The Patent Trial and Appeal Board (PTAB or Board) recently ruled in favor of the University of Washington and TwinStrand Biosciences on a challenge to all 30 claims of US Patent No. 10,760,127.
The patent is owned by U.W. and exclusively licensed to TwinStrand.
According to a TwinStrand press release about the ruling,
TwinStrand Biosciences is a precision genomics company advancing highly accurate DNA sequencing through its patented TwinStrand Duplex Sequencing® technology, originally developed at the University of Washington. Duplex Sequencing achieves more than 10,000-fold greater accuracy than conventional next-generation sequencing by independently sequencing and comparing both complementary strands of each DNA molecule. This enables reliable detection of ultra-low-frequency genetic variants that conventional methods often cannot distinguish from background sequencing errors. The technology supports applications across oncology, molecular diagnostics, genetic toxicology and drug development.
The ‘127 patent covers methods of lowering the error rate of massively parallel DNA sequencing using duplex consensus sequencing. The patent states that massively parallel DNA sequencing “offer[ed] the unique ability to detect minor variants within heterogeneous mixtures.”
The patent also noted the rapid development of clinical applications of deep sequencing in “prenatal screening for fetal aneuploidy, early detection of cancer and monitoring its response to therapy with nucleic acid-based serum biomarkers.”
In 2023, a jury awarded $83.4 million to U.W. and TwinStrand, finding that that cancer-testing kits made by Guardant Health, Inc. infringed the ‘127 patent and another patent. The jury also found that the infringement was willful.
In August of 2026, a US district court entered final judgement upholding the verdict. (A separate re-examination proceeding involving the other patent found to be infringed is ongoing.)
As Reuters reported, the court ordered Guardant to pay a 6% royalty on US sales of 11 products and services found to infringe the patents. The final judgment included the $83.4 million in original damages, $19.5 million in supplemental damages, $119.4 million in accrued royalties, and $22.9 million in pre- and post-judgment interest.
Guardant had filed a Petition seeking an inter partes review (IPR) of the patent claims. It asserted that the challenged claims would have been obvious in view of the prior art (Travers).
In its original Final Written Decision on the IPR, the Board held that Guardant had not proven that claims 1-30 of the ‘127 patent were unpatentable on obviousness grounds based on Travers ‘075 and Travers 2010, either alone or combined with other asserted prior art references.
In January of 2026, a Federal Circuit panel held that the Board erred by requiring Guardant to show a motivation to combine and a reasonable expectation of success for amplification. The court vacated the Board’s initial decision and remanded.
Pursuant to 35 U.S.C. § 318, the Board issued a new final written decision determining that Guardant had not shown, by a preponderance of the evidence, the unpatentability of any of the challenged claims.
The Board determined that Guardant had not met its burden to show “an ordinarily skilled artisan would have had a reason to combine the teachings of the two Travers references, and would have had a reasonable expectation of success in arriving at the claimed method.”
The PTAB rejected Guardant’s prior art references in the IPR, noting (among other things), that the SMRT sequencing approach “is based on eavesdropping on a single DNA polymerase molecule working in a continuous, processive manner.”
(SMRT sequencing (Single-Molecule Real-Time sequencing) is a third-generation DNA sequencing technology developed by Pacific Biosciences that reads genetic sequences as a single strand of DNA is synthesized in real time.)
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