Biotechnology Law: A Primer for Scientists

Author:   Alan Morrison
Publisher:   Columbia University Press
ISBN:  

9780231179386


Pages:   328
Publication Date:   04 February 2020
Format:   Hardback
Availability:   Out of stock   Availability explained
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Biotechnology Law: A Primer for Scientists


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Overview

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.

Full Product Details

Author:   Alan Morrison
Publisher:   Columbia University Press
Imprint:   Columbia University Press
ISBN:  

9780231179386


ISBN 10:   0231179383
Pages:   328
Publication Date:   04 February 2020
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   Out of stock   Availability explained
The supplier is temporarily out of stock of this item. It will be ordered for you on backorder and shipped when it becomes available.

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 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

Reviews

Brilliant inventors often create incredible products but struggle at the complex legal processes involved. In his educational read, patent lawyer Alan Morrison takes the reader through three main legal concepts encountered by every inventor: patent law, regulatory law, and contract law. The clear and succinct way Morrison describes these legal processes makes his book essential for every inventor, biotech company, and technology commercialization office, not only to understand the process, but to avoid making common costly mistakes. -- Jahanara Ali, director of the BioVenture eLab, Joan & Sanford I. Weill Medical College of Cornell University


Brilliant inventors often create incredible products but struggle at the complex legal processes involved. In this educational read, patent lawyer Alan Morrison takes the reader through three main legal concepts encountered by every inventor: patent law, regulatory law, and contract law. The clear and succinct way Morrison describes these legal processes makes his book essential for every inventor, biotech company, and technology commercialization office, not only to understand the process but also to avoid making common costly mistakes. -- Jahanara Ali, director of the BioVenture eLab, Joan & Sanford I. Weill Medical College of Cornell University This is an up-to-date, well-organized volume on biotechnology law suitable for scientific and business audiences. Alan J. Morrison walks biotechnology scientists through the legal issues they will confront during the natural process of planning, researching, developing, testing, and protecting their inventions. -- Aaron Fellmeth, Dennis S. Karjala Professor of Law, Science, and Technology, Sandra Day O'Connor College of Law This book provides an approachable overview of three complicated areas of law that are relevant to biotechnology: patent law, regulatory approval for drugs and biologics, and contract law. Aimed at scientists unfamiliar with the law and at others in the biotechnology industry, this book makes legal matters more accessible by using helpful examples and by covering the main points of the law without getting too bogged down in the details. -- W. Nicholson Price II, University of Michigan Law School


This book provides an approachable overview of three complicated areas of law that are relevant to biotechnology: patent law, regulatory approval for drugs and biologics, and contract law. Aimed at scientists unfamiliar with the law and at others in the biotechnology industry, this book makes legal matters more accessible by using helpful examples and by covering the main points of the law without getting too bogged down in the details. -- W. Nicholson Price II, University of Michigan Law School This is an up-to-date, well-organized volume on biotechnology law suitable for scientific and business audiences. Alan J. Morrison walks biotechnology scientists through the legal issues they will confront during the natural process of planning, researching, developing, testing, and protecting their inventions. -- Aaron Fellmeth, Dennis S. Karjala Professor of Law, Science, and Technology, Sandra Day O'Connor College of Law Brilliant inventors often create incredible products but struggle at the complex legal processes involved. In this educational read, patent lawyer Alan Morrison takes the reader through three main legal concepts encountered by every inventor: patent law, regulatory law, and contract law. The clear and succinct way Morrison describes these legal processes makes his book essential for every inventor, biotech company, and technology commercialization office, not only to understand the process but also to avoid making common costly mistakes. -- Jahanara Ali, director of the BioVenture eLab, Joan & Sanford I. Weill Medical College of Cornell University


Author Information

Alan J. Morrison is a lecturer in the Department of Biological Sciences at Columbia University. He practices biotechnology law in New York City.

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