Strategic considerations under the Biologics Price Competition and Innovation Act

John L Marquardt, Stephen R Auten
Expert Opinion on Therapeutic Patents 2013, 23 (8): 915-8
The Biologics Price Competition and Innovation Act provides a pathway for regulatory approval of generic drugs and the associated patent challenge. This article reviews strategic considerations during the patent litigation and injunction phases. Considerations during the initial patent litigation phase include when and whether to exchange a paragraph k application and the listing and exchange of patent information during the volley phase.

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