This Fifth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.

About the Author:

Martin A. Voet is a Senior Vice President and Chief Intellectual Property Counsel for a Fortune 500 pharmaceutical company with over 20 years experience in intellectual property practice. He has degrees in chemistry, business and law and years of practical experience in patenting pharmaceutical products, litigating with generic companies over them and providing practical, hands-on planning for pharmaceutical life-cycle management.

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