The generic pharmaceutical industry exists at the intersection of business, science, law, and government regulation. To be perform well in any of these disparate areas requires deep specialization (e.g. a Ph.D in science, a law degree, etc.), but for overall success of a generic drug company, or those interfacing with generic drug companies, it is essential to have a solid appreciation of the sectors outside one’s specialty and how they integrate to enable (and constrain) commercialization.
The Generic Challenge presents a uniquely broad, practical, and actionable overview of the important interplay of patents, government regulations, and business considerations that are essential for success in the pharmaceutical industry.
Author Martin Voet has experience as Senior Vice President Chief Intellectual Property Counsel at Allergan, and he now serves as a consultant and teaches intellectual property law at UCSD’s law school. His extensive experience as patent counsel is apparent, as he is able to deftly inform the reader of why patents are important, and of the vital strategic implications in their use, while avoiding the trap of explaining the minutiae of patent law (which is a topic best left to specialists).
For a book with this breadth of topics it is relatively short, at roughly 200 pages. This brevity exemplifies the challenge faced by Voet in covering the diverse subject matter without belaboring the reader with excessive detail. It is a considerable challenge. How does one efficiently cover important topics such as inducement of patent infringement or regulatory data exclusivity in a way that facilitates a productive understanding? Voet does this by firstly electing not to provide footnotes — forcing him to summarize topics rather than provide exhaustive coverage of examples and counter-examples — and he also provides useful case studies which help provide clear illustration to complement the technical discussion.
While reading The Generic Challenge I tried to model the audience for whom the book would be most useful. The topics covered are not trivial — launching a generic drug and avoiding patent infringement is not a simple matter. When filing or protecting patents, for example, the best course of action is to seek guidance from experienced specialists. So, who would benefit from a book toeing the line of enabling appreciation without going into too much detail? In conclusion it appears that the book is perfectly suited for introductory courses related the pharmaceutical industry and for most any pharmaceutical company employee who needs a better understanding of the industry within which they operate. With the potent introduction provided by this book the reader will be better equipped to decide how and when to seek help from experienced experts with knowledge of patents, FDA regulations, and other refined specialies within the pharmaceutical industry.