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Author: Alan J. Morrison Publisher: Columbia University Press ISBN: 0231550928 Category : Science Languages : en Pages : 466
Book Description
Biotechnology and law are inextricable. Patent, regulatory, and contract law profoundly shape the biotech industry, and each of these practice areas is deeply intertwined with the science it governs. Yet many in this industry lack even a basic grasp of these laws, jeopardizing their business success as a result. This book is an essential introduction to biotechnology law for scientists, startup founders, regulatory specialists, patent liaisons, investors, academics, students, and other nonattorneys with biotech backgrounds. It covers core topics such as patentability, patent prosecution and infringement, patent opinions, the development and FDA approval of small-molecule and biologic drugs, regulatory exclusivity, generic drugs and ANDA litigation, biosimilars and the patent dance, patent licenses, and collaboration agreements. Written with scientists in mind, Biotechnology Law is a clear, concise, and entirely practical primer on the topic, replete with straightforward, real-world examples to illustrate each key concept. Understanding the legal machinery through which science becomes business is not a luxury—it is a crucial part of a scientist’s training. Alan J. Morrison’s expert treatment embraces this new reality.
Author: Alan J. Morrison Publisher: Columbia University Press ISBN: 0231550928 Category : Science Languages : en Pages : 466
Book Description
Biotechnology and law are inextricable. Patent, regulatory, and contract law profoundly shape the biotech industry, and each of these practice areas is deeply intertwined with the science it governs. Yet many in this industry lack even a basic grasp of these laws, jeopardizing their business success as a result. This book is an essential introduction to biotechnology law for scientists, startup founders, regulatory specialists, patent liaisons, investors, academics, students, and other nonattorneys with biotech backgrounds. It covers core topics such as patentability, patent prosecution and infringement, patent opinions, the development and FDA approval of small-molecule and biologic drugs, regulatory exclusivity, generic drugs and ANDA litigation, biosimilars and the patent dance, patent licenses, and collaboration agreements. Written with scientists in mind, Biotechnology Law is a clear, concise, and entirely practical primer on the topic, replete with straightforward, real-world examples to illustrate each key concept. Understanding the legal machinery through which science becomes business is not a luxury—it is a crucial part of a scientist’s training. Alan J. Morrison’s expert treatment embraces this new reality.
Author: Hugh B. Wellons Publisher: American Bar Association ISBN: 9781590317617 Category : Biotechnology Languages : en Pages : 1016
Book Description
The book is written to help lawyers faced with the challenge of identifying the legal issues and processes that must be faced by their clients in building, marketing, and protecting a biotech business. The contributors are experts in this specialized area and provide thorough, yet accessible, overviews of biotech subspecialties with an eye to practical application. A biotech legal practice involves specialized subject matter and regulatory schemes that, generally, are not part of the business lawyer's repertoire and which can present many hazards for the uninitiated. Because of the expansion in biotech practice beyond the traditional organizations and their representatives, this guide was written to help lawyers find their way through the biotech maze.
Author: N. S. Sreenivasulu Publisher: Oxford University Press, USA ISBN: 9780199467488 Category : Law Languages : en Pages : 0
Book Description
Biotechnology: The Science of Wonders --Biotechnology Dynamics and Applications --Evolving a Policy Framework for Biotechnology --Intellectual Property Rights in Biotechnology --Biotechnology, Trade, and Environment --Human Rights Concerns in Biotechnology --Biotechnology Regulation in India.
Author: Alessandro Stasi Publisher: Springer Nature ISBN: 981992135X Category : Law Languages : en Pages : 155
Book Description
This book covers an extensive range of issues raised by biotechnological advancements from a regulatory perspective. Written in a clear and readable style, its main objective is to give readers an idea of the relationship between biotechnology and law. Biotechnology advancements and their ethical, moral, economic, and social implications in different fields and the consequential normative demands on the law are crucial to this book. The chapters cover a multitude of themes and some of the most important legal issues arising in relation to biotechnology, including the historical development of a legal framework sufficient to protect public safety, the current biotechnology regulatory system, and the rules directing the primary agencies that regulate the products of biotechnology, namely the US Food and Drug Administration, the US Department of Agriculture, and the US Environmental Protection Agency, patents and IP rights in biotechnology, the regulation of human genome editing and its impact on health research, law and emerging genome editing technologies from recombinant DNA to CRISPR/Cas9, the development of legal principles to protect property rights in the human body and allow the efficient use of human tissue, organs, DNA, and cell-lines in medical research, and legal issues arising from the use of genetic engineered plants and animals. Presenting arguments that have been drawn from careful examination of various international documents and decisions made by legal institutions and judicial bodies, this book would be a valuable read for practitioners as well as academics of biotechnology law.
Author: Kshitij Kumar Singh Publisher: Springer ISBN: 8132220595 Category : Law Languages : en Pages : 270
Book Description
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.
Author: Matthew Rimmer Publisher: Edward Elgar Publishing ISBN: 1848440189 Category : Law Languages : en Pages : 393
Book Description
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.
Author: Marit Melhuus Publisher: Berghahn Books ISBN: 0857455028 Category : Health & Fitness Languages : en Pages : 187
Book Description
The Biotechnology Act in Norway, one of the most restrictive in Europe, forbids egg donation and surrogacy and has rescinded the anonymity clause with respect to donor insemination. Thus, it limits people's choice as to how they can procreate within the boundaries of the nation state. The author pursues this significant datum ethnographically and addresses the issues surrounding contemporary biopolitics in Norway. This involves investigating such fundamental questions as the relation between individual and society, meanings of kinship and relatedness, the moral status of the embryo and the role of science, religion and ethics in state policies. Even though the book takes reproductive technologies as its focus, it reveals much about vital processes that are central to contemporary Norwegian society.
Author: National Research Council Publisher: National Academies Press ISBN: 0309084393 Category : Technology & Engineering Languages : en Pages : 201
Book Description
Genetic-based animal biotechnology has produced new food and pharmaceutical products and promises many more advances to benefit humankind. These exciting prospects are accompanied by considerable unease, however, about matters such as safety and ethics. This book identifies science-based and policy-related concerns about animal biotechnologyâ€"key issues that must be resolved before the new breakthroughs can reach their potential. The book includes a short history of the field and provides understandable definitions of terms like cloning. Looking at technologies on the near horizon, the authors discuss what we know and what we fear about their effectsâ€"the inadvertent release of dangerous microorganisms, the safety of products derived from biotechnology, the impact of genetically engineered animals on their environment. In addition to these concerns, the book explores animal welfare concerns, and our societal and institutional capacity to manage and regulate the technology and its products. This accessible volume will be important to everyone interested in the implications of the use of animal biotechnology.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309452058 Category : Science Languages : en Pages : 231
Book Description
Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Author: Alan J. Morrison
Author: Alan J. Morrison
Author: Hugh B. Wellons
Author: N. S. Sreenivasulu
Author: Michael J. Malinowski
Author: Alessandro Stasi
Author: Kshitij Kumar Singh
Author: Matthew Rimmer
Author: Marit Melhuus
Author: National Research Council
Author: National Academies of Sciences, Engineering, and Medicine