Invitae Corporation v. Natera, Inc.

CourtDistrict Court, D. Delaware
DecidedJune 5, 2025
Docket1:21-cv-00669
StatusUnknown

This text of Invitae Corporation v. Natera, Inc. (Invitae Corporation v. Natera, 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
Invitae Corporation v. Natera, Inc., (D. Del. 2025).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

LABORATORY CORPORATION OF AMERICA HOLDINGS, Plaintiff, C.A. No. 21-669-GBW v. NATERA, INC., Defendant.

LABORATORY CORPORATION OF AMERICA HOLDINGS, Plaintiff, C.A. No. 21-1635-GBW v. NATERA, INC., Defendant.

MEMORANDUM ORDER “In these two actions filed by [] Invitae Corporation (‘Invitae’) against Defendant Natera, Inc. (‘Natera’), [Plaintiff Laboratory Corporation of America Holdings (‘Labcorp’)] alleges infringement of United States Patent Nos. 10,604,799 (‘°799 patent’), 11,149,308 (°’308 patent’), and 11,155,863 (‘’863 patent’).” Invitae Corp. v. Natera, Inc., No. CV 21-1635-GBW, 2022 WL 10465138, at *1 (D. Del. Oct. 18, 2022).!

In April 2025, Labcorp was “substituted for Invitae Corporation as Plaintiff pursuant to Fed. R. Civ. P. 25(c)[.J” D.I. 269 J 1. Unless otherwise noted, references to docket cites refer to C.A. No. 21-1635.

Pending before the Court is Defendant Natera, Inc.’s Motion to Exclude under Daubert Expert Testimony That Fails to Apply the Court’s Claim Constructions (D.I. 190) (the “Motion”), which has been fully briefed (D.J. 191; D.I. 222; D.I. 242). For the following reasons, the Court denies the Motion. L BACKGROUND A. The Asserted Patents The ’799 patent, ’308 patent, and ’863 patent (collectively, the “Asserted Patents”) “share acommon written description” and “generally relate to the field of sequence assembly.” 2022 WL 10465138, at *1. “The claimed invention enables the identification of mutations with positional accuracy in a computationally tractable way.” Id. “On October 18, 2022, this Court issued a Memorandum Opinion and corresponding Order construing the claim terms of the Asserted Patents.” D.I. 244 at 2. Specifically, the Court construed the following claim terms of the Asserted Patents as follows (D.I. 62 at 1-3):

Disputed Constructions “sequence reads” raw reads as generated by the sequencing instrument?

“a plurality of sequence reads” (the °799 “sequence reads” to be defined as above, no patent) other construction necessary “the plurality of sequence reads” (the °863 patent) “the sequence reads” (the *308 patent)

2 On November 1, 2022, Invitae “request[ed] clarification and/or reconsideration of this Court’s construction of the term ‘sequence reads[.]’” D.I. 75 at 1. This request was denied. See D.I. 160 at 3 (“[T]he Court’s Opinion about ‘sequence reads’ is unambiguous, and Invitae’s motion for clarification is denied.”).

“said plurality of sequence reads” (the ’799 “sequence reads” to be defined as above, no patent) other construction necessary “the plurality of sequence reads” (the patent) “contig:reference descriptions of mutations” | a description of a mutation in a contig as it (799 patent) exists in the nucleic acid with reference to the genome “contig-to-reference descriptions of mutations” (’863 patent) “reference alignment(s)” ("308 patent) placement in a reference genome “read:contig descriptions” (°799 patent) a description of a sequence read with reference to a contig “read-to-contig descriptions” (°863 patent) “sequence read alignments” (°308 patent) placements of sequence reads “read:reference descriptions” (’799 patent) description of a sequence read with reference to the reference genome “read-to-reference descriptions” (’863 patent) “combining the contig:reference descriptions | no construction necessary. Plain and ordinary with the read:contig descriptions” (the ’799 meaning. patent) “combining the reference alignment and the sequence read alignments” (the ’308 patent) Agreed-Upon Construction “genotyping” (the *308 patent) assigning a genotype to

B. Defendant’s Motion Defendant’s Motion challenges the expert testimony of Dr. Joshua P. Earl (“Dr. Earl”) and Dr. Daniel E. Krane (“Dr. Krane”).

Specifically, Defendant challenges testimony found in: 1. The Expert Report of Joshua P. Earl (ECF No. 203-1 at PageID 7581-7598) (“Dr. Earl’s Opening Report” or the “Earl Opening Report”);? 2. The Reply Expert Report of Joshua P. Earl, Ph.D, to Rebuttal Expert Report of Istvan Albert, Ph.D (ECF No. 203-1 at PageID 7819-7821) (“Dr. Earl’s Reply Report” or the “Earl Reply Report”); 3. The Expert Report of Dan E. Krane (ECF No. 203-1 at PageID 7426-7506) (“Dr. Krane’s Opening Report” or the “Krane Opening Report”);° and 4. The Rebuttal Expert Report of Dan E. Krane to the Opening Expert Report of Michael Metzker, PhD (ECF No. 203-1 at PageID 7691-7772) (“Dr. Krane’s Rebuttal Report” or the “Krane Rebuttal Report”).° Il. LEGAL STANDARD A. Fed. R. Evid. 702Federal Rule of Evidence 702 governs the admissibility of expert testimony.” EcoFactor, Inc. v. Google LLC, ___ F Ath , No. 2023-1101, 2025 WL 1453149, at *3 (Fed. Cir.

3 As to Dr. Earl’s Opening Report, Defendant challenges Paragraphs 12, 15-16, 19-20, 22, 26-27, 29, and 38-42. D.I. 190 4 1. * As to Dr. Earl’s Reply Report, Defendant challenges Paragraph 2. D.I. 190 1. > As to Dr. Krane’s Opening Report, Defendant challenges Paragraphs 74, 79, 82, 88, 94, 97, 101, 103, 105, 109, 159, 165, 186, 190, 237, 245, and 251. D.I. 190 1. 6 As to Dr. Krane’s Rebuttal Report, Defendant challenges Paragraphs 66-72, 159-176, 237-238, 272-273, 369, 372, 496, 499-501, 540, 573, 619, 717-718, 740, 822, 827, 932, 1035-1036, 1142, and 1247. D.I. 19092. Ina separate motion (D.I. 172), Defendant moved to strike various portions of Dr. Krane’s Rebuttal Report. See D.I. 172-1 at 1 (proposed order to strike Paragraphs 69, 87, 161-163, 168, 173, 203, 205, 237, 240, 496, 499-500, 540, 573, 575, 615-616, 619, 714-715, 717- 719, 751, 784, 786, 932, 963, 1033, 1035, 1066, and 1244 of Dr. Krane’s Rebuttal Report); see also D.I. 191 at 1 n.1. The Court denied the preceding motion (D.I. 172). See D.L. 244 at 11.

May 21, 2025) (en banc). In Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993), the Supreme Court held that Federal Rule of Evidence 702 creates “a gatekeeping role for the [trial] judge” in order to “ensur[e] that an expert’s testimony both rests on a reliable foundation and is relevant to the task at hand.”’ “Because expert testimony ‘can be both powerful and quite misleading,’ the district court’s gatekeeping function under Rule 702 is an important one.” Trudell Med. Int'l Inc. v. D R Burton Healthcare, LLC, 127 F.4th 1340, 1349 (Fed. Cir. 2025) (quoting Daubert, 509 U.S, at 595). Rule 702 provides: A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if the proponent demonstrates to the court that it is more likely than not that: (a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert’s opinion reflects a reliable application of the principles and methods to the facts of the case. Fed. R. Evid. 702. As the Third Circuit has explained: Rule 702 embodies a trilogy of restrictions on expert testimony: qualification, reliability and fit. Qualification refers to the requirement that the witness possess specialized expertise. We have...

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