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Biotechnology Law

Author: Alan J. Morrison

Publisher: Columbia University Press

Published: 2020-02-04

Total Pages: 466

ISBN-13: 0231550928

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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.

Book Synopsis Biotechnology Law by : Alan J. Morrison

Download or read book Biotechnology Law written by Alan J. Morrison and published by Columbia University Press. This book was released on 2020-02-04 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 and the Law

Author: Hugh B. Wellons

Publisher: American Bar Association

Published: 2007

Total Pages: 1016

ISBN-13: 9781590317617

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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.

Book Synopsis Biotechnology and the Law by : Hugh B. Wellons

Download or read book Biotechnology and the Law written by Hugh B. Wellons and published by American Bar Association. This book was released on 2007 with total page 1016 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Problems of Conception

Author: Marit Melhuus

Publisher: Berghahn Books

Published: 2012-08-15

Total Pages: 187

ISBN-13: 0857455028

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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.

Book Synopsis Problems of Conception by : Marit Melhuus

Download or read book Problems of Conception written by Marit Melhuus and published by Berghahn Books. This book was released on 2012-08-15 with total page 187 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The International Law of Biotechnology

Author: Matthias Herdegen

Publisher: Edward Elgar Publishing

Published: 2023-01-20

Total Pages: 219

ISBN-13: 1035302055

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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.

Book Synopsis The International Law of Biotechnology by : Matthias Herdegen

Download or read book The International Law of Biotechnology written by Matthias Herdegen and published by Edward Elgar Publishing. This book was released on 2023-01-20 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Handbook on Biotechnology Law, Business, and Policy

Author: Michael J. Malinowski

Publisher:

Published: 2016

Total Pages: 0

ISBN-13: 9781634601535

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Softbound - New, softbound print book.

Book Synopsis Handbook on Biotechnology Law, Business, and Policy by : Michael J. Malinowski

Download or read book Handbook on Biotechnology Law, Business, and Policy written by Michael J. Malinowski and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Softbound - New, softbound print book.

Biotechnology and Patent Law

Author: N. S. Sreenivasulu

Publisher: Manupatra

Published: 2008

Total Pages: 264

ISBN-13: 8189542311

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Book Synopsis Biotechnology and Patent Law by : N. S. Sreenivasulu

Download or read book Biotechnology and Patent Law written by N. S. Sreenivasulu and published by Manupatra. This book was released on 2008 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Law Relating to Biotechnology

Author: N. S. Sreenivasulu

Publisher: Oxford University Press, USA

Published: 2016

Total Pages: 0

ISBN-13: 9780199467488

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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.

Book Synopsis Law Relating to Biotechnology by : N. S. Sreenivasulu

Download or read book Law Relating to Biotechnology written by N. S. Sreenivasulu and published by Oxford University Press, USA. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmaceutical and Biotech Patent Law

Author: Arnold & Porter Kaye Scholer Llp

Publisher:

Published: 2019-06-07

Total Pages: 1204

ISBN-13: 9781402431388

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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.

Book Synopsis Pharmaceutical and Biotech Patent Law by : Arnold & Porter Kaye Scholer Llp

Download or read book Pharmaceutical and Biotech Patent Law written by Arnold & Porter Kaye Scholer Llp and published by . This book was released on 2019-06-07 with total page 1204 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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, Bioethics and the Law

Author: Michele Goodwin

Publisher:

Published: 2015

Total Pages: 0

ISBN-13: 9780820559858

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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?

Book Synopsis Biotechnology, Bioethics and the Law by : Michele Goodwin

Download or read book Biotechnology, Bioethics and the Law written by Michele Goodwin and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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?

Patent Pools, Competition Law and Biotechnology

Author: Devdatta Malshe

Publisher: Routledge

Published: 2018-05-15

Total Pages: 102

ISBN-13: 0429016166

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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.

Book Synopsis Patent Pools, Competition Law and Biotechnology by : Devdatta Malshe

Download or read book Patent Pools, Competition Law and Biotechnology written by Devdatta Malshe and published by Routledge. This book was released on 2018-05-15 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.