The USPTO’s “Experimental Use Exception Request for Comments”

The USPTO released “Experimental Use Exception Request for Comments” in the Federal Register on Friday June 28, 2024. 89 Fed. Reg. 53,963 (June 28, 2024). 

Alleged infringers may argue in certain circumstances that activity is “experimental use” and therefore not infringing. The Federal Circuit, however, has narrowly construed the experimental defense to patent infringement. In Madey v. Duke University, the Federal Circuit concluded that ‘‘regardless of whether a particular institution or entity is engaged in an endeavor for commercial gain, so long as the act 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, the act does not qualify for the very narrow and strictly limited experimental use defense.’’ 307 F.3d 1361, 1352 (Fed.Cir. 2002). Similarly, in Roche Prod. V. Bolar Pharm. Co., 733 F.2d 858 (Fed. Cir. 1984), the Federal Circuit found the defendant’s conduct in developing a generic drug product infringing since the court “cannot construe the experimental use rule so broadly as to allow a violation of the patent laws in the guise of ‘scientific inquiry,’ when that inquiry has definite, cognizable, and not insubstantial commercial purposes.” Id. at 863.

Following the Roche v. Bolar decision, the United States codified a safe harbor provision for drug development at 35 U.S.C. 271(e)(1). This, and similar exemptions in other jurisdictions, are often referred to as a “Bolar exemption.” In addition, the Plant Variety Protection Act contains exemptions that allow for others to use the protected variety in research and for breeding.

The USPTO’s “Experimental Use” request for comments seeks to investigate whether the Bolar exemption should be broadened to include activities beyond drug development, and specifically singles out the agricultural industry as an area where a Bolar exemption may be of interest. The request for comments, however, seeks input from the public about an experimental use exception for all technologies. The current effort purports to be aimed at encouraging innovation and fair competition. The USPTO poses 8 questions along those lines. For example, Question 3:

Please explain what impact, if any, a statutory experimental use exception would have on the innovation and commercialization of new technologies including with respect to: (a) research and development; (b) ability to obtain funding; (c) investment strategy; (d) licensing of patents and patent applications; (e) product development; (f) sales, including downstream and upstream sales; (g) competition; and (h) patent enforcement and litigation.

Takeaways

Written comments must be submitted by Sept. 26, 2024, to be considered.