Gideon Korrell on LabCorp v. Qiagen and the Doctrine of Equivalents
The Federal Circuitâs decision in Laboratory Corp. of America Holdings v. Qiagen Sciences, LLC, No. 23-2350 (Fed. Cir. Aug. 13, 2025), serves as a pointed reminder that jury verdicts, particularly in technically complex patent cases, remain subject to strict appellate review. In a comprehensive reversal, the court vacated a Delaware juryâs willful infringement verdict involving two molecular diagnostics patents and ordered judgment as a matter of law (JMOL) of non-infringement.
Gideon Korrell views the decision as part of a broader trend: the Federal Circuit is increasingly unwilling to allow juries to resolve unresolved claim-scope disputes or fill evidentiary gaps with generalized narratives of technical similarity.
Case Background: Two Patents and Divergent Infringement Theories
The dispute centered on U.S. Patent Nos. 10,017,810 and 10,450,597, both covering DNA sample preparation methods for sequencing using PCR-based enrichment techniques. The patents describe workflows employing primers to selectively amplify specific regions of interest within a DNA sample.
Qiagen marketed accused kits used in DNA preparation. After a five-day trial, the jury found willful infringement of the â810 patent under the doctrine of equivalents and both literal and willful infringement of the â597 patent. The jury rejected Qiagenâs invalidity defenses and awarded approximately $4.7 million in damages. The district court denied Qiagenâs JMOL motions, prompting appeal.
On review, the Federal Circuit reversed in full, holding that the evidence could not support infringement findings for either patent.
Claim Construction: A Judicial Responsibility
The â810 patent required a âsecond target-specific primerâ with a nucleotide sequence âidentical to a second sequencing primer.â Qiagenâs accused primer was significantly shorter than the referenced sequencing primer. Labcorp argued that âidenticalâ could mean identical to only a portion of the sequencing primer, and the district court allowed the jury to resolve this dispute.
The Federal Circuit held that this was a legal error. Citing O2 Micro, the court reiterated that claim construction is a judicial function. Where a genuine dispute exists over claim scope, it must be resolved by the court, not delegated to the jury.
The panel emphasized that the intrinsic record distinguished between sequences that must be âidenticalâ and those that may be âidentical to a portion.â Reading an unclaimed modifier into the term would render other claim language meaningless.
Gideon Korrell notes that this aspect of the opinion reinforces a critical lesson: unresolved claim construction disputes can invalidate an entire verdict post-trial.
Doctrine of Equivalents: Evidence Must Be Particularized
Because literal infringement was unavailable for the â810 patent, Labcorp relied exclusively on the doctrine of equivalents. That theory also failed on appeal.
The court reaffirmed that equivalence must be shown on a limitation-by-limitation basis using particularized evidence under the function-way-result test. Generalized assertions of similarity are insufficient.
LabCorpâs evidence fell short:
Function: The claimed primer provided target specificity. Qiagenâs primer merely enabled sequencing compatibility and did not bind to the native target sequence.
Way: The accused primer operated by binding to a common added sequence, not by annealing directly to the target region.
Result: The accused primer amplified both target and non-target DNA, undermining any claim of equivalent outcomes.
The court also rejected attempts to combine the functions of multiple primers to satisfy a single claim limitation.
As Gideon Korrell observes, courts consistently reject âworking togetherâ theories when claims require specific elements to perform specific roles.
Literal Infringement and the Meaning of âTarget-Specificâ
Turning to the â597 patent, the Federal Circuit held that Qiagenâs forward primer did not literally infringe. Under the courtâs claim construction, a target-specific primer must anneal to the nucleic acid of interest and avoid non-target sequences.
Qiagenâs primer bound indiscriminately to adaptor sequences common to all DNA fragments. Binding to an adaptor, even one attached to a target molecule, did not satisfy the claim. Nor could Labcorp rely on other primers in the system to fill the gap.
Gideon Korrell highlights this reasoning as especially relevant in multi-component systems, where courts resist efforts to blur claim boundaries through collective behavior.
JMOL as a Meaningful Appellate Tool
Having found no legally sufficient evidence of infringement, the Federal Circuit reversed the denial of JMOL and ordered judgment of non-infringement, without reaching invalidity or damages issues.
Key Takeaways for Litigators
Claim construction disputes must be resolved by courts, not juries.
Doctrine-of-equivalents cases require precise, limitation-specific proof.
Literal infringement focuses on individual claim elements, not system-level cooperation.
Preserved JMOL motions remain a powerful appellate remedy.
As Gideon Korrell notes, LabCorp v. Qiagen reinforces a foundational principle of patent law: clear claims and disciplined proof matter, and juries cannot repair deficiencies left by either.