Law and Biotechnology

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Carolina Academic PressLaw Casebook Series

Advisory Board

❦

Gary J. Simson, ChairmanDean, Case Western Reserve University School of Law

Raj BhalaUniversity of Kansas School of Law

John C. Coffee, Jr.Columbia University Law School

Randall CoyneUniversity of Oklahoma College of Law

John S. DzienkowskiUniversity of Texas School of Law

Paul FinkelmanAlbany Law School

Robert M. JarvisShepard Broad Law Center

Nova Southeastern University

Vincent R. JohnsonSt. Mary’s University School of Law

Michael A. OlivasUniversity of Houston Law Center

Kenneth PortWilliam Mitchell College of Law

Michael P. ScharfCase Western Reserve University School of Law

Peter M. ShaneMichael E. Moritz College of Law

The Ohio State University

Emily L. SherwinCornell Law School

John F. Sutton, Jr.Emeritus, University of Texas School of Law

David B. WexlerJohn E. Rogers College of Law

University of Arizona

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Law and Biotechnology

Cases and Materials

Victoria SuttonRobert H. Bean Professor of Law

Texas Tech UniversitySchool of Law

Carolina Academic PressDurham, North Carolina

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Copyright © 2007Victoria SuttonAll Rights Reserved

ISBN 10: 0-89089-191-5, ISBN 13: 978-0-89089-191-9LCCN 2006924478

Carolina Academic Press700 Kent StreetDurham, North Carolina 27701Telephone (919) 489-7486Fax (919) 493-5668www.cap-press.com

Printed in the United States of America

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Contents

Table of Cases xiForeword xiiiPreface xvAbout the Author xviiAcknowledgments xix

Chapter One Introduction 31.1 The Relationship between Law and Biotechnology 3

1.1.1 Defining Biotechnology 41.1.1.1 Monoclonal Antibody Technology 41.1.1.2 Cell Culture Technology 51.1.1.3 Genetic Engineering Technology 51.1.1.4 Biosensor Technology 61.1.1.5 Antisense Technology 61.1.1.6 DNA Chip Technology 61.1.1.7 Tissue Engineering 71.1.1.8 Bioprocessing Technology 71.1.1.9 Bioinformatics 8

1.1.2 Defining Bioengineering 91.1.3 Defining Genomics 91.1.4 Defining Proteomics 101.1.5 Defining Nanobiotechnology 10

1.2 The History of Biotechnology and Law in Eurasia and the Americas 111.3 Introduction to the Scientific Method and Biotechnology 181.4 Biotechnology — What New Questions Have Been Raised? 20

Diamond v. Chakrabarty 20Notes 26Pioneer Hi-Bred International, Inc. v. J.E.M. Ag Supply 27Notes 29

Chapter Two Federalism: Distributions of Power to Regulate Biotechnology 312.1 Federal Government 31

2.1.1 Executive Branch 312.1.1.1 Regulation of Biotechnology 32

2.1.1.1.1 Early Developments in Modern Biotechnology Regulation 32

2.1.1.1.2 Federal Regulations — What Is Regulated? 362.1.2 Patents for Biotechnology 41

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2.1.3 Food and Drug Administration and the Environmental Protection Agency: Genetically Engineered Foods 422.1.3.1 History of Law and Food Regulation 422.1.3.2 The Controversy over Genetically Engineered Foods 47

Stauber v. Shalala and Kessler 48Alliance for Bio-Integrity v. Shalala 59Notes 66

2.1.3.3 The Regulation of Genetically Engineered Foods 672.1.3.4 Constitutional First Amendment Limitations

in State Labeling Regulations 70International Dairy Foods Association v. Amestoy,

Attorney General of the State of Vermont 70Notes 80

2.1.4 U.S. Environmental Protection Agency and Department ofAgriculture: Genetically Engineered Plants 82Foundation on Economic Trends v. Thomas 82Foundation on Economic Trends v. Lyng 86Notes 89

2.1.5 U.S. Environmental Protection Agency, National Institutes ofHealth: Genetically Modified Organisms 90Foundation on Economic Trends v. Heckler 90Foundation on Economic Trends v. Block 99Foundation on Economic Trends v. Bowen 101Notes 106

2.1.6 U.S. Department of Agriculture and BioPharming 106Center for Food Safety v. Veneman 110Center for Food Safety v. Johanns 111

2.2 Legislative Branch 1212.2.1 Legislation and Problems with Biotechnology 121

Notes 1292.2.2 Genetic Preservation 1292.2.3 Cloning Prohibition 130

2.3 State Governments and Biotechnology Regulation 1312.3.1 Biotechnology and State Support 1312.3.2 State Codes 132

Chapter Three Private Sector Profits and Biotechnology 1373.1 Introduction 1373.2 Biotechnology Issues in Fraud 138

3.2.1 Securities Fraud 138In Re Ribozyme Pharmaceuticals, Inc. Securities Litigation 138Notes 143

3.2.2 Contract Fraud 144Rhone-Poulenc Agro S.A. v. Monsanto Company and

Dekalb Genetics Corp. 1443.3 Intellectual Property Protection Issues 149

3.3.1 Trade Secrets as an Approach to Protecting Corporate Knowledge 149Microbix Biosystems, Inc. v. Biowhittaker, Inc. 150

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North Carolina Farm Partnership v.Pig Improvement Company, Inc. 152

3.3.2 Patenting as an Approach to Protecting Corporate Knowledge in Corporate Competitive Research 153Scripps Clinic and Research Foundation v. Genentech, Inc. 154

3.4 Bioprospecting — Private Sector Agreements with the Government 156Edmonds Institute v. Babbitt, Secretary of Interior 156

3.5 Patents in Biotechnology 1643.5.1 Biotechnology Patents Applications Requirements 167

3.5.1.1 The Utility Requirement 1683.5.1.2 The Written Description Requirement. 35 U.S.C. § 112 1683.5.1.3 The Enabling Requirement. 35 U.S.C. § 112 169

In Re Thomas Deuel 169Amgen, Inc. v. Hoechst 173

3.5.2 Unique Problems in Patenting Biotechnology 178Monsanto Canada, Inc. v. Schmeiser 178Schmeiser v. Monsanto Canada Inc. 191

3.6 New Professions and Legal Issues 2083.6.1 Bioengineers 2083.6.2 Genetic Counselors 209

Notes 211

Chapter Four Human Health, Medical Care, Medical Information Disclosure in Biotechnology 215

4.1 Disclosure of Medical Information and Privacy 2154.1.1 Right to Privacy 2154.1.2 Limited Right to Privacy 216

4.1.2.1 Limited Right to Privacy in the Military 216Mayfield v. Dalton 216

4.1.2.2 Adoption Right to Know 218In the Matter of Sandra L.G. v. Bouchey 218

4.1.3 Use of Genetic Information 2204.2 Informed Consent, High Risk Treatments and Research 224

Notes 2294.3 Insurance and Predisposition to Disease 229

Katskee v. Blue Cross/Blue Shield of Nebraska 229Notes 230

Chapter Five International Law and Biotechnology 2315.1 International Environment and Biotechnology Issues 2315.2 Introduction to Biodiversity and the Convention on

Biological Diversity (CBD) 2315.2.1 The Convention on Biological Diversity 232

5.2.1.1 History and Background of the Convention on Biological Diversity (CBD) 232

5.2.1.2 Structure of the Convention on Biological Diversity 2335.2.1.2.1 Article 8(j) 2355.2.1.2.2 Article 15. Access to Genetic Resources 236

5.3 Bioprospecting and International Biopiracy 237

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5.3.1 International Approaches to Bioprosecting 2385.3.1.1 Convention on Biological Diversity 2385.3.1.2 FAO International Treaty on Plant Genetic

Resources for Food and Agriculture 2385.3.1.3 WTO Agreement on Trade-Related Aspects of

Intellectual Property Rights 2385.3.1.4 International Convention for the Protection of

New Varieties of Plants 2395.3.1.5 Convention on International Trade in Endangered

Species of Wild Fauna and Flora 2405.3.1.6 The Antarctic Treaty 2405.3.1.7 Universal Declaration of Human Rights 2405.3.1.8 International Covenant on Economic, Social and

Cultural Rights 2405.3.2 Regional Agreements 240

5.4 International Codes of Conduct for Bioprospecting 2415.4.1 The Micro-Organisms Sustainable Use and Access

Regulation International Code of Conduct (MOSAICC) 2415.4.2 Bonn Guidelines on Access to Genetic Resources and

Fair and Equitable Sharing of the Benefits Arising Out of Their Utilization 244

5.5 International Intellectual Property and Biotechnology 2465.5.1 Patent Protection in the United States 2465.5.2 Patent Protection in Other Countries 2465.5.3 International Patenting 247

5.6 International Trade and Biotechnology 2475.6.1 Exporting Biotechnologies 2475.6.2 The Cartegena Biosafety Protocol 247

5.7 International Security 2485.8 International Human Rights and Biotechnology 248

5.8.1 United Nations Treaty on Indigenous Peoples and Human Rights 248

5.9 Human DNA 249

Chapter Six Bioethics, Religion and Biotechnology 2536.1 Law, Biotechnology and Religion: Humans’ Relationship with

Biotechnology and Religion 2536.1.1 Free Exercise Clause Challenge to Biotechnology 253

Alliance for Bio-Integrity v. Shalala 253Notes 256

6.1.2 Religious Views on Biotechnology 2566.1.2.1 Stem Cell Research and Religion 2566.1.2.2 Cloning and Religion 258

6.2 Ethics and Biotechnology 2606.2.1 Public Sector Considers Ethics and Biotechnology 2606.2.2 The Private Sector Considers Ethics and Biotechnology 262

6.3 Family Relations: Legal v. Biological 262Stitham v. Henderson 262

6.4 Reproductive Technologies 265

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Margaret S. v. Edwards 265Lifchez v. Hartigan 266Notes 2696.4.1 Post Mortem Sperm Collection 2706.4.2 Ectogenesis 272

6.5 Eugenics 2736.6 Stem Cell Research 274

6.6.1 The Controversy with Stem Cell Research 2746.6.2 What Are These Embryonic Stem Cells? 2766.6.3 Sources of Embryonic Stem Cells 2766.6.4 State Regulation of Stem Cell Research 276

Notes 2776.7 Cloning 2776.8 The Ethics of Contamination of Indigenous Crops with

Genetically Modified Crops 278

Chapter Seven Criminal Law and Biotechnology 2837.1 Existing Federal Crimes Applicable to New Problems in

Biotechnology 2837.1.1 Mail Fraud 283

United States v. Greene 2837.1.2 The Great Train Robbery in Biotechnology 284

7.2 The Use of DNA in Criminal Law 290Spencer v. Murray 290

7.3 New Federal Statutes for New Problems in Biotechnology 292United States v. Wise 293United States v. Slaughter 296Notes 300

7.4 Biotechnology and the Changing Concept of “Expectation of Privacy” 300Illinois v. Wealer 301People v. King 303Notes 306

7.5 Human Behavioral Genetics and Criminal Predisposition 306Buck v. Bell 310New York v. Weinstein 311Notes 314

7.6 Criminal Law Attorneys and Obligation to Understand Science 3147.6.1 The Genetics Defense 3147.6.2 Ineffective Assistance of Counsel 315

Mobley v. Head 315Ohio v. Lane 318

7.7 Biopiracy 319

Chapter Eight Scientific Evidence and Biotechnology 3218.1 Introduction 3218.2 The Legal Foundation of Scientific Evidence 321

Frye v. United States 322Daubert v. Merrell Dow Pharmaceuticals, Inc. 324General Electric Company v. Joiner 332

CONTENTS ix

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Kumho Tire Company v. Carmichael 3388.3 Mitochondrial DNA 346

United States v. Beverly 3478.4 Historical Forensics and the Use of DNA Evidence 353

8.4.1 Thomas Jefferson and Sally Hemings 3538.4.2 Abraham Lincoln and Marfan Syndrome? 353

Notes 354

Chapter Nine Biotechnology and Property Law 3559.1 Introduction 3559.2 Ownership Problems 355

Moore v. Regents of University of California 355Miles, Inc. v. Scripps Clinic and Research Foundation 362

9.3 Special Property Protection Problems of Biotechnology:Patent Ownership Problems 368In Re Thomas Deuel 369Animal Legal Defense Fund v. Quigg 375

9.4 Ownership of Human Organs 3789.5 Ownership of Human Fertilized Eggs 389

Kass v. Kass 3899.6 Umbilical Cord Blood Banks 391

Notes 393

Chapter Ten Biotechnology and Tort Law 39510.1 Intentional Torts 395

Moore v. Regents of University of California 396In Re Starlink Corn Products Liability Litigation 402

10.2 Unintentional Torts 40910.2.1 Wrongful Birth/Wrongful Life: Medical Malpractice 410

Shroeder v. Perkel 410Reed v. Campagnolo 415

10.2.2 Products Liability 427In Re Starlink Corn Products Liability Litigation 431

10.2.3 Strict Liability Legislation 435

Chapter Eleven The Future of Biotechnology and Law 437

Appendix 1 Primer on Cell Biology 447Appendix 2 Primer on Molecular Biology 451Appendix 3 Primer on DNA 455Appendix 4 Glossary 461

Index 473

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Alliance for Bio-Integrity v. Shalala, 59,66–67, 253

Amgen v. Hoechst, vii, 169, 173–178, 198Amgen, Inc. v. Hoechst, 173Animal Legal Defense Fund v. Quigg, 375Attorney General of the State of Vermont,

70Buck v. Bell, 310–311California v. Greenwood, 300Center for Food Safety v. Johanns, 111Center for Food Safety v. Veneman, 110Daubert v. Merrell Dow Pharmaceuticals,

Inc., 323–324, 332, 334–338, 340–346,349

Diamond v. Chakrabarty, 20, 27, 29,163–164, 169, 361, 373, 376–378

Edmonds Institute v. Babbitt, Secretary ofInterior, 156

Foundation on Economic Trends v. Block, 99Foundation on Economic Trends v. Bowen,

101Foundation on Economic Trends v. Heckler,

90, 96Foundation on Economic Trends v. Lyng,

86–88Foundation on Economic Trends v. Thomas,

82, 84Frye v. United States, 321–322, 324, 327, 330General Electric Company v. Joiner, 26, 332Illinois v. Wealer, 301In Re Deuel, 369In Re Ribozyme Pharmaceuticals, Inc. Secu-

rities Litigation, 138In Re Starlink Corn Products Liability Litiga-

tion, 402, 431In Re Thomas Deuel, 169, 369In the Matter of Sandra L.G. v. Bouchey, 218International Dairy Foods Association v.

Amestoy, Attorney General of the Stateof Vermont, 70, 129

Kass v. Kass, 389

Katskee v. Blue Cross/Blue Shield of Ne-braska, 229, 300–301

Katz v. United States, 300Kumho Tire Company v. Carmichael, 338Lifchez v. Hartigan, 266Margaret S. v. Edwards, 265, 267Mayfield v. Dalton, 216Microbix Biosystems, Inc. v. Biowhittaker,

Inc., 150, 152Miles, Inc. v. Scripps Clinic and Research

Foundation, 362Mobley v. Head, 315Monsanto Canada Inc. v. Schmeiser,

178–179, 191–192Moore v. Regents of University of Califor-

nia, 355–361, 364–366, 388, 396–401,426

New York v. Weinstein, 311North Carolina Farm Partnership v. Pig Im-

provement Company, Inc., 152Ohio v. Lane, 318Olmstead v. United States, 300People v. King, 302–303Pioneer Hi-Bred International, Inc. v. J.E.M.

Ag Supply, 27, 185Reed v. Campagnolo, 415–416, 418Rhone-Poulenc Agro S.A. v. Monsanto Com-

pany and Dekalb Genetics Corp., 144Schmeiser v. Monsanto Canada Inc., 191Scripps Clinic and Research Foundation v.

Genentech, Inc., 154Shroeder v. Perkel, 410Spencer v. Murray, 290Stauber v. Shalala and Kessler, 48Stitham v. Henderson, 262United States v. Beverly, 347United States v. Dina Abdelhaq, 314United States v. Greene, 283United States v. Kyllo, 301United States v. Slaughter, 296United States v. Wise, 293

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Table of Cases

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Foreword

As you embark on this interdisciplinary and multidisciplinary study of Law andBiotechnology, my hope is that this book will assist you in examining the immense im-pact that biotechnology and law has on our society. It will undoubtedly affect you inyour practice of law, in some way, during the course of your career; if not directly inmany areas of practice which include not only intellectual property, but internationaltrade, criminal law, agricultural law, business law and environmental law, to name but afew areas.

The practice of law is increasingly requiring a level of science literacy that will be re-quired of anyone who is graduating from law school, today. This is particularly true inthe field of biotechnology, which is a scientific field enjoying an explosion in growthand understanding, much like the scientific field of physics in the first half of the lastcentury. As law develops to shape the way that our society regulates behaviors, it mustquickly respond to the new and exciting possibilities of biotechnology. The opportuni-ties to provide legal expertise and guidance in this field are great; and it is with an un-derstanding of the science, scientists and engineers as well as the regulatory mecha-nisms that we can best optimize these opportunities for the benefit of society and futuregenerations.

As this book goes to press, it is with the realization that new discoveries and new ap-plications of the law in biotechnology will be developing as the ink is drying. But thefoundations that are set forth in this text, provide you with the intellectual toolkit thatshould serve you well as you enter what will certainly be an exciting time in our historyfor judges, practicing lawyers and legal scholars in the field of Law and Biotechnology.

Victoria SuttonLubbock, TX

March 2007

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Preface

This book provides a systematic look at law, policy, science and technology of biotech-nology in the context of the traditional fields of law and practice. Chapter One beginswith an introduction to the categories of biotechnologies as a way of understanding thescope of applications that are possible, raising awareness of law and policy issues. In thischapter, biotechnology is defined and the historical relationship between law and biotech-nology is examined beginning with the earliest biotechnologies of food processing, ani-mal breeding and winemaking and continuing up to the biotechnology explosion begin-ning in the 1980s. The chapter introduces the definitions for genomics, proteonomics,bionanotechnology and bioinformatics. An introduction to the scientific method and thesciences of biotechnology is explained at this early point in the book as a foundation tounderstanding. The chapter concludes by an introduction to the issue of whether life canbe patented through examination of the case, Diamond v. Chakrabarty.

Chapter Two addresses issues of distributions of power in the regulation of biotech-nology and a discussion of the earliest regulatory approaches in the development of thefederal regulatory framework. The scope of authority for the regulation of biotechnol-ogy is examined through the litigation concerning genetically engineered foods with theFood and Drug Administration and Environmental Protection Agency, including ad-ministrative decisionmaking and Constitutional issues. The regulation of geneticallymodified organisms including plants and the environmental impact is examinedthrough the litigation with the U.S. Environmental Protection Agency and Departmentof Agriculture and the National Institutes of Health. The work of biopharming is exam-ined in the context of litigation with the U.S. Department of Agriculture. Completingthis chapter is an examination of federal legislation which has been introduced concern-ing various policy issues of biotechnology, and the efforts of states to regulationbiotechnology.

Chapter Three turns to the private sector and corporate activities in biotechnology,the unique features of biotechnology patents as well as the new professions which aredeveloping around the emergence of biotechnologies in our lives. Unique problems forbiotechnology of patent ownership, enforcement and infringement are examined inMonsanto v. Schmeiser.

Chapter Four, addresses some of the unique law and policy issues of biotechnologyin human health, medical care and medical information. The constitutional right toprivacy, adoption right to know, experimental and treatment decisions, informed con-sent and predisposition to disease as it relates to health insurance are among the ideasdiscussed in this chapter.

Chapter Five addresses international laws in biotechnology which affect the UnitedStates in the context of patenting, biological diversity, trade, security, biodefense,human rights, indigenous peoples, bioprospecting and biopiracy. Discussions of the

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xvi PREFACE

FAO International Treaty on Plant Genetic Resources for Food and Agriculture, theWTO Agreement on Trade-related Aspects of Intellectual Property Rights, the WIPOconventions and treaties, the International Convention for the Protection of New Vari-eties of Plants, the United Nations Convention on the Law of the Sea, the Conventionon International Trade in Endangered Species of Wild Fauna and Flora, the AntarcticTreaty and the Human Genome Project are discussed in the context of biotechnologies.

Chapter Six tackles the broad area of ethics, religion and biotechnology by first ex-amining religion and biotechnology and then ethics and biotechnology. Work of theNational Bioethics Advisory Committee is reviewed as it explored the religious views ofstem cell research and cloning among religious denominations. The family perspectiveis also reviewed from the question of who is family? Legal vs. biological definitions offamily, reproductive technologies, eugenics, stem cell research and cloning are consid-ered in this broad field of ethics, law and biotechnologies. The chapter concludes withconsideration of the ethics of contamination of indigenous crops with genetically mod-ified crops.

Chapter Seven considers criminal law and the role biotechnology has played in arange of legal contexts. Federal criminal statutes both new and old are explored in theirapplication to biotechnologies. The use of DNA, and mitochondrial DNA in criminallaw, the changing “expectation of privacy” with the use of new biotechnologies, humanbehavioral genetics and criminal predisposition are among the topics examined in thischapter. This is followed with cases which raise issues of ineffective representation bycounsel where knowledge of biotechnology proves essential. A newly characterizedcrime of biopiracy is a final thought for the future in this chapter.

Chapter Eight reviews the foundation cases in scientific evidence and builds on theseto introduce DNA testing and evidence. The emerging study of historical forensics ex-amines some recent cases of interest to historians with legal consequences and raisesnew ethical issues for its practice.

Chapter Nine is introduced with the landmark case, of Moore v. Regents of Universityof California addressing the issue of ownership with human tissues. Special propertyprotection problems of biotechnology are examined including the ownership of humanorgans, fertilized human eggs, sperm and umbilical cord blood storage banks.

Chapter Ten considers the application of traditional tort law to the new biotechnolo-gies in the categories of intentional and unintentional torts, specifically trespass to land,conversion, private nuisance, public nuisance and negligence. Other torts are newlyemerging areas which may utilize biotechnologies including wrongful birth and wrong-ful life, medical malpractice and products liability and strict liability.

The book necessarily concludes with a look at the future of law and biotechnology inthe last Chapter Eleven.

Four appendices have been created specifically for the use of this book to assist inclarifying terms in biotechnology and general principles in the major scientific disci-plines which are used to develop biotechnologies: cell biology, molecular biology, aprimer on DNA and a glossary.

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About the Author

Victoria Sutton, M.P.A., Ph.D., J.D.Robert H. Professor of Law, Texas Tech University

Victoria Sutton is the Director of the Center for Biodefense, Law and Public Policy,Director of the Law and Science Certificate Program and the Robert H. Bean Professorof Law at Texas Tech University.

She holds a Ph.D. in Environmental Sciences from The University of Texas at Dallas;a J.D. from American University, magna cum laude; and a Master’s Degree in Public Ad-ministration (MPA), from Old Dominion University, who awarded her the Distin-guished Alumni Award in 2005. She also has two Bachelor of Science degrees in Zoologyand Animal Science, cum laude, from North Carolina State University.

Before coming to Texas Tech, she was Assistant Director in the Bush Administrationfrom 1990 to1993, in the Office of Science and Technology Policy in the White HouseScience Office, where she worked on national energy and environmental policy. Prior tothat, she worked in the U.S. Environmental Protection Agency as a Special Assistant inPolicy, Planning and Evaluation and EPA Liaison to the Office of Science and Technol-ogy Policy of the White House. Following the Bush Administration, she was appointedas the Executive Director of the Ronald Reagan Institute of Emergency Medicine inWashington, DC.

Since coming to Texas Tech, Dr. Sutton was a Visiting Lecturer at Yale Law School in2004 and also served in the President George W. Bush Administration as Chief Counselof the Research and Innovative Technology Administration, U.S. Department of Trans-portation from 2005 to 2007.

Dr. Sutton is a member of the District of Columbia Bar, U.S. Federal Circuit Bar andthe U.S. Supreme Court Bar. She has served as a consultant to a number of federal agen-cies in the area of biodefense, and is a frequent speaker for audiences of lawyers as wellas scientists.

Her awards include receiving the Distinguished Alumni Award from Old DominionUniversity. She received the Texas Tech University Book Award in 2003 for Law and Sci-ence: Cases and Materials; and the Law School Distinguished Research Award in 2002,2003 and 2005. She is also the author of Law and Bioterrorism, a first in the field, re-leased January 2003.

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xix

Acknowledgments

First, I want to acknowledge Professor D. Allan Bromley, Sterling Professor of the Sciences,Yale University, for his tireless review of several drafts of the book and for sharing with mehis incredible insight and knowledge of science, technology, science policy and life.

I would also like to thank the following contributors:

Anna McMinn for her research and explanations for Appendix 3. Primer on DNA.

Law students in my course, Law and Biotechnology, Texas Tech University School ofLaw, who used previous drafts of this book.

Chapter One

U.S. Department of Energy, Argonne National Laboratory, “Scientific Excellence,” Fron-tiers 2001 4–5 (2001).

These biotechnology descriptions are summarized from Helen Kreuzer, Ph.D. and Adri-anne Massey, Ph.D., Recombinant DNA and Biotechnology: A Guide for Teachers, 2dASM Press, Washington, D.C. (2001).

James Robert Dean, Jr, “FDA at War: Securing the Food That Secured Victory,” 53 FoodDrug L.J. 453, 467–8 (1998).

U.S. Department of Energy’s Lawrence Livermore National Laboratory, “ResearchHighlights,” Science and Technology Review, 10–13 (January/February 2001).

“The Birth of Biotech: Herbert Boyer and Stanley Cohen started a revolution,” Associa-tion of Alumni and Alumnae of the Massachusetts Institute of Technology, TechnologyReview 120 (July/August 2000).

Chapter Two

Executive Office of the President, Federal Coordinating Council for Science, Engineer-ing and Technology, “Biotechnology for the 21st Century,” (February 1992).

Stuart Auchincloss, “Does Genetic Engineering Need Genetic Engineers?: Should theRegulation of Genetic Engineering Include a New Professional Discipline?” 20 B.C.Envtl. Aff. L. Rev. 37 (Fall 1993).

Jesse D. Lyon, “OPEN FORUM: Coordinated Food Systems and Accountability Mecha-nisms for Food Safety: A Law and Economics Approach,” 53 Food Drug L.J. 729 (1998)describes the history of law governing food.

Alliance for bio-Integrity website at http://www.bio-integrity.org/list.html.

Linda Beebe, “Symposium Issue II Pesticides: What Will the Future Reap? Note: In re Star-link Corn: The Link between Genetically Damaged Crops and an Inadequate RegulatoryFrame Work for Biotechnology,” 28 Wm. & Mary Envtl. L. & Pol’y Rev. 511 (Winter 2004).

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xx ACKNOWLEDGMENTS

Rebecca M. Bratspies, Consuming (F)ears of Corn: Public Health and Biopharming, 30Am. J. L. and Med. 371 (2004).

Meredith A. Jagutis, “Comment: Insurer’s Access to Genetic Information: The Call forComprehensive Federal Legislation,” 82 Marq. L.Rev. 429, 434–435 (Winter 1999).

11 Biotechnology Newswatch 11 (1991).

Kourtney L. Pickens, “Don’t Judge Me By My Genes: A Survey of Federal Genetic Dis-crimination Legislation,” 34 Tulsa L.J. 161, 170–172 (Fall 1998).

Natalie E. Zindorf, in “Comment: Discrimination in the 21st Century: Protecting thePrivacy of Genetic Information in Employment and Insurance,” 36 Tulsa L. J. 703,714–715 (2001).

Chapter Three

Becca Alley, “The Biotechnology Process Patent Act of 1995: Providing Unresolved andUnrecognized Dilemmas in U.S. Patent Law,” 12 J. Intell. Prop. L. 229 (Fall 2004).

Margaret M .Duncan, Kathleen Harris, Duncan Curley and Patrick D. Richards, Mc-Dermott, Will & Emery, “Legal Implications for Patenting Genomics and Proteomics”Proceedings of The Biotech Law & Litigation Summit, Palo Alto, California (April30–May 1, 2001).

Beth Panitz, “Bioengineering: A Growing New Discipline,” PRISM American Society forEngineering Education 22–24 (November 1996).

Jeri E. Reutenauer: “NOTE: Medical Malpractice Liability in the Era of Genetic Suscep-tibility Testing,” 19 Quinnipiac L. Rev. 539 (2000).

Ernst and Young, LLP, Annual Biotechnology Industry Reports, 2000; Ernst and Young,Beyond Borders, 2002 and http://www.bio.org/speeches/pubs/er/statistics.asp are thesources of statistics for the biotechnology industry table in section 3.1.

Chapter Four

Renee C. Esfandiary, “NOTE: The Changing World of Genetics and Abortion: Why theWomen’s Movement Should Advocate for Limitations on the right to Choose in theArea of Genetic Technology,” 4 Wm. & Mary J. Of Women & L. 499 (Spring 1998).

Jeri E. Reutenauer, NOTE: Medical Malpractice Liability in the Era of Genetic Suscepti-bility Testing,” 19 Quinnipiac L. Rev. 539 (2000).

Chapter Six

Winona LaDuke, “Wild Rice and Ethics,” Cultural Survival Quarterly Issue 28.3 (Sep-tember 15, 2004).

Gregg Zoroya, USA Today, February 12, 2007, Science makes a new father of a fallenAmerican soldier: Banked sperm produces a son: ‘He’s a blessing’.

Jennifer S. Bard, “Immaculate Gestation? How Will Ectogenesis Change Current Para-digms of Social Relationships and Values?” Chap. Eleven, Ecotogensis: Artificial WombTechnology and the Future of Human Reproduction, eds. Scott Gelfand and John R.Shook (2006) [excerpt].

Chapter Seven

Justin Gillis, “20 Years Later, Stolen Gene Haunts a Biotech Pioneer,” Washington PostStaff Writer (Monday, May 17, 1999; Page A01).

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ACKNOWLEDGMENTS xxi

Cecilee Price-Huish, “COMMENT: Born to Kill?”Agression Genes” and Their Poten-tial Impact on Sentencing and the Criminal Justice System,” 50 SMU L. Rev. 603(Jan/Feb 1997).

Chapter Eight

Philip R. Reilly, Abraham Lincoln’s DNA and Other Adventures in Genetics 6–13 (ColdSpring Harbor Laboratory Press, 2000).

Chapter Nine

Sara Dastgheib-Vinarov, “COMMENT: A Higher Nonobviousness Standard for GenePatents: Protecting Biomedical Research from the Big Chill,” Marq. Intell. Prop. L. Rev.143 (2000).

Michael E. Sellers, “Patenting Nonnaturally Occurring, Man-Made Life: A PracticalLook at the Economic, Environmental, and Ethical Challenges Facing Animal Patents,”47 Ark. L. Rev. 269 (1994) New York Times, Blood Cord Banks.

Chapter Ten

Excerpt from Julie A. Davies and Lawrence C. Levine, “SYMPOSIUM: Biotechnologyand the Law: Biotechnology’s Challenge to the Law of Torts,” 32 McGeorge L. Rev. 221(Fall 2000).

Jeri E. Reutenauer, “NOTE: Medical Malpractice Liability in the Era of Genetic Suscep-tiblity Testing,” 19 Quinnipiac L. Rev. 539 (2000).

Chapter Eleven

Henry Greely, “SPEECH: The Revolution in Human Genetics: Implications for HumanSocieties,” 52 S.C. L. Rev. 377 (Winter 2001).

Appendix 4. Glossary

This entire appendix is from “A Survey of the Use of Biotechnology in Industry,” (Dept.of Commerce, 2003) at: http://www.technology.gov/reports/Biotechnology/CD120a_0310.pdf.

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