Access to Medicine in the Global Economy: International Agreements on Patents and Related Rights

421 Pages·2011·5.711 MB·English

by  Cynthia M. Ho

access to medicine in the global economy
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Access to Medicine in the Global
Economy :
INTERNATIONAL AGREEMENTS ON PATENTS AND
RELATED RIGHTS
Cynthia M. Ho
1
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1
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Library of Congress Cataloging-in-Publication Data
Ho, Cynthia M.
Access to medicine in the global economy : international agreements on patents and
related rights / Cynthia M. Ho.
p. cm.
Includes bibliographical references and index.
ISBN 978-0-19-539012-4 ((hardback) : alk. paper)
1. Drugs—Patents. I. Title.
K1519.D78H6 2011
346.04’86—dc22 2010048464
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Printed in the United States of America on acid-free paper
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List of Figures and Tables
Figures
1. Drug Development Process 8
2. Patentability Analysis 18
3. Patent versus Marketing Timelines 24
4. Domestic Exhaustion 39
5. International Exhaustion—Look to Importing Country (B’s) 41
6. “Global” Example 42
7. TRIPS Patent Term—Scenario 1 69
8. TRIPS Patent Term—Scenario 2 70
9. Indian Opposition Periods 100
Tables
1. Patent vs. Marketing Approval Requirements 23
2. International Exhaustion—Defi nitions of Related Terms 44
3. Are Imported Goods Permissible?—Summary of Related Terms 44
4. International Exhaustion—Sample Countries 49
5. “Unfair Commercial Use”—Possible Implications 81
6. TRIPS Compliance Dates 84
7. Indian Patent Rights Mailbox vs. Non-Mailbox Patent Remedies 114
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Preface

when i first began practicing law, I never imagined that I would write this book.
My fi rst job was as a patent attorney; in that role, I oft en represented the interests of large
companies, including multinational drug corporations. At the time, I did not seriously
question the assumption held by such entities that patents provide a critical incentive to
development of new medical treatments. However, since then I have developed a more
nuanced view; although I still believe that these companies perform an important role in
developing new drugs, patents do not always promote development of the most socially
benefi cial ones. Moreover, even drugs that are socially benefi cial may be of little use to
those who cannot aff ord to purchase them.
Th e issue of how patents impact medicine has increased in signifi cance within the last
decade. Just as I was transitioning from private practice to academia, a landmark interna-
tional agreement (TRIPS) was concluded that requires most countries to provide
patents. Signifi cantly, TRIPS required a fundamental shift in the laws of many countries
that previously excluded drugs from patentability. Th e requirement to patent drugs
obviously has implications on the cost of drugs and whether citizens in poor countries
have access to them.
Th e conclusion of TRIPS has increased attention on how patents impact access to
medicine, but this new focus has not always led to productive results. Discussions con-
cerning the impact on access to medicine oft en degenerate into fi nger-pointing. Patent-
owning companies are oft en vilifi ed as greedy corporations that place profi ts above people
while those who advocate greater access to drugs are accused of stealing private property.
Th ese accusations seem to be based on deeply held views about the role of patents (referred
to in the book as “competing patent perspectives”). On one hand, patents are seen as a
tool to promote innovation, and as such, they can (and should) be modifi ed. On the
other hand, patents are viewed as an important property right that should seldom be
subject to exceptions, especially considering its limited term. As explained in this book,
these competing views have led to confusion and obfuscation of the law. I was inspired to
write this book in part to clarify widely prevalent misconceptions, as refl ected in both
reports from the popular press and in some academic publications.
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