Biotechnology Law

A Primer for Scientists

Alan J. Morrison

Columbia University Press

Biotechnology Law

Pub Date: February 2020

ISBN: 9780231179386

304 Pages

Format: Hardcover

List Price: $70.00£54.00

Pub Date: February 2020

ISBN: 9780231550925

304 Pages

Format: E-book

List Price: $69.99£54.00

Biotechnology Law

A Primer for Scientists

Alan J. Morrison

Columbia University Press

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 scientists, 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. 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. Alan J. Morrison’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.
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

About the Author

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