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

By K. Shannon Mrksich, Ph.D. and Meredith Martin Addy

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")].'” Merck KGaA v. Integra Lifesciences I, Ltd., __ U.S. __, 125 S.Ct. 2372, 2383-84 (U.S. 2005) (quoting Brief of U.S. as Amicus Curiae 23) (“Integra II“).

Integra Lifesciences I, Ltd. (“Integra”) sued Merck KGaA and Scripps Research Institute (collectively, “Merck”) for infringement of five patents related to methods for contacting cells with tripeptides of the sequence Arg-Gly-Asp (“RGD peptides”). See, e.g., U.S. Patent No. 4,988,621. The patented methods promote cell adhesion, inhibit cell proliferation, and selectively detach malignant cells, amongst other claimed results.

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