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The Generic Challenge:

Understanding Patents, FDA and Pharmaceutical Life-Cycle Management

(Fifth Edition)

Copyright © 2016 Martin A. Voet. All rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transcribed in any form or by any means, electronic or mechanical including photocopying or recording, without written permission from the publisher.

BrownWalker Press

Boca Raton, Florida • USA

2016

www.brownwalker.com

ISBN: 978-1-62734-617-7 (pbk)

ISBN: 978-1-62734-618-4 (ePub)

ISBN: 978-1-62734-619-1 (Kindle)

ISBN: 978-1-62734-620-7 (Nook)

Library of Congress Cataloging-in-Publication Data

Voet, Martin A., 1942-

The Generic Challenge : Understanding Patents, FDA and Pharmaceutical Life-Cycle Management / Martin A. Voet. – 5th Ed.

p. ; cm.

ISBN: 978-1-62734-617-7 (pbk)

ISBN: 978-1-62734-618-4 (ePub)

ISBN: 978-1-62734-619-1 (Kindle)

ISBN: 978-1-62734-620-7 (Nook)

1. Drugs–Generic substitution–Law and legislation–United States.

2. Drugs–United States–Generic substitution–Patents. 3. Patent extensions–United States. 4. Pharmaceutical biotechnology–Patents. 5. Pharmaceutical biotechnology–Law and legislation. I. Title.

[DNLM: 1. Drugs, Generic–economics–United States. 2. Legislation, Drug–United States. 3. Drug Industry–economics–United States. 4. Drug Industry–legislation & jurisprudence–United States. 5. Patents as Topic–legislation & jurisprudence–United States. QV 33 AA1 V876g 2008]

KF3894.G45V64 2008

346.7304’86–dc22

2008003218