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Biotechnology law = a primer for scientists /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Biotechnology law/ Alan J. Morrison.
其他題名:	a primer for scientists /
作者:	Morrison, Alan.
出版者:	New York, NY :Columbia University Press, : c2020.,
面頁冊數:	1 online resource.
標題:	Biotechnology industries - Law and legislation - United States. -
電子資源:	http://www.degruyter.com/isbn/9780231550925
ISBN:	9780231550925

Biotechnology law = a primer for scientists /
Morrison, Alan.

Biotechnology lawa primer for scientists /[electronic resource] :Alan J. Morrison. - 1st ed. - New York, NY :Columbia University Press,c2020. - 1 online resource.

Includes bibliographical references and index.

Frontmatter --

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.

In English.

ISBN: 9780231550925

Standard No.: 10.7312/morr17938doi

LCCN: 2019023643Subjects--Topical Terms:

1406121
Biotechnology industries
--Law and legislation--United States.

LC Class. No.: KF1893.B56 / M67 2020

Dewey Class. No.: 343.730786606

Biotechnology law = a primer for scientists /
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300 $a 1 online resource.
504 $a Includes bibliographical references and index.
505 0 0 $t Frontmatter -- $t CONTENTS -- $t PREFACE -- $t INTRODUCTION -- $t SECTION I: PATENT LAW -- $t 1. THE PATENT AS A NEGATIVE RIGHT AND THE CLAIM AS ITS BUSINESS END -- $t 2. CONSTRUING THE PATENT CLAIM -- $t 3. THE PATENTABLE INVENTION -- $t 4. THE PATENT DOCUMENT'S ROLE IN SUPPORTING A CLAIMED INVENTION -- $t 5. THE LONG ROAD TO GETTING A PATENT -- $t 6. LENGTHENING AND SHORTENING A PATENT'S TERM -- $t 7. CONTINUING-APPLICATION PRACTICE AND THE MAKING OF A PATENT FAMILY -- $t 8. THE MURKY WORLD OF INVENTORSHIP -- $t 9. PATENT INFRINGEMENT AND ITS VARIATIONS -- $t 10. DEFENSES AND PREEMPTIVE CHALLENGES -- $t 11. PATENT OPINIONS -- $t 13. THE INTERPLAY BETWEEN TRADE SECRETS AND PATENTS -- $t SECTION II: REGULATORY LAW -- $t 14. THE INNOVATOR DRUG: FROM DEVELOPMENT TO APPROVAL -- $t 15. GENERIC DRUGS -- $t 16. BIOSIMILARS -- $t SECTION III: CONTRACT LAW -- $t 17. THE CONTRACT: AN ENFORCEABLE PROMISE -- $t 18. BIOTECHNOLOGY AGREEMENTS -- $t ACKNOWLEDGMENTS -- $t FURTHER READING -- $t GLOSSARY OF LEGAL ACRONYMS AND ABBREVIATIONS -- $t INDEX.
520 $a 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.
546 $a In English.
588 0 $a Description based on online resource; title from PDF title page (publisher's Web site, viewed 02. Mrz 2022)
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