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Webinar: Orange Book listing sheets under the microscope

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Nicholas Mitrokostas



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Image of Matthew Miner
Matthew Miner


Washington, D.C.

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27 April 2022

Preparing the Orange Book listing sheet (i.e., Form FDA 3542) for a U.S. patent is more than just checking the boxes. 

Generic drug companies have recently argued that statements made in those listing sheets could be used to preclude a patent owner in proving infringement; and the courts appear to be receptive to such arguments.

Listen to our discussion on recent caselaw that could implicate your Orange Book listing strategy and learn best practices and considerations to maximize the value of your pharmaceutical patents in the United States.