Scope Of Statutory Research Exemption Remains Unresolved

Law360, New York (July 2, 2013, 5:56 PM EDT) -- The statutory research exemption, 35 U.S.C. § 271(e)(1), affords immunization from patent infringement to developers of products subject to regulation by the U.S. Food and Drug Administration. Over the past several years, the Federal Circuit has embraced seemingly conflicting interpretations on the scope of the safe harbor.

On June 24, 2013, the U.S. Supreme Court declined an opportunity to resolve this tension when it denied a petition for a writ of certiorari by Momenta Pharmaceuticals Inc.[1] This article summarizes the legal landscape for the exemption and...
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