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Merck Kgaa V. Integra Lifesciences I, Ltd.: Does The Breadth Of Safe Harbor Protection Toll The Death Knell For Biotech Research Companies?, Tiffany L. Williams

Mercer Law Review

In Merck KGaA v. Integra Lifesciences I, Ltd., the United States Supreme Court held that use of patented inventions during research where there was a reasonable basis for believing that the experiments would produce information relevant to Food and Drug Administration ("FDA") approval was protected from patent infringement lawsuits under 35 U.S.C. § 271(e)(1), commonly referred to as the "safe harbor" provision. This decision affirmed almost two decades of judicial decisions affording broad interpretation to the safe harbor provision and reversed the Federal Circuit's creation of a bright-line test limiting the scope of section 271(e)(1).