Biotechnology law : a primer for scientists

著者

書誌事項

Biotechnology law : a primer for scientists

Alan J. Morrison

Columbia University Press, c2020

  • : cloth

大学図書館所蔵 件 / 全2件

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注記

Includes bibliographical references and index

内容説明・目次

内容説明

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.

目次

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

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