The Generic Challenge
The Generic Challenge:
Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition)
Martin A. Voet, B.S., M.B.A., J.D.
BrownWalker Press
Boca Raton
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
Dedication
I would like to dedicate this Fifth Edition to my Dutch immigrant parents, Andries and Henriette Voet, who first had the foresight to board a boat to America in early 1939 ahead of the German invasion of Holland, thereby allowing me the privilege of being born in America; and second, when I was wondering what to do with myself after graduating UC Berkeley with a degree in chemistry that I did not want to pursue further, suggested that perhaps I could be a patent attorney.
“The desire to take medicine is perhaps the greatest feature which distinguishes man from animals”
Sir William Osler, M.D.
Contents
| Introduction |
| Chapter 1 Overview of Patents |
Edison Patent for the Electric Light Bulb
A Patent is a Sword, Not a Shield!
Patent Term Adjustments and Extensions
First-to-invent v. First-to-file
Patent Cooperation Treaty (PCT)
Claims Define the Scope of the Invention
Basic Requirements for Patentability