Biotechnology and the Law


Book Description

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 Law


Book Description

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.




Biotechnology, Bioethics and the Law


Book Description

With every new advancement in biotechnology, ethical and legal questions arise. Sometimes, those questions are easily addressed and settled. However, more often, these issues are not easily resolved and at times are left to the democratic process or markets to establish the boundaries of technological pioneering. In Biotechnology, Bioethics, and the Law, the authors canvass the broader fields, valleys, and pastures of biotechnology, providing mostly cases, but at times law review and medical journal articles to provide a comprehensive look at a given technology. Their goal is to encourage a critical engagement on the topics shared in the book, whether on cloning animals and plants for human consumption, drug regulation, or human reproduction and eugenics. Many of the cases contained in the book provide novel questions for judges. Some of these cases are the first impression for the courts, meaning that judges are attempting to learn the law in these new areas and develop its jurisprudence at the same time that the public -- or the reader -- are doing the same. As students read the cases, they are asked to consider whether they would reach the same conclusions as the courts. Are these issues better left to legislatures? Are markets the best forum for efficiently resolving biotechnological conundrums?




Understanding Biotechnology Law


Book Description

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 and International Law


Book Description

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.




Biotechnology and Software Patent Law


Book Description

'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.




Law Relating to Biotechnology


Book Description

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.







Patent Pools, Competition Law and Biotechnology


Book Description

Exploring the relationship between competition law and technology pools, this book provides general-purpose details of the biotechnology patent pool scheme while discussing historical developments, approaches of the US Department of Justice, Federal Trade Commission, and the European Union Competition Commission via EU regulations. In addition to these regulatory approaches and evolution in concept and theory of technology pools, this book illustrates relationship issues including tying arrangements and essential facility consideration vis-à-vis technology pools. It analyzes the modalities of forming such pools in the area of biotechnology, specifically illustrating that the formation of technology pools is possible and can be safely undertaken, and proposes a viable solution and structure. Patent pools in the biotechnology industry will pave the way towards open collaborative research, reducing patent thickets. Formation of such pools will increase access to various technology and patents otherwise out of bounds, resulting in a reduction of licensing costs and a spur in the development of new solutions. Most importantly, such pools will reduce the frequency of patent toll gates, making the entire spectrum of research interesting from the perspective of researchers as well as investors. This book will be an aid to researchers studying intellectual property, patents, and biotechnology, as well as to interest groups including funding agencies, venture funds, angel investors, and proponents of the open-source movement.