Biotechnology Law

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Biotechnology and the Law

Author : Hugh B. Wellons
Publisher : American Bar Association
Page : 1016 pages
File Size : 48,8 Mb
Release : 2007
Category : Biotechnology
ISBN : 1590317610

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Biotechnology and the Law by Hugh B. Wellons Pdf

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

Author : Alan J. Morrison
Publisher : Columbia University Press
Page : 466 pages
File Size : 48,6 Mb
Release : 2020-02-04
Category : Science
ISBN : 9780231550925

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Biotechnology Law by Alan J. Morrison Pdf

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.

Law and Biotechnology

Author : Victoria Sutton
Publisher : Unknown
Page : 512 pages
File Size : 43,7 Mb
Release : 2007
Category : Law
ISBN : STANFORD:36105064170462

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Law and Biotechnology by Victoria Sutton Pdf

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.

Understanding Biotechnology Law

Author : Gale R. Peterson
Publisher : CRC Press
Page : 502 pages
File Size : 43,6 Mb
Release : 1993-05-27
Category : Science
ISBN : 0824789350

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Understanding Biotechnology Law by Gale R. Peterson Pdf

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 Law and Policy

Author : Alessandro Stasi
Publisher : Springer Nature
Page : 155 pages
File Size : 54,5 Mb
Release : 2023-05-20
Category : Law
ISBN : 9789819921355

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Biotechnology Law and Policy by Alessandro Stasi Pdf

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 International Law of Biotechnology

Author : Matthias Herdegen
Publisher : Edward Elgar Publishing
Page : 219 pages
File Size : 48,9 Mb
Release : 2023-01-20
Category : Law
ISBN : 9781035302055

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The International Law of Biotechnology by Matthias Herdegen Pdf

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.

Problems of Conception

Author : Marit Melhuus
Publisher : Berghahn Books
Page : 187 pages
File Size : 54,5 Mb
Release : 2012-08-15
Category : Health & Fitness
ISBN : 9780857455024

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Problems of Conception by Marit Melhuus Pdf

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 and Software Patent Law

Author : Arezzo, E. Ghidini, G.,Gustavo Ghidini
Publisher : Edward Elgar Publishing
Page : 361 pages
File Size : 51,7 Mb
Release : 2011
Category : Law
ISBN : 9780857938039

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Biotechnology and Software Patent Law by Arezzo, E. Ghidini, G.,Gustavo Ghidini Pdf

'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.

Biotechnology Law and Practice

Author : Wen De Keesee
Publisher : wil keesee
Page : 316 pages
File Size : 41,5 Mb
Release : 2021-04-15
Category : Medical
ISBN : 9781736209516

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Biotechnology Law and Practice by Wen De Keesee Pdf

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.

The International Law of Biotechnology

Author : Matthias Herdegen
Publisher : Edward Elgar Publishing
Page : 208 pages
File Size : 52,8 Mb
Release : 2024-06-15
Category : Biotechnology
ISBN : 9781786435965

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The International Law of Biotechnology by Matthias Herdegen Pdf

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.

A Guide to Biotechnology Law and Business

Author : Robert A. Bohrer
Publisher : Unknown
Page : 0 pages
File Size : 43,8 Mb
Release : 2007
Category : Biotechnology
ISBN : 1594600872

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A Guide to Biotechnology Law and Business by Robert A. Bohrer Pdf

This book is a guide to the "big picture" of biotechnology law and business, presenting and analyzing the issues that arise throughout the life cycle of the biotechnology product. The book focuses primarily on the pharmaceutical field, from university research through the development process and into the marketplace. The aim of the book is to provide guidance to the biotechnology legal and business communities by providing a practical and integrated discussion of the many different topics that arise in developing biotechnology products. It is intended to be used by I.P. lawyers, FDA lawyers, business lawyers and biotech executives who want a concise introduction to the most fundamental issues in biotechnology law and business. "Understanding the molecular pathways in disease processes is critical to discovering new drugs. The equally important task is to understand the legal pathways that enable biotechnology commercialization. This book charts the course in a way that greatly improves the odds of success."--Drew Senyei, M.D., Managing Director, Enterprise Partners Venture Capital, La Jolla, CA "Bob Bohrer has provided a thorough and thoughtful guide to the biotech industry. His experience, which is based on years of examining the biotech sector, is shared in this book and provides a comprehensive and organized overview for the scientist, investor, service provider and anyone else associated with the biotech industry. This is a must-read for both the experienced biotech executives and those new to the industry."--Lisa A. Haile, J.D., Ph.D., Partner and Co-Chair, Life Sciences Group, DLA Piper US LLP "Professor Bohrer is well positioned to write this comprehensive volume. He was most likely the first legal academician to definitively determine what biotechnology incorporates, and has never stopped reflecting upon the scientific, legal, and social/ethical issues involved. Not only will person now interested in biotechnology benefit from this book, but future historians will thank him."--Douglas Dale Busch, Former General Counsel of The Salk Institute

Law Relating to Biotechnology

Author : N. S. Sreenivasulu
Publisher : Oxford University Press, USA
Page : 0 pages
File Size : 44,6 Mb
Release : 2016
Category : Law
ISBN : 019946748X

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Law Relating to Biotechnology by N. S. Sreenivasulu Pdf

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.

Biotechnology and International Law

Author : Francesco Francioni,Tullio Scovazzi
Publisher : Bloomsbury Publishing
Page : 486 pages
File Size : 45,8 Mb
Release : 2006-06-15
Category : Law
ISBN : 9781847312693

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Biotechnology and International Law by Francesco Francioni,Tullio Scovazzi Pdf

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 Patent Law

Author : N. S. Sreenivasulu
Publisher : Manupatra
Page : 264 pages
File Size : 43,6 Mb
Release : 2008
Category : Biotechnology
ISBN : 9788189542313

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Biotechnology and Patent Law by N. S. Sreenivasulu Pdf

Handbook on Biotechnology Law, Business, and Policy

Author : Michael J. Malinowski
Publisher : Unknown
Page : 0 pages
File Size : 53,8 Mb
Release : 2016
Category : Biotechnology
ISBN : 163460153X

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Handbook on Biotechnology Law, Business, and Policy by Michael J. Malinowski Pdf

Softbound - New, softbound print book.