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Expert Opin Ther Pat · Aug 2013
EditorialStrategic considerations under the Biologics Price Competition and Innovation Act.
- John L Marquardt and Stephen R Auten.
- Expert Opin Ther Pat. 2013 Aug 1; 23 (8): 915-8.
AbstractThe 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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