ENGLISH

Biotechnology Law: A Primer for Scientists

Book information

Publisher
Columbia University Press
Year
2020
ISBN
0231179383, 9780231179386
Language
english
Format
EPUB
Filesize
1 MB (1162702 bytes)
Pages
328\0
Time added
2020-04-22 08:08:10

Description

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.

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