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April 20
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2005
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June 13
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2005
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Merck KGaA, Petitioner v Integra Lifesciences I, Ltd, et al
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545
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193
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125 S Ct 2372 162 L Ed 2d 160 2005 US LEXIS 4840 73 USLW 4468 74 USPQ2D (BNA) 1801 18 Fla L Weekly Fed S 394
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On writ of Cert to the United States Court of Appeals for the Federal Circuit ''Integra Lifesciences I, Ltd v Merck KGaA'', 331 F3d 860, 2003 US App LEXIS 11335 (Fed Cir, 2003)
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On remand at ''Integra Lifesciences I, LTD v Merck KGaA'', 2005 US App LEXIS 17342 (Fed Cir, Aug 17, 2005)
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The Court held that the use of patented compounds in preclinical studies is protected under ยง271(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
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1994-2005
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Scalia
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''unanimous''
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US Const
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'',
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 ".
- Complete text of the decision
- Kintisch, E. (2005, April 8). ''Case probes what's fair game in the search for new drugs''. In ''Science, 308'', 174.
- Mamudi, Sam, ''Supreme Court broadens research exemption'', Managing Intellectual Property, June 14, 2005
