A jury has reportedly ruled that Guardant Health, a precision oncology company, is on the hook for $83.4 million in a federal patent case. The U.S. District Court of Delaware jury found that Guardant Health's cancer-testing kits willfully infringed two patents, U.S. Patent Nos. 10,760,127 and 10,287,631, belonging to the University of Washington. The patents claim duplex sequencing technology and are exclusively licensed to the biotechnology company, TwinStrand Biosciences.
The technology has been described as "10,000 times more accurate than typical next-generation sequencing, by independently checking both strands of DNA and matching them up to eliminate reading errors". TwinStrand Biosciences uses this method to underpin its blood plasma tests for detecting rare and difficult-to-identify genetic mutations that are linked to various cancers. The patented method was reportedly developed by Twinstrand Biosciences' former CEO, Dr. Jesse Salk, while a medical student at the university, with his colleagues.
The licensee first filed a lawsuit against Guardant Health in 2021, claiming infringement through the sale of its FDA-approved Guardant 360 CDx product and other commercial products in cancer screening, detection and characterization. While the defendant did not challenge the validity of either patent at trial, they filed three petitions to the Patent Trial and Appeal Board ("PTAB") beforehand, two of which attacked the validity of the '127 patent. The PTAB only reviewed one petition on the '127 patent and ultimately rejected Guardant Health's invalidity arguments.
The jury agreed with the plaintiffs, finding that they were owed $83.4 million in royalty payments, which equated to 6% of about $1.4 billion in revenues. As noted by FierceBiotech, Guardant Health plans to appeal not only the jury's decision, but also the PTAB's findings, stating that they "believe the ruling ignores the strengths and merits of our R&D and intellectual property, which [they] painstakingly developed for over a decade".
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