Merck KGaA v. Integra Lifesciences I, Ltd.
Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), is a United States Supreme Court case with ramifications for patent law. The dispute dates to approximately 1996 and centers on a federal law known as the "FDA safe harbor" (§ 271(e)(1)). While the Court refused to "quibble" with the Court of Appeals over its conclusion that the exemption “does not globally embrace all experimental activity that at some point, however attenuated, may lead to an FDA approval process,” the Court held that: