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ARTICLE · 15 AUGUST 2013

Scope Of Statutory Research Exemption Remains Unresolved

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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.

United StatesIntellectual Property
David Harburger
David Harburger
Atulya Agarwal
Atulya Agarwal
Deborah Fishman
Deborah Fishman
Katie Scott
Katie Scott
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Law360, New York (July 02, 2013, 5:56 PM ET) - 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 offers strategic considerations for both patentees and companies developing therapeutics, diagnostics and medical devices.

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