On June 27, 2024, the United States Patent and Trade Office ("USPTO") published a request for comments ("RFC") in the Federal Register inquiring about the current state of the experimental use defense to patent infringement and to determine the potential value of legislative action on the issue. This RFC both supports the President's 2021 Executive Order on Promoting Competition in the American Economy and furthers the United States Department of Agriculture and the USPTO's joint commitment to evaluate "New proposals for incentivizing and protecting innovation in the seed and agricultural-related space, including the addition of research or breeders' exemptions for U.S. utility patents."1
Background
Also known as the research exemption, the experimental use exemption can be traced back to the appellate affirmation of a jury instruction provided in the 1813 case Whittemore v. Cutter.2 The Whittemore court presided over a patent infringement suit wherein the Defendant was alleged to have infringed upon a patent for a playing card manufacturing machine. The jury was instructed "the making of a machine fit for use, and with a design to use it for profit, was an infringement." On appeal, the Court found that the instruction was proper 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."
The general premise, that patent infringement cannot occur from an endeavor which is directed towards research, was affirmed by subsequent courts; however, research with commercial intent was not afforded the exemption. In Bonsack Machine v. Underwood,3 Roche Prod. v. Bolar Pharm. Co.,4and Embrex v. Service Engineering Corp. 5 the courts found that despite the alleged infringing activities being directed towards the pursuit of knowledge, the substantial commercial intent behind the acquisition of that information was sufficient to invalidate any experimental use exemption.
The doctrine was further narrowed by the U.S. Court of Appeals in the 2002 case Madey v. Duke University, wherein the court found that "so long as the [alleged 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, the act does not qualify for the very narrow and strictly limited experimental use defense."6 This highly restrictive understanding of the experimental use exception remains instructive jurisprudence today.
Justification for the Codification of the Exception
Following the Madey ruling, calls were made from academic and legal spheres to codify the exemption, either to further clarify or expand it.7 Some argued that the current interpretation of the exemption was overly narrow and frustrated the entire purpose of the patent system, to promote innovation in the useful arts, by directly preventing valuable experimentation from occurring. The United States has already codified some limited exemptions to experimental use, notably 35 U.S.C. 271(e)(1), the safe harbor exemption, which allows the use of patented inventions for the purposes of obtaining regulatory approval data for medical devices and pharmaceuticals.
The RFC continues by discussing the current legal status of similar exemptions to patent infringement overseas. In Europe, Asia, and the Americas, many countries have statutory experimental use exceptions with some nations providing broader protections than those afforded by the exemption domestically. Notably, in Germany,8 France,9 the UK,10 Spain,11 Italy,12, Switzerland,13 and the Netherlands,14 the statutory experimental use exemption applies to any experimental purpose.
The Request for Comments
The USPTO has provided the RFC with the intent of identifying the public's views on the impacts of the statutory use exception in particular subject areas such as the agricultural industry, wherein such a statutory change may incentivize innovation. The RFC continues by providing a series of questions which chiefly serve to identify the respondent's relationship to an industry, inquire how the current state of the experimental use exception jurisprudence may negatively or positively influence technology development in that area, and identify if and how a statutory exemption should be defined and enacted.
The comment period will be open to the general public until September 26, 2024 and should be submitted through the Federal eRulemaking Portal at https://www.regulations.gov. To submit comments via the portal, enter docket number PTO-C-2024-0023 on the homepage and click "Search." The site will provide a search results page listing all documents associated with this docket. Find a reference to this request for information and click on the "Comment" icon, complete the required fields, and enter or attach your comments. Comments will be available to the public and therefore personal information should not be included.
Footnotes
1 Agric. Mktg. Serv., U.S. Dep't Agric., More and Better Choices for Farmers: Promoting Fair Competition and Innovation in Seeds and Other Agricultural Inputs, at 6 (2023).
2 Whittemore v. Cutter, 29 F. Cas. 1120 (C.C.D. Mass. 1813) (Case No. 17,600)
3 Bonsack Mach. Co. v. Underwood, 73 F. 206 (C.C.E.D.N.C. 1896)
4 Roche Prod. v. Bolar Pharm. Co., 733 F.2d 858, 862 (Fed. Cir. 1984)
5 Embrex, Inc. v. Service Engineering Corp., 216 F.3d 1343 (Fed. Cir. 2000)
6 Madey v. Duke University, 307 F.3d 1361 (Fed. Cir. 2002) at 1352
7 John R. Thomas, Scientific Research and the Experimental Use Privilege in Patent Law, CRS Report No. RL32651 (2004).
8 Patentgesetz [Patent Act], Dec. 16, 1980, Bundesgesetzblatt, Teil I, [BGBl I] at 4074, as amended Aug. 30, 2021, section 11 No. 2 (Ger.).
9 French Code of Intellectual Property, L. 613-5.
10 U.K. Patents Act 1977, (1977) art. 60(5)(b), 37 Current Law 1 (Eng.).
11 Law 11/1986 of 20 March on Patents. Art. 52(1)(b).
12 Industrial Property Code (Legislative Decree No. 30 of February 10, 2005, as amended up to Law No. 102 of July 24, 2023) Art. 68(1)(a) (Italy).
13 Article 9(e) of the Federal Act on Patents for Inventions, adopted in 2008.
14 Netherlands Patent Act (15 Dec 1994, as amended) Art. 53(3).
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