The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents image

Applied Health Economics and Health Policy, August 2018, Vol. 14, Issue 73
Jonathan J. Darrow (Student Fellow Alumnus), Reed F. Beall, Aaron S. Kesselheim


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From the abstract: 


Most new brand-name drugs are protected by patents from generic competition, but these patents are occasionally granted in error. Invalidating such patents has traditionally been accomplished via court litigation by generic manufacturers, which is expensive and time consuming. In 2011, Congress created an administrative alternative to court litigation of patents, called inter partes review, intended to be much faster and less expensive.


To evaluate the use of inter partes review to challenge pharmaceutical patents, including the number of challenges, the number of associated drug products, and the extent to which challengers have been successful.


We obtained data pertaining to inter partes review proceedings, including identity of patent challenger, duration of proceedings, and outcome, from September 16, 2012 through April 24, 2017 from, and combined it with information about drug products and their associated patents, including patent type, contained in the US Food and Drug Administration’s Orange Book.

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health law policy pharmaceuticals