Description
Book SynopsisThis book is an essential introduction to biotechnology law for scientists and other nonattorneys with biotech backgrounds.
Biotechnology Law is a clear, concise, and entirely practical primer on the topic, replete with straightforward, real-world examples to illustrate each key concept.
Trade ReviewBrilliant inventors often create incredible products but struggle at the complex legal processes involved. In this 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 also to avoid making common costly mistakes. -- Jahanara Ali, director of the BioVenture eLab, Joan & Sanford I. Weill Medical College of Cornell University
This is an up-to-date, well-organized volume on biotechnology law suitable for scientific and business audiences. Alan J. Morrison walks biotechnology scientists through the legal issues they will confront during the natural process of planning, researching, developing, testing, and protecting their inventions. -- Aaron Fellmeth, Dennis S. Karjala Professor of Law, Science, and Technology, Sandra Day O'Connor College of Law
This book provides an approachable overview of three complicated areas of law that are relevant to biotechnology: patent law, regulatory approval for drugs and biologics, and contract law. Aimed at scientists unfamiliar with the law and at others in the biotechnology industry, this book makes legal matters more accessible by using helpful examples and by covering the main points of the law without getting too bogged down in the details. -- W. Nicholson Price II, University of Michigan Law School
Table of ContentsPreface
Introduction
Section I: Patent Law1. 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 Law14. The Innovator Drug: From Development to Approval
15. Generic Drugs
16. Biosimilars
Section III: Contract Law17. The Contract: An Enforceable Promise
18. Biotechnology Agreements
Acknowledgments
Further Reading
Glossary of Legal Acronyms and Abbreviations
Index
