Patent Politics: Life Forms Markets and the Public interest in the United States and Europe

299 Pages·2017·2.312 MB·English

by  Shobita Parthasarathy

Patent Politics

Patent
Life Forms, Markets,
and the Public Interest
Politics
in the United States
and Europe
shobita Parthasarathy
The
UniversiTy
of ChiCago
Press
Chicago and London
The University of Chicago Press, Chicago 60637
The University of Chicago Press, Ltd., London
© 2017 by The University of Chicago
All rights reserved. No part of this book may be used or reproduced in any
manner whatsoever without written permission, except in the case of brief
quotations in critical articles and reviews. For more information, contact the
University of Chicago Press, 1427 E. 60th St., Chicago, IL 60637.
Published 2017.
Printed in the United States of America
26 25 24 23 22 21 20 19 18 17  1 2 3 4 5
isBn- 13: 978- 0- 226- 43785- 9 (cloth)
isBn- 13: 978- 0- 226- 43799- 6 (e- book)
Doi: 10.7208/chicago/9780226437996.001.0001
Library of Congress Cataloging-in-Publication Data
Names: Parthasarathy, Shobita, author.
Title: Patent politics : life forms, markets, and the public interest in the
United States and Europe / Shobita Parthasarathy.
Description: Chicago : The University of Chicago Press, 2017. | Includes
bibliographical references and index.
Identifiers: LCCn 2016026515 | isBn 9780226437859 (cloth : alk. paper) |
isBn 9780226437996 (e-book)
Subjects: LCsh: Biotechnology—Patents. | Patent laws and legislation—
United States—History. | Patent laws and legislation—Europe—History. |
Bioethics—United States. | Bioethics—Europe.
Classification: LCC TP248.175 .P35 2017 | DDC 174.2–dc23
LC record available at https://lccn.loc.gov/2016026515
♾ This paper meets the requirements of ansi/niso Z39.48- 1992
(Permanence of Paper).
contents
Acronyms and Abbreviations vii
Introduction 1
1 Defining the Public Interest in the US and
European Patent Systems 21
2 Confronting the Questions of Life- Form Patentability 51
3 Commodification, Animal Dignity, and Patent- System Publics 81
4 Forging New Patent Politics Through the Human
Embryonic Stem Cell Debates 117
5 Human Genes, Plants, and the Distributive Implications
of Patents 155
Conclusion 191
Acknowledgments 201
Appendix 1: Major Events Related to the US and
European Life- Form Patent Controversies 205
Appendix 2: Methodological Note 207
Notes 217
Bibliography 259
Index 277

acronyms and abbreviations
aavs American Anti- Vivisection Society
aCLU American Civil Liberties Union
aLDf Animal Legal Defense Fund (US)
aMP Association for Molecular Pathology (US)
aPa Administrative Procedures Act (US)
asPCa American Society for the Prevention of Cruelty to Animals
BPD Biotech Patent Directive: formally, the EU Directive for the
Legal Protection of Biotechnological Inventions
BrCa1/2 Breast Cancer Genes 1 and 2
CafC Court of Appeals for the Federal Circuit (US)
CCPa Court of Customs and Patent Appeals (US)
CCsT California Council on Science and Technology (US)
cDNA complementary Dna
Cgs Center for Genetics and Society (US)
CirM California Institute for Regenerative Medicine (US)
Commission European Commission
Council Council of Europe
DoJ Department of Justice (US)
eBa Enlarged Board of Appeal (Europe)
eCJ European Court of Justice
eCLJ European Center for Law and Justice
eeC European Economic Community
efTa European Free Trade Association
ege European Group on Ethics in New Science and Technologies
ePa Environmental Protection Agency (US)
ePC European Patent Convention
epi Institute of Professional Representatives before the European
Patent Office (European Patent Institute)
ePo European Patent Office
esC Economic and Social Committee (Europe)
esT Expressed sequence tag
EU European Union
fDa Food and Drug Administration (US)
feT Foundation on Economic Trends (originally the People’s
Bicentennial Commission, then the People’s Business
Commission, and now feT) (US)
fTCr Foundation for Taxpayer and Consumer Rights (now
Consumer Watchdog) (US)
gaeiB Group of Advisors on the Ethical Implications of
Biotechnology (Europe)
hESC Human embryonic stem cells
hgP Human Genome Project
hhs Department of Health and Human Services (US)
iCTa International Center for Technology Assessment (US)
KPaL Kein Patent Auf Leben/No Patents on Life (Europe)
MeP Member of the European Parliament
Myriad Myriad Genetics (US)
nih National Institutes of Health (US)
nPos No Patents on Seeds (Europe)
nrC National Research Council (US)
Organization European Patent Organization
osgaTa Organic Seed Growers and Trade Association (US)
Parliament European Parliament
PBC People’s Business Commission (originally the People’s
Bicentennial Commission, now feT) (US)
PTo Patent and Trademark Office (US)
PubPat Public Patent Foundation (US)
raC Recombinant Dna Advisory Committee (US)
rDNA recombinant Dna
saCghs hhs Secretary’s Advisory Committee on Genetics, Health,
and Society (US)
saCgT hhs Secretary’s Advisory Committee on Genetic Testing (US)
saWs Sensitive Application Warning System (US PTo)
sCoTUs US Supreme Court
SeCa Sensitive Cases system (ePo)
SftP Science for the People (US)
TBa Technical Board of Appeal (Europe)
TriPs Trade- Related Intellectual Property Rights Agreement
UPov International Union for the Protection of New Varieties of
Plants
UsDa US Department of Agriculture
Warf Wisconsin Alumni Research Foundation (US)
introduction
The headquarters of the European Patent Office (ePo) is not a place known for
political activism. And yet, on a cool morning in October 2013, dozens of pro-
testors barricaded themselves in front of the ePo’s main buildings in Munich
and demanded that the patent bureaucracy “Stop Patents on Life.” These civil
society challengers—including farmers, environmentalists, representatives of
international development organizations, and average citizens—had gathered
to oppose the ePo’s decisions to permit patents on conventional plants and
animals bred using biotechnology, which, they argued, would accelerate dan-
gerous consolidation in the agricultural industry.1 Equally important, they
suggested, such patents would continue to disempower small farmers, who
would be forced to depend on patent holders for their crops and ultimately
have trouble maintaining independent businesses. But underlying all of these
arguments lay concerns that the ePo was, as their signs put it, a “democracy-
free zone”. Protestors charged that the patent bureaucracy did not adequately
consider the will of the European people, but instead privileged private inter-
ests while cloaking its decisions in technical and legal language.
Similarly, a few months earlier and an ocean away, breast cancer advocates
had stood on the steps of the United States Supreme Court decrying the US
Patent and Trademark Office’s (PTo) policy of allowing patents on human
genes.2 They, along with scientists, physicians, genetic counselors, and civil
rights advocates, argued that gene patents were immoral and illegal because
they commodified nature. Moreover, they noted, such patents made it difficult
for biologists to conduct fundamental research and for patients to access the
best health care. Instead of improving the public’s access to innovation, these
plaintiffs charged, human gene patents did the opposite. They would prevail
in June 2013, when the Supreme Court ruled in AMP v. Myriad that isolated
human genes were unpatentable.
In recent decades, we have seen hundreds of civil society– led challenges to
the world’s science and technology policymaking institutions, signaling grow-
ing citizen distrust. As science and technology have become ubiquitous in our
daily lives, they are having noticeably positive effects. But citizens have also
begun to wonder whether the systems that regulate the development, avail-
ability, and use of innovation reflect their values and concerns. Some, like the
environmentalists and patient advocates mentioned above, are even mobiliz-
1