United States Court of Appeals for the Federal Circuit ______________________

UNIVERSITY OF SOUTH FLORIDA BOARD OF TRUSTEES, Plaintiff-Appellant

v.

UNITED STATES, Defendant-Appellee ______________________

2022-2248 ______________________

Appeal from the United States Court of Federal Claims in No. 1:15-cv-01549-PEC, Judge Patricia E. Campbell- Smith. ______________________

Decided: February 9, 2024 ______________________

STEVEN B. KELBER, The Kelber Law Group, Bethesda, MD, argued for plaintiff-appellant. Also represented by JERRY STOUCK, North Bethesda, MD.

WALTER W. BROWN, Commercial Litigation Branch, Civil Division, United States Department of Justice, Wash- ington, DC, argued for defendant-appellee. Also repre- sented by BRIAN M. BOYNTON, GARY LEE HAUSKEN, KAVYASRI NAGUMOTU, CARRIE ROSATO. ______________________ Case: 22-2248 Document: 37 Page: 2 Filed: 02/09/2024

2 UNIVERSITY OF SOUTH FLORIDA BOARD OF TRUSTEES v. US

Before REYNA, TARANTO, and STOLL, Circuit Judges. TARANTO, Circuit Judge. University of South Florida Board of Trustees (USF) owns now-expired United States Patent No. 5,898,094, which was issued in 1999 and is titled “Transgenic Mice Expressing APPK670N,M671L and a Mutant Presenilin Transgenes.” In 2015, USF sued the United States in the Court of Federal Claims (Claims Court) under 28 U.S.C. § 1498(a), alleging that the United States was liable for in- fringement of the ʼ094 patent because, as is undisputed be- fore us, The Jackson Laboratory, with the government’s authorization and consent, had been producing and using mice covered by the patent for the government. As a de- fense, the government argued that the United States had a license to practice the patent, and have the patent prac- ticed on its behalf, under 35 U.S.C. § 202(c)(4), a provision of the Bayh-Dole Act, Pub. L. No. 96-517, § 6(a), 94 Stat. 3019–28 (1980) (codified as amended at 35 U.S.C. §§ 200– 12), which addresses patent rights in work funded by the federal government. After summary-judgment proceed- ings and a trial, the Claims Court agreed with the govern- ment and entered final judgment of noninfringement. University of South Florida, Board of Trustees v. United States, 162 Fed. Cl. 59 (2022) (Claims Court Decision). USF timely appealed. We have jurisdiction under 28 U.S.C. § 1295(a)(3). There is no dispute that the judgment must be affirmed if § 202(c)(4) applies. We conclude that the provision does apply. We therefore affirm. I A The ʼ094 patent describes and claims doubly trans- genic mice with accelerated pathology for Alzheimer’s Dis- ease, produced by the mice’s expression of both a mutant Swedish amyloid precursor protein transgene and a Case: 22-2248 Document: 37 Page: 3 Filed: 02/09/2024

UNIVERSITY OF SOUTH FLORIDA BOARD OF TRUSTEES v. US 3

mutant presenilin transgene. See ʼ094 patent, Abstract and col. 14, line 26 through col. 16, line 59. Claim 1 states: 1. A transgenic mouse with enhanced Alzheimer’s Disease related amyloid accumulation in its brain produced by: producing an F1 generation mouse by cross- ing a first transgenic mouse whose genome comprises at least one transgene compris- ing a DNA sequence encoding mutant pre- senilin M146L operably linked to a promoter with a second transgenic mouse whose genome comprises at least one transgene comprising a DNA sequence en- coding APP K670N,M671L operably linked to a promoter, wherein the first transgenic mouse expresses the DNA se