Patent Law

Book Review Monday: The Generic Challenge

By Stephen Albainy-Jenei

“Who do you think was the country?s biggest supplier of prescription drugs in 2007?  Was it P?zer or Merck or Bristol-Meyers-Squib or Novartis?   No. It was Teva Pharmaceuticals, a generic manufacturer.”

   ~ Martin Voet, The Generic Challenge:  Understanding Patents, FDA & Pharmaceutical Life-Cycle Management (Second Edition).

The Generic Challenge is about providing the necessary information to pharmaceutical executives, managers, regulatory, legal and business development professionals, those involved in strategic marketing and in research and development, among others in the pharmaceutical ?eld, to deal with the increasingly aggressive tactics of generic companies designed to legally copy innovative drug products.

I think we can agree that generic drugs are a reality and brand name drug companies that do not accept the challenge will do so at their own peril.  In the last 20 years since the Hatch-Waxman Act fostered the generics industry, the generics industry has grown steadily so that now it accounts for well over 50% of the drugs sold in America. As Voet puts it, the generic drug companies will not stop and we can expect them to attack virtually all new drug patents at the earliest possible time.

The purpose of this book is not to provide the complete review and study of pharmaceutical law and regulation.  It is a quick overview to familiarize the reader with both the strategic and tactical aspects of the interaction of patents, FDA regulations, the Hatch-Waxman Act and product improvements on pharmaceutical product life cycles.  This is a must read for pharmaceutical managers and executives who want to succeed in their jobs by becoming knowledgeable in these matters quickly so that they can plan for the successful development and long term success of their company?s pharmaceutical products.

While not intended to replace competent legal counsel, this concise little guide is intended for the busy executive to learn these subjects in understandable language so that you will be able to ask the right questions and understand the answers you receive. Broad in coverage, the book covers patent enforcement and infringement, pharmaceutical product life-cycle management, regulatory matters, and legislation related to pharmaceuticals with Take Home Messages at the end of each chapter summarizing the main points.

Martin A. Voet is a Senior Vice President and Chief Intellectual Property Counsel for Allergan.

The Generic Challenge:  Understanding Patents, FDA & Pharmaceutical Life-Cycle Management (Second Edition) is available at Amazon.

Full post as published by Patent Baristas on November 24, 2008 (boomark / email).