CAFC Reverses Jury Decision In Board Of Regents Of The University Of Texas System v. Boston Scientific Corp.

On July 27, 2026, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Board of Regents of the University of Texas System v. Boston Scientific Corp., reversing a jury trial verdict that found Boston Scientific Corporation (BSC) liable for infringing a Board of Regents of the University of Texas System (UT) owned patent for drug-releasing biodegradable fiber implants. In the reversal, the CAFC found that the '296 patent was anticipated by U.S. Patent No. 5,364,627 (the '627 patent, “Song”) and that BSC was entitled to judgment as a matter of law (JMOL) on both anticipation and non-infringement, returning the $49.4 million jury awarded damages to BSC.

UT owns U.S. Patent No. 6,596,296 (the '296 patent), which generally relates to biodegradable polymer fibers including two immiscible phases, with one phase including the polymer and the other including a dispersed therapeutic agent for controlled release. In 2017, UT filed a lawsuit alleging BSC infringed the '296 patent through the use and sale of their drug-releasing coronary stent systems. Claim 1, the representative independent claim of the '296 patent, claims a composition including at least one biodegradable polymer fiber including two immiscible phases, where one phase is the biodegradable polymer and the other is the dispersed therapeutic agent:

Claim 1. A composition comprising at least one biodegradable polymer fiber wherein said fiber is composed of a first phase and a second phase, the first and second phases being immiscible, and wherein the second phase comprises one or more therapeutic agents.

After the suit was transferred from the Western District of Texas to the District of Delaware, the district court completed claim construction proceedings and a jury found that BSC willfully infringed the asserted claims 1, 11, 17, and 26 of the '296 patent. The jury also ruled that the '296 patent was not anticipated by the '627 patent and awarded UT damages of $42 million (in addition to about $7.4 million in pre-judgment interest). While the district court later set aside the willfulness finding, the verdict was otherwise upheld, with the court entering judgment in favor of UT in June 2024. BSC appealed the verdict regarding infringement and anticipation, with UT additionally cross-appealing the willfulness finding. The JMOL denial was reviewed under the 3rd Circuit’s de novo standard as the CAFC applies regional circuit procedural law. The CAFC found that no reasonable jury could have ruled in UT’s favor and that BSC was entitled to JMOL on anticipation.

The '627 patent discloses a polymer-based delivery system for the gradual release of an active agent which includes discrete polymer and active compound phases. BSC’s JMOL motion was denied partially due to UT’s expert testimony which distinguished the mechanisms of polymer biodegradation and active ingredient diffusion in the chewing gum-related '627 patent when compared to the biodegradable polymer fibers of the '296 patent. The CAFC determined that this testimony could not reasonably support a finding of no anticipation as the '627 patent expressly discloses a broad range of active compounds dispersed within biodegradable polymer fibers which release when exposed to a solvent. The CAFC found that “Reading both the ’296 patent and Song for what they actually say, ‘no reasonable fact-finder could reach a conclusion other than’ that Song teaches the biodegradable polymer fiber required by claim 1 of the ’296 patent.”

The CAFC concluded that the '627 patent discloses the two required phases of UT’s claim, a polymer phase and an active compound phase, as is described in UT’s patent. The CAFC concluded that the '627 patent’s disclosure that the active compound “does not necessarily have to be in a contiguous phase” teaches discrete phases as required by UT’s claim. Additionally, the CAFC concluded that dependent claims 11 and 17 were anticipated because at least one alternative within each claimed group was disclosed by the '627 patent. Regarding claim 26, the CAFC affirmed the trial record in which UT offered no evidence against BSC’s expert testimony, thus finding all four asserted claims of the ’296 patent as being anticipated.

In addition to its determination on anticipation, the CAFC also addressed infringement. Previously the district court had construed the term “fiber” as meaning “a thread-like structure of any length or shape.” UT’s previously presented arguments regarding infringement focused on the stent’s polymer coating being separated from the metal frame of the stent. However, the CAFC determined that no reasonable jury could characterize the artificially separated section of the stent coating as “thread-like.” The CAFC further noted that the coating in BSC’s stent was not intended to be independent of the frame and was indeed not “thread-like,” being tubular in overall shape and appearing two-dimensional like a ribbon and not one-dimensional like a thread. With this determination, the CAFC also ruled that BSC was also entitled to JMOL regarding non-infringement.

Therefore, the CAFC ruled that BSC is entitled to JMOL on both anticipation and non-infringement, reversing the district court’s judgment but declining to address UT’s cross-appeal or BSC’s remaining challenges to the conduct of the trial. This decision demonstrates the weaknesses of infringement theories relying on artificial claim-element constructions, which in this case resulted in the return of substantial jury awarded damages.

This decision is available here.

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