Biotechnology and the Law

Author: Hugh B. Wellons,Eileen Smith Ewing,Robert Copple,Erika Leitzan,William Wofford

Publisher: American Bar Association

ISBN: 9781590317617

Category: Law

Page: 957

View: 9151

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 the law

Author: Iver P. Cooper

Publisher: Clark Boardman Callaghan


Category: Law

Page: N.A

View: 1034

This looseleaf treatise is a comprehensive examination of the legal protection available for genetically engineered processes and products in light of the precedent setting Chakrabarty case. Claim formats for protecting bio-engineering techniques and products are included in the work.

Biodiversity and the Law

Intellectual Property, Biotechnology and Traditional Knowledge

Author: Charles R. McManis

Publisher: Earthscan

ISBN: 1849770573

Category: Law

Page: 521

View: 4622

How do we promote global economic development, while simultaneously preserving local biological and cultural diversity? This authoritative volume, written by leading legal experts and biological and social scientists from around the world, addresses this question in all of its complexity. The first part of the book focuses on biodiversity and examines what we are losing, why and what is to be done. The second part addresses biotechnology and looks at whether it is part of the solution or part of the problem, or perhaps both. The third section examines traditional knowledge, explains what it is and how, if at all, it should be protected. The fourth and final part looks at ethnobotany and bioprospecting and offers practical lessons from the vast and diverse experiences of the contributors.

Pharmaceuticals Biotechnology and the Law

Author: Trevor M. Cook

Publisher: Butterworth-Heinemann

ISBN: 9780406914415

Category: England and Wales

Page: 925

View: 6566

Pharmaceuticals Biotechnology and the Law is the definitive guide to the law in Europe relating to pharmaceuticals, biotechnology and their related areas such as medical devices.Written by one of the country's leading patent and regulatory lawyers (Trevor Cook, Bird & Bird), this is the only text which comprehensively covers the wide variety of legal and regulatory issues which surround these industry sectors.The book examines the background to, and the impact of, the law affecting this area. The text is primarily written from the perspective of European Community law, although in those relatively few areas where this is not harmonised it is written from the perspective of English law.The book has been comprehensively updated if not re-written to take account of the enormous amount of development in the field since publication of the first edition in 1991.Virtually every single regulatory framework addressed is completely new or radically updated since then and, for example, only two of the materials in the appendix date back to the first edition (e.g., pricing transparency and contained use).Entire areas of law have developed since then, such as regulatory data, which is accorded three chapters of coverage within the book. The field has also seen the introduction of the EPC 2000, the Biotechnology Directive and the maturing of biotechnology patenting, which was in its infancy at the time of the first edition. From these developments has come a raft of case law which is cross-referred to throughout.

Environmental Contamination, Biotechnology, and the Law

The Impact of Emerging Genomic Information: Summary of a Forum

Author: National Research Council,Division on Earth and Life Studies,Board on Life Sciences,Robert Pool, Ph.D.

Publisher: National Academies Press

ISBN: 0309170974

Category: Science

Page: 44

View: 6057

On August 16, 2000, the Board on Life Sciences held a forum on "Environmental Contamination, Biotechnology, and the Law: The Impact of Emerging Genomic Information." The purpose of the forum was to explore the legal implications of current and developing biotechnology approaches to evaluating potential human health and environmental effects caused by exposure to environmental contaminants and to cleaning up contaminated areas. The forum brought together scientists from academe, government, and industry and members of the legal community, including lawyers and judges, to discuss the interface between the use of those approaches and the legal system.

Understanding Bioethics and the Law

The Promises and Perils of the Brave New World of Biotechnology

Author: Barry R. Schaller

Publisher: Greenwood Publishing Group

ISBN: 9780275999186

Category: Law

Page: 241

View: 3585

This special edition eBook of Poor Little Bitch Girl is available only for a short time. Included with the full text of the book is the following extra content: Jackie Collins explains the inspiration for the book A Q&A (including such gems as "Which Jackie Collins character has been portrayed by Sandra Bullock?") An annotated guide to great Jackie Collins characters - written by Jackie An illustrated Santangelo family tree A list of Jackie's all-time top-ten musical artists - you WILL be surprised Three twenty-something women, one hot rich guy, two mega movie stars, and a devastating murder: Poor Little Bitch Girl has it all. Denver Jones is a hotshot twenty-something attorney working in L.A. Carolyn Henderson is personal assistant to a powerful and very married Senator in Washington with whom she is having an affair. And Annabelle Maestro—daughter of two movie stars—has carved out a career for herself in New York as the madame of choice for discerning famous men. The three of them went to high school together in Beverly Hills—and although Denver and Carolyn have kept in touch, Annabelle is out on her own with her cocaine addicted boyfriend, Frankie. Then there is Bobby Santangelo Stanislopolous, the Kennedyesque son of Lucky Santangelo and deceased Greek shipping billionaire, Dimitri Stanislopolous. Bobby owns Mood, the hottest club in New York. Back in the day he went to high school with Denver, Carolyn and Annabelle. And he connected with all three of them. Frankie is his best friend. When Annabelle’s beautiful movie star mother is found shot to death in the bedroom of her Beverly Hills mansion, the five of them find themselves thrown together . . . and secrets from the past have a way of coming back to haunt everyone. . . . A new, sexy, and explosive novel from perennial bestseller Jackie Collins.

Biotechnology and International Law

Author: Francesco Francioni,Tullio Scovazzi

Publisher: Bloomsbury Publishing

ISBN: 1847312691

Category: Law

Page: 486

View: 2696

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.

Law and Biotechnology

Cases and Materials

Author: Victoria Sutton

Publisher: N.A


Category: Law

Page: 480

View: 9334

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.

The Law and Strategy of Biotechnology Patents

Biotechnology Series

Author: Kenneth D. Sibley

Publisher: Butterworth-Heinemann

ISBN: 1483161935

Category: Law

Page: 282

View: 1642

The Law and Strategy of Biotechnology Patents is a compendium of articles that sets to address and unravel the complexities of the laws and issues that apply to biotechnology inventions. The purpose of the book is to explain patent law, with special emphasis on the central role of patent claims, statutory subject matter, novelty, non-obviousness, disclosure considerations, and operation of the judicial system in relation to patents. The text also unveils the extent to which biotechnology merges established law with new requirements. Lawyers, inventors, researchers, technology development and transfer agents, venture capitalists, investment bankers, entrepreneurs, and researchers will find this book an important source of information and knowledge.

Legal Issues in Biotechnology and Human Reproduction

Artificial Conception and Modern Genetics

Author: Warren Freedman

Publisher: Greenwood Publishing Group

ISBN: 0899306357

Category: Business & Economics

Page: 229

View: 5714

Freedman provides a comprehensive examination of the legal, ethical, and moral dilemmas posed by recent advances in biological engineering and human reproduction. His wide-ranging analysis includes discussion of the rights of fetuses, donors, and adoptive parents; the liability of physicians; patentable organisms and other new developments in research; and a review of existing statutes, policies, and contracts that attempt to deal with these issues both here and abroad. In addition the author explores possible legal and policy remedies that may help to establish the rights and responsibilities of individuals, families, and the greater society in the face of these new developments.

Biotechnology and Intellectual Property Rights

Legal and Social Implications

Author: Kshitij Kumar Singh

Publisher: Springer

ISBN: 8132220595

Category: Law

Page: 254

View: 6257

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.

Law, Religion, and Health in the United States

Author: Holly Fernandez Lynch,I. Glenn Cohen,Elizabeth Sepper

Publisher: Cambridge University Press

ISBN: 1107164885

Category: Law

Page: 470

View: 7588

While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else - patient or physician, secular or devout - interested in how US law interacts with health care and religion.

Routledge Handbook of Biodiversity and the Law

Author: Charles R. McManis,Burton Ong

Publisher: Routledge

ISBN: 131553083X

Category: Law

Page: 422

View: 4919

This volume provides a reference textbook and comprehensive compilation of multifaceted perspectives on the legal issues arising from the conservation and exploitation of non-human biological resources. Contributors include leading academics, policy-makers and practitioners reviewing a range of socio-legal issues concerning the relationships between humankind and the natural world. The Routledge Handbook of Biodiversity and the Law includes chapters on fundamental and cutting-edge issues, including discussion of major legal instruments such as the Convention on Biological Diversity and the Nagoya Protocol. The book is divided into six distinct parts based around the major objectives which have emerged from legal frameworks concerned with protecting biodiversity. Following introductory chapters, Part II examines issues relating to conservation and sustainable use of biodiversity, with Part III focusing on access and benefit-sharing. Part IV discusses legal issues associated with the protection of traditional knowledge, cultural heritage and indigenous human rights. Parts V and VI focus on a selection of intellectual property issues connected to the commercial exploitation of biological resources, and analyse ethical issues, including viewpoints from economic, ethnobotanical, pharmaceutical and other scientific industry perspectives.

Problems of Conception

Issues of Law, Biotechnology, Individuals and Kinship

Author: Marit Melhuus

Publisher: Berghahn Books

ISBN: 0857455036

Category: Social Science

Page: 186

View: 9968

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.

Intellectual Property and Biotechnology

Biological Inventions

Author: Matthew Rimmer

Publisher: Edward Elgar Publishing

ISBN: 1848440189

Category: Law

Page: 392

View: 2855

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.

Clinical Research and the Law

Author: Patricia M. Tereskerz

Publisher: John Wiley & Sons

ISBN: 1118272161

Category: Medical

Page: 280

View: 7011

This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasses legal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for Institutional Review Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfalls encountered in medical research.


Law, Business, and Regulation

Author: Michael J. Malinowski,Beth E. Arnold

Publisher: Aspen Publishers Online

ISBN: 9780735503090

Category: Law

Page: 994

View: 6504

Biotechnology: Law, Business, and Regulation offers comprehensive analysis on the advancement of a biotech discovery into a commercial product, making it easy for you to identify legal issues as they arise in the R & D and commercialization process; anticipate forthcoming legal and regulatory challenges; and develop an effective strategy for efficient commercialization. Real product and industry examples are used throughout the handbook and pending legislation is discussed and analyzed. This is the first book to pull together all the legal issues associated with the burgeoning biotechnology industry. The author explains and analyzes the current dimensions of biotechnology law, with in-depth attention to: the markets for biotech products -- patent protection -- confidentiality and other intellectual property issues -- government-supported cooperative R & D agreements -- corporate securities issues -- clinical trial agreements, including informed consent, liability, and insurance issues -- FDA regulation and tracks to speed product approval and commercialization -- legal implications of foreign R & D -- public health and policy considerations -- legislation prohibiting discrimination on the basis of genetic information -- and ethical norms of the scientific and medical communities.