Case: 18-2198 Document: 92 Page: 1 Filed: 04/24/2020
NOTE: This disposition is nonprecedential.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, Red-
wood Shores, CA, argued for plaintiffs-appellants. Also
represented by CHRISTOPHER SHAWN LAVIN. Plaintiff-ap-
pellant Illumina, Inc. also represented by DEREK C.
WALTER.
MARK CHRISTOPHER FLEMING, Wilmer Cutler Pickering
Hale and Dorr LLP, Boston, MA, argued for defendants-
Case: 18-2198 Document: 92 Page: 2 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 in-
junction, supplemental damages, an accounting, and pre-
and post-judgment interest. The district court denied the
parties’ motions. Verinata and Illumina appeal the denial
of the permanent injunction, supplemental damages, an ac-
counting, 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 sub-
stantial evidence supports the district court’s denial of Ari-
osa’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 Veri-
nata 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 Illu-
mina (collectively “Illumina”), developed and offered a non-
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VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC. 3
invasive prenatal test (“NIPT”) for the early identification
of fetal chromosomal abnormalities. Appellee Ariosa Diag-
nostics, Inc., also conducts research and development in
the field of NIPT for fetal chromosomal abnormalities.
Roche Molecular Systems, Inc., acquired Ariosa in Decem-
ber 2014. In an effort to “streamline issues in the [l]itiga-
tion and avoid unnecessary discovery,” the parties
stipulated that “Ariosa will be deemed the Defendant re-
sponsible for the conduct that Illumina has accused of in-
fringing 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 pa-
tent”), which is directed to custom DNA assay optimization
techniques. The ’794 patent identifies seven inventors, in-
cluding 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 se-
quences into a sample and observing whether hybridiza-
tion occurs. An excerpt of claim 1 identifying the elements
relevant to this appeal is set forth below:
A multiplex for determining whether a sample con-
tains at least 100 different target sequences, com-
prising:
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 differ-
ent single-stranded probes, wherein each of
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4 VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC.
said more than 100 different probes com-
prises:
i) a first universal priming site,
wherein each of said more than 100
different probes has identical uni-
versal priming sites, and
ii) a target specific domain, such
that different double-stranded hy-
bridization complexes are formed,
each of the different hybridization
complexes comprising one of said
more than 100 different single-
stranded probes and one of the dif-
ferent single-stranded target se-
quences from the sample;
...
d) contacting said probes of the hybridiza-
tion complexes with a first enzyme and
forming different modified probes;
e) contacting said modified probes with:
i) at least a first primer that hy-
bridizes to said universal priming
site;
ii) NTPs; and
iii) an extension enzyme;
wherein said different modified probes are ampli-
fied and forming different amplicons;
f) immobilizing said different amplicons to
a second solid support, and
g) detecting said different amplicons immo-
bilized to said second solid support, thereby
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VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC. 5
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 pa-
tent”), 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 plural-
ity of maternal blood samples . . . comprising fetal
and maternal cell-free genomic DNA, said method
comprising:
...
(e) . . . enumerating sequence reads corre-
sponding to enriched and indexed fetal and
maternal non-random polynucleotide se-
quences . . . ; and
(f) . . . determining the presence or absence
of a fetal aneuploidy comprising using a
number of enumerated sequence reads cor-
responding to the first chromosome and a
number of enumerated sequence reads cor-
responding to the reference chromosome of
(e).
’430 patent at col. 63.
B
In 2008, both Dr. Stuelpnagel and Dr. Oliphant left Il-
lumina. 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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6 VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC.
Illumina, as a prospective investor in Ariosa, technical in-
formation about its product proposals under development.
In January 2012, seven months after the ’794 patent is-
sued, 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 Har-
mony test—“Harmony V1” and “Harmony V2.” For pur-
poses 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 la-
boratory robot to perform the steps summarized below in
Figure 1.
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VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC. 7
Figure 1
J.A. 3100-3101; J.A. 2067-2068. First, the sample’s double-
stranded fetal cfDNA is separated, or “denatured,” into in-
dividual strands. Next, a molecule called biotin is added to
the end of each cfDNA strand (represented by “B” in Fig-
ure 1). The robot then adds a solution containing a mixture
of single-stranded oligonucleotides that are complemen-
tary to the 6800 sequences Harmony V2 detects (orange
lines in Figure 1). The mixture contains three different ol-
igonucleotides for each of the 6800 target sequences, corre-
sponding 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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8 VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC.
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 re-
main 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 streptav-
idin, which binds strongly with the biotin on the cfDNA and
links it to the beads. The robot then immobilizes the mag-
netic 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., con-
nects, the three oligonucleotides, creating a single DNA
strand. This only happens if all three oligonucleotides cor-
responding 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 pri-
mer sequences on the first and third oligonucleotides ena-
ble this amplification.
During processing, the copies that result from the am-
plification step (termed “amplicons”) are purified and
added to a mixture that cuts (“digests”) them into frag-
ments. Then, detection begins by applying the digested re-
action 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 single-
stranded tail off the double-stranded sequence attached to
the solid support. Figure 2, below, shows how readout cas-
settes indicating target sequences on chromosomes 18 and
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VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC. 9
21 bind to the array while other readout cassettes remain
unbound.
Figure 2
Any materials that do not bind to the array, e.g., chromo-
somes 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 dif-
ferent colors of the fluorescent tags and their positions.
From these data, and using algorithms and analyses, Ari-
osa can calculate the probability that each of the 6800 se-
quences was present in the cfDNA sample.
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10 VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC.
D
Starting late 2012, Illumina and Verinata filed several
lawsuits against Ariosa and its parent company Roche ac-
cusing 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 Har-
mony versions infringed the ’794 patent. Ariosa argued
that the patents-in-suit were invalid and that it had an ex-
press 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 al-
tered polynucleotide which contains a universal
priming site and is capable of substantially hybrid-
izing to a target sequence.”
• “wherein said different modified probes are
amplified and forming different amplicons” means
“wherein the different modified probes are repli-
cated, 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 Ari-
osa 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 ap-
proximately $27 million in damages. Thereafter, the par-
ties filed post-trial motions.
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VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC. 11
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 chal-
lenging 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 sup-
ported the jury’s findings of no anticipation of the ’794 pa-
tent 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 mo-
tion 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-judg-
ment 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 ac-
counting, and pre-judgment interest at the prime rate. Ari-
osa 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 be-
low. 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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12 VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC.
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) lit-
erally 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 rele-
vant 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 element-
by-element basis, that the accused product performs sub-
stantially 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) “contact-
ing” 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 af-
ter the two-hour hybridization period. Ariosa further ar-
gued that Dr. Cooper presented no evidence that any
unbound single-stranded target sequences would bind to
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VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC. 13
all three probes during the short period between the addi-
tion 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 anneal-
ing reaction is less than 99% complete following the two-
hour 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 con-
cluded that, after annealing, at least 100,000 single-
stranded 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 sup-
port 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 “al-
low[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 biotin-
coated cell-free DNA fragments. J.A. 1951-1952. Given the
additional time and the strong bond between the solid sup-
port and the target sequences, Dr. Cooper testified that the
reaction allows for the 100 single-stranded target se-
quences 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 testi-
mony constitutes substantial evidence supporting the ver-
dict of infringement.
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14 VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC.
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” ele-
ment. 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 re-
quired 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 ampli-
cons immobilized to said second solid support.” ’794 patent
69 ll. 10-12. Ariosa argues that because the readout cas-
settes are washed away from the array before the detection
step takes place, the amplicons are not detected while at-
tached to a second solid support.
Finally, Ariosa argues that Illumina failed to prove in-
fringement 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 ev-
idence supports a doctrine of equivalents analysis. Ariosa
further contends that Illumina failed to prove that immo-
bilizing and detecting readout cassettes leads to insubstan-
tially 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 cas-
settes 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 se-
quences 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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VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC. 15
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 evi-
dence.
Ariosa appeals the district court’s holding of assignor
estoppel—that Ariosa is barred from challenging the valid-
ity of the ’794 patent because Drs. Stuelpnagel and Oli-
phant 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 Diagnos-
tics, 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 inva-
lid. 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 de-
nied 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 “sub-
stantial 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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16 VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC.
Illumina disagrees, arguing that Dr. Cooper’s testi-
mony 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 fur-
ther testified that Straus’s references to ID probes confirms
that there is no anticipation because ID probes “teach to-
wards 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 uni-
versal 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 ex-
pert 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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VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC. 17
We therefore affirm the jury’s verdict of no invalidity
and the district court’s subsequent denial of Ariosa’s mo-
tion for JMOL.
C
Next, we address whether substantial evidence sup-
ports 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 enable-
ment for substantial evidence.
Id. The enablement re-
quirement 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 experimen-
tation. 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 dis-
close 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 ref-
erence disclosures of “[m]ethods for determining fetal an-
euploidy 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 testi-
mony 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.
Case: 18-2198 Document: 92 Page: 18 Filed: 04/24/2020
18 VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC.
1344-1345). Ariosa argues that the ’430 patent discloses no
such modification. Ariosa argues that even if the disclo-
sures 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 in-
vention.
In response, Illumina raises three main arguments.
First, Illumina argues that Ariosa’s expert, Dr. Cantor, tes-
tified that the Quake 1 and Craig 2 prior art references dis-
close 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 se-
quences as claimed in the ’430 patent. Second, Illumina
argues that Dr. Rava testified that “the algorithms for ran-
dom . . . sequencing described in the publications refer-
enced 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 con-
firmed that the references in the ’430 patent disclose nu-
merous 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 tar-
geted 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 (pub-
lished August 30, 2007, filed February 2, 2007).
2 Craig, et al., “Identification of genetic variants us-
ing bar-coded multiplexed sequencing,” Nature Methods,
5(10):887-93 (2008).
Case: 18-2198 Document: 92 Page: 19 Filed: 04/24/2020
VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC. 19
statistical methods disclosed in the ’430 patent to deter-
mine 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 there-
fore 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-judg-
ment interest at the prime rate. We conclude that the dis-
trict 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 erro-
neous assessment of the evidence.
Id. A plaintiff seeking
a permanent injunction must satisfy a four-factor test be-
fore a court may grant such relief. eBay Inc. v. Mer-
cExchange, 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 com-
pensate for that injury; (3) considering the balance of hard-
ships 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
Case: 18-2198 Document: 92 Page: 20 Filed: 04/24/2020
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 com-
petition is a substantial basis for finding no irreparable
harm. 694 F.3d at 1338. We reversed the injunction be-
cause the defendant (Verizon) competed with ActiveVideo’s
third-party licensees but not with the patentee (ActiveVi-
deo).
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 dis-
trict 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 di-
rectly.
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 li-
censees.
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 reas-
serts that the district court erred in its reliance on
Case: 18-2198 Document: 92 Page: 21 Filed: 04/24/2020
VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC. 21
ActiveVideo and its reasoning that, where licensees com-
pete 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 Ac-
tiveVideo 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 per-
manent injunction.
Regarding Illumina’s request for supplemental dam-
ages, 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 en-
titled to supplemental damages and an accounting. We de-
cline 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) (de-
clining 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) (ex-
plaining 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 re-
quests we reverse and remand with an order to award pre-
judgment 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
Case: 18-2198 Document: 92 Page: 22 Filed: 04/24/2020
22 VERINATA HEALTH, INC. v. ARIOSA DIAGNOSTICS, INC.
district court’s decision does not constitute an abuse of dis-
cretion.
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 noninfringe-
ment and invalidity. We also conclude that substantial ev-
idence 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 in-
junction. We conclude that the district court did not abuse
its discretion in denying Illumina’s request for supple-
mental damages and an accounting. Finally, we conclude
that the district court did not abuse its discretion in award-
ing pre-judgment interest at the 52-week Treasury Bill
rate.
AFFIRMED
COSTS
The parties shall bear their own costs.
