Evaluating the Integraty of Biotechnology Research Tools: Merck v. Integra and the Scope of 35 U.S.C. Section 271(e)(1)
31 Pages Posted: 8 Jan 2009
Date Written: December 1, 2006
Abstract
Congress enacted 35 U.S.C. section 271(e)(1) to provide an exemption for uses of patented products directed toward submitting information to the FDA. Research tool use is "reasonably related" to this information submission, as required by section 271(e)(1). But, the "patented inventions" referred to in section 271(e)(1) refer to inventions that are themselves subject to FDA regulation. Because research tools are not incorporated into the final product submitted to FDA, they are not subject to FDA regulation and therefore are not "patented inventions" under section 271(e)(1). Consequently, research tools do not qualify for the section 271(e)(1) exemption.
Keywords: Patent, Infringement, Hatch-Waxman Safe Harbor
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