Well Cell Global LLC, Well Cell Support LLC v. Shawn Paul Calvit, Marc Pierre Desgraves, Iv, Charles Alexander Elliott, Insulinic…

N OTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
WELL CELL GLOBAL LLC, WELL CELL SUPPORT
LLC,
Plaintiffs-Appellees
v.
SHAWN PAUL CALVIT, MARC PIERRE
DESGRAVES, IV, CHARLES ALEXANDER
ELLIOTT, INSULINIC OF LAFAYETTE LLC,
INSULINIC OF HIALEAH LLC, INSULINIC OF
HAWAII, LLC,
Defendants-Appellants
PATRICK DALE LELEAUX, INSULINIC LLC,
INSULINIC OF HAMMOND, LLC, INSULINIC OF
GRETNA, LLC,
Defendants
______________________
2023-1229
______________________
Appeal from the United States District Court for the
Southern District of Texas in No. 4:22-cv-03062, Judge Lee
H. Rosenthal.
______________________
Decided: September 21, 2023
______________________
Case: 23-1229 Document: 74 Page: 1 Filed: 09/21/2023

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WELL CELL GLOBAL LLC v. CALVIT 2
L EMA BARAZI, Lloyd & Mousilli, Houston, TX, argued
for plaintiffs-appellees.
J AMIL ALIBHAI, Munsch Hardt Kopf & Harr, PC, Dal-
las, TX, argued for defendants-appellants. Shawn Paul
Calvit, Insulinic of Lafayette LLC also represented by
WINSTON O LIVER H UFF .
______________________
Before P ROST , CHEN, and CUNNINGHAM , Circuit Judges.
CHEN, Circuit Judge.
Shawn Paul Calvit, Marc Pierre Desgraves, IV,
Charles Alexander Elliott, Insulinc of Lafayette LLC, Insu-
linic of Hialeah LLC, and Insulinic of Hawaii, LLC (collec-
tively, Appellants) appeal a decision of the United States
District Court for the Southern District of Texas granting
a motion for preliminary injunction filed by Well Cell
Global LLC and Well Cell Support LLC (collectively, Well
Cell). Well Cell Glob. LLC v. Calvit, No. CV H-22-3062,
2022 WL 16857060, at *11 (S.D. Tex. Nov. 10, 2022) (Opin-
ion). The district court enjoined Appellants from, inter
alia, infringing certain patents owned by Well Cell and us-
ing Well Cell’s alleged trade secrets. On February 9, 2023,
Appellants filed an emergency motion to stay the prelimi-
nary injunction pending this appeal. ECF No. 18. On
March 16, 2023, we granted this motion. ECF No. 34. Af-
ter full briefing and argument, we conclude the district
court abused its discretion in granting the preliminary in-
junction because Well Cell’s motion failed to show a likeli-
hood of either success on the merits or irreparable harm.
We reverse and remand. 1
1 After oral argument, counsel for Appellants filed a
motion to withdraw as counsel with respect to the following
parties: Marc Pierre Desgraves, IV, Charles Alexander
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WELL CELL GLOBAL LLC v. CALVIT 3
BACKGROUND
I
U.S. Patent No. 10,533,990 (’990 patent)—assigned to
Well Cell—is directed to an individualized therapy for in-
fusing insulin intravenously to a patient. ’990 patent at
Abstract. Claim 1 reads:
1. A method for individualized intravenous exoge-
nous insulin-based treatment, comprising the steps
of:
creating a subject profile for a subject, the subject
profile comprising:
(i) a subject history;
(ii) subject physical reports including a subject
weight;
(iii) subject name;
(iv) subject contact information; and
(v) subject blood test results;
assessing metabolic factors of the subject and stor-
ing the metabolic factors in the subject profile,
wherein the metabolic factors include: a glucose
level, an insulin-sensitivity factor, and an individ-
ual target blood glucose level;
creating a care plan with a plurality of treatment
sessions for the subject and a plan goal, wherein
the care plan uses the assessed metabolic factors
and indicates a schedule of bolus introductions
Elliott, Insulinic of Hialeah LLC, and Insulinic of Hawaii,
LLC. ECF No. 68. Well Cell submitted a response, ECF
No. 72, and Appellants submitted a reply, ECF No. 73.
Counsel for Appellants’ motion is granted.
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WELL CELL GLOBAL LLC v. CALVIT 4
with at least one unequal time period and a quan-
tity and frequency of a plurality of boluses contain-
ing saline and insulin for sequential intravenous
introduction to the subject;
introducing glucose to the subject to stimulate gas-
trointestinal hormone production that results in a
release of enzymes from the subject’s liver and
causing blood glucose levels of the subject to be in
a therapeutic range;
testing the subject for blood glucose levels, compar-
ing tested blood glucose levels to a plurality of ther-
apeutic ranges, and verifying that the subject is in
at least one of the plurality of therapeutic ranges;
comparing the tested blood glucose levels to a dia-
betic treatment model;
mapping the tested blood glucose levels and the as-
sessed metabolic factors of the subject by using the
diabetic treatment model to determine the sched-
ule for bolus introductions;
introducing, sequentially, to the subject a plurality
of boluses by using the determined schedule for bo-
lus introductions based on the mapping;
comparing the subject profile to a plurality of
weight management protocols to identify a weight
management protocol for the subject based upon
the assessed metabolic functions of the subject and
saving the weight management protocol in the care
plan; and
implementing the weight management protocol
and the determined schedule of bolus introductions
for the subject to improve insulin sensitivity, cellu-
lar ATP functioning, or both, of the subject.
’990 patent at claim 1.
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WELL CELL GLOBAL LLC v. CALVIT 5
II
In the fall of 2021, Well Cell and Appellants entered
into a license agreement regarding Well Cell’s intellectual
property. Opinion, 2022 WL 16857060, at *4. In June
2022, Well Cell sent Appellants a “notice of default,” alleg-
ing Appellants’ billing practices breached the license agree-
ment, and on September 8, 2022, Well Cell filed a
complaint against Appellants and other parties alleging in-
fringement of Well Cell’s patents and copyrights, as well as
misappropriation of its trade secrets.2 Id. The day after
filing the complaint, Well Cell filed motions for a tempo-
rary restraining order (TRO)—which was granted—and
the preliminary injunction currently on appeal.
Regarding likelihood of success on the merits of Well
Cell’s patent infringement claims, the district court under-
stood Appellants—for purposes of the preliminary injunc-
tion—to have waived validity challenges to the patents
based on their representations at the preliminary injunc-
tion hearing. Id. at *7 (“[T]he defendants stated at the pre-
liminary injunction hearing that they do not, at this time,
challenge the validity of the patents.”) (citing J.A. 1382 at
ll. 18–20).3 The court also found Well Cell showed a likeli-
hood of infringement of the ’990 patent’s claimed method.
Id. at *8–9. It credited the testimony of Well Cell’s CEO
and sole witness Scott Hepford that “someone could per-
form the protocols and administer the appropriate doses of
insulin to individual patients using only the information
conveyed in the ’990 Patent” and that Appellants had
2 In addition to the ’990 patent, Well Cell asserted
U.S. Patent No. 9,652,595, but it is not germane to this ap-
peal.
3 Not all defendants in the underlying action ap-
pealed. The “defendants” referenced by the district court
here and at other points in this opinion include Appellants.
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WELL CELL GLOBAL LLC v. CALVIT 6
access to an “encrypted data room,” the contents of which
appeared to allow a person to perform the licensed method.
Id. at *8. The court did not find that the Appellants actu-
ally copied this information, only that the Appellants had
access to the information and had to copy the information
“to continue to use the Well Cell treatment after their li-
censes were terminated.” Id.
On the Appellants’ side, the court acknowledged “Cal-
vit testified that the therapy the defendants now perform
‘[is] similar in that we are still putting IV into somebody’s
veins, but the timing, the amounts, and their process is dif-
ferent.’” Id. at *9. Nonetheless, the court found “Calvit’s
testimony indicate[d] that the defendants continue to per-
form therapies aimed at treating metabolic conditions with
exogenous intravenous insulin therapy” and concluded
that “Calvit’s minimal ability to differentiate the current
therapy offered by the defendants does not effectively rebut
the charge that the defendants are infringing the ’990 Pa-
tent.” Id.
The district court also found Well Cell would be irrep-
arably harmed by Appellants’ continued actions absent an
injunction. Well Cell argued that “continued infringement
of its intellectual property risk[ed] doctor, patient, and con-
sumer confusion and irreparable harm to its reputation
and business goodwill.” Id. at *10. The district court found
that these alleged harms “are paradigmatic examples of ir-
reparable harm in the commercial context.” Id. The dis-
trict court also found that Well Cell established a causal
nexus between the alleged infringement and the alleged ir-
reparable harm, crediting testimony from Mr. Hepford ex-
plaining that “given the past relationship between Calvit,
Calvit’s Insulinic clinics, and Well Cell, if Calvit ‘does
things that are illegal and improper and ultimately ends
up getting in trouble for that . . . and then . . . point[s] his
fingers back and say[s], but these guys, they were the ones
that taught me all this stuff,’ then Well Cell is put at risk.”
Id.
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WELL CELL GLOBAL LLC v. CALVIT 7
The district court’s balancing of the equities analysis
consisted of a paragraph noting the lack of argument by
Appellants regarding irreparable harm to themselves dur-
ing the pendency of the TRO. Id. at *11. The district court
also disposed of the public interest question in one para-
graph. Id. The district court issued an order broadly out-
lining the enjoined activities. J.A. 1–2.
D ISCUSSION
While “we review a grant or denial of a preliminary in-
junction using the law of the regional circuit,” we
acknowledge our “body of precedent applying the general
preliminary injunction considerations to a large number of
factually variant patent cases” and thus give “dominant ef-
fect to Federal Circuit precedent insofar as it reflects con-
siderations specific to patent issues.” Murata Mach. USA
v. Daifuku Co., 830 F.3d 1357, 1363 (Fed. Cir. 2016) (inter-
nal quotations omitted). Our review of a district court’s
grant of a preliminary injunction is the same as in the Fifth
Circuit—we both review such an order for an abuse of dis-
cretion. Compare id., with Jiao v. Xu, 28 F.4th 591, 598
(5th Cir. 2022). In the context of a preliminary injunction,
an abuse of discretion necessarily exists if the district court
made an error of law or a clearly erroneous factual finding.
Tinnus Enters., LLC v. Telebrands Corp., 846 F.3d 1190,
1203 (Fed. Cir. 2017).
A district court may grant an injunction only after the
moving party demonstrates “a reasonable likelihood of suc-
cess on the merits, irreparable harm in the absence of a
preliminary injunction, a balance of hardships tipping in
its favor, and the injunction’s favorable impact on the pub-
lic interest.” Murata, 830 F.3d at 1363.
I
The party seeking a preliminary injunction must prove
it likely would be irreparably harmed absent an injunction.
Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008);
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WELL CELL GLOBAL LLC v. CALVIT 8
Koninklijke Philips N.V. v. Thales DIS AIS USA LLC, 39
F.4th 1377, 1380 (Fed. Cir. 2022). Well Cell failed to make
that showing, and the district court clearly erred in finding
otherwise.
Well Cell at best provided evidence of speculative
harm, not likelihood that such harm would occur as re-
quired to establish irreparable harm for a preliminary in-
jection. See Winter, 555 U.S. at 22 (2008) (noting the
proper standard for irreparable harm is “likely” irreparable
harm, not simply the “possibility” of such harm); Kon-
inklijke, 39 F.4th at 1380 (“Evidence of speculative harms,
such as customers merely expressing concern that a poten-
tial future ITC exclusion order could affect Thales’ ability
to deliver products down the road, is insufficient to show a
likelihood of irreparable harm.”). Well Cell argued—and
the district court found—that Well Cell’s reputation risked
being damaged if Appellants performed the claimed meth-
ods illegally or improperly and Well Cell was blamed for
such behavior. Opinion, 2022 WL 16857060, at *10–11.
Well Cell’s argument rests on two levels of specula-
tion—first that Appellants would perform the claimed
methods illegally or improperly and second that Well Cell
would then get pinned with the blame for Appellants’ mis-
conduct. But Well Cell never explained or proved why
there was reason to believe Appellants would likely misuse
Well Cell’s intellectual property, or, if they had, how and
why the public would assume Well Cell was at fault. Be-
cause Well Cell’s irreparable harm allegations rested on
unsubstantiated assertions, the court clearly erred by find-
ing that Well Cell sufficiently established a likelihood of
irreparable harm.
II
“To establish a likelihood of success on the merits, a
patentee must show that it will likely prove infringement
of the asserted claims and that its infringement claim will
likely withstand the alleged infringer’s challenges to
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WELL CELL GLOBAL LLC v. CALVIT 9
patent validity and enforceability.” Metalcraft of Mayville,
Inc. v. Toro Co., 848 F.3d 1358, 1364 (Fed. Cir. 2017). “A
preliminary injunction should not issue if the accused in-
fringer raises a substantial question concerning either in-
fringement or validity.” Id. (internal quotations omitted).
As with irreparable harm, Well Cell failed to make a case
for establishing a likelihood of success on the merits.
A
We first address whether the district court abused its
discretion in finding Appellants waived their invalidity ar-
gument based on 35 U.S.C. § 101. See Columbia Sports-
wear N. Am., Inc. v. Seirus Innovative Accessories, Inc., 942
F.3d 1119, 1132 (Fed. Cir. 2019) (“We review a district
court’s decision to exercise or, as here, not exercise its in-
herent power to find waiver for an abuse of discretion.”). In
Appellants supplemental response brief to Well Cell’s pre-
liminary injunction motion, Appellants only addressed the
second step of the two-step Alice inquiry and did so in an
entirely conclusory manner. J.A. 564–65 (only addressing
the “inventive concept” inquiry and not whether the as-
serted claims were “directed to” an abstract idea); see Alice
Corp. v. CLS Bank Int’l, 573 U.S. 208, 217–18 (2014). In
addition, at the oral hearing, Appellants’ counsel stated
they were not challenging the validity of the asserted pa-
tents. Opinion, 2022 WL 16857060, at *7 (“[T]he defend-
ants stated at the preliminary injunction hearing that they
do not, at this time, challenge the validity of the patents.”)
(citing J.A. 1382 at ll. 18–20). Based on this record, we find
the district court did not abuse its discretion in finding this
argument waived for purposes of the preliminary injunc-
tion. See Opinion, 2022 WL 16857060, at *7; cf. Fresenius
USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1296 (Fed.
Cir. 2009) (“[I]f a party fails to raise an argument before
the trial court, or presents only a skeletal or undeveloped
argument to the trial court, we may deem that argument
waived on appeal.”). We accordingly decline to hear this
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WELL CELL GLOBAL LLC v. CALVIT 10
argument on appeal. See Conoco, Inc. v. Energy & Env’t
Int’l, L.C., 460 F.3d 1349, 1358–59 (Fed. Cir. 2006).
B
As to likelihood of proving patent infringement or trade
secret misappropriation, Well Cell’s presentation was
simply too conclusory. For a preliminary injunction mo-
tion, “[t]he burden is always on the movant to show that it
is likely to succeed on the merits.” BlephEx, LLC v. Myco
Indus., Inc., 24 F.4th 1391, 1398 (Fed. Cir. 2022).
“[W]hether performed at the preliminary injunction stage
or at some later stage in the course of a particular case,
infringement and validity analyses must be performed on
a claim-by-claim basis.” Amazon.com, Inc. v. Barnesand-
noble.com, Inc., 239 F.3d 1343, 1351 (Fed. Cir. 2001). But
the record shows Well Cell never identified any particular
claim of the ’990 patent in its likelihood of infringement ar-
guments, and the district court’s opinion never analyzed
any particular claim either. Nor did Well Cell ever estab-
lish on the record what particular steps and procedures Ap-
pellants perform when providing their insulin therapy.
Instead of comparing one of the patent claims to Appel-
lants’ established procedures, Well Cell and the district
court appeared to assume the Appellants must have per-
formed at least one of the claimed methods during the pen-
dency of the license, and Appellants must have continued
practicing the same procedures without a license unless
Appellants could prove otherwise. Opinion, 2022 WL
16857060, at *9 (“Calvit’s minimal ability to differentiate
the current therapy offered by the defendants does not ef-
fectively rebut the charge that the defendants are infring-
ing the ’990 Patent.”) (emphasis added). Despite some
Appellants having been former licensees, Well Cell’s in-
fringement theory still rests on assumptions, not proof. On
the facts of this case, this argument cannot support a find-
ing of a likelihood of success on the merits for infringement.
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WELL CELL GLOBAL LLC v. CALVIT 11
With respect to the trade secret misappropriation alle-
gation, both the district court and Well Cell failed to iden-
tify the alleged trade secrets and these failures are fatal to
Well Cell’s case. “To succeed on the merits of its misappro-
priation of trade secrets claim, [the moving party] must
show that: (1) a trade secret existed, (2) the trade secret
was acquired through a breach of a confidential relation-
ship or discovered by improper means, and (3) the defend-
ant used the trade secret without authorization from the
plaintiff.” CAE Integrated, L.L.C. v. Moov Techs., Inc., 44
F.4th 257, 262 (5th Cir. 2022). The district court’s discus-
sion of Well Cell’s alleged trade secrets never explained
what they were. Opinion, 2022 WL 16857060, at *9–10.
The entirety of Well Cell’s attempt below to identify its
trade secret came at the preliminary injunction hearing.
See Appellee’s Br. at 34–35 (citing J.A. 1453, J.A. 1490, J.A.
1559, J.A. 1561–62, J.A. 1595, J.A. 1642). At most, these
passages identify a “four- to eight-minute dynamic dosing”
as a trade secret. J.A. 1561–62. However, this was publicly
disclosed in the ’990 patent and thus cannot constitute a
trade secret. See Accent Packaging, Inc. v. Leggett & Platt,
Inc., 707 F.3d 1318, 1329 (Fed. Cir. 2013); see also ’990 pa-
tent at FIG. 1A & 1B (noting an unequal time period of 240-
480 secs between bolus introductions) and J.A. 1605 at
ll. 6–19. At oral argument, Well Cell could not explain
what its alleged trade secrets are. Oral Arg. at 24:24–
26:44. As Well Cell cannot describe its alleged trade se-
crets, it cannot show a likelihood of success on its misap-
propriation claim.
CONCLUSION
Because we conclude there was a failure of proof of ir-
reparable harm and likelihood of success on the merits, we
find the district court abused its discretion in granting the
preliminary injunction. We thus reverse the district court’s
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WELL CELL GLOBAL LLC v. CALVIT 12
order and remand for further proceedings consistent with
this opinion.4
REVERSED AND REMANDED
COSTS
Costs to Appellants.
4 We note Appellants’ concern that the district
court’s injunction was overly broad without specifying the
methods enjoined. On remand, should a new injunction is-
sue later in the case, the district court must describe the
methods enjoined with specificity consistent with our case
law. See Int’l Rectifier Corp. v. IXYS Corp., 383 F.3d 1312
(Fed. Cir. 2004).
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