USPTO Seeks Public Input on Patents and the Right to Research

By: Charles Duan

July 10, 2024

On June 28, the U.S. Patent and Trademark Office issued a request for public comments on potential legislation for an experimental use exception in patent law. [1] Comments are due to the USPTO by September 26, 2024. This comment period presents an important opportunity for researchers and other interested parties to weigh in on the effects of intellectual property on research activities, and potentially to shape future limitations and exceptions to IP laws.

I. PATENTS AND RESEARCH: CURRENT LAW

Similar to other IP rights, a patent provides its holder with exclusive rights over an invention or technology, including exclusive rights to make, use, and sell the invention. Research work intersects with these patent exclusivities in at least two ways. First, a researcher may use patented tools, such as laboratory equipment or genetically modified test samples.

Second and perhaps more importantly, researchers may want to experiment with the patented invention itself: emissions issues with a patented car, safety or efficacy problems with a patented drug, cybersecurity vulnerabilities in patented software. Conducting these experiments requires the researcher to use the patented item, potentially constituting patent infringement.

Patent law recognizes an “experimental use” exception to infringement, but the exception is “very narrow and limited to actions performed for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry.” [2] Among other things, research institutions’ activities that attract “grants, students and faculty” do not qualify for the exception, because those benefits are “legitimate business objectives” of the researchers. [3] Thus, it is widely recognized that the experimental use exception of patent law is virtually impossible to satisfy. [4]

II. CONCERNS WITH THE LACK OF A PATENT EXPERIMENTAL USE EXCEPTION: DRUGS AND SEEDS

American patent law’s lack of an effective exception for researchers has raised concerns among policymakers over the years. In the context of pharmaceuticals, for example, a 1984 case held that it was unexcused patent infringement to conduct the research on a generic drug necessary to obtain approval for the drug from the U.S. Food and Drug Administration. [5] Within the same year, Congress abrogated the decision, creating a specific exception to patent infringement for research necessary to secure FDA approval for a drug. [6]

More recently, attention has turned to research on patents in agriculture. In 2021, the Biden Administration’s executive order on competition directed the U.S. Department of Agriculture to prepare a report on patents and competition in markets for seed and other agricultural inputs. [7] The USDA released its report in 2023. [8] With regard to research and patents, the report observed that research into developing new plant varieties can often take many years, so a research exception in patent law could be “necessary in the field of plant breeding to maximize the potential for innovation.” [9] Furthermore, the report noted: “Intellectual property rights that restrict research prevent analysis of the genetic composition” of agricultural products, raising concerns of national food security. [10]

These concerns led the USDA to recommend collaboration with the USPTO to consider new legal proposals, “including the addition of research or breeding exemptions for U.S. utility patents.” [11] The current USPTO request for comments on a research exception to patent law stems in part from this report and concerns about the impact of patent law on agricultural research. [12]

III. INFORMATION BEING REQUESTED, AND NEXT STEPS

In its request for comments, the USPTO seeks information on “the current state of the common law experimental use exception and whether legislative action should be considered to enact a statutory experimental use exception.” [13] Particularly, the agency is looking for information about what researchers do with patented inventions, examples of how patent law has affected researchers, and what protections for researchers would be useful. The request for comments asks about how current law “impacts investment and/or research and development in any field of technology,” and “what impact, if any, a statutory experimental use exception would have on . . . research and development.” [14]

While the USPTO does not say specifically what it will do with comments received, it likely will use them to prepare a report of stakeholder views on potential legislation about an experimental use exception. Past USPTO reports based on similar requests for comments have largely focused on summarizing the quantity and nature of responses received. [15]

While the agency itself does not have authority to create an exception to patent infringement, its views as an expert patent law authority will likely be important to lawmakers. Congress has already been considering a research exception to patent law in recent legislation that would otherwise potentially expand patent protection relating to scientific discoveries and natural phenomena. [16]

This request for comments thus represents an important opportunity for researchers and the public to provide input on significant legislative efforts that may affect IP law and the right to research.

IV. ABOUT THE AUTHOR

Charles Duan is an assistant professor at the American University Washington College of Law. His research focuses on intellectual property laws and their effects on the public interest. He is also the Vice Chair of the Patent Public Advisory Committee of the U.S. Patent and Trademark Office. The views expressed in this article are his own and not those of any affiliated institutions.

Footnotes:

[1] See Experimental Use Exception Request for Comments, 89 Fed. Reg. 53963 (Pat. & Trademark Off. June 28, 2024).

[2] Madey v. Duke Univ., 307 F.3d 1351, 1362 (Fed. Cir. 2002) (quoting Embrex, Inc. v. Serv. Eng’g Corp., 216 F.3d 1343, 1349 (Fed. Cir. 2000)) (internal quotations omitted).

[3] Id.

[4] See, e.g., Katherine J. Strandburg, What Does the Public Get—Experimental Use and the Patent Bargain, 2004 Wis. L. Rev. 81.

[5] See Roche Prods. v. Bolar Pharm. Co., 733 F.2d 858, 861 (Fed. Cir. 1984).

[6] See Drug Price Competition and Patent Term Restoration Act, Pub. L. No. 98-417, 98 Stat. 1585 (1984); 35 U.S.C. § 271(e)(1).

[7] See Exec. Order No. 14036, 3 C.F.R. 609, § 5(i)(v), at 617 (2022).

[8] See Agric. Mktg. Serv., U.S. Dep’t of Agric., More and Better Choices for Farmers: Promoting Fair Competition and Innovation in Seeds and Other Agricultural Inputs (Mar. 2023), https://www.ams.usda.gov/sites/default/files/media/SeedsReport.pdf.

[9] Id. at 32 (quoting International Seed Federation).

[10] Id. at 63.

[11] Id. at 40.

[12] See Experimental Use Exception Request for Comments, 89 Fed. Reg. 53963, 53965 (Pat. & Trademark Off. June 28, 2024).

[13] Id. at 53963.

[14] Id. at 53965.

[15] See, e.g., U.S. Pat. & Trademark Off., Patent Eligible Subject Matter: Public Views on the Current Jurisprudence in the United States (June 2022), https://www.uspto.gov/sites/default/files/documents/USPTO-SubjectMatterEligibility-PublicViews.pdf.

[16] See Michael Borella, Senate Subcommittee on Intellectual Property Holds Hearings on Proposed Revisions to 35 U.S.C. § 101, Pat. Docs (June 17, 2019), https://www.patentdocs.org/2019/06/senate-subcommittee-on-intellectual-property-holds-hearings-on-proposed-revisions-to-35-usc-101.html.