An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology provides a comprehensive look at the biggest technologies that have revolutionized biology since the early 20th century, also discussing their impact on society. The book focuses on issues related to bioethics, biosafety and intellectual property rights, and is written in an easy-to-understand manner for graduate students and early career researchers interested in the opportunities and challenges associated with advances in biotechnology. Important topics covered include the Human Genome Project, human cloning, rDNA technology, the 3Rs and animal welfare, bioterrorism, human rights and genetic discrimination, good laboratory practices, good manufacturing practices, the protection of biological material and much more. Full of relevant case studies, practical examples, weblinks and resources for further reading, this book offers an essential and holistic look at the ways in which biotechnology has affected our global society. - Provides a comprehensive look at the ethical, legal and social implications of biotechnology - Discusses the global efforts made to resolve issues - Incorporates numerous case studies to more clearly convey concepts and chart the development of guidelines and legislation regulating issues in biotechnology - Takes a straightforward approach to highlight and discuss both the benefits and risks associated with the latest biotechnologies

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.

. . . recommended to anyone interested in the thrilling subject of the relationship of IPRs and innovation. Ralf Uhrich, Journal of Intellectual Property This is an outstanding piece of scholarship. It will serve as a powerful stimulant for new research in the field and as a reliable guide for practitioners. Calestous Juma, Harvard University, US Intellectual property rights (IPRs), particularly patents, occupy a prominent position in innovation systems, but to what extent they support or hinder innovation is widely disputed. Through the lens of biotechnology, this book delves deeply into the main issues at the crossroads of innovation and IPRs to evaluate claims of the positive and negative impacts of IPRs on innovation. An international group of scholars from a range of disciplines economic geography, health law, business, philosophy, history, public health, management examine how IPRs actually operate in innovation systems, not just from the perspective of theory but grounded in their global, regional, national, current and historical contexts. In so doing, the contributors seek to uncover and move beyond deeply held assumptions about the role of IPRs in innovation systems. Scholars and students interested in innovation, science and technology policy, intellectual property rights and technology transfer will find this volume of great interest. The findings will also be of value to decision makers in science and technology policy and managers of intellectual property in biotechnology and venture capital firms.

Dr Rimmer s book is a marvellous introduction to a crucial topic of our time. He writes engagingly, provocatively and always with good humour. A highly technical and complex area of law has been reduced to clear descriptions and searching analysis. Truly, this is an important book on an essential topic that will help define the ethics of a future that includes nothing less than the future of our species. From the foreword by the Hon Justice Michael Kirby AC CMG, the High Court of Australia . . . the author has done an excellent job by explaining the subject in an open and accessible manner. This book is a timely and very thought-provoking analysis of patent law and biotechnology. . . The book is a unique theoretical contribution to the controversial public debate over commercialization of biological inventions. . . there is an extensive bibliography. . . a valuable resource for further reading. The book will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists. Journal of Intellectual Property Rights Rimmer s book is highly recommended for anyone interested in the issues and debate related to biological inventions, regardless of which side the reader is on. Stefan M. Miller, Journal of Commercial Biotechnology . . . this book gives an excellent account of the most celebrated biotechnology cases from three continents, and for this alone is to be thoroughly recommended. David Rogers, European Intellectual Property Review Rimmer has put a great deal of thought and effort into this series of chapters. For those looking at how to reform, direct and develop laws in relation to biotechnology, this book is brimming with ideas, suggestions and recommendations of what to do next. Rebecca Halford-Harrison, Chartered Institute of Patent Attorneys . . . an excellent introduction to a wide range of legal thinking in an increasingly controversial and relevant area to humankind. Sharon Givoni, Australian Intellectual Property Law Bulletin Rimmer s new book is a timely and very thought-provoking analysis of patent law and biotechnology and asks a very serious question: can a 19th century patent system adequately deal with a 21st century industry? Kate McDonald, Australian Life Scientist This book documents and evaluates the dramatic expansion of intellectual property law to accommodate various forms of biotechnology from micro-organisms, plants, and animals to human genes and stem cells. It makes a unique theoretical contribution to the controversial public debate over the commercialization of biological inventions. The author also considers the contradictions between the Supreme Court of Canada rulings in respect of the Harvard oncomouse, and genetically modified canola. He explores law, policy, and practice in both Australia and New Zealand in respect to gene patents and non-coding DNA. This study charts the rebellion against the European Union Biotechnology Directive particularly in respect of Myriad Genetics BRCA1 and BRCA2 patents, and stem cell patent applications. The book also considers whether patent law will accommodate frontier technologies such as bioinformatics, haplotype mapping, proteomics, pharmacogenomics, and nanotechnology. Intellectual Property and Biotechnology will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists.

This book presents the perspectives of policy-makers and economists on a highly topical subject. Plant breeding patents, the ownership of biological innovation and associated intellectual property rights (IPR) are the subject of increased attention worldwide. They are particularly relevant in the field of agricultural biotechnology, but until recently evoked little policy analysis.IPRs are particularly relevant in the field of agricultural biotechnology. They are issues affecting public and private sector organizations and companies, and are significant for developing as well as developed countries.

This book is a highly readable and entertaining account of the co-evolution of the patent system and the life science industries since the mid-19th century. The pharmaceutical industries have their origins in advances in synthetic chemistry and in natural products research. Both approaches to drug discovery and business have shaped patent law, as have the lobbying activities of the firms involved and their supporters in the legal profession. In turn, patent law has impacted on the life science industries. Compared to the first edition, which told this story for the first time, the present edition focuses more on specific businesses, products and technologies, including Bayer, Pfizer, GlaxoSmithKline, aspirin, penicillin, monoclonal antibodies and polymerase chain reaction. Another difference is that this second edition also looks into the future, addressing new areas such as systems biology, stem cell research, and synthetic biology, which promises to enable scientists to OC inventOCO life forms from scratch.

This book integrates a science and business approach to provide an introduction and an insider view of intellectual property issues within the biotech industry, with case studies and examples from developing economy markets. Broad in scope, this book covers key principles in pharmaceutical, industrial, and agricultural biotechnology within four parts. Part 1 details the principles of intellectual property and biotechnology. Part 2 covers plant biotechnology, including biotic and abiotic stress tolerance, GM foods in sustainable agriculture, microbial biodiversity and bioprospecting for improving crop health and productivity, and production and regulatory requirements of biopesticides and biofertilizers. The third part describes recent advances in industrial biotechnology, such as DNA patenting, and commercial viability of the CRISPR/Cas9 system in genome editing. The final part describes intellectual property issues in drug discovery and development of personalized medicine, and vaccines in biodefence. This book is an ideal resource for all postgraduates and researchers working in any branch of biotechnology that requires an overview of the recent developments of intellectual property frameworks in the biotech sector.