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2005 United States Supreme Court case From Wikipedia, the free encyclopedia
Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), is a United States Supreme Court case with ramifications for patent law.[1] The dispute dates to approximately 1996 and centers on a federal law known as the "FDA safe harbor" (§ 271(e)(1)).[2]
Merck KGaA v. Integra Lifesciences I, Ltd. | |
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Argued April 20, 2005 Decided June 13, 2005 | |
Full case name | Merck KGaA, Petitioner v. Integra Lifesciences I, Ltd., et al. |
Citations | 545 U.S. 193 (more) 125 S. Ct. 2372; 162 L. Ed. 2d 160; 2005 U.S. LEXIS 4840; 73 U.S.L.W. 4468; 74 U.S.P.Q.2d (BNA) 1801; 18 Fla. L. Weekly Fed. S 394 |
Case history | |
Prior | Integra Lifesciences I, Ltd. v. Merck KGaA, 331 F.3d 860 (Fed. Cir. 2003); cert. granted, 543 U.S. 1041 (2005). |
Subsequent | On remand at Integra Lifesciences I, LTD. v. Merck KGaA, 496 F.3d 1334 (Fed. Cir. 2005). |
Holding | |
The Court held that the use of patented compounds in preclinical studies is protected under § 271(e)(1) at least as long as there is a reasonable basis to believe that the compound tested could be the subject of an FDA submission and the experiments will produce the types of information relevant to an IND or NDA. | |
Court membership | |
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Case opinion | |
Majority | Scalia, joined by unanimous |
Laws applied | |
U.S. Const.; |
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:
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