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U.S. Supreme Court
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Merck KGaA v. Integra Lifesciences I — FDA Safe Harbor Covers All Pre-Clinical Research Reasonably Related to Drug Approval

The Supreme Court held that 35 U.S.C. § 271(e)(1)’s safe harbor exempts from patent infringement all uses of patented compounds that are reasonably related to generating information for an FDA submission, including preclinical studies that do not themselves produce data submitted to the FDA.

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