A U.S. district court has entered a judgment that requires Guardant Health to provide a substantial monetary award to TwinStrand Biosciences and the University of Washington following a patent infringement dispute centered on advanced DNA sequencing technology. The decision affirms a prior jury finding that Guardant’s diagnostic offerings incorporated core sequencing methods owned by TwinStrand without obtaining a license.
The court’s order obligates Guardant to remit ongoing royalties on sales of a range of products and services that fall within the scope of the disputed patents. These royalties will continue until the patents reach the end of their protected term, at which point the licensing obligations will cease. In addition to the royalty stream, the judgment mandates that Guardant supply TwinStrand and the university with regular accounting statements detailing U.S. sales of the affected offerings, ensuring transparency and compliance throughout the royalty period.
Guardant Health has announced its intention to appeal the ruling, emphasizing its disagreement with the court’s conclusions. In a public statement, the company asserted confidence that its technologies do not infringe the patents in question and indicated that it will pursue all available legal avenues to overturn the judgment.
TwinStrand’s proprietary Duplex Sequencing approach is distinguished by its ability to achieve markedly higher accuracy compared to conventional next‑generation sequencing methods. By evaluating both strands of a DNA molecule, the technology can detect genetic variants that many other platforms fail to distinguish, thereby addressing a long‑standing challenge in the field of genomics.
The invention of these sequencing methods traces back to research conducted at the University of Washington by a then‑medical student and his academic collaborators. The inventors subsequently founded TwinStrand, securing exclusive licensing rights to the patents from the university. This exclusive arrangement underpins TwinStrand’s business model and its commitment to protecting the intellectual property that fuels its technological advances.
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Chair of TwinStrand, Chad Waite, highlighted the significance of the judgment, noting that the court’s affirmation of the jury’s verdict shows the importance of respecting patented innovations that enhance diagnostic accuracy for clinicians and researchers worldwide.
The products identified in the judgment include the Guardant360 assay, a blood‑based test used to guide therapeutic decisions in oncology, as well as earlier iterations of Guardant Reveal and Guardant Shield. While the company maintains that its current versions of Reveal and Shield are excluded from the order, it also reported that design refinements have been implemented in Guardant360 and related services to mitigate any potential impact from the royalty obligations.
Beyond the core damages and royalty obligations, the judgment incorporates additional monetary components such as supplemental damages, accrued royalties, and interest that have accumulated since the initial infringement period. These elements collectively contribute to the overall financial responsibility imposed on Guardant.
Parallel to the courtroom proceedings, TwinStrand continues to engage with the United States Patent and Trademark Office and the Patent Trial and Appeal Board in ongoing patent‑related matters. “We will continue to defend these patents and the innovation they protect for the researchers and clinicians worldwide who rely on the accuracy our technology makes possible,” Waite said.
The resolution of this case shows the critical role that patent protection plays in supporting technological innovation within the genomics sector. By upholding the rights of inventors and license holders, the judicial system reinforces the incentive structure that drives the development of cutting‑edge diagnostic tools capable of delivering more precise and reliable results for patients.
