Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 1 of 21 PageID #:
`32943
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`NATERA, INC.,
`
`CAREDX, INC.,
`
`Plaintiff,
`
`v.
`
`Defendant.
`
`Civil Action No. 20-38-CFC-CJB
`(CONSOLIDATED)
`
`Jack B. Blumenfeld, Derek J. Fahnestock, and Anthony D. Raucci, MORRIS,
`NICHOLS, ARSHT, & TUNNELL LLP, Wilmington, Delaware; Kevin P.B.
`Johnson, QUINN EMANUEL URQUHART & SULLIVAN, LLP, Redwood
`Shores, California; Sandra L. Haberny, QUINN EMANUEL URQUHART &
`SULLIVAN, LLP, Los Angeles, California; Andrew M. Holmes and Jeff
`Nardinelli, QUINN EMANUEL URQUHART & SULLIVAN, LLP, San
`Francisco, California; Bianca Fox, QUINN EMANUEL URQUHART &
`SULLIVAN, LLP, New York, New York
`
`Counsel for Plaintiff
`
`Brian E. Farnan and Michael J. Farnan, FARNAN LLP, Wilmington, Delaware;
`Edward R. Reines, Derek C. Walter, Nate Ngerebara, August Melcher, Concord
`Cheung, and Shawn Chi, WEIL, GOTSHAL & MANGES LLP, Redwood Shores,
`California; W. Sutton Ansley, WEIL, GOTSHAL & MANGES LLP, Washington,
`D.C.
`
`Counsel for Defendant
`
`MEMORANDUM OPINION
`
`February 24, 2025
`Wilmington, Delaware
`
`

`

`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 2 of 21 PageID #:
`32944
`
`COLMF~OLLY
`C EF JUDGE
`
`I held a five-day jury trial in this patent infringement case brought by
`
`Plaintiff Natera, Inc. against Defendant CareDx, Inc. Natera asserted at trial
`
`claims of two patents: U.S. Patent No. 11 ,111 ,544 (the #544 patent) and U.S.
`
`Patent No. 10,655,180 (the #180 patent). In the first phase of trial, the jury found
`
`that two CareDx cell-free DNA (cfDNA) blood tests used to determine whether an
`
`organ transplant is being rejected-AlloSure and AlloSeq-infringed the asserted
`
`claims of the #544 patent but did not infringe the asse1ied claims of the # 180
`
`patent. D.I. 460 at 1-2. The jury also found that none of the asserted claims were
`
`invalid for obviousness or lack of adequate written description. D.I. 460 at 4-5.
`
`And finally, for each asserted claim, the jury found that none of the limitations of
`
`that claim both individually and in combination with each other were well(cid:173)
`
`understood, routine, or conventional as of the priority date of the asserted claim.
`
`D.I. 460 at 6-11. In the second phase of trial, the jury awarded Natera a damages
`
`award of approximately $96 million, consisting of $83.7 million in lost profits for
`
`infringing sales of AlloSure, $12.5 million in reasonable royalties for sales of
`
`AlloSure, and $92,350 in reasonable royalties for infringing sales of AlloSeq. See
`
`D.I. 461 at 1-3.
`
`

`

`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 3 of 21 PageID #:
`32945
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`Pending before me is CareDx, Inc.'s "Motion for Judgment as a Matter of
`
`Law Under [Federal Rule of Civil Procedure] 50 or, in the Alternative, New Trial
`
`Under [Federal Rule of Civil Procedure] 59." D.I. 485. CareDx seeks by its
`
`motion a judgment of invalidity of the asserted claims of the #544 and# 180
`
`patents for lack of adequate written description and a judgment of ineligibility of
`
`the #180 patent claims under 35 U.S.C. § 101. D.I. 486 at 2-19. CareDx also asks
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`that I hold as a matter of law that foreign damages were improper in this case and
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`that the jury's lost profits award was unsupported and excessive. D.I. 486 at 19-
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`21. In the alternative, CareDx asks for a new trial or remittitur of damages.
`
`D.I. 486 at 21-22.
`
`I.
`
`THE ASSERTED PATENT CLAIMS
`
`A.
`
`The #544 Patent
`
`In Natera's words, "[t]he claims of the [#]544 [p]atent" are:
`
`directed to preparing preparations of amplified DNA
`derived from a biological sample and measuring DNA in
`a biological sample using synthetic pieces of DNA,
`including amplification products, which are produced
`using synthetic tools such as primers, to provide a novel
`and innovative solution to problems peculiar to the
`particular problem of amplifying and measuring small
`amounts of DNA from one individual or organism in a
`biological sample of another individual or organism.
`
`D.I. 120 ,I 28. Natera asserted three claims of the #544 patent at trial: claims 21,
`
`26, and 27.
`
`2
`
`

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`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 4 of 21 PageID #:
`32946
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`Claim 21 claims:
`
`A method for preparing a preparation of amplified DNA
`derived from a biological sample of a second individual
`useful for determining genetic data for DNA from a first
`individual in the biological sample, the method
`compnsmg:
`
`extracting cell-free DNA from the biological
`sample;
`
`preparing a preparation of amplified DNA by
`amplifying a plurality of target loci on the cell-free
`DNA extracted from the biological sample to
`generate amplified DNA;
`
`analyzing the preparation of amplified DNA by
`sequencing the amplified DNA using sequencing(cid:173)
`by-synthesis to obtain genetic data of the plurality
`of target loci, and determining the most likely
`genetic data for DNA from the first individual
`based on allele frequencies in the genetic data at
`the plurality of target loci.
`
`#544 patent at claim 21.
`
`Claims 26 and 27 depend from claim 21. Claim 26 claims "[t]he method of
`
`claim 21, wherein the amplifying comprises targeted PCR and universal PCR."
`
`#544 patent at claim 26. Claim 27 claims "[t]he method of claim 21, wherein the
`
`sequencing-by-synthesis comprises clonal amplification of the amplified DNA and
`
`measurement of sequences of the clonally amplified DNA." # 544 patent at claim
`
`27.
`
`3
`
`

`

`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 5 of 21 PageID #:
`32947
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`B.
`
`The #180 Patent
`
`According to Natera, the claims of the #180 patent are:
`
`directed to measuring DNA in a sample using synthetic
`pieces of DNA, including amplification products, which
`are produced using synthetic tools such as primers, to
`provide a novel and innovative solution to problems
`peculiar to the particular problem of amplifying and
`measuring small amounts of DNA from one individual or
`organism in a biological sample of another individual or
`orgamsm.
`
`D.I. 119, 26. Natera asserted two claims of the #180 patent at trial: claims 14 and
`
`15.
`
`Claim 14 claims:
`
`A method for measuring an amount of DNA in a
`biological sample, the method comprising:
`
`(a) performing a targeted PCR amplification for
`more than 100 SNP loci on one or more
`chromosomes expected to be disomic in a single
`reaction mixture using more than 100 PCR primer
`pairs, wherein the reaction mixture comprises cell(cid:173)
`free DNA extracted from a biological sample of a
`subject comprising DNA of mixed origin, wherein
`the DNA of mixed origin comprises DNA from the
`subject and DNA from a genetically distinct
`individual, wherein neither the subject nor the
`genetically distinct individual is a fetus, wherein
`the DNA of mixed origin comprises DNA from a
`transplant, and wherein the amplified SNP loci
`comprise SNP loci on at least chromosome 1, 2,
`or 3· '
`
`4
`
`

`

`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 6 of 21 PageID #:
`32948
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`(b) measuring a quantity of each allele at a
`plurality of amplified SNP loci that comprise an
`allele present in the genetically distinct individual
`but not the subject, wherein the quantity of each
`allele at a plurality of amplified SNP loci are
`measured by high-throughput sequencing;
`
`(c) measuring an amount of the DNA from the
`genetically distinct individual in the biological
`sample using the quantity of each allele at the SNP
`loci and an expected quantity of each allele at the
`SNP loci for different DNA fractions,
`
`wherein the method is performed without prior
`knowledge of genotypes of the genetically distinct
`individual.
`
`# 180 patent at claim 14.
`
`Claim 15 claims:
`
`[t]he method of claim 14, further comprising determining
`a bias of the PCR amplification, and using the bias to
`statistically correct the determined quantity of each allele
`at the plurality of SNP loci on the one or more
`chromosomes expected to be disomic before the quantity
`of each allele is used to determine the amount of the
`DNA from the genetically distinct individual.
`
`# 180 patent at claim 15.
`
`II. LEGAL STANDARDS
`
`CareDx brought the pending motion pursuant to Rule 50(b ). Under that rule,
`
`"the movant may file a renewed motion for judgment as a matter of law and may
`
`include an alternative or joint request for a new trial under Rule 59." Fed. R. Civ.
`
`5
`
`

`

`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 7 of 21 PageID #:
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`P. 50(b ). A motion filed under Rule 50(b) "should be granted only if, viewing the
`
`evidence in the light most favorable to the nonmovant and giving it the advantage
`
`of every fair and reasonable inference, there is insufficient evidence from which a
`
`jury reasonably could find liability." Lightning Lube, Inc. v. Witco Corp., 4 F .3d
`
`1153, 1166 (3d Cir. 1993).
`
`III. ANALYSIS
`
`A.
`
`Judgment of Invalidity of the Asserted Claims as a Matter of Law
`
`CareDx argues that the jury's verdict cannot stand and that CareDx is
`
`entitled to judgment of invalidity of the asserted claims of both patents as a matter
`
`of law for lack of adequate written description because the asserted patents'
`
`specifications ( 1) do not disclose the inventions in the asserted claims as an
`
`integrated whole as opposed to a collection of claim limitations and (2) do not
`
`disclose key individual claim elements of the asserted claims. D.I. 486 at 2-16.
`
`CareDx also argues that the # 180 patent is invalid as a matter of law because it
`
`claims unpatentable subject matter. D.I. 486 at 16-19.
`
`As discussed below, I agree with CareDx that it is entitled to judgment of
`
`invalidity of the asserted claims as a matter of law for lack of adequate written
`
`description. Having made that determination, I need not and do not address
`
`CareDx's arguments regarding the patentability of the #180 patent's subject matter.
`
`See Northpoint Tech., Ltd. v. MDS Am., Inc., 413 F.3d 1301, 1306 (Fed. Cir. 2005)
`
`6
`
`

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`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 8 of 21 PageID #:
`32950
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`("Because we uphold the judgment as to invalidity on [ anticipation and
`
`enablement] grounds, it is not necessary for us to reach the issues of obviousness
`
`and indefiniteness.").
`
`1.
`
`The Legal Requirements of a Patent's Written Description
`
`Section 112(a) of the Patent Act requires that the specification of a patent
`
`"contain a written description of the invention." 35 U.S.C. § 112(a). To satisfy
`
`this requirement, a patent's written description must "reasonably convey[] to those
`
`skilled in the art that the inventor had possession of the claimed subject matter as
`
`of the filing date." Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351
`
`(Fed. Cir. 2010). In other words, the patent's specification must "clearly allow
`
`persons of ordinary skill in the art to recognize that [the inventor] invented what is
`
`claimed." Id. (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir.
`
`1991)).
`
`"This inquiry ... is a question of fact." Id. And "determining whether a
`
`patent complies with the written description requirement will necessarily vary
`
`depending on the context." Id. The description can be made using "words,
`
`structures, figures, diagrams, formulas, etc." Lockwood v. Am. Airlines, Inc., 107
`
`F.3d 1565, 1572 (Fed. Cir. 1997). And the patentee can also "rely on information
`
`that is 'well-known in the art' to satisfy written description." Streck, Inc. v. Rsch.
`
`& Diagnostic Sys., Inc., 665 F.3d 1269, 1285 (Fed. Cir. 2012) (citation omitted).
`
`7
`
`

`

`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 9 of 21 PageID #:
`32951
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`But to meet§ 112(a)'s requirements, the specification must "describ[e] the
`
`invention, with all its claimed limitations, not that which makes [the invention]
`
`obvious." Lockwood, 107 F .3d at 1572 ( emphasis in the original). Federal Circuit
`
`case law makes clear that "[a] description which renders obvious the invention ...
`
`is not sufficient" to satisfy § 112(a). Id. Thus, "[w]hile the written description
`
`requirement does not require that the specification recite the claimed invention in
`
`any particular way, pointing to an 'amalgam of disclosures' from which an artisan
`
`could have created the claimed invention does not satisfy this requirement."
`
`Flash-Control, LLC v. Intel Corp., 2021 WL 2944592, at *3 (Fed. Cir. July 14,
`
`2021) ( quoting Novozymes AIS v. DuPont Nutrition Biosciences APS, 723 F .3d
`
`1336, 1349 (Fed. Cir. 2013)). "Instead, the specification must present each claim
`
`as an 'integrated whole."' Id. (quoting Novozymes, 723 F.3d at 1349). "A patent
`
`owner cannot show written description support by picking and choosing claim
`
`elements from different embodiments that are never linked together in the
`
`specification." Flash-Control, 2021 WL 2944592, at *4.
`
`2.
`
`The #544 Patent
`
`Claim 21, from which claims 26 and 27 depend, claims a method by which
`
`(1) cell-free DNA is extracted from a biological sample of one individual (i.e., the
`
`"second individual"); (2) target loci on the extracted cell-free DNA is "amplified"
`
`and "sequenc[ed by] synthesis to obtain genetic data"; and (3) "the most likely
`
`8
`
`

`

`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 10 of 21 PageID
`#: 32952
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`genetic data" for DNA from another individual (i.e., the "first individual") in the
`
`obtained genetic data is "determin[ ed]" from that data "based on allele
`
`frequencies." CareDx argues, and I agree, that no reasonable jury could find,
`
`based on the evidence adduced at trial, that the #544 patent's written description
`
`sufficiently demonstrates that the inventors possessed the full scope of this claimed
`
`method.
`
`As an initial matter, and as CareDx's expert Dr. Brian Van Ness testified at
`
`trial, nowhere in the text of the #544 patent is there a description of the
`
`combination of claim 21 's elements as an integrated whole. 1.24.24 Trial Tr.
`
`(docketed as D.I. 468) at 813:17-815:16. Natera does not dispute the absence of
`
`an explanation in the patent's written description of the combination of the claimed
`
`steps. Indeed, in rebutting CareDx' s contention that the patent lacks adequate
`
`written description, Natera cites only two portions of the patent's written
`
`description: (1) lines 44 and 45 in column 8 for the proposition that "sequencing(cid:173)
`
`by-synthesis can 'be used for genotyping and SNP analysis,"' D.I. 510 at 8-9
`
`( emphasis added); and (2) line 36 in column 54 through line 38 in column 65 for
`
`the propositions that the written description "discloses analysis via Matched
`
`Filtering of mixed samples processed using sequencing-by-synthesis" and
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`"methods that do not require genetic information about a related individual,"
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`D.I. 510 at 10.
`
`9
`
`

`

`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 11 of 21 PageID
`#: 32953
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`Instead of pointing to specific text in the patent to show that the written
`
`description adequately describes the combination of the claimed steps as an
`
`integrated whole, Natera relies exclusively on this testimony of its expert Dr. John
`
`Quackenbush:
`
`Q. And were you here -- did you hear Dr. Van Ness
`opine yesterday that the [ #] 544 Patent does not include
`written description of the [#]544 Patent claims as a
`whole?
`
`A. I was here, and I heard him make those arguments.
`And from the perspective of a person of ordinary skill in
`the art, if you look at the claims, right, you see how they
`fit together. You see worked examples of different
`pieces. And if you know enough about the field -- and
`remember, Dr. Van Ness set a high very bar for a person
`of ordinary skill in the art; lots of experience, lots of
`computational and genetics experience, you should be
`able to put these things together.
`
`If you do word searches, you may find it. But if
`you actually read it and understand what it's telling you,
`right, like mixed samples being mixed samples, then you
`understand that this entire whole of Claim 21 is
`disclosed.
`
`1.25.24 Trial Tr. (docketed as D.I. 469) at 1095:5-21. This conclusory testimony,
`
`however, is "far too general" to support the jury's finding of adequate written
`
`description for claim 21 ( as well as for claims 26 and 27, since they both depend
`
`from claim 21). Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330,
`
`1336-37 (Fed. Cir. 2021) (rejecting district court's reliance on expert testimony
`
`10
`
`

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`that was "far too general" and holding that district court erred in not granting
`
`judgment of inadequate written description as a matter of law because "substantial
`
`evidence d[id] not support the jury's finding of adequate written description").
`
`Even if Dr. Quackenbush had identified "worked examples of different pieces" in
`
`the patent's specification, he never pointed to any text in the patent's written
`
`description that would lead an artisan of ordinary skill to know that the inventor
`
`had invented a combination of those different pieces. 1.25 Tr. at 1095: 11-12. At
`
`most, Dr. Quackenbush identified textual support for certain elements of claim 21
`
`and asked the jury to take it on his word that an artisan of ordinary skill "should· be
`
`able to put these things together." 1.25 Tr. at 1095:15-16. That strategy fails as a
`
`matter of law. "[P]ointing to an 'amalgam of disclosures' from which an artisan
`
`could have created the claimed invention does not satisfy th[ e] [ written
`
`description] requirement." Flash-Control, 2021 WL 2944592, at *3 (quoting
`
`Novozymes, 723 F.3d at 1349).
`
`A rational juror could not have found the #544 patent's written description
`
`adequate for the additional reason that no substantial evidence was adduced at trial
`
`to show that the inventor possessed a sequencing-by-synthesis technique to
`
`measure allele frequencies in cell-free DNA. Natera admits, as it must, that "[t]he
`
`[#]544 Patent includes no working examples of experiments that used sequencing(cid:173)
`
`by-synthesis." D.I. 447,I 53. It also admits, as it must, that "[t]he [#]544 Patent
`11
`
`

`

`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 13 of 21 PageID
`#: 32955
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`includes no working examples of experiments on cell-free DNA." D.I. 447154.
`
`The patent's written description refers to sequencing-by-synthesis only once, and it
`
`teaches away from it. See #544 patent at 8:44-48 (stating that "[p]yrosequencing,
`
`or sequencing[-]by[-]synthesis, can also be used for genotyping and SNP analysis"
`
`but "is not currently conducive to high-throughput parallel analysis"). And
`
`although Dr. Quackenbush testified at trial that mini-sequencing is a form of
`
`sequencing-by-synthesis and that the written description "talk[ s] about" mini(cid:173)
`
`sequencing, 1.24 Tr. at 986:8-9, he did not identify any text in the patent that
`
`would show to an artisan of ordinary skill that mini-sequencing is capable of
`
`measuring allele frequencies in cell-free DNA. Moreover, the two brief
`
`discussions about mini-sequencing in the written description teach away from the
`
`idea that mini-sequencing was a technique contemplated by the inventor for use in
`
`practicing the claimed method. Specifically in column 4, the patent identifies
`
`mini-sequencing as one of "a number of advanced technologies that enable the
`
`diagnosis of genetic aberrations at one or a few loci at the single cell level" but
`
`states in the next two sentences that "[t]he reliability of the data generated by all of
`
`these techniques relies on the quality of the DNA preparation" and that "[b Jetter
`
`methods for the preparation of single-cell DNA for amplification and PGD are
`
`therefore needed." #544 patent at 4:3-11. And in column 7, the patent states that
`
`"mini-sequencing permits analysis of very small DNA fragments with low ADO
`12
`
`

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`#: 32956
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`rate," but states in the next sentence that "[b]etter methods for the preparation of
`
`single-cell DNA for amplification and PGD are therefore needed." #544 patent at
`
`7:29-32.
`
`There being no substantial evidence to support the jury's finding of adequate
`
`written description in the #544 patent, judgment of invalidity of the asserted claims
`
`of the #544 patent as a matter of law is warranted. Natera argues that "[t]he jury
`
`could have reasonably concluded that CareDx failed to meet its burden even if
`
`Natera had not presented any evidence on written description." D.I. 556 at 5
`
`( emphasis in the original). In support of this assertion, it relies on a statement in
`
`Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565 (Fed. Cir. 1986)
`
`that "[a] patent being presumed valid at birth, a patentee need submit no evidence
`
`in support of a conclusion of validity by a court or a jury." Id. at 1570 ( emphasis
`
`in the original) (citation omitted). But as the two sentences that immediately
`
`follow that statement in Orthokinetics make clear, to defeat a defendant's motion
`
`for judgment of invalidity as a matter of law, the patentee need not submit
`
`evidence only if the evidence of invalidity adduced by the defendant was "totally
`
`inadequate" to support an invalidity finding:
`
`If the patent challenger introduces evidence that might
`lead to a conclusion of invalidity, a patentee would be well
`advised to introduce evidence sufficient to rebut that of the
`If the challenger's evidence be totally
`challenger.
`inadequate, a patentee's motion for judgment or directed
`13
`
`

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`#: 32957
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`verdict that the challenger's § 282 burden had not been
`carried would be appropriately granted before the patentee
`introduces any rebuttal evidence.
`
`Id. ( emphasis added). If, however, the challenger introduces evidence that would
`
`justify a conclusion of invalidity, the patentee has "the burden of going forward
`
`with evidence" to rebut that conclusion. Tech. Licensing Corp. v. Videotek, Inc.,
`
`545 F.3d 1316, 1327 (Fed. Cir. 2008).
`
`In this case, given Dr. Van Ness' s testimony and the absence of supporting
`
`text in the #544 patent's written description, that burden of production required
`
`Natera to "produc[ e] additional evidence and present[] persuasive argument based
`
`on new evidence or evidence already of record." Id. Natera, however, failed to
`
`identify existing evidence or adduce new evidence of disclosures in the #544
`
`patent that describe either claim 21 's limitations as an integrated whole or a
`
`sequencing-by-synthesis technique to measure allele frequencies in cell-free DNA.
`
`Accordingly, I will grant CareDx's motion for judgment of invalidity of the
`
`asserted claims of the #544 patent as a matter of law for lack of adequate written
`
`description.
`
`3.
`
`The #180 Patent
`
`The #180 patent's written description for asserted claims 14 and 15 is
`
`inadequate as a matter of law for the same reason the #544 patent's written
`
`description is inadequate-i.e., Natera did not adduce at trial substantial evidence
`
`14
`
`

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`#: 32958
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`that the patent's text shows that the inventor possessed the combination of the
`
`elements of the claimed methods.
`
`Natera argues that "Dr. Quackenbush explained [at trial] how the claims are
`
`integrated as a whole because the written description, when read in its entirety, sets
`
`forth the basis for a[ n] [ artisan of ordinary skill] to understand what the claimed
`
`invention is." D.I. 510 at 16 ( citing 1.25 Tr. ( docketed as D.I. 469) at 1163 :5-
`
`1164 :5). It cites the following testimony-and only the following testimony-in
`
`support of this assertion:
`
`Q. So tying this together, do you have any opinions on
`whether Dr. Van Ness'[s] position that the Natera patents
`do not describe the claimed methods in enough detail to
`show the inventors possessed them is consistent with his
`opinion that they were so routine and conventional they
`would have been obvious?
`
`A. So this is something I found really confusing about
`Dr. Van Ness'[s] presentation, right? He said, oh, if I
`look at other things, it's obvious this is true. Right? So
`it's pulling puzzle pieces from different boxes and trying
`to fit them in.
`
`But if I look at the patent, I can 't [sic] figure out
`how to put those pieces together, right? If it was really
`routine and conventional, then somebody can look at the
`patent and fill in the gaps. Right? You don't have to
`read everything in the patent. It doesn't all have to be
`there. You apply your experience as someone skilled in
`the art.
`
`The fact that he didn 't find written description
`means he couldn 't fill those things in, but that's
`15
`
`

`

`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 17 of 21 PageID
`#: 32959
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`inconsistent with the fact that you reach out and grab a
`bunch of other things and plug them in. Right?
`
`So, you know, my opinion is that it's there. If I
`look from the perspective ofa person of ordinary skill
`in the art, I see it's there, and I see deficiencies with
`these other external references.
`
`1.25 Tr. at 1163:5-1164:5 (emphasis added).
`
`As an initial matter, it's not clear to me that Dr. Quackenbush intended to
`
`say, "But if I look at the patent, I can't figure out how to put those pieces
`
`together." I think there's some chance Dr. Quackenbush meant to say, "I can
`
`figure out how to put those pieces together." On the other hand, it may be that Dr.
`
`Quackenbush very much intended to use the words attributed to him in the
`
`transcript, that he was paraphrasing Dr. Van Ness's written description opinions,
`
`and that he was pretending to speak as ifhe were Dr. Van Ness and therefore using
`
`the first-person "I." But putting that ambiguity aside and reading Dr.
`
`Quackenbush's testimony in the light most favorable to Natera, the entirety of the
`
`justification Dr. Quackenbush offered at trial for his opinion that the #180 patent's
`
`written description adequately described the combination of the asserted claims'
`
`elements was "it's there" and "I see it's there." That opinion is the epitome of
`
`conclusory. And, as a matter of law, it does not constitute substantial evidence that
`
`would justify a jury's finding of adequate written description for the asserted
`
`claims integrated as wholes. See Juno, 10 F.4th at 1337. Accordingly, as Natera
`16
`
`

`

`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 18 of 21 PageID
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`does not cite any other evidence to counter CareDx's argument that the #180
`
`patent's written description does not adequately describe the combination of the
`
`elements of the claimed methods, I will grant CareDx' s motion for judgment of
`
`invalidity of the asserted claims of the # 180 patent as a matter of law.
`
`B.
`
`New Trial
`
`Rule 50( c )( 1) provides that "[i]f the court grants a renewed motion for
`
`judgment as a matter of law, it must also conditionally rule on any motion for a
`
`new trial by determining whether a new trial should be granted if the judgment is
`
`later vacated or reversed." Fed. R. Civ. P. 50(c)(l). The law of the district court's
`
`circuit governs the standard for ordering a new trial in a patent case. SynQor, Inc.
`
`v. Artesyn Techs., Inc., 709 F.3d 1365, 1383 (Fed. Cir. 2013). Under Third Circuit
`
`law, " [a] new trial may be granted when the verdict is contrary to the great weight
`
`of the evidence; that is, 'where a miscarriage of justice would result if the verdict
`
`were to stand."' Pryer v. C.O. 3 Slavic, 251 F.3d 448,453 (3d Cir. 2001) (quoting
`
`O/ejins Trading, Inc. v. Han Yang Chem Corp., 9 F.3d 282, 289 (3d Cir. 1993)).
`
`CareDx argues that a new trial is warranted because "the jury verdict is
`
`contrary to the great weight of the evidence and the damages award is excessive."
`
`D.I. 486 at 22. For the reasons stated above, I agree that the jury's determination
`
`that the written descriptions of the asserted patents are adequate is contrary to the
`
`evidence. But, assuming for the purposes of Rule 50( c )( 1) that the Federal Circuit
`
`17
`
`

`

`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 19 of 21 PageID
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`
`disagrees with that conclusion, I do not agree that the jury's damages award would
`
`require a new trial.
`
`First, the jury's damages award for infringing sales of AlloSure-i.e., all but
`
`$92,350 of the total damages award of $96 million-was not contrary to the great
`
`weight of the evidence. Natera adduced substantial record evidence to support the
`
`jury's lost profits award, as that evidence provided a basis for a rational juror to
`
`conclude that there was a "reasonable probability" that but-for CareDx's
`
`infringement, Natera would have made a portion of CareDx' s infringing sales. The
`
`evidence, including admissions by CareDx, showed the advantages of cfDNA
`
`testing over non-cfDNA testing and provided a basis to use the market for cfDNA
`
`testing as the relevant market for a lost profits assessment. See, e.g., 1.26.24 Trial
`
`Tr. (docketed as D.I. 470) at 1495:11-1496:10 {PTX-279, detailing advantages of
`
`cfDNA testing over "less accurate" DSA and "invasive" biopsy); 1496: 15-1497:6
`
`{PTX-456, CareDx brochure describing drawbacks of biopsy); 1497:8-1498:4
`
`(CareDx describing advantages of ctDNA tests over biopsy and creatinine );
`
`1576:2-1577:20 (admissions from CareDx expert). The evidence further showed
`
`that CareDx made $350 million in infringing sales in the cfDNA testing market
`
`during the damages period, 1.26 Tr. at 1572:22-1573:6, and that CareDx competed
`
`directly with Natera and Euro fins in that market, 1.26 Tr. at 1489: 19-1491 :21. It
`
`also provided a basis for the jury to conclude that Natera and Eurofins would
`18
`
`

`

`Case 1:20-cv-00038-CFC-CJB Document 558 Filed 02/24/25 Page 20 of 21 PageID
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`capture CareDx's market share in a but-for world in which CareDx did not
`
`compete. 1.26 Tr. at 1489:19-1491 :25, 1500:17-1501 :11.
`
`Second, although I agree with CareDx that the jury erred in awardiQ.g
`
`compensatory damages for foreign sales of AlloSeq and that the $92,350 award of
`
`reasonable royalties for sales of AlloSeq "ignores the final jury instructions,"
`
`D.I. 486 at 19 ( quoting D.I. 458 at 4), that error by the jury can be remedied
`
`without a new trial. CareDx is correct that Natera adduced no evidence at trial that
`
`any sale of AlloSeq was made in the United States; nor did Natera adduce any trial
`
`evidence to show that any domestic infringement caused foreign sales of AlloSeq.
`
`Natera does not dispute in its briefing that it adduced no record evidence of sales of
`
`AlloSeq in the United States. See D.I. 510 at 20. Natera argues instead that record
`
`evidence showed that CareDx used AlloSeq in its research laboratory to perform
`
`the asserted claims in the United States and that "evidence connect[ ed] AlloSeq
`
`foreign sales to CareDx's domestic infringement." D.I. 510 at 20 (citing 1.23.24
`
`Trial Tr. (docketed as D.I. 467) at 383:22-384:11). The testimony Natera cites in
`
`support of this connection, however, does not make a connection between
`
`CareDx's domestic infringement and foreign sales of AlloSeq. See 1.23 Tr. at
`
`383:22-384:2.
`
`Because there was no evidence from which a rational juror could have
`
`concluded that foreign sales of AlloSeq practiced the asserted claims in the United
`19
`
`

`

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`#: 32963
`
`States, had I denied CareDx's motion for judgment of invalidity as a matter of law,
`
`I would have set aside the jury's $92,350 damages award for AlloSeq sales. See
`
`Tucker v. Spalding, 80 U.S. 453, 455 (1871) ("[I]t ... remains the essential nature
`
`of the jury trial that while the court may on [a] mixed question of law and fact, lay
`
`down to the jury the law which should govern them, so as to guide them to truth,
`
`and guard them against error, and may, if they disregard instructions, set aside their
`
`verdict[.]"). CareDx does not argue, however, and there is no basis to conclude,
`
`that the jury's damages award for AlloSeq sales had any bearing on its award for
`
`infringing AlloSure sales. Accordingly, I will conditionally deny CareDx's motion
`
`for a new trial.
`
`IV. CONCLUSION
`
`For the reasons stated above, I will grant CareDx' s motio

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