Law and Biotechnology
Cases and Materials
Victoria Sutton .
ROBERT
H.
BEAN PROFESSOR OF LAW
TEXAS TECH UNIVERSITY
SCHOOL OF LAW
CAROLINA ACADEMIC PRESS
Durham, North Carolina
Contents
Table of Cases
Foreword
Preface
About the Author
Acknowledgments
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Chapter One Introduction
1.1 The Relationship between Law and Biotechnology
1.1.1 Defining Biotechnology
1.1.1.1 Monoclonal Antibody Technology
1.1.1.2 Cell Culture Technology
1.1.1.3 Genetic Engineering Technology
1.1.1.4 Biosensor Technology
1.1.1.5 Antisense Technology
1.1.1.6 DNA Chip Technology
1.1.1.7 Tissue Engineering
1.1.1.8 Bioprocessing Technology
1.1.1.9 Bioinformatics
1.1.2 Defining Bioengineering
1.1.3 Defining Genomics
1.1.4 Defining Proteomics
1.1.5 Defining Nanobiotechnology
1.2 The History of Biotechnology and Law in Eurasia and the Americas
1.3 Introduction to the Scientific Method and Biotechnology
1.4 Biotechnology-What New Questions Have Been Raised?
Diamond v. Chakrabarty
Notes
Pioneer Hi-Bred International, Inc. v. f.E.M. Ag Supply
Notes
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Chapter Two Federalism: Distributions of Power to Regulate Biotechnology
2.1 Federal Government
2.1.1 Executive Branch
2.1.1.1 Regulation of Biotechnology
2.1.1.1.1 Early Developments in Modern
Biotechnology Regulation
2.1.1.1.2 Federal Regulations- What Is Regulated?
2.1.2 Patents for Biotechnology
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CONTENTS
2.1.3
Food and Drug Administration and the Environmental
Protection Agency: Genetically Engineered Foods
2.1.3.1 History of Law and Food Regulation
2.1.3.2 The Controversy over Genetically Engineered Foods
Stauber v. Shalala and Kessler
Alliance for Bio-Integrity v. Shalala
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2.1.4
2.1.5
2.1.3.3 The Regulation of Genetically Engineered Foods
2.1.3.4 Constitutional First Amendment Limitations
in State Labeling Regulations
International Dairy Foods Association v. Amestoy,
Attorney General of the State of Vermont
Notes
U.S. Environmental Protection Agency and Department of
Agriculture: Genetically Engineered Plants
Foundation on Economic Trends v. Thomas
Foundation on Economic Trends v. Lyng
Notes
U.S. Environmental Protection Agency, National Institutes of
Health: Genetically Modified Organisms
Foundation on Economic Trends v. Heckler
Foundation on Economic Trends v. Block
Foundation on Economic Trends v. Bowen
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2.1.6
2.2
2.3
U.S. Department of Agriculture and BioPharming
Center for Food Safety v. Veneman
Center for Food Safety v. Johanns
Legislative Branch
2.2.1 Legislation and Problems with Biotechnology
Notes
2.2.2 Genetic Preservation
2.2.3 Cloning Prohibition
State Governments and Biotechnology Regulation
2.3.1 Biotechnology and State Support
2.3.2 State Codes
Chapter Three Private Sector Profits and Biotechnology
3.1 Introduction
3.2 Biotechnology Issues in Fraud
3.2.1 Securities Fraud
In Re Ribozyme Pharmaceuticals, Inc. Securities Litigation
Notes
3.2.2 Contract Fraud
Rhone-Poulenc Agro S.A. v. Monsanto Company and
Dekalb Genetics Corp.
3.3 Intellectual Property Protection Issues
3.3.1 Trade Secrets as an Approach to Protecting Corporate
Knowledge
Microbix Biosystems, Inc. v. Biowhittaker, Inc.
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CONTENTS
3.4
3.5
3.6
North Carolina Farm Partnership v.
Pig Improvement Company, Inc.
3.3.2 Patenting as an Approach to Protecting Corporate
Knowledge in Corporate Competitive Research
Scripps Clinic and Research Foundation v. Genentech, Inc.
Bioprospecting-Private Sector Agreements with the Government
Edmonds Institute v. Babbitt, Secretary of Interior
Patents in Biotechnology
3.5.1 Biotechnology Patents Applications Requirements
3.5.1.1 The Utility Requirement
3.5.1.2 The Written Description Requirement. 35 U.S.c. § 112
3.5.1.3 The Enabling Requirement. 35 U.s.c. § 112
In Re Thomas Deuel
Amgen, Inc. v. Hoechst
3.5.2 Unique Problems in Patenting Biotechnology
Monsanto Canada, Inc. v. Schmeiser
Schmeiser v. Monsanto Canada Inc.
New Professions and Legal Issues
3.6.1 Bioengineers
3.6.2 Genetic Counselors
Notes
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Chapter Four
4.1
4.2
4.3
Human Health, Medical Care, Medical Information
Disclosure in Biotechnology
Disclosure of Medical Information and Privacy
4.1.1 Right to Privacy
4.1.2 Limited Right to Privacy
4.1.2.1 Limited Right to Privacy in the Military
Mayfield v. Dalton
4.1.2.2 Adoption Right to Know
In the Matter of Sandra L. G. v. Bouchey
4.1.3 Use of Genetic Information
Informed Consent, High Risk Treatments and Research
Notes
Insurance and Predisposition to Disease
Katskee v. Blue Cross/Blue Shield ofNebraska
Notes
Vll
Chapter Five International Law and Biotechnology
5.1 International Environment and Biotechnology Issues
5.2 Introduction to Biodiversity and the Convention on
Biological Diversity (CBD)
5.2.1 The Convention on Biological Diversity
5.2.1.1 History and Background of the Convention on
Biological Diversity (CBD)
5.2.1.2 Structure of the Convention on Biological Diversity
5.2.1.2.1 Article 8(j)
5.2.1.2.2 Article 15. Access to Genetic Resources
5.3 Bioprospecting and International Biopiracy
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5.3.1
5.4
5.5
5.6
5.7
5.8
5.9
International Approaches to Bioprosecting
5.3.1.1 Convention on Biological Diversity
5.3.1.2 FAO International Treaty on Plant Genetic
Resources for Food and Agriculture
5.3.1.3 WTO Agreement on Trade-Related Aspects of
Intellectual Property Rights
5.3.1.4 International Convention for the Protection of
New Varieties of Plants
5.3.1.5 Convention on International Trade in Endangered
Species of Wild Fauna and Flora
5.3.1.6 The Antarctic Treaty
5.3.1.7 Universal Declaration of Human Rights
5.3.1.8 International Covenant on Economic, Social and
Cultural Rights
5.3.2 Regional Agreements
International Codes of Conduct for Bioprospecting
5.4.1 The Micro-Organisms Sustainable Use and Access
Regulation International Code of Conduct (MOSAICC)
5.4.2 Bonn Guidelines on Access to Genetic Resources and
Fair and Equitable Sharing of the Benefits Arising
Out of Their Utilization
International Intellectual Property and Biotechnology
5.5.1 Patent Protection in the United States
5.5.2 Patent Protection in Other Countries
5.5.3 International Patenting
International Trade and Biotechnology
5.6.1 Exporting Biotechnologies
5.6.2 The Cartegena Biosafety Protocol
International Security
International Human Rights and Biotechnology
5.8.1 United Nations Treaty on Indigenous Peoples and
Human Rights
Human DNA
Chapter Six Bioethics, Religion and Biotechnology
6.1 Law, Biotechnology and Religion: Humans' Relationship with
Biotechnology and Religion
6.1.1 Free Exercise Clause Challenge to Biotechnology
Alliance for Bio-Integrity v. Shalala
Notes
6.1.2 Religious Views on Biotechnology
6.1.2.1 Stem Cell Research and Religion
6.1.2.2 Cloning and Religion
6.2 Ethics and Biotechnology
6.2.1 Public Sector Considers Ethics and Biotechnology
6.2.2 The Private Sector Considers Ethics and Biotechnology
6.3 Family Relations: Legal v. Biological
Stitham v. Henderson
6.4 Reproductive Technologies
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CONTENTS
6.5
6.6
6.7
6.8
Margaret S. v. Edwards
Lifchez v. Hartigan
Notes
6.4.1 Post Mortem Sperm Collection
6.4.2 Ectogenesis
Eugenics
Stem Cell Research
6.6.1 The Controversy with Stem Cell Research
6.6.2 What Are These Embryonic Stem Cells?
6.6.3 Sources of Embryonic Stem Cells
6.6.4 State Regulation of Stem Cell Research
Notes
Cloning
The Ethics of Contamination of Indigenous Crops with
Genetically Modified Crops
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Chapter Seven Criminal Law and Biotechnology
7.1 Existing Federal Crimes Applicable to New Problems in
Biotechnology
7.1.1 Mail Fraud
United States v. Greene
7.1.2 The Great Train Robbery in Biotechnology
7.2 The Use of DNA in Criminal Law
Spencer v. Murray
7.3 New Federal Statutes for New Problems in Biotechnology
United States v. Wise
United States v. Slaughter
Notes
7.4 Biotechnology and the Changing Concept of "Expectation of Privacy"
Illinois v. Wealer
People v. King
Notes
7.5 Human Behavioral Genetics and Criminal Predisposition
Buck v. Bell
New York v. Weinstein
Notes
7.6 Criminal Law Attorneys and Obligation to Understand Science
7.6.1 The Genetics Defense
7.6.2 Ineffective Assistance of Counsel
Mobley v. Head
Ohio v. Lane
7.7 Biopiracy
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Chapter Eight Scientific Evidence and Biotechnology
8.1 Introduction
8.2 The Legal Foundation of Scientific Evidence
Frye v. United States
Daubert v. Merrell Dow Pharmaceuticals, Inc.
General Electric Company v. Joiner
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CONTENTS
Kumho Tire Company v. Carmichael
8.3
Mitochondrial DNA
8.4
Historical Forensics and the Use of DNA Evidence
8.4.1 Thomas Jefferson and Sally Hemings
8.4.2 Abraham Lincoln and Marfan Syndrome?
Notes
United States v. Beverly
Chapter Nine Biotechnology and Property Law
9.1 Introduction
9.2 Ownership Problems
Moore v. Regents of University of California
Miles, Inc. v. Scripps Clinic and Research Foundation
9.3
Special Property Protection Problems of Biotechnology:
Patent Ownership Problems
In Re Thomas Deuel
Animal Legal Defense Fund v. Quigg
9.4
9.5
9.6
Ownership of Human Organs
Ownership of Human Fertilized Eggs
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Kass v. Kass
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Umbilical Cord Blood Banks
Notes
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Chapter Ten Biotechnology and Tort Law
10.1 Intentional Torts
Moore v. Regents of University of California
In Re Starlink Corn Products Liability Litigation
10.2 Unintentional Torts
10.2.1 Wrongful BirthfWrongful Life: Medical Malpractice
Shroeder v. Perkel
Reed v. Campagnolo
10.2.2 Products Liability
In Re Starlink Corn Products Liability Litigation
10.2.3 Strict Liability Legislation
Chapter Eleven
Appendix 1
Appendix 2
Appendix 3
Appendix 4
Index
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The Future of Biotechnology and Law
Primer on Cell Biology
Primer on Molecular Biology
Primer on DNA
Glossary
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