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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