Devices Not Subject to FDA Pre-Market Approval Not Immune from Infringement under the “Safe Harbor”

On August 5, the U.S. Court of Appeals for the Federal Circuit delivered a significant opinion regarding the so-called “safe harbor” provision of 35 U.S.C. § 271(e)(1). In the case of Proveris Scientific Corp. v. Innovasystems, Inc., No. 07-1428 (Fed. Cir. Aug. 5, 2008), the Federal Circuit held that an infringing device, which is not subject to the Food and Drug Administration’s (FDA’s) pre-market approval process itself, is not entitled to the benefit of the safe harbor. Slip op. at 15.

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