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The Resource Biotechnology law : a primer for scientists, Alan J. Morrison

Biotechnology law : a primer for scientists, Alan J. Morrison

Creator
Author
Summary
"The biotechnology industry and the law are inextricable. Patent, regulatory, and contract law profoundly shape this industry, and each of these practice areas is deeply intertwined with the science it governs. Yet many in the biotech 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 startup founders, regulatory specialists, patent liaisons, investors, academics, students, and other non-attorneys 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. Biotechnology Law is a clear, concise, and entirely practical primer on the topic, replete with straightforward, real-world examples to illustrate each key concept. The author's expert treatment embraces the new reality that 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 is a lecturer in the Department of Biological Sciences at Columbia University. He practices biotechnology law in New York City"--
Language
eng
Work
Publication
Extent
1 online resource
Contents
  • Intro -- Table of Contents -- Preface -- Introduction -- Section I: Patent Law -- 1. The Patent as a Negative Right and the Claim as Its Business End -- 2. Construing the Patent Claim -- 3. The Patentable Invention -- 4. The Patent Document's Role in Supporting a Claimed Invention -- 5. The Long Road to Getting a Patent -- 6. Lengthening and Shortening a Patent's Term -- 7. Continuing-Application Practice and the Making of a Patent Family -- 8. The Murky World of Inventorship -- 9. Patent Infringement and Its Variations -- 10. Defenses and Preemptive Challenges -- 11. Patent Opinions
  • 12. The Patent Portfolio -- 13. The Interplay Between Trade Secrets and Patents -- Section II: Regulatory Law -- 14. The Innovator Drug: From Development to Approval -- 14. The Innovator Drug: From Development to Approval -- 15. Generic Drugs -- 16. Biosimilars -- Section III: Contract Law -- 17. The Contract: An Enforceable Promise -- 18. Biotechnology Agreements -- Acknowledgments -- Further Reading -- Glossary of Legal Acronyms and Abbreviations -- Index
Isbn
9780231550925
Instance
Label
Biotechnology law : a primer for scientists
Title
Biotechnology law
Title remainder
a primer for scientists
Statement of responsibility
Alan J. Morrison
Creator
Author
Subject
Genre
Language
eng
Summary
"The biotechnology industry and the law are inextricable. Patent, regulatory, and contract law profoundly shape this industry, and each of these practice areas is deeply intertwined with the science it governs. Yet many in the biotech 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 startup founders, regulatory specialists, patent liaisons, investors, academics, students, and other non-attorneys 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. Biotechnology Law is a clear, concise, and entirely practical primer on the topic, replete with straightforward, real-world examples to illustrate each key concept. The author's expert treatment embraces the new reality that 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 is a lecturer in the Department of Biological Sciences at Columbia University. He practices biotechnology law in New York City"--
Assigning source
Provided by publisher
Cataloging source
DLC
http://library.link/vocab/creatorName
Morrison, Alan J
Dewey number
343.7307/86606
Index
index present
LC call number
KF1893.B56
LC item number
M67 2019
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
http://library.link/vocab/subjectName
  • Biotechnology industries
  • Biotechnology
  • Biotechnology industries
  • Biotechnology
  • SCIENCE / Biotechnology
  • Biotechnology industries
  • Biotechnology
  • United States
Label
Biotechnology law : a primer for scientists, Alan J. Morrison
Instantiates
Publication
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
  • nc
Carrier MARC source
rdacarrier
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Contents
  • Intro -- Table of Contents -- Preface -- Introduction -- Section I: Patent Law -- 1. The Patent as a Negative Right and the Claim as Its Business End -- 2. Construing the Patent Claim -- 3. The Patentable Invention -- 4. The Patent Document's Role in Supporting a Claimed Invention -- 5. The Long Road to Getting a Patent -- 6. Lengthening and Shortening a Patent's Term -- 7. Continuing-Application Practice and the Making of a Patent Family -- 8. The Murky World of Inventorship -- 9. Patent Infringement and Its Variations -- 10. Defenses and Preemptive Challenges -- 11. Patent Opinions
  • 12. The Patent Portfolio -- 13. The Interplay Between Trade Secrets and Patents -- Section II: Regulatory Law -- 14. The Innovator Drug: From Development to Approval -- 14. The Innovator Drug: From Development to Approval -- 15. Generic Drugs -- 16. Biosimilars -- Section III: Contract Law -- 17. The Contract: An Enforceable Promise -- 18. Biotechnology Agreements -- Acknowledgments -- Further Reading -- Glossary of Legal Acronyms and Abbreviations -- Index
Control code
1104854344
Extent
1 online resource
Form of item
online
Isbn
9780231550925
Lccn
2019023644
Media category
computer
Media MARC source
rdamedia
Media type code
  • n
http://library.link/vocab/ext/overdrive/overdriveId
22573/ctvspdn9k
Specific material designation
remote
System control number
(OCoLC)1104854344
Label
Biotechnology law : a primer for scientists, Alan J. Morrison
Publication
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
  • nc
Carrier MARC source
rdacarrier
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Contents
  • Intro -- Table of Contents -- Preface -- Introduction -- Section I: Patent Law -- 1. The Patent as a Negative Right and the Claim as Its Business End -- 2. Construing the Patent Claim -- 3. The Patentable Invention -- 4. The Patent Document's Role in Supporting a Claimed Invention -- 5. The Long Road to Getting a Patent -- 6. Lengthening and Shortening a Patent's Term -- 7. Continuing-Application Practice and the Making of a Patent Family -- 8. The Murky World of Inventorship -- 9. Patent Infringement and Its Variations -- 10. Defenses and Preemptive Challenges -- 11. Patent Opinions
  • 12. The Patent Portfolio -- 13. The Interplay Between Trade Secrets and Patents -- Section II: Regulatory Law -- 14. The Innovator Drug: From Development to Approval -- 14. The Innovator Drug: From Development to Approval -- 15. Generic Drugs -- 16. Biosimilars -- Section III: Contract Law -- 17. The Contract: An Enforceable Promise -- 18. Biotechnology Agreements -- Acknowledgments -- Further Reading -- Glossary of Legal Acronyms and Abbreviations -- Index
Control code
1104854344
Extent
1 online resource
Form of item
online
Isbn
9780231550925
Lccn
2019023644
Media category
computer
Media MARC source
rdamedia
Media type code
  • n
http://library.link/vocab/ext/overdrive/overdriveId
22573/ctvspdn9k
Specific material designation
remote
System control number
(OCoLC)1104854344

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