Federal Jury Finds Guardant Health Willfully Infringes University of Washington Duplex Sequencing Patents Exclusively Licensed to TwinStrand Biosciences, Inc., Awards $83.4M in Damages; PTAB Rejects Invalidity Arguments on UW Patents

• Federal jury finds Guardant Health, GH (NASDAQ), willfully infringes University of Washington duplex sequencing patents exclusively licensed to TwinStrand Biosciences, Inc. and awards $ 83.4M in damages.
• Jury finds FDA-approved product Guardant 360® CDx infringes the University of Washington's patents, along with all of Guardant Health's commercial products which analyze cell free DNA obtained from blood draws to detect, screen, and/or characterize cancer.
• Guardant Health did not challenge the validity of the patents in district court.
• Previously, on October 10, 2023, the Patent Trial and Appeal Board rejected all of Guardant' Health's invalidity arguments regarding 30 claims of UW's '127 patent.
• The duplex sequencing technology that is covered by these patents can deliver 10,000x greater accuracy than standard next generation sequencing, allowing for exquisitely sensitive mutation and genetic allele detection to inform critical medical decisions and drug development pipelines.

SEATTLE, Nov. 15, 2023 /PRNewswire/ -- TwinStrand Biosciences®, the pioneer in Duplex Sequencing technology, which delivers accurate insights to researchers in applications ranging from residual cancer detection to genetic toxicology, announced a successful jury verdict in the federal patent infringement case it brought with the University of Washington against Guardant Health. The jury found that Guardant Health willfully infringed two of the University of Washington's duplex sequencing patents in the sale of its FDA-approved Guardant 360 CDx product, as well as all of its commercial products in cancer screening, detection, and characterization. The patents at issue were U.S. Patent No. 10,760,127 and U.S. Patent No. 10,287,631, both owned by the University of Washington and exclusively licensed to TwinStrand Biosciences, Inc., which was founded by the inventors of the patents. 

"We are grateful that the jury has protected the foundational duplex sequencing invention of Dr. Michael Schmitt, Dr. Jesse Salk, and Dr. Lawrence Loeb and the rights of those who own and license it, so we can continue to invest in research and development without being punished by unrestrained infringement," stated Ron Andrews, Chief Executive Officer and Director of TwinStrand.

At trial, Guardant Health did not challenge the validity of either of the patents at issue. In advance of the infringement trial, however, Guardant Health filed three petitions to the Patent Trial and Appeal Board on the two patents, with two different petitions filed challenging the validity of all 30 claims of UW's '127 patent on different grounds. The Patent Board refused to review the petition Guardant Health filed on the '631 patent and one of the petitions filed on the '127 patent (further denying Guardant Health's request for a panel rehearing and a Precedential Opinion panel review on that decision). The PTAB did review Guardant Health's second petition on the '127 patent and rejected Guardant Health's invalidity arguments as to all 30 claims of the patent in its final written decision. 

The patented technology at issue in the case enables the detection of ultra-low frequency DNA mutations with a resolution 10,000 times greater than conventional NGS tools on the market. TwinStrand Duplex Sequencing overcomes the inherent limitations in today's NGS technologies by reducing background noise, which enables quantification and characterization of variants that were previously undetectable, a critical unmet clinical need for blood-based monitoring of certain diseases.

TwinStrand and the University of Washington are represented by a team from Sterne Kessler Goldstein & Fox led by Trey Powers, Byron Pickard, Chandrika Vira, William Milliken, Anna Phillips and Tyler Dutton.

About TwinStrand Biosciences

TwinStrand Biosciences' Duplex Sequencing patent estate is the foundational technology enabling the ability to accurately identify ultra-low frequency genomic variants that are undetectable by conventional NGS methods. The company's highly sensitive and specific patented Duplex Sequencing technology delivers clearer insights to researchers and clinicians in applications ranging from residual cancer detection to genetic toxicology. This data can inform critical decisions in clinical medicine, public health, and other fields of science on a faster timescale when actions are most impactful. TwinStrand's scientist-leaders have authored more than thirty peer-reviewed articles using Duplex Sequencing technology and have developed a portfolio of more than 150 patents and patent applications. The company has partnered with pharmaceutical companies, academic centers, clinical research networks, molecular diagnostic companies and federal regulatory agencies to bring high precision genomics to the forefront of their science. For more information visit www.twinstrandbio.com.

Media Contact

TwinStrand Biosciences
Matt Edwards
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SOURCE TwinStrand Biosciences