In Proveris Scientific Corp. v. Innovasystems, Inc., 536 F.3d 1256 (Fed. Cir. 2008), the Federal Circuit addressed whether the “safe-harbor” provision of the Hatch-Waxman Act (codified at 21 U.S.C.
Proveris Scientific Corp. v. Innovasystems, Inc.: Federal Circuit Addresses 'Safe-Harbor' Immunity
In <i>Proveris Scientific Corp. v. Innovasystems, Inc.,</i> the Federal Circuit addressed whether the "safe-harbor" provision of the Hatch-Waxman Act applies to immunize infringement if the accused product is reasonably related to the development and submission of information to the FDA for regulatory approval purposes.
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