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Generic Pharmaceutical Patent and FDA Law

Copyright © DrugPatentWatch. Originally published at

Generic Pharmaceutical Patent and FDA Law covers Food and Drug Administration approval of generic drugs and the interaction of patents and FDA law.

Some books in this space are written by consultants. Others are written by lawyers. What makes this book especially valuable is that it is written by a long-time in-house counsel with extensive experience leading patent and regulatory issues. Accordingly it brings a fresh new voice and a different set of perspectives than other books in the space.

Because of the author’s years of experience as in-house counsel at generic drug companies The overall tone of Generic Pharmaceutical Patent and FDA Law is very different than books written by external counsel or consultants. Many detailed examples are provided from the author’s experience, and overall the book is well suited for in-house counsel needing to better understand legal and regulatory strategies; it is also very useful for company leadership who need to interface with counsel.

Practice tips are distributed throughout the book. For example the author explains that because patent litigation may hinge on how the material would be interpreted by someone with ‘ordinary’ skills in the technical subject matter, using a Nobel laureate or someone with ‘extra-ordinary’ skill as an expert witness may actually hurt one’s legal case. The text is also liberally complemented by footnotes and annotated citations, helping interested readers delve deeper into the topics.

Another valuable aspect of the book the coverage of emerging trends such as 505(b)(2) drug applications and Competitive Generic Generic Therapy exclusivity. These areas are in flux, yet the author does not shy away from describing the present situation. Much detail is also provided on topics such as how counsel should interface with generic approvals on important matters like responding to FDA-requested changes to manufacturing processes, or to changes in suppliers, to ensure noninfringement of patents.

Much of the text is extremely detailed and technical, which may limit its appeal to readers without legal backgrounds. For example, extensive guidance is provided into drafting, attacking, and defending patent claims, and to how to determine priority dates pre- and post-AIA. Additional deep details are provided into vital areas such avoiding patent infringement and discussion of leading cases in calculating damages. This material is clearly very important for counsel, but those in portfolio management or other business-oriented positions will likely find these sections too technical.

For all the hard work done by the author in assembling this important contribution, I find myself troubled by a decision made by the publisher. Generic Pharmaceutical Patent and FDA Law is likely to be used repeatedly for years. So, it is important that the book be treated as an investment — it should be durable. Yet, the book is only available in softcover and is printed using an extremely light paper stock. This means that the covering is ill-equipped to withstand constant handling and the pages are liable to be torn in the course of regular use. For future editions I would encourage the publisher to pay greater attention to enhancing the durability of the book.

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Generic Pharmaceutical Patent and FDA law
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