Evolution Nutraceuticals Incorporated v. ThermoLife International LLC

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WO
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA
Evolution Nutraceuticals Incorporated,
Plaintiff,
v.
ThermoLife International LLC,
Defendant.
No. CV-25-00461-PHX-DJH
ORDER
On November 21, 2025, Plaintiff Evolution Nutraceuticals Inc. d/b/a Cardio Miracle
(“Plaintiff” or “Cardio Miracle”) filed a Motion and Memorandum in Support of Motion
for Preliminary Injunction (Doc. 83). Defendant ThermoLife International LLC
(“Defendant” or “ThermoLife”) then filed a Response in Opposition (Doc. 84), and
Plaintiff filed a Reply (Doc. 85). For the following reasons, the Court denies Plaintiff’s
Motion.
I. Background
Plaintiff produces dietary supplement products to stimulate safe, sustained nitric
oxide in the body’s vasculature. (Doc. 1 at ¶ 21). Defendant is a raw material supplier for
dietary supplements and holds multiple patents, including the one at issue here—U.S.
Patent No. 8,455,531 (’531 Patent). (Id. at ¶¶ 25–26). The ’531 Patent is directed to nitrate-
containing amino acid compositions and their use in a human or animal for increasing
bioabsorption of amino acids or vasodilative characteristics. (Doc. 1-1 at 1). The parties
primarily dispute whether Plaintiff infringed upon Defendant’s ’531 Patent and whether
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the ’531 Patent is valid. At particular issue here is claim 62, which states:
A solid supplement formulation comprising: at least one non-ester nitrate
compound; and at least one isolated amino acid compound selected from the
group consisting of Agmatine, Beta Alanine, Citrulline, L-Histidine,
Norvaline, Ornithine, Aspartic Acid, Cysteine, Glycine, Lysine, Methionine,
Praline, Tyrosine, and Phenylalanine, wherein the at least one isolated amino
acid compound is a separate compound than the at least one non-ester nitrate
compound.
(Id. at 6).
Since 2013, Plaintiff has produced its dietary supplements and sold its products on
a “variety of online platforms,” including Amazon.com. (Doc. 1 at ¶ 21, 23). On
Amazon.com, the at-issue products were sold under the Amazon Standard Identification
Numbers (“ASINs”): B071T51TWY, B0CWW3GD39, and B01H6BTRFO (the “Accused
Products”), and the sales generated from these listings accounted for approximately 20%
of the Accused Products’ total sales. (Id. at ¶ 23). In October of 2024, Defendant filed one
or more complaints (the “Takedown Notices”) with Amazon claiming that the Accused
Products infringed upon its patented nitrate and requesting that Amazon remove the
Accused Products’ listings. (Id. at ¶¶ 4–5). Upon receipt of the Takedown Notices,
Amazon sent Policy Violation Notices to Plaintiff and deactivated Accused Products’
listings. (Id. at ¶¶ 4, 81). Plaintiff, in response to his removal, sent two non-infringement
letters to Amazon and asked for the listings to be restored. (Id. at ¶¶ 31–32). When the
attempts were unsuccessful, Plaintiff brought this action against Defendant on February
12, 2025, alleging that the removal of its products from Amazon has caused lost sales, loss
of customer goodwill, and damage to its rankings. (See id. at ¶¶ 78–84).
Plaintiff seeks declaratory judgment of non-infringement of the ’531 Patent and
declaratory judgment of invalidity of the ’531 Patent. (Id. at ¶¶ 88–155). Plaintiff asserts
that Accused Products held no more than a de minimis amount of nitrate and, therefore,
did not infringe on Defendant’s ’531 Patent. (Id. at ¶¶ 31–56). Further, Plaintiff claims
that, if the de minimis amount of nitrate in its Accused Products infringed the ’531 Patent,
then the Patent is invalid as obvious or anticipated by prior art supplements. (Id. at ¶¶ 57–
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73).
On April 26, 2025, Plaintiff filed a Motion for Preliminary Injunction to enjoin
Defendant’s allegedly wrongful assertion of the ’531 Patent and compel Defendant to
withdraw Amazon takedown requests concerning the Accused Products. (See Doc. 20).
The parties then stipulated to a partial injunction and agreed to conduct expedited
discovery. (Doc. 23). The Court granted this stipulation, and the timeline for briefing the
original Preliminary Injunction Motion was extended, ultimately becoming ripe for ruling
on September 5, 2025. (See Docs. 23, 57). However, Defendant filed a Motion to Strike
Plaintiff’s Reply in support of its Motion, arguing that Plaintiff’s Reply raised new factual
arguments that were not presented in its Motion and were not responsive to arguments in
Defendant’s Response. (Doc. 61). After the Motion to Strike was fully briefed, the Court
found that the Reply contained newly raised arguments but, in light of the discovery efforts
that had occurred, determined that the best course forward was to deny Plaintiff’s Motion
for Preliminary Injunction without prejudice and with leave to re-file. (See Doc. 78).
Plaintiff’s renewed and fully briefed Motion for Preliminary Injunction is now before the
Court.
II. Legal Standard
Injunctive relief is an “extraordinary remedy only granted upon a clear showing that
a [petitioner] is entitled to such relief.” Nat’l Ass’n for Gun Rts., Inc. v. Motl, 188 F. Supp.
3d 1020, 1028 (D. Mont. 2016) (citing Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7,
24 (2008)). The standards governing temporary restraining orders and preliminary
injunctions are “substantially identical.” Washington v. Trump, 847 F.3d 1151, 1159 n.3
(9th Cir. 2017) (citation omitted). On an application for a temporary restraining order or
preliminary injunction, the plaintiff has the burden to establish that (1) he is likely to
succeed on the merits, (2) he is likely to suffer irreparable harm if the preliminary relief is
not granted, (3) the balance of equities favors the plaintiff, and (4) the injunction is in the
public interest. Winter v. Natural Res. Def. Council, Inc., 555 U.S. 5, 20 (2008).
In the Ninth Circuit, the Winter factors may be evaluated on a sliding scale: “serious
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questions going to the merits, and a balance of hardships that tips sharply toward the
plaintiff can support issuance of a preliminary injunction, so long as the plaintiff also shows
that there is a likelihood of irreparable injury and that the injunction is in the public
interest.” All. for the Wild Rockies v. Cottrell, 632 F.3d 1127, 1134–35 (9th Cir. 2011).
“To reach this sliding scale analysis, however, a moving party must, at an ‘irreducible
minimum,’ demonstrate some chance of success on the merits.” Global Horizons, Inc. v.
U.S. Dep’t of Lab., 510 F.3d 1054, 1058 (9th Cir. 2007) (citing Arcamuzi v. Cont’l Air
Lines, Inc., 819 F.2d 935, 937 (9th Cir. 1987)).
The movant carries the burden of proof on each element of the test. See Los Angeles
Memorial Coliseum Comm’n v. National Football League, 634 F.2d 1197, 1203 (9th Cir.
1980); see also BlephEx, LLC v. Myco Industries, Inc., 24 F.4th 1391, 1398 (Fed. Cir.
2022) (“The burden is always on the movant to show that it is likely to succeed on the
merits.”). The plaintiff may meet this burden if it “demonstrates either a combination of
probable success on the merits and the possibility of irreparable injury or that serious
questions are raised and the balance of hardships tips sharply in his favor.” Johnson v. Cal.
St. Bd. of Acct., 72 F.3d 1427, 1429 (9th Cir. 1995) (internal quotation marks and citation
omitted); see also BelphEx, 24 F.4th at 1399 (“If an alleged infringer attacks the validity
of a patent at the preliminary injunction stage…it bears the initial burden ‘to come forward
with evidence of invalidity,’ just as it would at trial.”).
III. Discussion
After reviewing the briefing on Plaintiff’s Motion, the Court is most concerned with
Plaintiff’s claim that it has and will continue to suffer irreparable damage if a preliminary
injunction is not issued. The Court accordingly starts the discussion there because even
under a sliding scale approach to preliminary injunctions, “plaintiffs may not obtain a
preliminary injunction unless they can show that irreparable harm is likely to result in the
absence of the injunction.” Cottrell, 632 F.3d at 1135.
In its Motion, Plaintiff argues that removal of the Accused Products has caused lost
sales as well as damage to its “standing, status, and goodwill which is irreparable with
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money damages.” (Doc. 83 at 16). Plaintiff says its “inability to supply customers
threatens ‘reputation’ as a ‘dependable distributor’ ” and that its nonquantifiable damages
include losing its “previously held first-page status” on Amazon. (Id. at 16–17). Defendant
contends that Plaintiff has not shown that irreparable harm is likely to result in the absence
of an injunction because it has only supported its claim of irreparable harm with
conclusory, uncorroborated statements. (See Doc. 84 at 19–21). Upon review of the
record, the Court finds that Plaintiff has failed to produce sufficient evidence of irreparable
harm.
“Irreparable harm is traditionally defined as harm for which there is no adequate
legal remedy, such as an award of damages.” Arizona Dream Act Coalition v. Brewer, 757
F.3d 1053, 1068 (9th Cir. 2014). An injunction ordered on any lesser showing is
“inconsistent” with the “characterization of injunctive relief as an extraordinary remedy[.]”
Winter, 555 U.S. at 22. Importantly, a plaintiff moving for a preliminary injunction “must
proffer evidence sufficient to establish a likelihood of irreparable harm.” Herb Reed
Enterprises, LLC v. Fla. Ent. Mgt., Inc., 736 F.3d 1239, 1251 (9th Cir. 2013); Boring v.
Murillo, 2024 WL 3608331, *2 (C.D. Cal. 2024) (“Generally the showing of irreparable
harm to the Plaintiff must be supported with concrete evidence.”).
Here, Plaintiff’s discussion of irreparable harm is cursory, including little to no
analysis on this crucial Winter factor. Although it provides two cases supporting its claim
of irreparable harm, Plaintiff offers almost no evidence to buttress its irreparable harm
argument. Plaintiff’s “evidence” amounts to allegations in its Complaint and to averments
made by Plaintiff’s Vice President of Finance in support of its original motion for
preliminary injunction. (See Doc. 83 at 16–17).
These allegations fail to establish a likelihood that Plaintiff will suffer irreparable
harm without an order directing Defendant to stop seeking takedown requests for its dietary
supplements. Initially, Plaintiff’s Complaint is not verified, and allegations in a complaint
are not evidence. See, e.g., In re Nassbridges, 464 B.R. 494, *12 (Bankr. App. 9th Cir.
2011) (“[A]llegations in a complaint do not constitute evidence.”). Further, meeting the
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high bar to obtain preliminary injunctive relief “requires factual support beyond the
allegations of the complaint[.]” CI Games S.A. v. Destination Films, 2016 WL 9185391,
*11 (C.D. Cal. 2016).
The general averments provided by Bruce Haglund, an outside consultant
functioning as Plaintiff’s VP of Finance, also fail to provide the Court with concrete
evidence of irreparable harm. Mr. Haglund avers that:
Online market share and rankings on Amazon.com can take months to gain
and are based upon algorithms that take into account consecutive sales and
sales velocity. Products are thus ranked higher, or near the top of the search,
for products with ongoing and positive sales. Cardio Miracle has invested
significant resources, time, and money into improving and maintaining its
Amazon ranking in order to be highly placed in Amazon’s ranking system
for the Accused Products.
As a result of the Takedown Notices and the deactivated listings for the
Accused Products, there was a significant time period of no sales for the
Accused Products on Amazon. This has a negative effect on the rankings of
the Accused Products.
It will take significant amount of time and money to recapture Cardio
Miracle’s high ranking prior to the October 21, 2024 Takedown Notice in
order to once again be competitive in the supplement market. However
Cardio Miracle may never be able to fully restore its ranking and goodwill.
(Doc. 20-4 at ¶¶ 14–16). These statements do not provide any concrete evidence of
irreparable harm. They are both speculative and vague, lacking any specificity from which
the Court could conclude that irreparable harm is likely imminent. VMR Products, LLC v.
V2H ApS, 2016 WL 7669497, *14 (C.D. Cal. 2016) (“Cursory, speculative, and conclusory
allegations of irreparable harm are insufficient.”) (citing Herb Reed, 736 F.3d at 1250).
Notably, this is Plaintiff’s renewed Preliminary Injunction Motion; since the
inception of this case, the removed Accused Products’ ASINs have been restored. In
consequence, Plaintiff should have been able to provide specific information about the
effect of the removal and substantiate the harm that would likely befall Plaintiff if the
Takedown Notices were reasserted. Instead, Plaintiff relied on statements made in a
declaration attached to its original motion that, at most, assert Plaintiff “may never be able
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to fully restore its ranking and goodwill.” (Doc. 20-4 at ¶ 16).
Plaintiff cites the out-of-circuit case, John B. Hull, Inc. v. Waterbury Petroleum
Products, Inc., 588 F.2d 24 (2d Cir. 1978) for the premise that the “inability to supply
customers threatens ‘reputation’ as a ‘dependable distributor.’ ” (Doc. 83 at 16 (citing John
B. Hull, 588 F.2d at 29)). In John B. Hull, the court considered whether irreparable harm
to the plaintiff’s goodwill could be found in a price discrimination case. John B. Hull, 588
F.2d at 29. The court noted that the “cases in which loss of goodwill previously has been
held to constitute irreparable injury have involved the termination of franchise or
distributorship relationships.” Id. And it further observed that “[i]n that situation, the
plaintiff is deprived totally of the opportunity to sell an entire line of merchandise and may
incur injury to its goodwill and reputation ‘as a dependable distributor which offers a full
line’ of goods.” Id. (quoting Supermarket Services, Inc. v. Hartz Mt. Corp., 382 F. Supp.
1248, 1256 (S.D.N.Y. 1974)). Initially, John B. Hull concerned a claim of unlawful price
discrimination in violation of the Clayton Act between two companies selling heating oil,
so its factual circumstances are not comparable to Plaintiff’s. Id. at 26. Even still,
notwithstanding factual differences, no holding in John B. Hull supports Plaintiff’s claim
of irreparable harm because the court determined that the defendant waived its argument
about loss of goodwill and consequently did not reach a decision about whether the
plaintiff’s claimed loss of goodwill constituted an irreparable injury. See id. at 29.
The text from John B. Hull that Plaintiff cites appears in the court’s discussion of
other cases in which the plaintiff’s loss of goodwill established irreparable harm. See id.
The John B. Hull court was specifically quoting Supermarket Services. Supermarket
Services involved alleged violations of the Sherman Act “through territorial and customer
limitations allegedly imposed by [the defendant] on [the plaintiff], and by [the defendant’s]
alleged monopolization or attempting to monopolize the sale and distribution of pet
accessories and bird food, particularly to mass merchandising outlets.” 382 F. Supp. at
1248–49. Examining irreparable harm, the court found a “distinct possibility that [the
plaintiff’s] business reputation and good will may be irreparably harmed.” Id. at 1256. In
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finding so, the court noted that “[s]ome customers [had] already been informed by [the
defendant] of [the plaintiff’s] termination,” and that the defendant would not be able to “fill
the orders of other customers because its inventories of [the defendant’s] products have
been drastically reduced by [the defendant’s] refusal to fill [the plaintiff’s] orders. Id.
Therefore, “[the plaintiff’s] reputation in the industry as a dependable distributor which
offers a full line of non-food items is in jeopardy.” Id. Here, dissimilar to the Supermarket
Services plaintiff, Cardio Mircale does not identify how its reputation could be damaged,
nor does it offer any evidence to corroborate a claim of reputational harm.
Plaintiff also relies on Medcursor Inc. v. Shenzen KLM Internet Trading Co., Ltd.,
543 F. Supp. 3d 866 (C.D. Cal. 2021). (See Doc. 83 at 17). The district court in Medcursor
found “that Plaintiff’s product delisting, if left unchecked, will likely result in
nonquantifiable damages relating to lost business opportunities on Amazon, including
product placement disadvantages such as losing Plaintiff’s previously held first-page
status.” Id. at 879. The Court agrees that placement disadvantages can amount to
nonquantifiable damages supporting a finding of irreparable harm. But unlike the plaintiff
in Medcursor, Plaintiff has failed to substantiate its claims of irreparable harm in any
manner.
The plaintiff in Medcursor provided specifics to the court about its likely irreparable
harm by attesting to facts such as “Amazon notified Plaintiff that its [12,00 pieces of]
inventory will be subject to mandatory return;” “[b]ased on Plaintiff’s prior experience, a
prolonged delisting of multiple [items] will result in deactivation of its selling account at
any time;” and “Plaintiff has already lost its first page spot on Amazon, which it achieved
through years of diligent sales and active marketing.” See id. at 877–78 (internal quotation
marks omitted). Significantly, the plaintiff also offered testimony showing that it sold “its
products almost exclusively on Amazon and, as happened to Plaintiff in 2019 when
Defendants filed their first infringement notice [], if left in place, the infringement notice
will likely again result in deactivation of Plaintiff’s seller’s account,” which would have
effectively put the plaintiff out of business. Id. at 878. By contrast, Plaintiff has provided
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no evidence that it lost or will lose its first-page status and certainly has not shown that the
viability of its business is threatened by the Takedown Notices. Plaintiff only states that
deactivated listings have a “negative effect” on the Accused Products. (Doc. 20-4 at ¶ 15).
Finding irreparable harm on the basis of a singular, vague assertion would be inconsistent
with the extraordinary relief requested by Plaintiff.
Undoubtedly, courts have concluded that damage to reputation, loss of goodwill,
and lost business opportunities constitute irreparable harm. But no amount of supporting
caselaw negates the requirement that a party moving for a preliminary injunction furnish
sufficient evidence of its own likelihood of imminent, irreparable harm. Herb Reed, 736
F.3d at 1250 (“As with its speculation on future harm, citation to a different case with a
different record does not meet the standard of showing ‘likely’ irreparable harm.”); see
also California Power Athletes, Inc. v. Cali Power Inc., 2025 WL 3691843, *4 (C.D. Cal.
2025). In its Response, Defendant highlights the dearth of evidence establishing
irreparable harm. (See Doc. 84 at 20 (“Cardio Miracle offers no concrete evidence. It
identifies no customer who is even aware of ThermoLife’s infringement assertions, much
less reluctant to do business as a result. It submits no customer affidavits, no data showing
lasting loss of market share, and no proof of reputational injury.”)). Yet, in its Reply,
Plaintiff only addressed irreparable harm by asserting, “[f]or the reasons stated in Cardio
Miracles [sic] opening brief, the remaining three factors of irreparable harm, balance of
equities, and public interest are clearly met and not reasonably disputed by ThermoLife.”
(Doc. 85 at 14).
Simply put, the Court finds that Plaintiff has not met its burden to substantiate a
likelihood of irreparable harm. And “[w]ithout showing irreparable harm, the Plaintiff[]
[has] failed to meet [its] burden for issuing a preliminary injunction.” Defs. of Wildlife v.
Salazar, 812 F. Supp. 2d 1205, 1210 (D. Mont. 2009); Dunn v. Cate, 2010 WL 1558562,
*2 (E.D. Cal. 2010) (“An essential prerequisite to the granting of a preliminary injunction
is a showing of irreparable injury in its absence.”) (citation omitted).
Accordingly,
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IT IS ORDERED that Plaintiff’s Motion and Memorandum in Support of Motion
for Preliminary Injunction (Doc. 83) is DENIED.
Dated this 13th day of April, 2026.
Honorable Diane J. Humetewa
United States District Judge
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