The Preclinical Research Statutory Infringement Exemption: How Far Back Is 'Reasonably Related'?

On June 13, 2005, the U.S. Supreme Court expanded the safe harbor provision of 35 U.S.C. '271(e)(1) to the "use of patented compounds in preclinical studies ... as long as there is a reasonable basis for believing that the experiments will produce 'the types of information that are relevant to an [Investigational New Drug application ("IND")] or [New Drug Application ("NDA")].'" <i>Merck KGaA v. Integra Lifesciences I, Ltd.</i>, __ U.S. __, 125 S.Ct. 2372, 2383-84 (U.S. 2005) (quoting Brief of U.S. as Amicus Curiae 23) ("<i>Integra II</i>").

23 minute read October 06, 2005 at 09:21 AM
By
K. Shannon Mrksich, Ph.D. and Meredith Martin Addy
The Preclinical Research Statutory Infringement Exemption: How Far Back Is 'Reasonably Related'?

On June 13, 2005, the U.S. Supreme Court expanded the safe harbor provision of 35 U.S.C. '271(e)(1) to the “use of patented compounds in preclinical studies … as long as there is a reasonable basis for believing that the experiments will produce 'the types of information that are relevant to an [Investigational New Drug application ("IND")] or [New Drug Application ("NDA")].'”

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