TwinStrand Biosciences, Inc. & University of Washington v. Guardant Health, Inc.

CourtDistrict Court, D. Delaware
DecidedJune 16, 2026
Docket1:21-cv-01126
StatusUnknown

This text of TwinStrand Biosciences, Inc. & University of Washington v. Guardant Health, Inc. (TwinStrand Biosciences, Inc. & University of Washington v. Guardant Health, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
TwinStrand Biosciences, Inc. & University of Washington v. Guardant Health, Inc., (D. Del. 2026).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE TWINSTRAND BIOSCIENCES, INC, & UNIVERSITY OF WASHINGTON, Plaintiffs, Civil Action No. 21-1126-GBW-SRF v. GUARDANT HEALTH, INC., Defendant.

MEMORANDUM OPINION Adam W. Poff, Samantha G. Wilson, Colin A. Keith, YOUNG CONAWAY STARGATT & TAYLOR, LLP, Wilmington, Delaware; Byron Pickard, R. Wilson Powers II, Ph.D., Chandrika Vira, William H. Milliken, Anna G. Phillips, Tyler J. Dutton, David H. Holman, Christopher M. Gallo, Ph.D., Brady P. Gleason, STERNE, KESSLER, GOLDSTEIN & FOX, P.L.L.C,, Washington, District of Columbia. Counsel for Plaintiffs Jeff Castellano, Erin E. Larson, DLA PIPER LLP (US), Wilmington, Delaware; Mark Fowler, Susan Krumplitsch, Peiyao Zhang, DLA PIPER LLP (US), Palo Alto, California; Tracy Block, DLA PIPER LLP (US), New Yerk, New York; Ellen Scordino, Nancy C, Braman, DLA PIPER LLP (US), Boston, Massachusetts; Travis Jensen, ORRICK, HERRINGTON & SUTCLIFFE LLP, Menlo Park, California. Counsel for Defendant

June 16, 2026 Wilmington, Delaware

lA

GREGORY B. WILLIAMS UNITED STATES DISTRICT JUDGE

This is an action for patent infringement brought by Plaintiffs TwinStrand Biosciences, Inc. (“TwinStrand”) and the University of Washington (“UW”) (together, “Plaintiffs”) against Defendant Guardant Health Inc, (“Guardant” or “Defendant”) involving DNA sequencing technology. Following a jury trial in November 2023, the jury returned a verdict that Defendant had infringed Claim 1 of U.S, Patent No, 10,287,631 (the “°631 Patent’) and Claims 24 and 30 of U.S. Patent No. 10,760,127 (the “’127 Patent”) (together, the “Asserted Claims” of the “Asserted Patents”). The jury also found willfulness. Now pending before the Court are the following motions:! (1) Defendant’s Motion for Judgment as a Matter of Law Or, in the Alternative, New Trial (“Defendant’s Motion for JMOL or New Trial”) (D.L 530), which has been fully briefed (D.I. 531; D.1. 550; 556); (2) Plaintiffs’ Motion for Enhanced Damages, Attorneys’ Fees, an Ongoing Royalty, and Other Relief (D.I. 532) (“Plaintiffs’ Enhanced Damages Motion”), which has been fully briefed (D.1. 535; D.I. 548; D.I. 557); and (3) Defendant’s Motion for Relief under Rule 60(b) (“Defendant’s Rule 60(b) Motion”) (D.I. 592), which has been fully briefed (D.I. 593; D.I. 595; D.I. 599).

1 The parties have also filed supplemental briefing with respect to the post-trial motions. D.I. 610; D.I. 614; DI. 618.

For the reasons set forth below, Defendant’s Motion for JMOL or New Trial (D.I. 530) is denied, Plaintiffs’ Enhanced Damages Motion (D.I. 532) is granted-in-part and denied-in-part, and Defendant’s Rule 60(b) Motion (D.1. 592) is denied. I. BACKGROUND A. Pre-Trial History” On August 3, 2021, Plaintiffs filed their Complaint, alleging infringement by Defendant of the ’127 Patent, the °631 Patent, as well as U.S. Patent Nos. 10,689,699 (the “699 Patent”) and 10,752,951 (the “’951 Patent”). DI. 1. On January 12, 2022, Defendant filed its Amended Answer, Affirmative Defenses, and Counterclaims to Plaintiffs’ Complaint, alleging Plaintiffs’ infringement of four of Defendant’s patents, as well as counterclaims regarding the patentability and enforceability of some of Plaintiffs’ then-asserted patents, inter alia. D.1, 30. On December 6, 2022, Magistrate Judge Sherry R. Fallon presided over a claim construction hearing and, on December 29, 2022, issued a Report and Recommendation recommending the construction of several terms. D.I. 190. On June 2, 2023, the Court issued a Memorandum Order overruling Defendant’s objections to the Report and Recommendation. D.I. 320. The parties’ claims and counterclaims narrowed leading up to trial. On September 22, 2023, the parties stipulated to the dismissal of Defendant’s patents and Plaintiffs’ related counterclaims, D.I. 441. On October 17, 2023, the parties stipulated to the dismissal of Plaintiffs’ infringement claims with respect to the °699 Patent and the ’951 Patent and Defendant’s related counterclaims. D,I. 450.

2-The Court writes for the benefit of the patties and only sets forth the procedural history necessary for the discussion herein. For a fuller discussion of the procedural history, see D.I. 465 at I nl,

Shortly before trial, the parties raised new issues of claim construction regarding (1) prosecution history estoppel of the ’631 Patent as it pertains to the “strand-distinguishing nucleotide sequence” limitation and (2) whether the claims of the ’127 Patent and ’631 Patent must be performed in order. See D.L. 462 (citing D.L. 460, Ex. 17). On October 30, 2023, the Court issued an Oral Order directing the parties to file supplemental briefing on these issues and scheduled a supplemental claim construction hearing. Id. On October 31, 2023, the Court issued two Memorandum Orders resolving the parties’ summary judgment motions and Daubert motions (D.I. 465 and D.I. 466) and an Oral Order granting Defendant’s motion to strike (D.I. 467), On November 1, 2023, the Court issued an Order resolving the parties’ motions in dimine. D.I. 469. On November 2, 2023, the Court presided over a supplemental claim construction hearing and the parties’ pretrial conference, On the following day, the Court issued a Memorandum Order regarding supplemental claim construction. D.1. 475. B. Trial and the Jury’s Verdict A five-day jury trial began on November 6, 2023, Following trial, the jury returned a verdict finding that Defendant infringed each of the Asserted Claims. D.I. 497 at 2. The jury also found that Defendant’s infringement was willful. Jd at 3. The jury awarded Plaintiffs $83.4 million in damages in the form ofa reasonable royalty, arriving at this damages figure by applying a 6% royalty rate to a $1.39 billion revenue base, which included $106 million in revenue from sales of Defendant’s services. Jd at 4-5. The Court entered judgment in favor of Plaintiffs in accordance with the jury’s verdict, D.I. 520 at 1 (providing that judgment was “subject to modification following the Court’s consideration of the parties’ post-trial motions”).

Cc, The Asserted Patents and Claims The °127 Patent is titled “Methods of lowering the error rate of massively parallel DNA sequencing using duplex consensus sequencing.” Claims 24 and 30 depend from Claim 22. The relevant claim language is as follows: 22. A method of sequencing DNA comprising: a) attaching partially single-stranded adapters comprising barcodes selected from a plurality of distinct barcode sequences to double-stranded DNA fragments obtained from a bodily sample, wherein attachment of the adapters to double- stranded DNA fragments generates a library of tagged double-stranded adapter-DNA molecules; b) amplifying strands from a plurality of the double-stranded adapter-DNA molecules in the library to produce strand copies; c) sequencing a plurality of the strand copies to obtain strand sequence reads comprising one or more barcode sequences and DNA fragment-specific information, and d) for at least some of the double-stranded adapter-DNA molecules in the library— grouping the strand sequence reads into families based on i) the barcode sequence, and ii} DNA fragment- specific infermation; collapsing a plurality of strand sequence reads within the families to provide a consensus sequence for each of at least some of the double-stranded DNA molecules in the library; comparing the consensus sequence to a_ reference sequence; and analyzing one or more correspondences between the consensus sequence and the reference sequence to identify a sequence variation. OR

24, The method of claim 22, wherein at least some of the double- stranded DNA fragments are derived from a tumor or circulating neoplastic cells.

30. The method of claim 22, wherein the barcode sequences are 3, 4, 5, 6, 7 or 8 nucleotides in length. Patent at Claims 22, 24, 30 (emphasis added).

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TwinStrand Biosciences, Inc. & University of Washington v. Guardant Health, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/twinstrand-biosciences-inc-university-of-washington-v-guardant-health-ded-2026.