Biotechnology law : a primer for scientists / Alan J. Morrison

By:

Morrison, Alan J [VerfasserIn]

Resource type: Ressourcentyp: Buch (Online)Book (Online)Language: English Publisher: New York, NY : Columbia University Press, [2020]Copyright date: © 2020Description: 1 Online-Ressource (XIV, 308 Seiten)ISBN:

9780231550925

Subject(s):

Additional physical formats: 9780231179386 | Erscheint auch als: Biotechnology law. Druck-Ausgabe New York : Columbia University Press, 2020. XIV, 308 pagesDDC classification:

343.730786606

LOC classification:

KF1893.B56

DOI: DOI: 10.7312/morr17938Online resources:

Zugang im Netz des KIT

Summary: 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 realitySummary: Frontmatter -- CONTENTS -- PREFACE -- INTRODUCTION -- 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 -- 13. THE INTERPLAY BETWEEN TRADE SECRETS AND PATENTS -- 14. THE INNOVATOR DRUG: FROM DEVELOPMENT TO APPROVAL -- 15. GENERIC DRUGS -- 16. BIOSIMILARS -- 17. THE CONTRACT: AN ENFORCEABLE PROMISE -- 18. BIOTECHNOLOGY AGREEMENTS -- ACKNOWLEDGMENTS -- FURTHER READING -- GLOSSARY OF LEGAL ACRONYMS AND ABBREVIATIONS -- INDEXPPN: PPN: 1696104343Package identifier: Produktsigel: EBA-EBKALL | EBA-EEBKALL | EBA-ESTMALL | EBA-PPALL | EBA-STMALL | GBV-deGruyter-alles | ZDB-23-DGG | ZDB-23-DPM | EBA-BACKALL | EBA-EBACKALL

Holdings ( 0 )
Title notes ( 5 )

No physical items for this record

restricted access:

http://purl.org/coar/access_right/c_16ec

[Online-Ausgabe]

Mode of access: Internet via World Wide Web.

In English