Tina Dorr, Ph.D.

In several previous articles (1, 2a, 2b), we reviewed key cases on the common law experimental use exemption and the statutory safe harbor under the Hatch Waxman Act. In this last installment, we  will provide practical advice on what it takes to successfully invoke the exemptions during litigation or (where possible) avoid litigation entirely.  We thus conclude our series of with some practical tips for both patentees and defendants dealing with (A) the common law research exemption and (B) activities “reasonably related” to the development and submission of information under the Hatch-Waxman Act, including an update from the Federal Circuit’s § 271(e)(1) safe harbor jurisprudence.

In a previous article, we analyzed the contours of the common law experimental use exemption. Now, we will explore the application of the exemption to common research activities, including those at universities and research institutions, in cases spanning recent decades. These cases illustrate the narrow confines of the experimental use exemption and its limited applicability in scenarios involving activities with direct or indirect commercial or business-related objectives. As a result, researchers should tread carefully and not count on the exemption to shield them from liability for patent infringement.   

When exploring exemptions to patent infringement, there are several key U.S. Court of Appeals for the Federal Circuit cases to be aware of. First, we will examine a number of cases that have shaped the contours of the common law experimental use exemption, which applies to all industries, and secondly, we will look at recent decisions evaluating activities under the safe harbor of 35 U.S.C. § 271(e)(1) for products requiring U.S. Food and Drug Administration (“FDA”) approval.