Columbia University Press
Biotechnology Law
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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.
Aaron Fellmeth, Dennis S. Karjala Professor of Law, Science, and Technology, Sandra Day O'Connor College of Law:
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.
Jahanara Ali, director of the BioVenture eLab, Joan & Sanford I. Weill Medical College of Cornell University:
Brilliant 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.
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Frontmatter
i -
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CONTENTS
v -
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PREFACE
xiii -
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INTRODUCTION
1 - SECTION I: PATENT LAW
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1. THE PATENT AS A NEGATIVE RIGHT AND THE CLAIM AS ITS BUSINESS END
13 -
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2. CONSTRUING THE PATENT CLAIM
24 -
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3. THE PATENTABLE INVENTION
29 -
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4. THE PATENT DOCUMENT’S ROLE IN SUPPORTING A CLAIMED INVENTION
49 -
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5. THE LONG ROAD TO GETTING A PATENT
57 -
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6. LENGTHENING AND SHORTENING A PATENT’S TERM
70 -
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7. CONTINUING-APPLICATION PRACTICE AND THE MAKING OF A PATENT FAMILY
78 -
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8. THE MURKY WORLD OF INVENTORSHIP
89 -
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9. PATENT INFRINGEMENT AND ITS VARIATIONS
101 -
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10. DEFENSES AND PREEMPTIVE CHALLENGES
116 -
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11. PATENT OPINIONS
129 -
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13. THE INTERPLAY BETWEEN TRADE SECRETS AND PATENTS
151 - SECTION II: REGULATORY LAW
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14. THE INNOVATOR DRUG: FROM DEVELOPMENT TO APPROVAL
163 -
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15. GENERIC DRUGS
180 -
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16. BIOSIMILARS
207 - SECTION III: CONTRACT LAW
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17. THE CONTRACT: AN ENFORCEABLE PROMISE
225 -
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18. BIOTECHNOLOGY AGREEMENTS
242 -
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ACKNOWLEDGMENTS
283 -
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FURTHER READING
285 -
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GLOSSARY OF LEGAL ACRONYMS AND ABBREVIATIONS
295 -
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INDEX
297