Digital Commons Network^™

Merck Kgaa V. Integra Lifesciences I, Ltd.: Greater Research Protection For Drug Manufacturers, Samuel Rubin

Duke Journal of Constitutional Law & Public Policy Sidebar

Merck sought protection under a statutory exemption from claims of patent infringement brought by Integra Lifesciences. The Court held unanimously that the safe harbor contained in 35 U.S.C. § 271(e)(1) protected the use of patented inventions used in preclinical research where the results were not submitted to the FDA. The Court's interpretation of the safe harbor provision broadened protection for those engaged in drug research at a substantial cost to patent-holders.