An Introduction To Legal Regulatory And Intellectual Property Rights Issues In Biotechnology

Author : Alessandro Stasi,Tan Weng Chiang David
Publisher : Bentham Science Publishers
Page : 165 pages
File Size : 49,5 Mb
Release : 2023-01-17
Category : Business & Economics
ISBN : 9789815080636

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An Introduction to Legal, Regulatory and Intellectual Property Rights Issues in Biotechnology by Alessandro Stasi,Tan Weng Chiang David Pdf

Biotechnology, a branch of science and a fast-growing source of developing technologies, has shown immense potential for its utility across all the dimensions of our lives. Its applications range from drugs and therapeutics, industrial, household applications, biofuels, and information technology to almost all resource-based sectors, such as manufacturing, aquaculture, agriculture, and forestry. Biotechnology offers outstanding potential to meet the growing demand for food and energy production in a sustainable way. Recognizing its economic and strategic value, countries have implemented several measures to generate a homegrown biotechnology sector and help science-based companies develop. This book covers some of the most important legal issues arising in relation to biotechnology. Topics covered in chapters include 1) the historical development of a legal framework sufficient to protect public safety, 2) the current biotechnology regulatory system and the rules directing the primary agencies that regulate the products of biotechnology (namely the FDA, USDA and EPA), 3) the regulation of human genome editing and its impact on health research, 4) law and emerging genome editing technologies from recombinant DNA technology to CRISPR/Cas9 editing, 5) 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 6) legal issues arising from the use of genetic engineered plants and animals. The authors have ensured that the contents are easy to understand, making this an accessible reference for a broad range of readers. This book, therefore, serves as a quick summary of the prominent legal and regulatory issues in the biotech industry for professionals, as well as scholars in legal study programs.

Author : Kshitij Kumar Singh
Publisher : Springer
Page : 270 pages
File Size : 43,8 Mb
Release : 2014-10-27
Category : Law
ISBN : 9788132220596

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Biotechnology and Intellectual Property Rights by Kshitij Kumar Singh Pdf

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 : Matthias Herdegen
Publisher : Edward Elgar Publishing
Page : 208 pages
File Size : 42,7 Mb
Release : 2024-06-26
Category : Biotechnology
ISBN : 9781786435965

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The International Law of Biotechnology by Matthias Herdegen Pdf

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.

Author : Padma Nambisan
Publisher : Academic Press
Page : 392 pages
File Size : 41,5 Mb
Release : 2017-06-21
Category : Medical
ISBN : 9780128092514

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An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology by Padma Nambisan Pdf

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

Author : Han Somsen
Publisher : Edward Elgar Publishing
Page : 291 pages
File Size : 50,8 Mb
Release : 2007-01-01
Category : Science
ISBN : 9781847204417

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The Regulatory Challenge of Biotechnology by Han Somsen Pdf

. . . a compilation of 12 invaluable contributions on this issue by internationally known experts in their respective fields. . . a valuable resource for academic professionals, policy makers and legislators, advocacy groups and scholars in legal and development studies. It is a storehouse of learning and practical knowledge for anyone interested in environmental policy, biosafety issues, biotechnology processes and associated regulatory constraints. Marcelin Tonye Mahop, Review of European Community and International Environmental Law For bioethicists, legal scholars and regulators struggling with what controls to place on biotechnology, this is required reading. John Avellanet, Journal of Commercial Biotechnology Biotechnology has prompted a revolution in science and society in the truest sense of the word. For what superficially appears to be a revolution in biotechnology, in effect touches upon the fundamentals of life and the way in which humans relate to it. This book will make a significant contribution to the debate surrounding the effective regulation of biotechnology. The contributing authors assess how regulatory regimes can accommodate the many different and often conflicting issues to which biotechnology is giving rise to (including a very tainted public image). The book s ultimate aim is to explore ways of designing a regulatory regime that takes heed of these different demands whilst, at the same time, answering to the imperatives of effectiveness and efficiency. The book synthesizes three fields of legal analysis; the first focuses on the risk-dominated regulation of GM food and bio-agriculture; the second involves human genetics as a field dominated by considerations of ethics. Finally, patent law has been chosen as an area captured by notions of property. With its holistic approach, The Regulatory Challenge of Biotechnology will be of great interest to academics, policymakers and regulators as well as biotechnology and law students.

Author : Graham Dutfield
Publisher : World Scientific
Page : 429 pages
File Size : 45,7 Mb
Release : 2009
Category : Law
ISBN : 9789812832283

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Intellectual Property Rights and the Life Science Industries by Graham Dutfield Pdf

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.

Author : Graham Dutfield
Publisher : Routledge
Page : 301 pages
File Size : 43,9 Mb
Release : 2017-03-02
Category : Law
ISBN : 9781351927130

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Intellectual Property Rights and the Life Science Industries by Graham Dutfield Pdf

This book analyses the history of the international patent regime and the life science industries, both of which can be traced back to the late 19th century. The development of patent law is inextricably linked to expanding capacities to elucidate, manipulate and commercially exploit the molecular properties of micro-organisms, plants, animals and other organic raw materials. The story of the life science industries begins with the European synthetic dyestuff firms and culminates in present-day conglomerates like Aventis, Novartis and Pharmacia. Throughout the last century, chemical, pharmaceutical, seed and biotechnology firms were actively involved in reforming patent law and plant variety rights. The major beneficiaries have been the largest firms whose market dominance and influence over peoples' lives - aided by friendly intellectual property laws - has never been greater. This sparkling and stimulating book reveals the key repercussions caused by the expansion of life science industries for issues of international equity, public health, food security and biological diversity.

Author : Harikesh Bahadur Singh,Alok Jha,Chetan Keswani
Publisher : CABI
Page : 276 pages
File Size : 52,6 Mb
Release : 2016-09-26
Category : Science
ISBN : 9781780646534

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Intellectual Property Issues in Biotechnology by Harikesh Bahadur Singh,Alok Jha,Chetan Keswani Pdf

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.

Author : Matthew Rimmer
Publisher : Edward Elgar Publishing
Page : 393 pages
File Size : 49,9 Mb
Release : 2008-01-01
Category : Law
ISBN : 9781848440180

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Intellectual Property and Biotechnology by Matthew Rimmer Pdf

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 : Wen De Keesee
Publisher : wil keesee
Page : 316 pages
File Size : 54,9 Mb
Release : 2021-04-15
Category : Medical
ISBN : 9781736209516

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Biotechnology Law and Practice by Wen De Keesee Pdf

The Biotech "Gold Rush" is On! What are you waiting for? We are entering an explosive new era of medical and scientific discovery and the opportunities are huge for those who grasp the moment This Biotechnology Law and Practice Four book series is the most current, and informative work of its kind, and heralded by lawyers, scientists, and entrepreneurs as a must-have guidebook which simplifies complex issues at the frontiers of the law and biomedicine. With over 1600 power-packed pages of bioscience-biotech law, intellectual property, biomedicine, pharmaceuticals, regulatory, business strategies, and entrepreneurship, these books will launch you into this explosive new field, and you will have a precious asset, which you may routinely consult on your great new quest. Biotech Stocks are on fire! Potentially 100’s of new little biotech companies will develop new generations of medicines and medical devices while creating vast numbers of new millionaires.

Author : David Castle
Publisher : Edward Elgar Publishing
Page : 475 pages
File Size : 53,9 Mb
Release : 2009
Category : Science
ISBN : 9781849801935

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The Role of Intellectual Property Rights in Biotechnology Innovation by David Castle Pdf

. . . 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.

Author : Hugh B. Wellons
Publisher : American Bar Association
Page : 1016 pages
File Size : 48,6 Mb
Release : 2007
Category : Biotechnology
ISBN : 1590317610

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Biotechnology and the Law by Hugh B. Wellons Pdf

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 : United States. Congress. House. Committee on the Judiciary. Subcommittee on Intellectual Property and Judicial Administration
Publisher : Unknown
Page : 124 pages
File Size : 43,9 Mb
Release : 1993
Category : Political Science
ISBN : STANFORD:36105026904024

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Biotechnology Development and Patent Law by United States. Congress. House. Committee on the Judiciary. Subcommittee on Intellectual Property and Judicial Administration Pdf

Author : Anonim
Publisher : Unknown
Page : 128 pages
File Size : 44,6 Mb
Release : 2024-06-26
Category : Electronic
ISBN : 9789814470582

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Intellectual Property Rights and the Life Science Industries by Anonim Pdf

Author : Frederic H. Erbisch,Karim M. Maredia
Publisher : Oxford University Press, USA
Page : 248 pages
File Size : 40,5 Mb
Release : 1998
Category : Agricultural biotechnology
ISBN : UOM:35112202449528

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Intellectual Property Rights in Agricultural Biotechnology by Frederic H. Erbisch,Karim M. Maredia Pdf

During the last twenty years, biotechnology has revolutionized agricultural research. The enormous potential, together with a landmark decision by the US Supreme Court to allow the patenting of genetically-engineered organisms, has encouraged the private sector to invest heavily in research, resulting in the rapid growth of a multi-million dollar industry. These changes have influenced the way in which information and materials are exchanged and combined with developments in global agricultural research have resulted in a worldwide need for scientists to be educated in the implications of intellectual property rights. This book presents definitive information on intellectual property law in a simplified form (with a minimum of legal jargon) not available in other texts on the subject. The first section begins with an introductory chapter and goes on to consider diverse issues including protection, transference and capacity building, both at the national and institutional level. The second section consists of eleven country and regional case studies from around the world which track the international variation in intellectual property law and its application to agricultural biotechnology. The presentation is intended for both scientists and policy makers in industrialized and developing nations