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.
Table of Content
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
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.
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