The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management

by Martin A. Voet

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.

Genres: Nonfiction, Science

230 pages, Paperback

First published January 15, 2005

Reviews

[Brian · Rating 4 out of 5]

The Generic Challenge is a no nonsense straight to the point overview of how the pharmaceutical life cycle works. It is focused heavily on the role of patents and their offensive capabilities (as opposed to defensive as most people envision) and how the process works in the US, EU and Asia. He covers the when and why to get patents and what types of patents a drug can receive. There is limited talk for biotech and medical devices throughout the book as well. The last part of the book focuses on how to extend patents and maximize coverage. Overall straight to the point and you will either be very interested in this topic or want nothing to do with it.

[Rex · Rating 4 out of 5]

This is very short introduction to patent issues, regulatory issues, and business considerations that are relevant to bringing generic drugs to market (or alternatively preventing the drugs from coming to market). The edition I read (3rd) is very short (174 pages). I appreciated the concise overview. Voet is not shy about his opinions. I just don't have enough background to make any normative judgements about them.