Biotechnology Law

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.

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.

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.

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.

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.

As with any rapid technological development, the biotechnology revolution is putting great strains on the ability of law to adapt to new challenges and threats. Although there is general agreement on the need to regulate biotechnology in many different fields of human activity (agriculture, life sciences, forensic science) domestic law remains deeply divided over the best approach to take. This book is the first attempt at covering the most pressing legal issues raised by the impact of biotechnologies on different categories of international norms. Through the contribution of a selected group of international scholars and experts from international organizations, the book addresses 1) the international status of genetic resources, both in areas of national jurisdiction and in common spaces such as the international sea bed area and Antarctica; 2) the relevance of environmental principles in the governance of modern biotechnologies; 3) the impact of biotechnologies on trade rules, including intellectual property law; 4) the human rights implications, especially in the field of human genetics; and 5) the intersection between general international law and regional systems, especially those developed in Europe and Latin America. The overall objective of the book is to provide an up-to-date picture of international law as it stands today and to stimulate critical reflection and further research on the solutions that will be required in years to come.

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.

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.