Merck Kgaa v. Integra Lifesciences I, Ltd.

Summary

The Court held that the safe harbor protection of 35 U.S.C. § 271(e)(1) extends to all uses of patented inventions reasonably related to the development and submission of any information under the FDCA, including preclinical studies. The exemption covers experimentation on compounds that do not ultimately result in an FDA submission if there was a reasonable basis to believe they would generate relevant information.