The U.S. Court of Appeals for the Federal Circuit in Washington, D.C., has overturned a previous ruling by a district court in a significant patent infringement case involving Laboratory Corp. of America Holdings (LabCorp) and Qiagen Sciences, LLC. The appellate court found that the jury’s conclusions regarding patent infringement were not backed by adequate evidence and that the district court had improperly allowed the jury to make determinations on claim construction.
LabCorp possesses two patents focused on methods for preparing DNA samples for sequencing, aiming to enhance whole-genome sequencing techniques. The dispute arose when LabCorp accused Qiagen of infringing on these patents through various kits utilized in DNA preparation for sequencing. During the initial claim construction process, the district court provided definitions for several patent terms essential to the case.
The first patent was described in terms that clearly delineated the “second target-specific primer” and “second adaptor primer.” The jury determined that Qiagen had infringed upon LabCorp’s first patent under the doctrine of equivalents and had also willfully violated the second patent, leading to a damages award for LabCorp. However, upon appeal, Qiagen sought to challenge these findings.
In its appeal, Qiagen presented two main arguments against the infringement claims related to the first patent. The Federal Circuit agreed with both points. First, the court found it was a mistake to allow the jury to interpret the term “identical” without proper legal guidance. The court highlighted that there was a fundamental difference in lengths between the accused second target-specific primer, known as the Sample Index Primer (SIP), and the second sequencing primer, known as the Read2 primer. This overlap in sequence did not constitute identity, as the two primers were of differing lengths.
The court emphasized that the interpretation of “identical” should not have been left to the jury, as it was a matter of claim construction. The specifications of the patents clearly defined that the second target-specific primer must be fully “identical” to its corresponding sequencing primer, while an adaptor primer required only a partial match. This distinction was crucial, and the district court’s error in allowing the jury to conflate these definitions led to the appellate court’s ruling.
Additionally, the Federal Circuit concurred with Qiagen’s argument regarding the suitability of the SIP under the doctrine of equivalents. The court noted that LabCorp did not provide sufficient evidence demonstrating a significant similarity in function, utilization, or results between its claimed primer and Qiagen’s accused primer.
Qiagen also contested the jury’s finding of literal infringement concerning the second patent by arguing that its Forward Primer (FP) did not meet the necessary criteria to be classified as a “target-specific primer.” The Federal Circuit sided with Qiagen on this point, stating that the FP targets an artificial sequence rather than the specific nucleic acid of interest, and thus failed to align with the patent definitions.
Despite the finding, the appellate court did not address Qiagen’s second argument regarding interaction between the claimed DNA sequences and the accused primers. The ruling marked a pivotal moment for patent litigation and clarified the standards for understanding key terms in patent specifications.
The implications of this ruling may reshape how patent claims are interpreted and how courts allow juries to engage with technical aspects of patent law.
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