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.







The International Law of Biotechnology


Book Description

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.




Problems of Conception


Book Description

The Biotechnology Act in Norway, one of the most restrictive in Europe, forbids egg donation and surrogacy and has rescinded the anonymity clause with respect to donor insemination.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, 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?




Pharmaceutical and Biotech Patent Law


Book Description

Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace - invalidate competitors' patents by proving that they fail to meet key requirements - protect against various forms of patent infringement - and successfully rebut charges of infringement. It includes detailed checklists that help you resolve thorny patent problems in the complex pharmaceutical and biotech fields, and is regularly updated to reflect Federal Circuit rulings and other significant court decisions.




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.







Intellectual Property and Biotechnology


Book Description

Dr Rimmer s book is a marvellous introduction to a crucial topic of our time. He writes engagingly, provocatively and always with good humour. A highly technical and complex area of law has been reduced to clear descriptions and searching analysis. Truly, this is an important book on an essential topic that will help define the ethics of a future that includes nothing less than the future of our species. From the foreword by the Hon Justice Michael Kirby AC CMG, the High Court of Australia . . . the author has done an excellent job by explaining the subject in an open and accessible manner. This book is a timely and very thought-provoking analysis of patent law and biotechnology. . . The book is a unique theoretical contribution to the controversial public debate over commercialization of biological inventions. . . there is an extensive bibliography. . . a valuable resource for further reading. The book will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists. Journal of Intellectual Property Rights Rimmer s book is highly recommended for anyone interested in the issues and debate related to biological inventions, regardless of which side the reader is on. Stefan M. Miller, Journal of Commercial Biotechnology . . . this book gives an excellent account of the most celebrated biotechnology cases from three continents, and for this alone is to be thoroughly recommended. David Rogers, European Intellectual Property Review Rimmer has put a great deal of thought and effort into this series of chapters. For those looking at how to reform, direct and develop laws in relation to biotechnology, this book is brimming with ideas, suggestions and recommendations of what to do next. Rebecca Halford-Harrison, Chartered Institute of Patent Attorneys . . . an excellent introduction to a wide range of legal thinking in an increasingly controversial and relevant area to humankind. Sharon Givoni, Australian Intellectual Property Law Bulletin Rimmer s new book is a timely and very thought-provoking analysis of patent law and biotechnology and asks a very serious question: can a 19th century patent system adequately deal with a 21st century industry? Kate McDonald, Australian Life Scientist This book documents and evaluates the dramatic expansion of intellectual property law to accommodate various forms of biotechnology from micro-organisms, plants, and animals to human genes and stem cells. It makes a unique theoretical contribution to the controversial public debate over the commercialization of biological inventions. The author also considers the contradictions between the Supreme Court of Canada rulings in respect of the Harvard oncomouse, and genetically modified canola. He explores law, policy, and practice in both Australia and New Zealand in respect to gene patents and non-coding DNA. This study charts the rebellion against the European Union Biotechnology Directive particularly in respect of Myriad Genetics BRCA1 and BRCA2 patents, and stem cell patent applications. The book also considers whether patent law will accommodate frontier technologies such as bioinformatics, haplotype mapping, proteomics, pharmacogenomics, and nanotechnology. Intellectual Property and Biotechnology will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists.




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.