Trudell Medical International Inc. v. D R Burton Healthcare, LLC, Appeal Nos. 2023-1777, -1779 (Fed. Cir. Feb. 7, 2025)

This week’s Case of the Week presents a cautionary tale for litigators to be sure they’ve timely complied with Fed. R. Civ. P. 26(a)(2) by the conclusion of discovery.  In a precedential opinion, the Federal Circuit found that the district court erred by admitting late-disclosed non-infringement testimony for appellee D R Burton.

Appellant Trudell Medical sued D R Burton for infringement of Trudell’s U.S. Patent No. 9,808,588, which concerns portable devices for use in oscillatory positive expiratory pressure (OPEP) therapy.  Almost a month after the discovery deadline, D R Burton submitted a seven-page declaration from their expert, Dr. John Collins, in response to Trudell’s motion for summary judgment on infringement. The district court later denied Trudell’s motion in limine to exclude Dr. Collins’ testimony from trial. After deliberations, the jury found the claims at issue valid, but not infringed. Trudell appealed the allowance of Dr. Collins’s testimony and the denial of their motion for judgment as a matter of law (JMOL) or a new trial, and requested reassignment of the case to a new judge if the case were to be remanded.

The Federal Circuit agreed with Trudell, and ruled that D R Burton ’s failure to serve their expert on noninfringement in a timely fashion was not substantially justified or harmless as required by Rule 26 of the Federal Rules of Procedure and Fourth Circuit law. The Court reasoned that the district court abused its discretion in allowing the untimely testimony because it provided no reason for why the failure might be substantially justified. Further, the Court explained that the admission of Dr. Collins’s testimony was not harmless, because it provided nearly all D R Burton ’s evidence of noninfringement, and the ability to cross-examine Dr. Collins did not cure Trudell’s loss of opportunity to depose him on that issue. Even if the admission had been timely, the Court found that Dr. Collins’s infringement declaration was unreliable under Federal Rule of Evidence 702, because the declaration was misaligned with the district court’s claim constructions.

The Federal Circuit vacated the jury’s finding of noninfringement, remanded the case for a new trial, and affirmed the district court’s denial of Trudell’s JMOL. The Court also agreed with Trudell’s request for reassignment and remanded the case to a different district court judge. The Federal Circuit emphasized the trial judge’s objectionable statements, which were similar to some made previously by the same judge in another case that was ordered reassignment on remand. The court reasoned that such statements  exposed the trial judge’s determination to terminate the case quickly, and signaled the trial judge had not intended to manage a fair trial with respect to the issues.

The opinion can be found here.

By Brittani Gambrell 

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HD Silicon Solutions LLC v. Microchip Technology Inc., Appeal No. 2023-1397 (Fed. Cir. Feb. 6, 2025)

In this appeal from the United States Patent and Trademark Office Patent Trial and Appeal Board (the “Board”), the Federal Circuit affirmed the Board’s finding that U.S. Patent 6,774,033 (“the ‘033 patent”) was unpatentable as obvious. The ’033 patent is directed to a local interconnect layer in an integrated circuit, which provides relatively short electrical paths between the transistors.  The Federal Circuit agreed with the Board that the ’033 patent was unpatentable as obvious, but first found that the Board’s underlying claim construction was in error, particularly with regard to the meaning of the phrase “comprising tungsten.” The Board had construed the phrase as having two possible meanings: purely elemental tungsten and tungsten compounds. The Federal Circuit disagreed, finding the term “comprising tungsten” required elemental tungsten, but ultimately decided the error was harmless because the Board’s obviousness finding was supported regardless of the construction.

The opinion can be found here.

By Mario E. Delegato

Wuhan Healthgen Biotechnology Corp. v. ITC, Appeal No. 2023-1389 (Fed. Cir. Feb. 7, 2025)

In an appeal following a Section 337 investigation, the Federal Circuit affirmed a determination of the International Trade Commission that recombinant albumin products imported by appellant Healthgen infringed a patent owned by intervenor Ventria Bioscience Inc., and that Ventria had satisfied the domestic industry requirement of 19 U.S.C. § 1337(a)(2). At issue on appeal was whether Ventria had satisfied the “economic prong” of the domestic industry requirement, which depended on whether Ventria had made “significant” or “substantial” U.S. investments when it provided the patented products. The Court rejected Healthgen’s argument that Ventria’s investments had been “too small” to establish a domestic industry, finding that high investment-to-revenue ratios were indicative of the industry’s value, and this provided sufficient evidence to support the Commission’s determination. In making its ruling, the Court noted legislative commentary that “[s]maller businesses should not be denied the right to seek relief merely because they may have made smaller financial investments than large companies,” and collected precedent to support its conclusion that “[s]mall market segments can still be significant and substantial enough to satisfy the domestic industry requirement.” The Court also rejected Healthgen’s non-infringement argument, and affirmed the Commission’s decision as supported by substantial evidence.

The full opinion can be found here.

By Jason A. Wrubleski

This article summarizes aspects of the law. This article does not constitute legal advice. For legal advice regarding your situation, you should contact an attorney.