Generic Challenge:. Martin a. Voet

      

      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

       Disclaimer

       Acknowledgments

       About the Author

       Preface to the Fifth Edition

       Preface to the First Edition

Introduction

Chapter 1 Overview of Patents

       Origins of U.S. Patents

       Is a Patent a Legal Monopoly?

       Edison Patent for the Electric Light Bulb

       What is a Product or Process?

       A Patent is a Sword, Not a Shield!

       Basic Term of a Patent

       Harmonization

       Submarine Patents

       Patent Term Adjustments and Extensions

       How are Patents Obtained?

       First-to-invent v. First-to-file

       Provisional Applications

       Foreign Filings

       Patent Cooperation Treaty (PCT)

       Costs of Filing

       Patent Contents

       Specification

       Claims Define the Scope of the Invention

       What is Not Patentable?

       Laws of Nature

       Natural Substances

       Inherency

       Story of Aspirin

       Basic Requirements for Patentability

       New

       Useful

       Novel