Biotechnology Law And Policy

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.

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.

This casebook addresses a broad range of issues in many areas of law which are affected by recent advances in biotechnology. The book seeks to examine the law and the underlying science and policy of biotechnology in addressing these issues. This interdisciplinary book will include biotechnology issues in biologically engineered plants and foods, genetically engineered organisms, cloning, DNA, the Human Genome Project, patenting, property law, criminal law, evidence, and international aspects of law and biotechnology. The governmental management of these issues through the Executive Branch, the Legislative Branch and the Judicial Branch, as well as the private sector interaction, is examined. Several appendices are included in the casebook, which are useful reference tools for the student or the practitioner.

Softbound - New, softbound print book.

Detailing the intellectual-property aspects of biotechnology law - from initial identification and reporting through licensing - this comprehensive reference explains the rules, regulations and procedures typically encountered by researchers in the development of their innovations.;Focusing on the fundamental legal concepts that should be understood by scientists, academicians and technicians working in the field, Understanding Biotechnology Law: considers the role of the inventor in the preparation of a patent application; describes the patent application process from discovery of an invention to issuance of a patent; discusses the law governing ownership of laboratory discoveries and products; examines intellectual-property policies, research agreements, consulting agreements, and conflicts of interest; presents the rules for determining inventorship; reviews patent infringement laws, including claim interpretation, literal infringement, and infringement under the doctrine of equivalents; and outlines modern license agreements, providing the principal terms encountered in biotechnology licenses.;Written by authorities in the field, Understanding Biotechnology Law is a reference for molecular and cell biologists, microbiologists, virologists, bioprocess technologists, biochemists, food scientists and technologists, pharmacologists, and pharmacists.

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.

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.