Generic Challenge:. Martin a. Voet
Читать онлайн.| Название | Generic Challenge: |
|---|---|
| Автор произведения | Martin a. Voet |
| Жанр | Медицина |
| Серия | |
| Издательство | Медицина |
| Год выпуска | 0 |
| isbn | 9781627346252 |
U.S. Patent Term Adjustments and Extensions
Litigation over Patent Term Extensions
Scope of Patent Term Extensions
New Dosage Forms/Delivery/Conditions of Use
Orange Book Listing and De-listing
Over-The-Counter (OTC) Strategy
Examples of Life-Cycle Management
The Alphagan (brimonidine) Story
| Chapter 9 | Conclusions and Final Thoughts |
Drug Policy v. Industrial Policy
Uniform International Approval Standards
Price Controls and “free ride” Issues
Prescribing Generic Drugs Even More Often
Disclaimer
This book is intended to provide information about the subject matter covered. It is sold with the understanding that the publisher and author are not engaged in rendering legal services or providing legal advice. If legal advice is required, the services of a competent legal adviser should be obtained.
Reasonable efforts have been made to make this book accurate as well as informative. However, there may be mistakes, both typographical and in content, or omissions. Therefore, this text should be used only as a general guide and is not to be relied on in any particular, keeping in mind that laws and interpretation of regulations change over time.
The purpose of this book is to educate and inform. The author and publisher shall have neither liability nor responsibility to any person or entity with respect to any loss or damage caused or alleged to be caused directly or indirectly by the information contained in this book.
The opinions expressed in this book are solely the personal opinions of the author in his individual capacity. Nothing in this book shall be attributable to the author in any representational capacity or to any other person or legal entity.
Acknowledgments
I have not attempted to cite in the text all of the authorities and sources consulted in the preparation of this book. To do so would make the book cumbersome and probably unreadable to the non-professional. Besides, I wanted to write an enjoyable book that would be easy to read and understand and by implication, that means no footnotes.
A special thanks to my long time good friend and teaching colleague, George Lasezkay, for encouraging me to write this book, whose genesis was a chapter outline sketched out on a yellow legal pad in the spring sunshine of Sun Valley, Idaho between ski runs on Baldy.
About the Author
Martin A. Voet was formerly Senior Vice President and Chief Intellectual Property Counsel for a Fortune 500 pharmaceutical company with over twenty-five years’ experience in pharmaceutical intellectual property practice. He is currently a consultant in intellectual property management and pharmaceutical product exclusivity and Adjunct Professor of Law at the University of San Diego Law School.
He graduated from the University of California at Berkeley with a B.S. in Chemistry; received an M.B.A. from Pepperdine University School of Business and Management and was awarded a J.D. with Honors from the George Washington University National Law Center. He is a member of the State Bar of California.
He has been a contributor to the Practicing Law Institute’s Global Intellectual Property Series and its annual Patent Litigation series, contributor and member of the Editorial Board of Managing Intellectual Property, speaker at ACI’s annual Maximizing Pharmaceutical Patent Life Cycles in New York and co-chaired ACI’s West Coast conference on Paragraph IV Disputes.
He recently published an article in the American Bar Association IP Journal Landslide Magazine with Louis Cullman titled “Re-Purposing and Enforcement during Patent Term Extensions for Pharma Products”, July/August 2016.
Preface to the Fifth Edition
The U.S. Food and Drug Administration (FDA) approved 45 new drugs in 2015 bettering the number (41) approved in 2014, which had been the highest number approved since 1996. The number of such approvals is generally considered to be a barometer of the pharmaceutical industry’s innovation and the FDA’s efficiency in reviewing and approving new therapies. While this trend is good news for industry and patients, it is likely to fuel the ongoing debate over rising prescription drug prices.
One is told that prescription drug prices are too high and annual increases are out of step, e.g., total spending on prescription drugs in the U.S. rose 12.2% from 2014 to $425 billion in 2015. But recall the admonition popularized by Mark Twain that “There were three kinds of lies: lies, damned lies and statistics”. While the foregoing statistic is true based on list prices, IMS Health estimates that manufacturers actually received $310 billion after rebates and discounts averaging 27%, only a 2.8% increase over such receipts in 2014. And IMS reports the average patient share of the cost for a brand name prescription has increased only about 25% since 2010, averaging $44 per prescription in 2015. In addition almost 90% of new prescriptions in 2015 were for generic drugs which typically cost the consumer a fraction of the cost of brand name drugs.
Spending based on list prices of the top five brand name prescription drugs in the U.S. for 2015 (in billions of dollars) were as follows:
| Gilead’s Harvoni for hepatitis C | $14.3 |
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AbbVie’s Humira
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