Friday, August 24, 2007

Experiments Protected From Patent Infringement Finding by FDA Exemption

Case: Integra Lifesciences I, Ltd. v. Merck KGaA (Fed. Cir. No. 02-1052 7/27/07)

The One Sentence Summary: After remand from the Supreme Court, the panel reversed a district court judgment of patent infringement, holding that the FDA safe harbor exemption of 35 U.S.C. ยง 271(e)(1) protected the defendants' medical experiments because the experiments "meet the criteria of being reasonably related to research that, if successful, would be appropriate to include in a submission to the FDA."

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