Biotechnology And The 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.

In this thoroughly updated second edition, Matthias Herdegen provides a comprehensive and contemporary assessment of the regulation of biotechnology processes and products from an international and comparative perspective, complete with analysis of intricate legal and ethical debates.

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.

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.

'The art of editing is to bring contributions together, which melt into one book. This is what Emanuela Arezzo and Gustavo Ghidini have achieved with their own critical mind by composing a book of papers, in which internationally renowned experts measure the tensions created for the patent system by the needs and problems of protecting biotechnological and software inventions. All together, they present a comparative law challenge to the very fundaments of patent protection. As such, they are or may become a "must read".' Hanns Ullrich, College of Europe, Bruges, Belgium 'Arezzo and Ghidini have put together a fine collection of essays addressing developments in patent law from general themes to emerging ones in the infotech and biotech sectors. It is notable that the international array of authors includes contributions from both established and rising young scholars, all of them ably tackling difficult issues that merit our attention.' Rudolph J.R. Peritz, New York Law School, US The new millennium has carried several challenges for patent law. This up-to-date book provides readers with an important overview of the most critical issues patent law is still facing today at the beginning of the twenty first century, on both sides of the Atlantic. New technological sectors have emerged, each one with its own features with regard to innovation process and pace. From the most controversial cases in biotech to the most recent decisions in the field of software and business methods patent, patent law has tried to stretch its boundaries in a way to accommodate such new and controversial subject matters into its realm. Biotechnology and Software Patent Law will strongly appeal to postgraduate students specializing in IP law, international law, commercial and business law, competition law as well as IP scholars, academics and lawyers.