Bradley J Olson
The Supreme Court's Merck KGaA v. Integra Lifesciences I, LTD. Opinion extends the Exemption from Infringement under Section 271(e)(1) to Biotechnology “Research Tools”
Introduction
The exemption from patent infringement under 35 U.S.C. § 271(e)(1) was significantly extended by the Supreme Court in Merck KGaA v. Integra Lifesciences I, Ltd. (“Merck KGaA”) to encompass biotechnology “research tools.” The Merck KGaA opinion permits otherwise infringing use of patented research tools pursuant to the safe harbor provision of Section 271(e)(1) if such activity can be objective supported as being “reasonably related” to the gathering of information intended to be submitted to the Food and Drug Administration (“FDA”) for a new drug approval (“NDA”). In this paper, a brief overview is provided of the Merck KGaA matter and several strategic tools are presented to lessen the negative consequences to research tool manufacturers from the effect of the broadened exemption from infringement after Merck KGaA.
Journal of International Biotechnology Law, Walter de Gruyter
Print ISSN: 1612-6068
Volume: 3, 01/2006
Pages: 16 - 24
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