Good-faith investigation defeats preindictment delay challenge

Addressing the constitutional limits of preindictment delay in a trade secret and wire fraud prosecution arising from alleged misuse of proprietary unemployment insurance software, the US Court of Appeals for the Fourth Circuit clarified both the standard of review for due process claims based on delay and the substantive threshold required to dismiss an indictment on that basis. United States of America v. David Gerald Minkkinen, Case No. 23-4443 (4th Cir. Feb. 26, 2026) (Wynn, Richardson, Rushing, JJ.)

Between 2009 and 2013, David Minkkinen and Sivaraman Sambasivam worked at a business management consulting firm, where they helped develop a proprietary unemployment insurance software platform called uFACTS. In 2013 they both joined Sagitec, where they participated in building a new unemployment claims system for the Maryland and West Virginia Consortium. In 2016, state employees identified references in Sagitec materials that suggested possible use of the prior company’s intellectual property, prompting a federal investigation. Investigators examined whether other former employees transferred design documents or source materials to Sagitec. While some individuals acknowledged retaining prior project materials, they disputed ownership or claimed the materials were only used as templates. The investigation was prolonged and complicated by the unexpected deaths of key witnesses.

In August 2022, Minkkinen and Sambasivam were indicted on charges including trade secret misappropriation, wire fraud, and false statements. Efforts by the defendants to obtain historical project documents were hindered by routine document destruction policies at state agencies. The government also later filed a superseding indictment focused on alleged misuse of the prior company’s proprietary files. The defendants moved to dismiss for unconstitutional preindictment delay, arguing that the loss of witness testimony and documents prejudiced their defense. The district court agreed in part, finding the missing evidence highly significant and the government’s justification for the lengthy investigation insufficient, and dismissed 10 of 14 counts. The government appealed.

The Fourth Circuit determined that in reviewing a claim of unconstitutional preindictment delay, it would apply clear-error review of the district court’s factual findings and de novo review to its legal conclusions. The Court further determined that the specific issue at stake here (i.e., whether the prosecution offended “fundamental conceptions of justice” and society’s sense of “fair play and decency”) was a mixed question of law and fact that should be reviewed de novo. The Court reasoned that the second prong of the preindictment delay test requires courts to apply a broad constitutional standard by balancing the government’s justification for delay against prejudice to the defendant, and appellate courts have a special role in defining the limits of constitutional standards through case-by-case adjudication. Accordingly, the Court concluded it would apply de novo review to the district court’s ultimate due process determination regarding the dismissed counts.

The Fourth Circuit determined that the district court erred in dismissing counts based on unconstitutional preindictment delay. Applying the second prong of the due process analysis, the Court concluded that the government’s delay was attributable to a prolonged good-faith investigation and not to any improper motive, tactical advantage, or [...]

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Coiled in controversy: Summary judgment on Walker Process claim unwound

The US Court of Appeals for the Federal Circuit vacated a district court’s grant of summary judgment on inequitable conduct and a Walker Process antitrust claim arising from allegations that a patent owner withheld material prior art during patent prosecution and sought to enforce the patents against a competitor in the coiled tubing market. Global Tubing v. Tenaris Coiled Tubes, Case Nos. 23-1882; -1883 (Fed. Cir. Feb. 26, 2026) (Taranto, Hughes, Stark, JJ.)

Global Tubing filed a declaratory judgment action seeking a ruling that its coiled tubing product did not infringe Tenaris’ patents. After uncovering a document in discovery that it characterized as evidence that Tenaris attempted to withhold material information during patent prosecution, Global Tubing amended its complaint to assert inequitable conduct and Walker Process fraud, alleging that Tenaris sought to use fraudulently obtained patents to monopolize the market. Following the completion of discovery, the parties filed cross-motions for summary judgment. The district court granted summary judgment of inequitable conduct to Global Tubing and summary judgment of no liability for Walker Process fraud to Tenaris. As to the Walker Process fraud claim, the court determined that because Tenaris was such a small market player, Global Tubing could not prove it had the market power sufficient to achieve a monopoly. Both parties appealed.

The Federal Circuit determined that the district court erred in granting summary judgment to Global Tubing, finding that genuine disputes of material fact remained as to whether the single most reasonable inference was that the inventor acted with specific intent to deceive the United States Patent and Trademark Office (USPTO), making summary judgment on inequitable conduct inappropriate.

Addressing the Walker Process fraud claim, the Federal Circuit likewise vacated the district court’s grant of summary judgment in favor of Tenaris, finding that the record contained genuine disputes of material fact that precluded judgment as a matter of law. The Court explained that the evidence could support a finding that the inventor knowingly withheld a material prior art reference from the USPTO with intent to deceive, and that Global Tubing had raised a triable issue as to the first prong of its Walker Process claim: whether Tenaris obtained and enforced the patent through knowing and willful fraud on the USPTO.

Turning to the second prong of a Walker Process fraud claim (attempted monopolization), the Federal Circuit observed that the parties advanced competing definitions of the relevant market. The Court concluded that the district court erred by characterizing Tenaris as a small market participant with no dangerous probability of achieving monopoly power without first defining the relevant product and geographic markets or determining whether genuine disputes of material fact existed on those issues.

The Federal Circuit also concluded that genuine disputes of material fact remained as to whether Tenaris engaged in predatory or otherwise anticompetitive conduct. The Court noted that there may have been a triable issue regarding the appropriate date at which to measure Tenaris’ share of the relevant yet undefined market. Considering these unresolved factual questions, the Court [...]

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Tree-mendous award: Damages expert royalty opinions are lit

The US Court of Appeals for the Federal Circuit affirmed a damages verdict amounting to tens of millions of dollars. The Court found that the patentee’s damages expert correctly apportioned value to the patented feature and rejected challenges to her methodology. Willis Electric Co., Ltd. v. Polygroup Ltd., Case No. 24-2118 (Fed. Cir. Feb. 17, 2026) (Moore, Stark, Oetken, JJ.)

Willis sued Polygroup for infringing its patent related to pre-lit artificial trees with decorative lighting. In response, Polygroup filed multiple inter partes review (IPR) petitions challenging the asserted claims. Following extensive IPR proceedings, only a dependent claim that required coaxial trunk connectors remained for trial.

A jury found the claim infringed and not obvious, and awarded about $42.5 million in damages, equating to a $4-per-tree royalty. Polygroup moved for judgment as a matter of law of obviousness or, alternatively, for a new trial on damages. The district court denied both motions. Polygroup appealed.

Effect of prior IPR ruling

Polygroup argued that because the independent claim from which the asserted claim depended was held unpatentable, damages should be limited to only the incremental value of the coaxial connectors recited in the asserted dependent claim. The Federal Circuit rejected that argument, explaining that the IPR applied the broadest reasonable interpretation standard, while the district court construed the independent claim under the Phillips standard. Under the district court’s construction, the independent claim required forming simultaneous mechanical and electrical connections regardless of rotational orientation, a feature that was not required under the IPR construction. Because the independent claim had not been held unpatentable under the district court’s construction, the Federal Circuit reasoned that the IPR ruling did not preclude Willis from relying on that one-step functionality in calculating the value attributable to the coaxial connectors recited in the dependent claim.

The Federal Circuit emphasized that what value was attributable to the claimed coaxial connectors was a question of fact for the jury. Substantial evidence supported the jury’s finding that the value included rotationally independent, simultaneous connection functionality, not merely the physical presence of coaxial connectors.

Rule 702 and damages methodology

Willis’ damages expert presented two independent apportionment analyses.

Under an income-based approach, the expert compared profit margins for Willis’ “One Plug” trees and Polygroup’s Quick Set trees against comparable noninfringing trees to derive a royalty range. Under a market-based approach, she analyzed several license agreements to establish a reasonable royalty range, which she combined with her income approach to arrive at an expanded reasonable royalty range. She then applied the Georgia-Pacific factors to select a $5-per-tree royalty, resulting in a jury award of $4 per tree.

Polygroup argued that the expert failed to adequately apportion value and relied on non-comparable licenses and improper averaging methods. The Federal Circuit disagreed, emphasizing the district court’s gatekeeping role under Federal Rule of Evidence 702 while reinforcing the distinction between admissibility and weight.

The Federal Circuit explained that reasonable royalty determinations inherently involve approximation and uncertainty. Where an expert’s methodology is grounded in record evidence, including internal sales [...]

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Did you account for the entire corresponding disclosed structure?

The US Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment of noninfringement of a means-plus-function claim element, emphasizing that a patentee must compare the accused product to the entire disclosed structure, not just a selected subset. Genuine Enabling Tech. v. Sony Group Corp., et al., Case No. 24-1686 (Fed. Cir. Feb. 19, 2026) (Dyk, Taranto, Chen, JJ.)

Genuine Enabling Technology (GET) sued Sony for patent infringement, alleging that Sony’s PlayStation 3 and 4 infringed its patent related to synchronizing data streams from multiple input devices. The district court ruled in favor of Sony, granting summary judgment of noninfringement and excluding the infringement conclusion of GET’s expert. GET appealed.

The Federal Circuit affirmed. The parties agreed that the term “encoding means” for synchronizing two separate streams, present in each asserted claim, was a means-plus-function limitation under 35 U.S.C. § 112(f). Neither party disputed that the corresponding structure consisted of the entirety of a logic block disclosed in the patent specification.

GET’s expert focused solely on the bit-rate clock appearing in the logic block, neglecting most of the other disclosed components, and did not provide an explanation for these omissions in his “way” analysis. The Federal Circuit explained that this approach failed to satisfy the function-way-result test for structural equivalence, which requires demonstrating that the accused product is equivalent to the disclosed structure by showing that both the accused and corresponding disclosed structures perform the identical function in substantially the same way to achieve substantially the same result. The Court clarified that while a component-by-component examination is not necessary, the analysis must consider all components of the identified structure or justify any omissions. GET’s expert did not meet the burden of describing the “way” the “encoding means” structure in the patent performed its function.

GET’s expert attempted to simplify structural equivalence to “anything that synchronizes to a clock.” The Federal Circuit explained that this approach improperly reduced the function-way-result test to function-result alone, contradicting the patent’s specific synchronization scheme. Because of the lack of analytical support for the expert’s structural-equivalence conclusion, the Federal Circuit upheld the district court’s exclusion of the expert’s opinion.

Since GET did not seek discovery of the accused product’s Bluetooth schematics until the end of fact discovery, GET’s expert never examined the internal design of the accused Bluetooth modules. Instead, his infringement theory relied solely on assumptions about generic Bluetooth behavior, which the Federal Circuit found to be conclusory, legally insufficient, and inconsistent with the patent’s detailed circuitry disclosed in the specification. The Federal Circuit affirmed the district court’s partial exclusion of GET’s expert’s testimony.

Practice note: When litigating means-plus-function claims under 35 U.S.C. § 112(f), an opining expert must address the entirety of the corresponding structure disclosed in the specification. Selectively focusing on only one or two elements without explaining omissions can be fatal.




Manufactured host cells markedly different from naturally occurring cells may be patent eligible

Addressing subject matter eligibility in the life sciences context, the US Court of Appeals for the Federal Circuit reversed a district court’s summary judgment ruling that certain claims directed to genetically engineered host cells were patent ineligible as directed to a natural phenomenon. The Federal Circuit found that the claimed cells contained recombinant nucleic acid molecules that were markedly different from anything occurring in nature and therefore were patent eligible under 35 U.S.C. § 101. REGENXBIO Inc. v. Sarepta Therapeutics, Inc., Case No. 24-1408 (Fed. Cir. Feb. 20, 2026) (Dyk, Hughes, Stoll, JJ.)

REGENXBIO owns a patent directed to genetically engineered host cells containing a recombinant nucleic acid molecule (adeno-associated virus (AAV) rh.10 sequences). These host cells are human made and do not exist in nature. The recombinant nucleic acid molecule is created by chemically splicing together nucleic acid sequences from two different organisms. REGENXBIO sued Sarepta, alleging infringement of its patent. Both parties moved for summary judgment on whether the asserted claims were patent eligible under Section 101. The parties did not assert that claims were ineligible as an abstract idea but rather debated whether the claims disclosed natural products.

The district court analogized the claims to those considered in the 1949 Supreme Court decision in Funk Brothers Seed v. Kalo Inoculant, where two strains of bacteria from two different organisms were merely put together. The district court concluded that the invention, “taking ‘two sequences from two different organisms and put[ting] them together,’” amounted to merely packaging natural products together and found the asserted claims ineligible. REGENXBIO appealed.

The Federal Circuit reversed. Relying on the Supreme Court’s decisions in Diamond v. Chakrabarty (1980) and Association for Molecular Pathology v. Myriad Genetics (2013), the Federal Circuit explained that the relevant inquiry was whether the claimed composition as a whole possessed “markedly different characteristics” from what occurs in nature. The Court emphasized that the claimed recombinant nucleic acid molecules were not naturally occurring and cannot form in nature without human intervention. The claims required a recombinant molecule encoding both an AAV vp1 capsid protein and a heterologous sequence, created by combining genetic material from different sources.

The Federal Circuit explained that like the engineered bacterium in Chakrabarty, the claimed host cells here were “not nature’s handiwork” but a product of human ingenuity. And like the cDNA claims upheld in Myriad, the recombinant molecules represented something “distinct from” naturally occurring DNA. In contrast to Funk Brothers, where the bacteria performed exactly as they did in nature and were merely packaged together, the claimed host cells here contained a newly engineered molecule that did not exist in nature and that enabled gene therapy applications.

The Federal Circuit also noted that the claimed compositions had the potential for significant utility, specifically in gene delivery and gene therapy, further distinguishing them from the ineligible claims in Funk Brothers. Although the claims did not expressly recite a specific therapeutic use, the Court explained that potential utility may be considered in evaluating whether a composition is markedly [...]

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