To answer these questions, this book takes a comparative case study approach and draws upon empirical data collected from 12 GI initiatives in two countries, France and Vietnam. In doing so, this book not only provides new insights and perspectives to the ongoing international legal dispute over GIs, it also contributes to unpacking the factors that make GIs work in practice to bring about economic and non-economic benefits and ultimately support the empowerment of local producers. This book will be of interest to legal academics and practitioners as well as food sociologists, economists, anthropologists and rural development experts.

EU legislation for the protection of designs has been described as a 'third way?'in contrast to traditional concepts of design protection. This book provides a thorough appraisal of the EU's unique Design Approach; assessing its formation, development and impact over the past decade. The EU Design Approach explores the rationale behind the creation of the Approach; including contributions from two leading EU scholars who were involved in its conception. The contributing authors provide an assessment of the impact that the Design Approach has had on present EU laws, national law systems and adjacent areas of law including copyright and competition law. Chapters also explore more problematic issues associated with the Approach such as: the role of design law in the wider EU framework for the protection of product shapes, and the balancing of interests between rights holders and users. Overall, this book demonstrates that the Design Approach has been largely successful in its aims despite there being some on-going points of contention. IP scholars will find this book to be a valuable resource of historical and comparative analysis. Practicing IP lawyers and policy makers will also benefit from the inclusion of up to date EU and national case law. Contributors include: G. Dinwoodie, S. Dogan, P. Fabbio, F. Kur, M. Levin, A. Ohly, J. Schovsbo, S. Teilmann-Lock, Q. Yin, W. Zhang

This commentary offers the definitive guide to supplementary protection certificates (SPC); a key element in the regulation of the pharmaceutical and medical market within Europe. Beyond providing an overview of the European legislation and the CJEU case-law on SPCs, it also depicts and summarises national law and jurisprudence on leading pharmaceutical markets such as Germany, France and the United Kingdom as well as The Netherlands, Italy and Switzerland. Patent lawyers, those practising in the medical and pharmaceutical field as well as judges and academics will find this an invaluable resource.

'Ventose makes a fresh, lively and incredibly thorough contribution to the literature in this work. He canvasses the European, English and American authorities in a systematic, methodical and - dare I say - surgical manner. The book is a 'must read' for practitioners, academics and students alike interested in patentable subject matter, public policy and medico-legal ethics. It will be a welcome addition to any legal collection.' Emir Aly, University of Windsor, Barrister & Solicitor, Law Society of Upper Canada and Co-Founder and Co-Chair, Harold G. Fox Intellectual Property Moot 'Medical patents are a matter of life and death. Such patents have a critical impact upon patient care, medical research, and the administration of healthcare (and, indeed, are in part responsible for ballooning health care budgets). This comprehensive book by Eddy D. Ventose provides a systematic comparative analysis of medical patents. The work explores the historical taboo against patenting methods of human treatment; charts the spectrum of policy positions on medical patents, ranging from permissive to prohibitive; and examines contemporary battles over patenting methods of medical correlation in the Supreme Court of United States.' Matthew Rimmer, The Australian National University College of Law and ACIPA, Australia This book provides a detailed and comparative examination of medical patent law and the issues at the heart of the medical treatment exclusion for therapeutic treatments, surgical treatments and diagnostic methods. It first considers the historical basis for exclusion and the development of law and policy in Europe, the United States and other commonwealth countries. The book goes on to provide a detailed analysis of the issues related to new medical technologies, such as gene therapy, dosage regimes, and medical diagnostics, in light of the medical treatment exclusion. Medical Patent Law will strongly appeal to patent agents and attorneys, solicitors and barristers working in patent and intellectual property law and medical law worldwide, as well as medical practitioners and healthcare professionals; scientists, researchers and managers in the chemicals, medical; pharmaceuticals and biotechnology industries. Postgraduates on LLM medical law and intellectual property courses and academics specializing in medical law or patent law, will also find much to interest them.