Impact of Standard of Review: Federal Circuit Reverses Multimillion-Dollar Patent Jury Verdict

By: Nayyer Siddiqi

Can procedural matters determine the outcome of an appeal in patent litigation? This issue played out in the Federal Circuit Court of Appeals recently in the matter of Board of Regents of the University of Texas System v. Boston Scientific Corp., (No. 2024-2062, 2024-2063, decided July 27, 2026). Here, the Federal Circuit reversed a jury’s decision, wiping out an almost $50 million verdict awarded to the University of Texas against Boston Scientific. The decision is a powerful reminder that how an issue is presented or preserved on appeal may be just as consequential as the strength of the underlying case.

Background

The patent in question, U.S. Patent No. 6,596,296 (issued in 2003), is assigned to the University of Texas and claims a composition containing a drug-releasing biodegradable polymer fiber, i.e., a fiber in which a therapeutic agent is dispersed. The fibers have two separate, non-mixing parts: the fiber material itself, and small regions containing the drug that are dispersed throughout it. The composition may be used, for example, in an implant. The fibers dissolve over time while releasing medicine, such as anti-inflammatory drugs or heart medications.

Moving forward to 2017, the University of Texas sued Boston Scientific, alleging infringement of their ’296 patent by Boston Scientific’s heart stents. The stents employed by Boston Scientific include a metal frame with linked rings. The frame is dipped and rolled in a liquid biodegradable coating containing a drug of interest. The drug of interest is released over time as the coating on the stent biodegrades. At trial, the jury found that Boston Scientific had infringed the asserted claims willfully, rejected Boston Scientific’s argument that the claims were invalid for anticipation by a prior-art reference (called “Song”), and awarded damages. Anticipation occurs when a single prior art reference discloses every single part of a claimed invention. The jury awarded the University of Texas roughly $50 million in judgment and interest.

Post-trial motions were filed by both parties. Boston Scientific sought judgment as a matter of law (JMOL) of patent invalidity for anticipation, of non-infringement, of non-willfulness, and sought a new trial on the ground that the University of Texas engaged in prejudicial conduct during trial. The district court (1) denied Boston Scientific’s motion for JMOL on invalidity and noninfringement; (2) granted Boston Scientific’s motion for JMOL of non- willfulness; and (3) denied the motion by the University of Texas for enhanced damages. Both sides subsequently appealed to the Federal Circuit.

The Federal Circuit’s Analysis and Decision

The Federal Circuit reversed the district court’s denial of JMOL to Boston Scientific on both anticipation and noninfringement. Boston Scientific’s argument was that the Song patent anticipated the invention claimed in the ’296 patent, thereby rendering that patent invalid. Song disclosed a fiber capable of gradually releasing a substance (e.g., a pharmaceutical agent or chewing gum flavoring) upon exposure to liquid. The University of Texas characterized Song as directed solely to chewing gum applications and therefore inapplicable to medical device contexts. The Federal Circuit rejected this characterization by the University of Texas, finding that Song’s specification expressly identified drugs as one of the substances contemplated for delivery, and was not limited to flavoring agents. The Federal Circuit determined that Song satisfied each technical limitation of the ’296 patent, including a biodegradable fiber composition, discrete non-intermixing regions containing the active substance, and variable release rates over time.

Additionally, the Federal Circuit held that Boston Scientific’s stents did not infringe the patent on independent grounds, finding that they failed to satisfy the claim language. The ’296 patent requires a fiber that is construed as a “thread-like structure.” However, the infringement theory presented by the University of Texas relied on a single strip of coating that could hypothetically be peeled from a discrete section of the metal frame, as opposed to the whole stent. The Federal Circuit rejected this theory, finding that the coating was not designed to exist as an independent structure, was merely applied to and dried upon the frame. Further, an expert witness from the University of Texas devoted substantial attention to distinguishing Song’s release mechanism (effected through mastication and physical deformation of the gum) from the passive, time-based release exhibited by Boston Scientific’s stents. The Federal Circuit found this distinction to be immaterial, as the governing claim construction imposed no requirement as to the specific mode of release.

One impactful factor on appeal was the standard of review applied by the Federal Circuit. Ordinarily, a jury verdict is afforded substantial deference. In other words, the bar for overturning a jury verdict is very high: reversal by an appellate court is appropriate only when the record provides essentially no evidentiary basis for the jury’s decision. However, Boston Scientific chose to challenge the denial of its motion for judgment as a matter of law (JMOL) rather than directly attacking the underlying factual findings of the jury. Because the Federal Circuit applies the procedural law of the regional circuit in which the case was being tried, the standard of review for the JMOL denial was governed by the law of the Third Circuit, which reviews JMOL denials de novo. Conducting a de novo review means that the appellate body will evaluate the legal issues with zero deference to the conclusions reached by the previous fact-finder. This mattered, because it secured a more favorable standard of appellate review.

Final Takeaway

Because the appeal by Boston Scientific was structured as a challenge to the denial of judgment as a matter of law and because the case had been tried in Delaware, review proceeded under Third Circuit procedural standards, which call for de novo appellate review rather than the customary deferential standard. This allowed considerably greater latitude to the Federal Circuit to reassess the evidentiary record independently, and reverse the jury verdict. Additionally, this case illustrates that presenting expert testimony to show distinctions between the patent at issue and a prior art reference is futile when those features are not required by the operative claim construction.

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