This innovative book explores the complex interplay between intellectual property for biotechnological innovations and human rights. Examining the clash between the drive to incentivise innovations that can fulfil human needs and the desire to grant global access to healthcare technologies, it presents thoughtful solutions to the challenges of protecting the human rights of all parties impacted by biotechnological patents and other relevant IP rights.
Biotechnology is a field that inspires complex legal and ethical debates on an international scale. Taking a fresh approach to the subject, Matthias Herdegen provides a comprehensive assessment of the regulation of biotechnology processes and products from an international and comparative perspective.
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.
Introduction -- Defining the public interest in the US and European patent systems -- Confronting the questions of life-form patentability -- Commodification, animal dignity, and patent-system publics -- Forging new patent politics through the human embryonic stem cell debates -- Human genes, plants, and the distributive implications of patents -- Conclusion
This book offers a valuable contribution to contemporary legal literature, providing deep insights into the interface between law and genetics, highlighting emerging issues and providing meaningful solutions to current problems. It will be of interest to a broad readership, including academics, lawyers, policy makers and scholars engaged in interdisciplinary research. In the context of examining and analyzing the legal and social implications arising from the recent conjunction of biotechnology and intellectual property rights, the book particularly focuses on human genes and gene variations. Emphasis is placed on “patent law,” as a considerable percentage of genetic inventions are covered by patents. The book presents a comparative and critical examination of patent laws and practices related to biotechnology patents in the United States, Canada, European Union and India, in order to gather the common issues and the differences between them. The international patent approach regarding biotechnology is also analyzed in light of the constant conflict between differentiation and harmonization of patent laws. The book highlights the potential gaps and uncertainties as to the scope of numerous terms such as invention, microorganisms, microbiological processes, and essential biological processes under TRIPS. Also analyzed are the social and policy implications of patents relating to genetic research tools and genetic testing. The intricacies involved in providing effective intellectual property protection to bioinformatics and genomic databases are also examined. Bearing in mind the collaborative nature of bioinformatics and genomic databases, the book evaluates the pros and cons of open biotechnology and assesses the implications of extending intellectual property rights to human genetic resources, before explaining the ownership puzzle concerning human genetic material used in genetic research.
Stem cell research, and particularly embryonic stem cell research, while offering the prospect of developing theories for serious life-threatening diseases, also raises a number of difficult and controversial moral questions. This is reflected in a variety of moral perspectives and regulatory regimes, already adopted or in the process of being developed, in EU Member States. In particular the "moral exclusion" clause in Article 6 of the EC Directive on the legal protection of biotechnological inventions has created much uncertainty in this field. This collection of original essays provides comprehensive analysis of the EU patent system as applied to biotechnological inventions and particularly stem cell research, dealing with the overlapping EPC, EU, international and national law regimes bearing on the exclusion of patents in a morally fragmented and contested field. In this multidisciplinary study, the editors aim to clarify the legal scope of Article 6, which they deem essential for the fostering of research and investment in Europe, while ensuring that such research is conducted within clear ethical limits which address the concerns of society. As well as a complete overview of the application of the European patent law in the field of human embryonic stem cells, topics covered include legal and philosophical accounts of the boards of the European Court of Justice and European Patent Offices' reasoning in the leading litigated cases, as well as the institutional tensions between national and transnational European research and patent regimes. With its broad research in the fields of patent law, ethics and philosophy, the book analyzes a wide range of issues in a way no other book has previously done and suggests solutions to unblock the current stalemate surrounding the patentability of human embryonic stem cell related inventions. The book will be welcomed by a broad readership, including experts and academics in both ethical and legal disciplines as well as policy makers and regulators in the field of embryonic stem cell research in Europe.
American patent law has reached an unprecedented crossroads, prodded by a landmark Supreme Court decision this spring and the prospect of sweeping new federal legislation this fall. At this critical time, Biotechnology and the Patent System: Balancing Innovation and Property Rights provides a timely look at the complex issues involved in making patent law for cutting-edge high-tech industries such as the biotechnology and computer software sectors.
The patenting and licensing of human genetic material and proteins represents an extension of intellectual property (IP) rights to naturally occurring biological material and scientific information, much of it well upstream of drugs and other disease therapies. This report concludes that IP restrictions rarely impose significant burdens on biomedical research, but there are reasons to be apprehensive about their future impact on scientific advances in this area. The report recommends 13 actions that policy-makers, courts, universities, and health and patent officials should take to prevent the increasingly complex web of IP protections from getting in the way of potential breakthroughs in genomic and proteomic research. It endorses the National Institutes of Health guidelines for technology licensing, data sharing, and research material exchanges and says that oversight of compliance should be strengthened. It recommends enactment of a statutory exception from infringement liability for research on a patented invention and raising the bar somewhat to qualify for a patent on upstream research discoveries in biotechnology. With respect to genetic diagnostic tests to detect patient mutations associated with certain diseases, the report urges patent holders to allow others to perform the tests for purposes of verifying the results.
This book assesses the scientific value and merit of research on human genetic differencesâ€"including a collection of DNA samples that represents the whole of human genetic diversityâ€"and the ethical, organizational, and policy issues surrounding such research. Evaluating Human Genetic Diversity discusses the potential uses of such collection, such as providing insight into human evolution and origins and serving as a springboard for important medical research. It also addresses issues of confidentiality and individual privacy for participants in genetic diversity research studies.
