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Merck V. Integra: The Impact of a Broader "Safe Harbor" Exemption on Nanobiotechnology
Volume 2, Issue 3

Stephen B. Maebius, Foley & Lardner
Harold C. Wegner, Foley & Lardner

The safe harbor established under 35 U.S.C. § 271(e)(1) allows one to use a patented invention solely for uses reasonably related to FDA approval. Courts have alternately focused on the solely for part of the statutory phrase when they wanted to narrow the reach of the safe harbor and the reasonably related part of the statutory phrase when they wished to expand the safe harbor. In this article, Stephen B. Maebius and Harold C. Wegner analyze the recent Supreme Court decision in Merck KGaA v. Integra LifeSciences I, Ltd. Maebius and Wegner conclude that there is uncertainty ahead for Americas research use exemption to patent infringement, which might only be clarified through future case law or a legislative solution. However, although some kinds of nanobiotech patents may be weakened by the Merck ruling, there are still plenty of reasons to continue patenting research tools in nanotech and other areas.

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