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Narratives of Gene Patenting
Jorge L. Contreras*
Abstract
The decades-old debate over gene patenting in the United States reached a climax in June 2013 with the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics. The Myriad case was remarkable for many reasons, not least of which because it engaged hundreds of scientists, physicians, patients, lawyers, activists, and policy makers, each expressing strong, often opposing, views regarding the case and gene patenting more generally. From this multitude of voices emerged six distinct narratives, which I term the Science, Innovator, Administrative, Access, Dystopian, and Congestion narratives. In this Article, I trace the origins of each of the narratives in Myriad from press accounts, published literature, and the extensive record in the case. I then assess how each narrative influenced and became incorporated into the resulting decisions. This analysis demonstrates the strong influence of narrative on judicial decisionmaking, not only in the area of gene patenting, but more broadly across common law jurisprudence.
I. Introduction | 1134 |
II. Myriad and the Gene Patenting Debate in the U.S. | 1137 |
A. Genes and Cancer | 1138 |
B. Finding BRCA | 1139 |
C. Patenting BRCA | 1142 |
1. Gene Patents in the United States | 1142 |
2. Myriad's Patents | 1144 |
D. BRCA Testing | |
1. Competition in the BRCA Testing Market (1996-2000) | |
2. Myriad's BRCA Testing Program (1996-2013) | 1146 |
(a) Types of Tests | 1146 |
(b) Pricing of Diagnostic Tests | 1147 |
(c) Access and Reimbursement | 1147 |
E. The Myriad Litigation | 1149 |
III. Six Narratives of Gene Patenting | 1151 |
A. The Narratives and Associated Arguments | 1152 |
1. The Science Narrative | 1152 |
(a) Reductio ad Absurdum | 1153 |
(b) Collective Effort | 1153 |
(c) (In)significance of Findings | 1154 |
(d) Public Funding | 1155 |
(e) Disdain for Financial Gain | 1156 |
(f) Impeding Research | 1156 |
2. The Innovator Narrative | 1157 |
(a) Ingenuity | 1157 |
(b) Incentives | 1158 |
3. The Administrative Narrative | 1160 |
4. The Access Narrative | 1162 |
5. The Dystopian Narrative | 1165 |
6. The Congestion Narrative | 1169 |
B. Divergent Narratives | 1171 |
1. Narrative Timeframes | 1174 |
2. Audience | 1175 |
IV. Mapping Narrative to Law | 1177 |
A. Narrative and Adjudication | 1177 |
B. Adjudication of the Myriad Case | 1177 |
1. District Court | 1177 |
(a) First Among Many | 1178 |
(b) Standard Procedures | 1179 |
(c) Not One of Us | 1179 |
(d) Other Peoples' Money | 1179 |
(e) Winning by a Nose | 1180 |
(f) Anticommons | 1181 |
(g) Access and Pricing | 1181 |
(h) The District Court's Holding | 1182 |
2. Federal Circuit | 1182 |
(a) Majority Opinion - Myriad's Story | 1182 |
(b) Concurrence - Economic Impact | 1184 |
(c) Dissent - Science | 1186 |
3. Supreme Court | 1186 |
C. Comparing Adjudicatory Narratives | 1187 |
1. Correlation Between Narrative and Outcome | 1188 |
2. The Influence of Judicial Background | 1189 |
3. Judicial Audiences | 1190 |
D. Toward a Narrative Typology in Innovation Cases? | 1191 |
V. Conclusion | 1195 |
* Associate Professor, University of Utah S.J. Quinney College of Law and Adjunct Associate Professor, Department of Human Genetics. J.D., Harvard Law School; B.S.E.E., B.A., Rice University. Earlier versions of this Article have benefitted from feedback and commentary at the “IP in the Trees” Symposium at Lewis & Clark Law School, the Fourteenth Annual Intellectual Property Scholars Conference (IPSC) at the University of California Berkeley, the 2014 Workshop of the International Society for the History and Theory of Intellectual Property (ISHTIP) at Uppsala University, the 2013 ISHTIP Workshop at the University of Paris-Sorbonne, the 2012 Mid-Atlantic Patent Works in Progress (MAP-WIP) workshop at American University, and a faculty workshop at the University of Utah. Additional thanks are due to Jonas Anderson, Dan Burk, Michael Carroll, Robert Cook-Deegan, Amos Guiora, Andrew Hessick, Heather Hughes, Andrew Laird-Johnson, Daithi Mac Sithigh, John Martinez, Nancy McLaughlin, Binny Miller, Laura Pedraza-Farina, Amelia Rinehart, Jacob Rooksby, Joshua Sarnoff, David Snyder, Sean Tavtigian, and Deborah Threedy for their thoughtful input, comments, and discussion. Vikrant Deshmukh, Hilary Gawrilow, Amy Biegelsen, and Ripple Weistling provided invaluable research assistance. The author is also grateful to Lisa Schlager, Julia Fuld, Virginia Bruner, Dara Lyn Petersen, Beth Citrin West, Andrea Downing, Caroline Pruce, Teri Smieja, and the other members of Facing Our Risk of Cancer Empowered (FORCE) who generously offered their time and insight as part of the background research for this project. The research and writing of this Article were supported in part by a Leonardo da Vinci Fellowship awarded by the Center for the Protection of Intellectual Property (CPIP) at George Mason University School of Law.
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I. Introduction
The debate over gene patenting in the United States, which has been ongoing for nearly three decades, reached a climax in June 2013 with the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics1. The Myriad case was significant for many reasons. It sent shock waves through the biotechnology community when the Court de-