The safe harbor provision set forth in 35 U.S.C. § 271(e)(1) immunizes many types of activities in pursuit of a Food and Drug Administration (FDA) submission from patent infringement claims. Research tools are frequently used in pursuit of an FDA submission, such as drug development, testing and screening. But research tools themselves generally are not subject to FDA or other regulatory approval. Depending on the circumstances, using research tools to submit data to the FDA may not be protected by the safe harbor provision and thus may expose companies to patent infringement claims.