USPTO Requests Comments on the Experimental Use Exception

USPTO Requests Comments on the Experimental Use Exception

The United States Patent and Trademark Office ("USPTO") is seeking public input about the need for a statutory experimental use exception in light of the common law jurisprudence.

On June 28, 2024, the USPTO issued a request for comments ("RFC") seeking public input on the current state of the common law experimental use exception to patent infringement and whether Congress should enact a statutory experimental use exception. The RFC is "consistent with the President's 2021 Executive Order on Promoting Competition in the American Economy" and asks for public views on the impact of the experimental use exception in all technology areas. 89 Fed. Reg. 53963, 53965 (June 28, 2024).

The RFC states that under current jurisprudence an alleged infringer cannot invoke an experimental use defense if "the act [of infringement] is in furtherance of the alleged infringer's legitimate business and is not solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry." Id. at 53964 (citing Madey v. Duke Univ., 307 F.3d 1352, 1362 (Fed. Cir. 2002)). The request compares "[t]his narrow and strictly limited experimental use defense" to the broader statutory exemptions in Europe, Asia, Canada, and Latin America. Id. In addition, the request acknowledges that Congress has enacted the safe harbor provision under 35 U.S.C. 271(e)(1), which "allows for the experimental use of a patented invention by parties to collect regulatory approval data for medical devices and drugs," and that 7 U.S.C. § 2544 contains an exemption allowing for "the use and reproduction of a protected variety for plant breeding or other bona fide research." Id. As such, the RFC asks the public if the United States should adopt a statutory experimental use exception, and if so, how it should be defined.

The USPTO seeks comments on, inter alia: (i) the impact of current U.S. experimental use exception jurisprudence on investment and/or research and development; (ii) the impact of a statutory experimental use exception on innovation and commercialization of new technologies; (iii) how the current jurisprudence has impacted the public's willingness to utilize the U.S. patent system; and (iv) how a statutory exception, if any, should be defined and public policy reasons relating to maintaining the status quo or adopting such exception. 

The deadline to submit comments is September 26, 2024.

Insights by Jones Day should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without the prior written consent of the Firm, to be given or withheld at our discretion. To request permission to reprint or reuse any of our Insights, please use our “Contact Us” form, which can be found on our website at This Insight is not intended to create, and neither publication nor receipt of it constitutes, an attorney-client relationship. The views set forth herein are the personal views of the authors and do not necessarily reflect those of the Firm.