Biotechnology Law and Policy: Emerging Legal Issues, Cases and Materials

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. Preface Acknowledgements Contents About the Author 1 Background and Overview of Biotechnology Biotechnology and Its Applications Red Biotechnology White Biotechnology Green Biotechnology The First Genetically Modified Crop: Roundup Ready Soybean Seeds Blue Biotechnology Development of Biotechnology Techniques and Products References 2 A Brief History of the Fda and Its Role in Regulating Biotechnology Products A Historical Overview The Coordinated Framework Regulatory Agencies and the Intersection of Science with Public Health The Debate Over Genetically Engineered Foods: Safety and Regulation References 3 Products of Biotechnology and IP System IP Rights in Biotechnology Patentable Subject Matter in Biology-Related Inventions Copyrighting the Human Genome Sequence Data Preventing Unauthorized Use of Biotech Trade Secrets The Evolution of International IP Protection References 4 The Application of Patent Law to Biotechnology The Adrenalin Patent and Patentability of Biological Materials The Role of Parke-Davis V. Mulford in the Evolution of Patent Law The Advent of Recombinant DNA and the Evolution of Patent Law Asilomar Conference Guidelines for Recombinant DNA Research References 5 The Birth of the Biotechnology Industry The Rise of Biotech: The Three Key Events That Paved The Way Patentability of Living Organisms Commercialization of Academic Research: The Bayh–Dole Act The Founding and Success of Genentech References 6 The Limits and Challenges of Gene Editing From Creation to Controversy: The Harvard Oncomouse Patent Human Genome Diversity Project and Indigenous Peoples’ Rights Navigating the Complexities of Gene Patenting The CRISPR Revolution: Advancements and Applications in Gene Editing References