Integra Lifesciences I, Ltd. v. Merck KGaA, Nos. 02-1052, -1065 (Fed. Cir. July 27, 2007)

Case Description

The Federal Circuit ruled on the Supreme Court’s broad interpretation of the regulatory review exemption to patent infringement, also known as the Bolar exemption. The Federal Circuit reversed its previous decision of infringement, holding that Merck’s preclinical development activities that were ultimately not the subject of a submission to United States Food and Drug Administration (FDA) were still exempt from infringement under the regulatory review exemption.  

Decision Year
Post-grant flexibilities