Mary C. Till and Amanda K. Murphy highlight the USPTO’s request for public comment regarding the experimental use exception.
On 28 June 2024, the United States Patent and Trademark Office (‘USPTO’) issued a Federal Register notice[1] seeking the public’s view on the experimental use exception to patent infringement. The experimental use exception is a common law defence that essentially nullifies an otherwise infringing act if the defendant can prove that the use amounted to non-commercial experimentation.
The experimental use exception first came about in the form of a jury instruction in the 1813 case, Whittemore v Cutter,[2] which stated that ‘The making of a machine fit for use, and with a design to use it for profit, was an act of infringement of the patent right.’ In issuing the jury instruction, Judge Richard Story noted that the ‘for profit’ limitation was ‘certainly favorable to the defendant’, because ‘it could never have been the intention of the legislature to punish a man, who constructed such a machine merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its described effects.’
Following Whittemore, in determining whether a use was sufficiently experimental so as to avoid infringement, other courts looked to whether the infringing act created a benefit for the accused infringer. Where the use was to show superior properties of a competing product (Bonsack Machine v Underwood[3]), establish data for submission to a federal agency (Roche Prod. v Bolar Pharm. Co.[4]), or was ‘expressly for commercial purposes’ (Embrex v Service Engineering Corp.[5]), the courts have found the experimental use exception does not apply.
Five months after the Roche v Bolar decision, Congress codified 35 U.S.C. § 271(e)(1), allowing for the experimental use of a patented invention by parties to collect regulatory approval data for medical devices or drugs. The courts, however, have consistently declined to expand the scope of the experimental use exception. In Madey v Duke University,[6] the Federal Circuit had the opportunity to revisit the scope of the experimental use exception defence to infringement. There, the Federal Circuit narrowly construed the exception which represents the current jurisprudence on experimental use, concluding that, ‘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 defence.’[7]
The USPTO does not appear to have taken a position for or against the experimental use exception in its request for public input. Although the USPTO does not typically concern itself with patent infringement, and although the experimental use defence is touted as not technology specific, the request appears to be driven by a collaboration between the USPTO and the United States Department of Agriculture as part of President Biden’s historic executive order titled ‘Promoting Competition in the American Economy.’ In particular, the ability of the public to experiment with seeds and other agricultural products without being subjected to allegations of patent infringement could potentially enhance the collaborative group’s focus on promoting fairer competition in seeds and other agricultural inputs while also enhancing the delivery of services to the public.
Therefore, the USPTO is seeking input on the following questions relating to the impact of the experimental use exception and potential legislative efforts to codify an experimental use exception to patent infringement claims. The specific questions asked are:
The deadline for responding to the request for comments is 26 September 2024.
Mary Till is Of Counsel in the Washington, DC office of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (‘Finnegan’) and Amanda Murphy is a partner in Finnegan’s London office. The opinions expressed are those of the authors and do not necessarily reflect the views of their firm, its clients, or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice
[1] ‘Experimental Use Exception Request for Comments’, 89 Fed. Reg. 53963, 28 June 2024.
[2] 29 F. Cas, 1120 (C.C.D. Mass 1813).
[3] 73 F.206 (C.C.E.D.N.C. 1896).
[4] 733 F.2d 858 (Fed. Cir. 1984).
[5] 216 F.3d 1343 (Fed. Cir 2000).
[6] 307 F.3d 1351 (Fed. Cir. 2002).
[7] Id. at 1352.
