Preclinical research that is not included in an FDA submission can be exempt from patent infringement under 35 U.S.C. § 271(e)(1) if the drug maker has a reasonable basis for believing that the research, if successful, would be appropriate to include in an FDA submission.

Preclinical research that is not included in an FDA submission can be exempt from patent infringement under 35 U.S.C. § 271(e)(1) if the drug maker has a reasonable basis for believing that the research, if successful, would be appropriate to include in an FDA submission.