Lab’y Corp. of Am. Holdings v. Qiagen Sciences, LLC
Authored by: Jeremy J. Gustrowsky
In a significant decision for the biotech and patent law communities, the Federal Circuit has reversed a $4.7 million jury verdict against Qiagen Sciences, LLC, finding that its DNA sequencing kits did not infringe two patents owned by Laboratory Corporation of America Holdings (LabCorp) and others. The patents in question—U.S. Patent No. 10,017,810 and U.S. Patent No. 10,450,597—cover methods for preparing DNA samples for sequencing, specifically focusing on techniques to enrich for regions of interest in genetic material.
The core of the dispute centered on how certain DNA primers—short strands of DNA used to start the copying process—are defined and used in these patented methods. The district court had allowed the jury to decide whether the term “identical” in the patent claims could mean “identical to a portion” of a DNA sequence, rather than requiring a primer to be exactly the same as another sequence. The Federal Circuit found this was a mistake, clarifying that “identical” means exactly the same, not just similar or matching in part. This distinction was crucial because Qiagen’s accused products only matched a portion of the required sequence, not the whole.
The court also found that there was not enough evidence to support the jury’s finding of infringement under the “doctrine of equivalents,” a legal rule that sometimes allows for infringement even if the accused product doesn’t literally meet every claim requirement. Here, the Federal Circuit held that Qiagen’s products did not perform the same function, in the same way, or achieve the same result as the patented inventions. For the second patent, the court concluded that Qiagen’s primers targeted artificial adaptor sequences rather than the specific DNA regions of interest, which did not meet the patent’s requirements.
This decision highlights the importance of precise language in patent claims and reinforces that courts—not juries—must resolve disputes over the meaning of key terms. It also underscores that careful claim drafting in prosecution, and understanding the technical details of both patents and accused products later in litigation are both essential.