Current Trends In Biologics-Related Inter Partes Reviews

By John Molenda and Richard Praseuth (July 20, 2017, 12:28 PM EDT) -- Inter partes review is increasingly becoming the method of choice for challenging patents directed to blockbuster biopharmaceuticals and methods of their manufacture. Examples include challenges to patents relating to aging biologics such as Rituxan[1] and Humira,[2] next-generation biologics such as Kadcyla,[3] and methods of manufacturing biologics.[4]

IPRs provide a number of distinct advantages over litigating biologics cases in district court, including lower cost, lower burden of proof, and faster time to final judgment, as well as the enhanced technical expertise of the administrative patent judges.[5] And for biosimilar applicants in particular, the relative simplicity and speed of IPRs can be an attractive...

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