Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-18-02303/USCOURTS-ca13-18-02303-0/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 

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NOTE: This disposition is nonprecedential.

United States Court of Appeals 

for the Federal Circuit ______________________

VERINATA HEALTH, INC., ILLUMINA, INC.,

Plaintiffs-Appellants

v.

ARIOSA DIAGNOSTICS, INC, ROCHE 

MOLECULAR SYSTEMS, INC.,

Defendants-Cross-Appellants

______________________

2018-2198, 2018-2303, 2018-2305, 2018-2306, 2018-2317

______________________

Appeals from the United States District Court for the 

Northern District of California in Nos. 3:12-cv-05501-SI,

3:14-cv-01921-SI, 3:15-cv-02216-SI, Senior Judge Susan Y. 

Illston.

______________________

Decided: April 24, 2020

______________________

EDWARD R. REINES, Weil, Gotshal & Manges LLP, Redwood Shores, CA, argued for plaintiffs-appellants. Also 

represented by CHRISTOPHER SHAWN LAVIN. Plaintiff-appellant Illumina, Inc. also represented by DEREK C.

WALTER. 

 MARK CHRISTOPHER FLEMING, Wilmer Cutler Pickering 

Hale and Dorr LLP, Boston, MA, argued for defendantsCase: 18-2303 Document: 3 Page: 1 Filed: 04/24/2020
2 VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC.

cross-appellants. Also represented by TIMOTHY ANDREW 

COOK, KATHERINE P. KIECKHAFER; CHRISTOPHER ASTA, 

THOMAS SAUNDERS, Washington, DC; ROBERT J. GUNTHER,

JR., OMAR KHAN, CHRISTOPHER R. NOYES, New York, NY;

DAVID ISAAC GINDLER, ALAN J. HEINRICH, Irell & Manella 

LLP, Los Angeles, CA; LISA GLASSER, Newport Beach, CA.

 ______________________

Before REYNA, WALLACH, and HUGHES, Circuit Judges.

REYNA, Circuit Judge.

After trial on the merits, a jury found two U.S. patents

valid and infringed. Ariosa Diagnostics, Inc., and Roche 

Molecular Systems, Inc., moved for judgment as a matter 

of law on invalidity and noninfringement. Verinata 

Health, Inc., and Illumina, Inc., moved for a permanent injunction, supplemental damages, an accounting, and preand post-judgment interest. The district court denied the 

parties’ motions. Verinata and Illumina appeal the denial 

of the permanent injunction, supplemental damages, an accounting, and pre-judgment interest. Ariosa and Roche

cross-appeal the denial of judgment as a matter of law on 

invalidity and noninfringement. We conclude that substantial evidence supports the district court’s denial of Ariosa’s motion for judgment as a matter of law on

noninfringement and invalidity. We also conclude that the 

district court did not abuse its discretion by denying Verinata and Illumina’s motion for a permanent injunction, 

supplemental damages, an accounting, and pre-judgment 

interest. We affirm.

BACKGROUND

A

Appellant Illumina, Inc., develops, manufactures, and 

markets integrated systems and tools for DNA analysis. 

Verinata Health, Inc., a wholly-owned subsidiary of Illumina (collectively “Illumina”), developed and offered a nonCase: 18-2303 Document: 3 Page: 2 Filed: 04/24/2020
VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC. 3

invasive prenatal test (“NIPT”) for the early identification 

of fetal chromosomal abnormalities. Appellee Ariosa Diagnostics, Inc., also conducts research and development in 

the field of NIPT for fetal chromosomal abnormalities. 

Roche Molecular Systems, Inc., acquired Ariosa in December 2014. In an effort to “streamline issues in the [l]itigation and avoid unnecessary discovery,” the parties 

stipulated that “Ariosa will be deemed the Defendant responsible for the conduct that Illumina has accused of infringing the asserted claims” and that Roche would be 

dismissed from the litigation and subsequently “deemed a 

party to any judgment to the same extent as Ariosa.” 

J.A. 11606-07.

Illumina owns U.S. Patent No. 7,955,794 (the “’794 patent”), which is directed to custom DNA assay optimization 

techniques. The ’794 patent identifies seven inventors, including Dr. John Stuelpnagel and Dr. Arnold Oliphant. Dr. 

Stuelpnagel was a co-founder of Illumina, and Dr. Oliphant 

served as Illumina’s executive vice president of scientific 

operations. 

The ’794 patent describes the detection of DNA target 

sequences by introducing probes with complementary sequences into a sample and observing whether hybridization occurs. An excerpt of claim 1 identifying the elements 

relevant to this appeal is set forth below:

A multiplex for determining whether a sample contains at least 100 different target sequences, comprising:

a) providing a sample which may contain at 

least 100 different single-stranded target 

sequences attached to a first solid support;

b) contacting said target sequences with a 

probe set comprising more than 100 different single-stranded probes, wherein each of 

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said more than 100 different probes comprises:

i) a first universal priming site, 

wherein each of said more than 100 

different probes has identical universal priming sites, and 

ii) a target specific domain, such 

that different double-stranded hybridization complexes are formed, 

each of the different hybridization 

complexes comprising one of said 

more than 100 different singlestranded probes and one of the different single-stranded target sequences from the sample;

. . . 

d) contacting said probes of the hybridization complexes with a first enzyme and 

forming different modified probes;

e) contacting said modified probes with:

i) at least a first primer that hybridizes to said universal priming 

site;

ii) NTPs; and

iii) an extension enzyme;

wherein said different modified probes are amplified and forming different amplicons;

f) immobilizing said different amplicons to 

a second solid support, and

g) detecting said different amplicons immobilized to said second solid support, thereby 

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determining whether the sample contains 

at least 100 different target sequences.

’794 patent col. 68 ll. 46-67, col. 68 l. 65-col. 69 l. 12.

Verinata owns U.S. Patent No. 8,318,430 (the “’430 patent”), which is directed to methods for NIPT screening of 

fetal chromosomal abnormalities. An excerpt of claim 1 is 

appended below identifying the elements relevant to this 

appeal:

1. A method for determining a presence or absence 

of a fetal aneuploidy in a fetus for each of a plurality of maternal blood samples . . . comprising fetal 

and maternal cell-free genomic DNA, said method 

comprising:

. . . 

(e) . . . enumerating sequence reads corresponding to enriched and indexed fetal and 

maternal non-random polynucleotide sequences . . . ; and 

(f) . . . determining the presence or absence 

of a fetal aneuploidy comprising using a 

number of enumerated sequence reads corresponding to the first chromosome and a 

number of enumerated sequence reads corresponding to the reference chromosome of 

(e).

’430 patent at col. 63.

B

In 2008, both Dr. Stuelpnagel and Dr. Oliphant left Illumina. By late 2009, Dr. Stuelpnagel launched Ariosa. 

Dr. Oliphant rejoined Dr. Stuelpnagel at Ariosa shortly 

thereafter. They sought to develop a NIPT for the detection 

of fetal aneuploidies, which can lead to conditions such as 

Down Syndrome. Between 2010 and 2011, Ariosa provided 

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Illumina, as a prospective investor in Ariosa, technical information about its product proposals under development. 

In January 2012, seven months after the ’794 patent issued, Ariosa entered into a three-year sale and supply 

agreement (“SSA”) with Illumina. J.A. 4326, J.A. 4349-

4350 (excerpts from SSA).

C

In March 2012, Ariosa launched a DNA-sequencing 

test called the Harmony Prenatal Test. The test consisted 

of materials supplied by Illumina. The Harmony Prenatal 

Test is a multiplex method that analyzes fetal cell-free 

DNA (or cfDNA). Ariosa designed two versions of the Harmony test—“Harmony V1” and “Harmony V2.” For purposes of this appeal, we focus our discussion of the relevant 

technology on Harmony V2.

Harmony V2 tests a sample of isolated fetal cfDNA for 

the presence of about 6800 gene sequences by using a laboratory robot to perform the steps summarized below in 

Figure 1. 

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Figure 1

J.A. 3100-3101; J.A. 2067-2068. First, the sample’s doublestranded fetal cfDNA is separated, or “denatured,” into individual strands. Next, a molecule called biotin is added to 

the end of each cfDNA strand (represented by “B” in Figure 1). The robot then adds a solution containing a mixture 

of single-stranded oligonucleotides that are complementary to the 6800 sequences Harmony V2 detects (orange 

lines in Figure 1). The mixture contains three different oligonucleotides for each of the 6800 target sequences, corresponding to the beginning, middle, and end portions of the 

target sequence. The oligonucleotide for the beginning of 

each sequence contains a “readout cassette,” which is a 

short, artificial DNA segment that is uniquely assigned to 

each of the 6800 sequences tested in Harmony V2. If the 

cfDNA sample contains one of the 6800 target sequences, 

each of the three oligonucleotides corresponding to that 

target sequence will hybridize to it, creating a section of 

double-stranded DNA with two gaps (between the first and 

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second and between the second and third oligonucleotides). 

If the cfDNA does not contain a certain target sequence, 

the oligonucleotides corresponding to that sequence will remain unbound in solution. 

The test allows the oligonucleotides two hours to bind 

to target sequences. After the two hours elapse, the robot

adds magnetic beads coated with a protein called streptavidin, which binds strongly with the biotin on the cfDNA and 

links it to the beads. The robot then immobilizes the magnetic beads (and therefore the sample DNA and any bound 

oligonucleotides) and washes away anything that is left in 

solution, including any unbound oligonucleotides. 

Next, the robot adds an enzyme that ligates, i.e., connects, the three oligonucleotides, creating a single DNA 

strand. This only happens if all three oligonucleotides corresponding to the target sequence are bound to the sample 

cfDNA. The robot then denatures, i.e., separates, the 

newly-joined oligonucleotides from the sample cfDNA and 

amplifies the newly-joined oligonucleotides. Universal primer sequences on the first and third oligonucleotides enable this amplification. 

During processing, the copies that result from the amplification step (termed “amplicons”) are purified and 

added to a mixture that cuts (“digests”) them into fragments. Then, detection begins by applying the digested reaction mixture, including the readout cassettes, to an

array. An array is a chip (or device) containing thousands 

of short DNA sequences attached to a solid support. If a 

readout cassette corresponding to one of the 6800 target 

sequences is present, part of the readout cassette will bind 

to a DNA sequence on the array. The other part of the 

readout cassette remains unbound, hanging like a singlestranded tail off the double-stranded sequence attached to 

the solid support. Figure 2, below, shows how readout cassettes indicating target sequences on chromosomes 18 and 

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21 bind to the array while other readout cassettes remain 

unbound.

Figure 2

Any materials that do not bind to the array, e.g., chromosomes Y, X, and 13 in Figure 2, are washed away. Readout 

cassettes remain bound to the array. Fluorescently labeled 

oligonucleotides that are complementary to the readout 

cassettes’ free single-stranded tails are then added. After 

the labeled oligonucleotides are given time to bind to the 

single-stranded tails on the readout cassettes, they are 

chemically joined or ligated to the DNA strand attached to 

the chip. The array is then heated up to separate the 

readout cassettes from the fluorescently tagged chip. The 

readout cassettes are then washed away, leaving only the 

labeled oligonucleotides attached to the DNA strands. 

A machine then analyzes the array and detects the different colors of the fluorescent tags and their positions. 

From these data, and using algorithms and analyses, Ariosa can calculate the probability that each of the 6800 sequences was present in the cfDNA sample. 

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D

Starting late 2012, Illumina and Verinata filed several 

lawsuits against Ariosa and its parent company Roche accusing the Harmony V1 and V2 tests of infringing the ’794 

patent and the ’430 patent. Verinata alleged Harmony V1 

infringed the ’430 patent, and Illumina alleged both Harmony versions infringed the ’794 patent. Ariosa argued 

that the patents-in-suit were invalid and that it had an express license to the ’794 patent. Ariosa also asserted a 

counterclaim for breach of contract. 

During claim construction, the parties disputed the 

construction of two terms of the ’794 patent: (a) “modified 

probes” and (b) “wherein said different modified probes are 

amplified and forming different amplicons.” The district 

court construed those claims as follows:

• “modified probe” means “an enzymatically altered polynucleotide which contains a universal 

priming site and is capable of substantially hybridizing to a target sequence.” 

• “wherein said different modified probes are 

amplified and forming different amplicons” means 

“wherein the different modified probes are replicated, in whole or in part, to yield amplification 

products of each of the different modified probes.” 

The district court held a jury trial from January 8 to 

January 25, 2018. The jury returned a verdict finding the 

’430 patent not invalid and infringed by the Harmony V1 

product and the ’794 patent not invalid and infringed by 

both the Harmony V1 and Harmony V2 products; that Ariosa did not have an express license to the Harmony V1 

product under the SSA; and that Illumina did not breach 

the SSA by suing Ariosa. The jury awarded plaintiffs approximately $27 million in damages. Thereafter, the parties filed post-trial motions. 

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Ariosa moved for judgment as a matter of law 

(“JMOL”), under Fed. R. Civ. P. 50(b), on the jury’s various 

infringement and validity determinations. Illumina moved 

for a permanent injunction, a Fed. R. Civ. P. 52 conclusion 

of law that Ariosa was estopped as an assignor from challenging the validity of the ’794 patent, and an accounting, 

supplemental damages, pre-judgment interest at the prime 

rate and post-judgment interest. 

The district court denied Ariosa’s motions for JMOL. 

The district court found that substantial evidence supported the jury’s findings of no anticipation of the ’794 patent by U.S. Patent Application No. 2003/0228599 A1 to 

Straus (“Straus”); that the Harmony V2 product infringes 

the ’794 patent; that the ’430 patent meets the enablement 

requirement; and that the Harmony V2 product infringes 

the ’430 patent. The district court granted Illumina’s motion for a Rule 52 conclusion of law and denied Illumina’s 

motion for an accounting, and supplemental damages. The 

district court granted pre-judgment interest at the 52-week 

Treasury Bill rate and granted post-judgment interest at 

the statutory rate but deferred on calculating post-judgment interest until after appeal once the final amount of 

the judgment is known. 

These appeals ensued. Illumina appeals the denial of 

a permanent injunction, supplemental damages, an accounting, and pre-judgment interest at the prime rate. Ariosa cross-appeals the denial of JMOL on validity of the ’430 

patent and the ’794 patent and infringement of only the 

’794 patent by Ariosa’s Harmony V2 product. 

DISCUSSION

We address Ariosa’s cross-appeal in §§ A, B, and C below. Then, in § D, we address Illumina’s appeal.

A

We begin by addressing the district court’s denial of 

Ariosa’s motion for JMOL of noninfringement of the ’794 

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patent. Ariosa argues that Harmony V2 does not literally 

infringe claim 1, steps (a) and (b). Ariosa also argues that 

Harmony V2 does not infringe claim 1, steps (f) and (g) literally or under the doctrine of equivalents. The district 

court’s denial of Ariosa’s motion for JMOL is supported by 

substantial evidence.

We review denials of JMOL under the law of the relevant regional circuit, in this case, the Ninth Circuit. A 

TEN Int’l Co., Ltd. v. Uniclass Tech. Co., Ltd., 932 F.3d 

1364, 1367 (Fed. Cir. 2019). The Ninth Circuit reviews a 

denial of JMOL de novo. Harper v. City of Los Angeles, 533 

F.3d 1010, 1021 (9th Cir. 2008). JMOL is proper when the 

evidence permits only one reasonable conclusion that itself 

is contrary to the jury’s verdict. Id. But the jury’s verdict 

must be upheld if it is supported by substantial evidence. 

Id. Substantial evidence is “such relevant evidence as a 

reasonable mind might accept as adequate to support a 

conclusion.” TVIIM, LLC v. McAfee, Inc., 851 F.3d 1356, 

1362 (Fed. Cir. 2017) (citation and quotation omitted). 

A party asserting infringement under the doctrine of 

equivalents may prove its case by showing, on an elementby-element basis, that the accused product performs substantially the same function in substantially the same way 

with substantially the same result as each claim limitation 

of the patented product. See, e.g., Crown Packaging Tech., 

Inc. v. Rexam Beverage Can Co., 559 F.3d 1308, 1312 (Fed.

Cir. 2009). 

Ariosa argues that its Harmony V2 does not literally 

infringe the step (a) “providing” and the step (b) “contacting” processes of the ’794 patent. Cross-App. Br. 40-47. 

Ariosa argues that Dr. Cooper, Illumina’s expert, offered no 

evidence that at least 100 different single-stranded target 

sequences remain completely unbound from any probe after the two-hour hybridization period. Ariosa further argued that Dr. Cooper presented no evidence that any 

unbound single-stranded target sequences would bind to 

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all three probes during the short period between the addition of the streptavidin beads and the washing-away of the 

probes. 

Dr. Cooper detailed the reaction conditions in Ariosa’s 

Harmony V2 that practice the method recited in step (a). 

J.A. 1965-1968. He explained that Harmony V2’s annealing reaction is less than 99% complete following the twohour incubation time. Id. He explained that Harmony V2’s 

hybridization would occur after step (a) as a function of the 

relative rates of the slower “annealing reaction” compared 

to the faster “hybridization reaction.” J.A. 1951-1952; J.A. 

1955; J.A. 1964-1965; J.A. 2675-2676. Dr. Cooper concluded that, after annealing, at least 100,000 singlestranded target sequences attach to a solid support before 

hybridization takes place. J.A. 1967. Dr. Cooper testified 

that, given the reaction setup, the annealing reaction is 

“unlikely to complete or come close.” See J.A. 2676. 

Dr. Cooper also testified regarding how the solid support first attaches to 100 different single-stranded target 

sequences and how the target sequences hybridize to the 

probes as recited in step (b). According to Dr. Cooper, after 

two hours, the solid support is added and the process is “allow[ed] continued time to proceed.” J.A. 1964-1965. Dr. 

Cooper explained that the solid support streptavidin beads 

quickly attach to the target sequences given the “extremely 

strong” covalent bond between streptavidin and biotincoated cell-free DNA fragments. J.A. 1951-1952. Given the 

additional time and the strong bond between the solid support and the target sequences, Dr. Cooper testified that the 

reaction allows for the 100 single-stranded target sequences to “hybridize with their oligos.” J.A. 1964-1965. 

Dr. Cooper concluded, therefore, that Ariosa’s Harmony V2 

practices steps (a) and (b) of claim 1. Dr. Cooper’s testimony constitutes substantial evidence supporting the verdict of infringement. 

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Ariosa argues that the Harmony V2 does not literally 

infringe claim 1, steps (f) and (g) of the ’794 patent because 

its readout cassettes do not meet claim 1’s “amplicons” element. Cross-App. Op. Br. 28-31. Ariosa argues that after 

the amplification step performed in Harmony V2, the

readout cassette is only a portion of each of the amplified 

DNA segments and not the complete “amplicon” that is required by the claims. Ariosa argues in the alternative that 

even if the readout cassettes are amplicons, Harmony V2 

does not practice step (g)’s “detecting said different amplicons immobilized to said second solid support.” ’794 patent 

69 ll. 10-12. Ariosa argues that because the readout cassettes are washed away from the array before the detection 

step takes place, the amplicons are not detected while attached to a second solid support. 

Finally, Ariosa argues that Illumina failed to prove infringement of claim 1, steps (f) and (g) under the doctrine 

of equivalents. Cross-App. Br. at 31-35. Ariosa contends 

that the differences between the claimed amplicons and 

Ariosa’s readout cassettes are substantial such that no evidence supports a doctrine of equivalents analysis. Ariosa 

further contends that Illumina failed to prove that immobilizing and detecting readout cassettes leads to insubstantially different results from immobilizing and detecting 

amplicons. We disagree.

Even were we to accept Ariosa’s arguments for literal 

infringement, Ariosa fails to demonstrate that a reasonable 

jury could not find infringement under the doctrine of 

equivalents. Dr. Cooper testified that the readout cassettes and amplicons serve substantially the same function 

of “immobiliz[ing] onto a solid support”; in substantially 

the same way of “hybridization of [the] DNA molecule”; to 

achieve the same result of “detection of the target sequences that were in the original mixture.” J.A. 2683-2684, 

J.A. 1979-1985. That testimony constitutes evidence that 

a reasonable mind could accept as proving infringement 

under the doctrine of equivalents.

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B

Next, we address the district court’s denial of JMOL of 

invalidity of the ’794 patent. We conclude that the district 

court’s denial of JMOL is supported by substantial evidence.

Ariosa appeals the district court’s holding of assignor 

estoppel—that Ariosa is barred from challenging the validity of the ’794 patent because Drs. Stuelpnagel and Oliphant are inventors of the ’794 patent, they assigned their 

rights to the patent to Illumina, and they are in privity 

with Ariosa. See Verinata Health, Inc. v. Ariosa Diagnostics, Inc., 329 F. Supp. 3d 1070, 1113-18 (N.D. Cal. 2018). 

Despite its finding of assignor estoppel, the district court 

analyzed anticipation of the ’794 patent and found it invalid. Because we affirm the jury verdict of no invalidity, we 

need not reach the issue of assignor estoppel.

Ariosa contends that the district court improperly denied its motion for JMOL on anticipation of the ’794 patent 

based on the Straus prior art reference. Straus discloses 

multiplex methods for detecting more than 250 nucleic-acid 

sequences, such as the signature sequences of pathogens in 

a blood sample using DNA probes. See J.A. 5395-5441.

Ariosa argues that a skilled artisan reading Straus and 

the method depicted in Straus Figure 5 would understand 

that it discloses “‘numerous’ pathogens includ[ing] using at 

least 100 different target sequences and over 100 different 

single-stranded probes” as claimed in claim 1 of the ’794 

patent. Ariosa further argues that Straus’s disclosure of “a 

large number of distinct ID probes” anticipates the claimed 

universal priming sites because those probes disclose “substantial if not complete identity in the probes’ priming 

sites.” Finally, Ariosa argues that Straus need not disclose 

all the claimed limitations in a single disclosure or figure

in order to anticipate. 

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Illumina disagrees, arguing that Dr. Cooper’s testimony shows why Straus fails to anticipate the ’794 patent. 

Dr. Cooper focused on Straus’s failure to disclose claim 1, 

step (b)(i) (“a first universal priming site, wherein each of 

said more than 100 different probes has identical universal 

priming sites”). Dr. Cooper testified that Straus discloses 

only forty-eight probes in Figure 5, well below the “level of 

multiplexing” required by the ’794 Patent, and that Straus

is silent as to the actual number of primers that would be

used. J.A. 2597-2598; see also J.A. 2602. Dr. Cooper further testified that Straus’s references to ID probes confirms 

that there is no anticipation because ID probes “teach towards multiple different amplification sequences” and not 

a single universal primer as required by claim 1, step (b)(i). 

See J.A. 2600-2602. Dr. Cooper opined that even if some 

isolated disclosure in Straus did disclose or suggest a universal primer, that disclosure would fail to anticipate 

claim 1, step (b)(i), for it is unlinked to the disclosures on 

which Ariosa relies for anticipation, namely Figure 5. See

J.A. 2654.

Ariosa’s arguments are unavailing. Ariosa asks this 

court to reweigh the credibility of the parties’ respective expert witnesses. This court does not engage in fact finding,

nor does it weigh the credibility of expert testimony. See 

Impax Labs. Inc. v. Lannett Holdings Inc., 893 F.3d 1372, 

1382 (Fed. Cir. 2018). Our task is to review whether the 

jury’s verdict is supported by substantial evidence.

Here, the jury heard conflicting expert testimony on 

whether Straus discloses a single universal primer. The 

jury was free to adopt Dr. Cooper’s testimony over that of 

Dr. Cantor’s in concluding that Straus did not disclose a 

single universal primer. See i4i Ltd. P’ship v. Microsoft 

Corp., 598 F.3d 831, 848 (Fed. Cir. 2010), aff’d, 564 U.S. 91 

(2011). We conclude that the jury verdict on invalidity is 

supported by substantial evidence.

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We therefore affirm the jury’s verdict of no invalidity 

and the district court’s subsequent denial of Ariosa’s motion for JMOL.

C

Next, we address whether substantial evidence supports the district court’s denial of Ariosa’s motion for JMOL 

of no enablement of the ’430 patent. We conclude that the 

jury’s finding and the district court’s denial of JMOL are 

supported by substantial evidence.

Enablement is a question of law reviewed de novo. 

Trustees of Bos. Univ. v. Everlight Elecs. Co., 896 F.3d 

1357, 1361 (Fed. Cir. 2018). However, in the context of a 

jury trial, we review the factual underpinnings of enablement for substantial evidence. Id. The enablement requirement ensures that a patent contains a written 

description of the invention that enables “any person 

skilled in the art to which [the invention] pertains . . . to 

make and use the [invention]” without undue experimentation. 35 U.S.C. § 112(a); Storer v. Clark, 860 F.3d 1340, 

1345 (Fed. Cir. 2017). 

Ariosa argues that the ’430 patent does not meet the

enablement requirement because the patent fails to disclose an algorithm for determining the presence or absence 

of a fetal aneuploidy in the context of a targeted sequencing 

approach as claimed in claim 1, step (f). Cross-App. Br. 55-

58. Ariosa agrees that the ’430 patent incorporates by reference disclosures of “[m]ethods for determining fetal aneuploidy using random sequencing techniques.” Id. at 56 

(citing J.A. 268 (12:49-55)). Ariosa contends, however, that

a skilled artisan would not be able to adapt those random 

sequencing techniques into non-random sequencing data 

without undue experimentation. Ariosa relies on the testimony of Dr. Rava, a named inventor of the ’430 patent, and 

argues that Dr. Rava testified that a skilled artisan would 

be unable to use “random sequencing techniques . . . in a 

non-random method without modification.” Id. (citing J.A. 

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1344-1345). Ariosa argues that the ’430 patent discloses no 

such modification. Ariosa argues that even if the disclosures incorporated by reference could be modified for use 

in random sequencing techniques, their limited disclosure 

would not suffice to enable the full scope of the claimed invention.

In response, Illumina raises three main arguments. 

First, Illumina argues that Ariosa’s expert, Dr. Cantor, testified that the Quake1 and Craig2 prior art references disclose the alleged missing enablement teachings of the ’430 

patent and that a skilled artisan is presumed to be aware 

of all pertinent prior art. Appellant Reply and Resp. Br. 62 

(citing J.A. 2490). Illumina argues that these references

disclose methods for analyzing targeted regions of DNA sequences as claimed in the ’430 patent. Second, Illumina 

argues that Dr. Rava testified that “the algorithms for random . . . sequencing described in the publications referenced in the ’430 [p]atent can be ‘very similar to the ones 

that would be use[d] in a directed sequencing approach’ but 

‘would have to be optimized.’” Id. at 64 (citing J.A. 1344-

1345). Illumina further contends that Dr. Cooper confirmed that the references in the ’430 patent disclose numerous enabling techniques to determine fetal aneuploidy. 

Third, Illumina argues that, according to Dr. Cooper, “the 

exact statistical methods the ’430 Patent discloses based on 

Z-scores were in fact used by Roche scientists—and were 

‘quite effective’ at determining fetal aneuploidy for the targeted approach.” Id. (citing J.A. 2619-2621).

We conclude that a reasonable mind might accept Dr. 

Cooper’s testimony that Roche scientists used the same 

1 U.S. Patent App. Pub. No. 2007/0202525 (published August 30, 2007, filed February 2, 2007).

2 Craig, et al., “Identification of genetic variants using bar-coded multiplexed sequencing,” Nature Methods, 

5(10):887-93 (2008).

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statistical methods disclosed in the ’430 patent to determine fetal aneuploidy in a targeted approach as evidence 

to support enablement of the ’430 patent. See Hybritech 

Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384,

(Fed. Cir. 1986) (finding specification was enabling where 

evidence showed the necessary screening and producing 

methods for making the monoclonal antibodies used in the 

claimed invention were known in the prior art). We therefore affirm the jury’s verdict regarding enablement and the 

district court’s subsequent denial of Ariosa’s motion for 

JMOL.

D

Finally, we address whether the district court abused 

its discretion in denying Illumina’s request for injunctive 

relief, supplemental damages, an accounting, and pre-judgment interest at the prime rate. We conclude that the district court did not abuse its discretion.

We review a district court’s grant or denial of injunctive 

relief for abuse of discretion. Genband US LLC v. 

Metaswitch Networks Corp., 861 F.3d 1378, 1381 (Fed. Cir. 

2017). A district court abuses its discretion if its ruling is 

based on an erroneous view of the law or on a clearly erroneous assessment of the evidence. Id. A plaintiff seeking 

a permanent injunction must satisfy a four-factor test before a court may grant such relief. eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006). A plaintiff 

must demonstrate that: (1) it has suffered an irreparable 

injury; (2) remedies available at law are inadequate to compensate for that injury; (3) considering the balance of hardships between the plaintiff and defendant, a remedy in 

equity is warranted; and (4) the public interest would not 

be disserved by a permanent injunction. Id. Because we 

affirm the district court’s conclusion on irreparable injury 

and adequacy of monetary damages, we need not reach the 

district court’s conclusions on balance of harms and public 

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20 VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC.

interest. See Nichia Corp. v. Everlight Americas, Inc., 855 

F.3d 1328, 1340 (Fed. Cir. 2017).

Regarding irreparable injury, Illumina argues that the 

district court failed to recognize that Roche and Illumina 

are direct competitors and that Roche’s infringement 

causes irreparable injury because each sale made by Roche 

is a sale forever lost by Illumina. Appellant Op. Br. 22-23. 

Illumina argues that the district court’s understanding of

ActiveVideo Networks, Inc. v. Verizon Communications, 

Inc., 694 F.3d 1312 (Fed. Cir. 2012), was too broad and 

caused it to err in its conclusion of no direct competition. 

Id. at 26-30. We disagree. 

In ActiveVideo Networks, we held a lack of direct competition is a substantial basis for finding no irreparable 

harm. 694 F.3d. at 1338. We reversed the injunction because the defendant (Verizon) competed with ActiveVideo’s 

third-party licensees but not with the patentee (ActiveVideo). Id. The harm to ActiveVideo was therefore indirect, 

and ActiveVideo’s loss was a “[s]traight-forward monetary 

harm” and “certainly not irreparable.” Id. Here, the district court found that Illumina licenses its patents and 

products under the SSA, allowing third party laboratories 

to conduct their own tests. J.A. 58 (citing J.A. 2109:9-15). 

The district court also found that Ariosa does not utilize a 

licensing model but instead sells its Harmony V2 test directly. Id. Relying on ActiveVideo, the district court found 

that the different sales models evidenced a lack of direct 

competition because defendants compete with Illumina’s licensees. Id. The district court concluded that defendants’

losses would be quantifiable based at least on licensing fees 

per lost subscriber. J.A. 59. As we find no reason to disturb 

the district court’s findings on irreparably injury, we turn 

to the next eBay factor, available remedies.

Illumina argues that the district court erred by finding 

that monetary relief would be adequate. Illumina reasserts that the district court erred in its reliance on 

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VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC. 21

ActiveVideo and its reasoning that, where licensees compete with the infringer, royalties are adequate forms of 

compensation. See J.A. 60 (citing ActiveVideo, 694 F.3d at 

1338). As noted above, the district court’s reliance on ActiveVideo does not constitute an abuse of discretion. And

Illumina does not challenge the district court’s finding that 

third-party licensees compete with Ariosa. See J.A. 58-59.

Because Illumina failed to establish irreparable injury and 

inadequacy of monetary relief, the district court did not 

abuse its discretion in denying Illumina’s request for a permanent injunction.

Regarding Illumina’s request for supplemental damages, and an accounting, Illumina argues that the district 

court’s order deferring its request until after the resolution 

of this appeal created confusion regarding whether it is entitled to supplemental damages and an accounting. We decline to decide, in the first instance, whether Illumina is 

entitled to the supplemental damages it seeks. See La Van 

v. United States, 382 F.3d 1340, 1350 (Fed. Cir. 2004) (declining to award damages in the first instance on appeal). 

And we do not fault the district court’s decision to defer this 

issue. Cf., Sanofi-Aventis Deutschland GmbH v. Glenmark 

Pharm. Inc., USA, 748 F.3d 1354, 1357 (Fed. Cir. 2014) (explaining that district court’s provision for an accounting of 

any additional damages that may accrue if the decision is 

affirmed on appeal did not negate finality of the judgment). 

Regarding the district court’s granting of pre-judgment 

interest at the 52-week Treasury Bill rate, Illumina requests we reverse and remand with an order to award prejudgment interest at the prime rate. Appellant Op. Br. 50-

51. But Illumina articulates no reason in its opening brief 

for why a higher rate is appropriate. District courts have 

wide latitude in the selection of interest rates, Uniroyal, 

Inc. v. Rudkin-Wiley Corp., 939 F.2d 1540, 1545 (Fed. Cir. 

1991), and prejudgment interest awards at the Treasury 

Bill rate are well within the court’s discretion. See Laitram

v. NEC Corp., 115 F.3d 947, 955 (Fed. Cir. 1997). The 

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22 VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC.

district court’s decision does not constitute an abuse of discretion.

CONCLUSION

We have considered the parties’ remaining arguments 

and find them unpersuasive. For the foregoing reasons, we 

conclude that substantial evidence supports the district 

court’s denial of Ariosa’s motion for JMOL of noninfringement and invalidity. We also conclude that substantial evidence supports the district court’s denial of Ariosa’s

motion for JMOL of no enablement of the ’430 patent. 

We conclude that the district court did not abuse its 

discretion in denying Illumina’s motion for a permanent injunction. We conclude that the district court did not abuse 

its discretion in denying Illumina’s request for supplemental damages and an accounting. Finally, we conclude 

that the district court did not abuse its discretion in awarding pre-judgment interest at the 52-week Treasury Bill 

rate. 

AFFIRMED

COSTS

The parties shall bear their own costs.

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