Amgen Inc. v. Colorado Prescription Drug Affordability Review Board et al

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLORADO
Judge Nina Y. Wang
Civil Action No. 24-cv-00810-NYW-SBP
AMGEN INC.;
IMMUNEX CORPORATION; and
AMGEN MANUFACTURING, LIMITED,
Plaintiffs,
v.
GAIL MIZNER, MD, in her official capacity as Chair of the Colorado Prescription Drug
Affordability Review Board;
SAMI DIAB, MD, in his official capacity as a member of the Colorado Prescription Drug
Affordability Review Board;
AMARYLIS GUTIERREZ, PharmD, in her official capacity as a member of the Colorado
Prescription Drug Affordability Review Board;
CATHERINE HARSHBARGER, in her official capacity as a member of the Colorado
Prescription Drug Affordability Review Board;
JAMES JUSTIN VANDENBERG, PharmD, in his official capacity as a member of the
Colorado Prescription Drug Affordability Review Board;
MICHAEL CONWAY, in his official capacity as Commissioner of the Colorado Division of
Insurance; and
PHILIP WEISER, in his official capacity as Attorney General of the State of Colorado,
Defendants.
MEMORANDUM OPINION AND ORDER
This matter is before the Court on Plaintiffs’ Motion for Summary Judgment and
Memorandum in Support [Doc. 24 (“Plaintiffs’ Motion for Summary Judgment”)] and
Defendants’ 	Combined 	Cross-Motion 	for 	Summary 	Judgment 	and 	Response 	in
Opposition to Plaintiffs’ Motion for Summary Judgment [Doc. 29 (“Defendants’ Motion for
Summary Judgment”)] (collectively, the “Motions”).
The Court has reviewed the Motions and the related briefing, see [Doc. 35; Doc.
42], the applicable case law, and the entire docket. 	For the reasons set forth herein,
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Defendants’ Motion for Summary Judgment is respectfully GRANTED as to standing, and
Plaintiffs’ 	Complaint 	is 	DISMISSED 	without 	prejudice 	for 	lack 	of 	subject 	matter
jurisdiction. Plaintiffs’ Motion for Summary Judgment is therefore DENIED as moot.
BACKGROUND
I. 	Factual Background
Plaintiffs Amgen, Inc.; Immunex Corporation; and Amgen Manufacturing, Limited
(collectively referred to as “Plaintiffs” or “Amgen”) are the manufacturer and exclusive
patent licensees of a prescription medication designed to treat various autoimmune
conditions called ENBREL® (hereinafter, “Enbrel”). [Doc. 24 at 10].1 Enbrel is covered
by several United States patents, including two patents that limit competing biosimilar
products from entering the market until 2029 (at the earliest). [Id. at 20; Doc. 1 at ¶¶ 52–
53].
The prescription drug supply chain. As a manufacturer, Amgen sits at the top
of the pharmaceutical supply chain, which “starts with the manufacturer who sells to a
wholesaler for the wholesale acquisition cost (‘list price’),” and “[w]holesalers then sell to
the pharmacy, who dispense the product to the patient with a doctor’s prescription.” In re
EpiPen (Epinephrine Injection, USP) Mktg., Sales Practs. & Antitrust Litig., 44 F.4th 959,
965 (10th Cir. 2022). Nearly all of Amgen’s domestic sales are to wholesale distributors
for the list price (or “WAC”), and the wholesalers then sell Amgen’s products to providers,
hospitals, and pharmacies. 	[Doc. 29 at 13–14 & nn.1–3]; see also Amgen, Letter to
Shareholders (2023) at 2, 42, 76, https://investors.amgen.com/static-files/eeb1013b-
1 When citing to the Parties’ briefing, the Court uses the page numbers assigned by the
Court’s Case Management/Electronic Case File system.
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5d9a-4ff3-934f-3905972207f3.
Health plans or “payers” and pharmacy benefit managers (“PBMs”) also play a key
role 	in 	the 	pharmaceutical 	market. 	As 	to 	health 	plans, 	insured 	patients 	access
prescription drugs through the prescription drug benefits of their health plans. 	Pharm.
Care Mgmt. Ass’n v. Mulready, 78 F.4th 1183, 1188 (10th Cir. 2023). 	The cost of a
prescription drug is shared between an insured and their health plan; an insured’s share
of the cost is determined by the scope of the prescription drug benefit under their health
plan. In re EpiPen, 44 F.4th at 965. The health plan controls the scope of the prescription
drug benefit, including “what drugs the plan covers (the formulary), how much the plan
will pay for those drugs (the cost-sharing terms), and at which pharmacies beneficiaries
can have prescriptions filled (the pharmacy network).” Mulready, 78 F.4th at 1188.
Health plans often outsource the formulation and oversight of prescription drug
benefits to PBMs. 	Id. 	Before a pharmacy fills a patient’s prescription, the pharmacy
checks with the PBM to confirm whether the prescription drug is covered under the
patient’s health plan and to ascertain the patient’s payment. 	See Rutledge v. Pharm.
Care Mgmt. Ass’n, 592 U.S. 80, 84 (2024). 	The PBM reimburses the pharmacy on the
health plan’s behalf in exchange for reimbursements and fees from the health plan. 	Id.
PBMs also negotiate directly with manufacturers for rebates on prescription drugs. See
Mulready, 78 F.4th at 1188.
Amgen is a member of PhRMA, a “voluntary nonprofit association representing the
nation’s leading research-based pharmaceutical and biotechnology companies,” and
Amgen’s CEO serves on PhRMA’s Board of Directors. [Doc. 27 at 1; Doc. 29 at 16 n.6].
According to PhRMA, “prices paid by wholesalers, pharmacies, PBMs, and health plan
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sponsors all vary and are determined by negotiations between stakeholders, each with
varying degrees of negotiating power.” [Doc. 29 at 16 (quoting PhRMA, Follow the Dollar:
Understanding How the Pharmaceutical Distribution and Payment System Shapes the
Prices 	of 	Brand 	Medicines 	1 	(2017),
https://cdn.aglty.io/phrma/global/resources/import/pdfs/Follow-the-Dollar-Report.pdf
(“Follow the Dollar”))]. As a result of this structure, even though an insured patient’s “cost-
sharing amount may exceed the price the health plan actually pays for a medicine
or . . . what the patient would pay at the pharmacy counter without using insurance,”
pharmacies may be contractually prohibited from informing patients about the lower cost
alternative (i.e., paying cash for a prescription at the pharmacy counter). [Doc. 29 at 17
(citing Follow the Dollar at 6)].
In a hearing before Congress, Amgen’s CEO, Robert Bradway, testified that while
“[c]ompanies in virtually every other industry compete by offering the lowest price,” the
pharmaceutical industry players are “often . . . require[d] [to] match[] a competitor’s higher
price.” 	[Id. at 16 & n.7 (quoting Unsustainable Drug Prices: Testimony from the CEOs
(Part II): Hearing Before the H. Comm. on Oversight & Reform, 116th Cong. 5 (2020)
(statement of Robert Bradway, CEO, Amgen), https://tinyurl.com/mtj35txr)]. “Prescription
drug list prices increase so that manufacturers can absorb more and more payer
demands for rebates and other discounts.” 	[Id. at 16–17 & n.8 (quoting Smart Brevity
Studio 	x 	Amgen, 	Inside 	the 	Drug 	Pricing 	Loop, 	Axios,
https://www.axios.com/sponsored/amgen/inside-the-drug-pricing-loop (last visited Mar.
26, 2025)]. Amgen’s CEO also testified that “the primary reason the list price of Enbrel®
has increased as much as it has” is due to a pharmaceutical market “structured in a way
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to benefit intermediaries”—e.g., wholesalers, PBMs, health plans, and pharmacies—and
“not in a way to get lower prices to patients.” 	[Id. at 24 & n.21 (quoting Testimony of
Robert A. Bradway, Chairman and Chief Executive Officer Amgen Inc., Before the U.S.
House 	Committee 	on 	Oversight 	and 	Reform 	7 	(Oct. 	1, 	2020),
https://tinyurl.com/mufwzev3 	(“Bradway 	Written 	Statement”))]. 	Indeed, 	the
pharmaceutical industry is rife with “counterintuitive pricing behavior.” 	See Bradway
Written Statement 8. 	For example, Amgen often “pay[s] higher and higher rebates to
remain on [PBMs’] formulary,” and “increases in list prices . . . significantly increase total
rebates paid to the PBMs” but “generally have limited impact on net prices.” Id. at 7. As
a result, “Amgen has increased list prices over the years in response to competitor list
price increases to remain available as a choice on PBM formularies.” Id.
Colorado’s Prescription Drug Affordability Review Program. 	In 2021, the
Colorado General Assembly enacted legislation to “protect Colorado consumers from
excessive prescription drug costs.” Colo. Rev. Stat. § 10-16-1403(1); see also Colo. Rev.
Stat. §§ 10-16-1401 to -1416 (the “Act”); 2021 Colo. Sess. Laws 1256. 	The Act also
established a five-member “Prescription Drug Affordability Review Board” (or “the
Board”), Colo. Rev. Stat. § 10-16-1402, tasked with (1) “[p]erform[ing] affordability reviews
of prescription drugs,” and (2) potentially “establish[ing] upper payment limits for”
prescription 	drugs 	(like 	Enbrel) 	that 	the 	Board 	deems 	unaffordable 	for 	Colorado
consumers, id. § 10-16-1403(1). 	The Board implemented procedures for these two
statutory directives through both rules and policies. 	See 3 Colo. Code. Regs. §§ 702-
9:1.1 to -9:5.1; Prescription Drug Affordability Board (“PDAB”) Policies 01 to 05,
https://tinyurl.com/djct93ch; see also [Doc. 29 at 18]. The Court refers to the Act and the
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Board’s procedure-implementing rules and policies collectively as the “Affordability
Program.”
According to the Board, the focus of the affordability review is not to determine “the
appropriateness of a manufacturer’s price,” but “whether use of a drug, consistent with
standard medical practice or the FDA label, is unaffordable for Colorado consumers.”
[Doc. 29 at 19 (emphasis added) (citing Colo. Rev. Stat. § 10-16-1406(3))]. 	The Board
further contends that an unaffordability determination “does not impact any rights or
obligations of anyone selling or purchasing the [subject] prescription drug,” because it is
“not a final agency action” and “serve[s] standalone purposes of transparency and
accountability.” 	[Id. 	at 	20 	(citing 	Colo. 	Rev. 	Stat. 	§§ 	10-16-1407(1), 	-1407(9), 	-
1408(1)(c))].
The Board approved a list of 604 prescription drugs eligible for affordability reviews
in June 2023. 	[Doc. 24 at 20–21; Doc. 29 at 25]. 	Approximately six weeks later, the
Board selected five of those prescription drugs for affordability reviews, one of which was
Enbrel. [Doc. 24 at 21; Doc. 29 at 25; Doc. 1-2 at 5]. In February 2024, members of the
Board—acting 	pursuant 	to 	the 	Affordability 	Program—voted 	to 	declare 	Enbrel
unaffordable for Colorado consumers and voted to “select Enbrel for establishment of an
upper payment limit” (or “UPL”). 	[Doc. 24 at 11]; see also Colo. Rev. Stat. § 10-16-
1407(1)(a) (providing that the Board may establish a UPL if it determines that a drug is
“unaffordable for Colorado consumers”). The Act defines UPLs as “the maximum amount
that may be paid or billed for a prescription drug that is dispensed or distributed in
Colorado in any financial transaction concerning the purchase of or reimbursement for
the prescription drug.” Colo. Rev. Stat. § 10-16-1401(23). In other words, a UPL sets a
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price ceiling applicable to various purchase points along the pharmaceutical supply chain,
provided that the drug purchased is dispensed or distributed in Colorado. See id.
Amgen’s participation in the affordability review of Enbrel. 	The Board’s
affordability review of Enbrel occurred over a span of six months and included three public
Board meetings on December 8, 2023; February 16, 2024; and February 23, 2024. [Doc.
29 at 25 & n.22 (citing publicly available recordings of 2023 and 2024 Board meetings,
respectively)]. Amgen participated at each of the foregoing Board meetings; participated
in a September 2023 stakeholder meeting facilitated by the Board; voluntarily submitted
information to the Board in October 2023; and provided written comments to the Board
ahead of both February 2023 Board meetings. [Doc. 29 at 25].
The 	Board’s 	affordability 	review 	of 	Enbrel 	culminated 	in 	a 	500-plus-page
affordability review report, which the Board approved by vote on February 23, 2024. [Id.
at 26]; PDAB 2023 Affordability Review Summary Report: Enbrel (Feb. 23, 2024). 	The
Board subsequently voted to initiate rulemaking to establish a UPL for Enbrel and set a
preliminary timeline for rulemaking hearings in September, October, and December 2024.
[Doc. 29 at 26 & n.23]. The timeline was later modified by the Board and based on the
record before the Court, the first rulemaking hearing for establishing a UPL for Enbrel is
set for April 11, 2025. See [Doc. 46; Doc. 47; Doc. 48; Doc. 48-1].
II. 	Procedural History
On March 22, 2024, Amgen filed this action seeking declaratory and injunctive
relief with respect to the constitutionality of the Act. [Doc. 1]. Amgen asserts four claims
challenging the validity of the Act: (1) preemption under federal patent law (“Count I”); (2)
violation of due process (“Count II”); (3) interference with federal healthcare programs
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(“Count III”); and (4) violation of the Commerce Clause (“Count IV”). [Id. at 26–36].
In May 2024, the Parties sought and received leave to file consolidated cross-
motions for summary judgment without separate statements of undisputed material facts
as contemplated by Local Rule 56.1. [Doc. 18; Doc. 20]. The Court held oral argument
on the Motions for Summary Judgment on October 22, 2024. See [Doc. 42]. The Motions
are ripe for review and the Court addresses the Parties’ arguments below.
LEGAL STANDARD
I. 	Standing
Federal courts are courts of limited jurisdiction. 	Under Article III of the United
States Constitution, federal courts only have jurisdiction to hear certain “cases” and
“controversies.” Susan B. Anthony List v. Driehaus, 573 U.S. 149, 157 (2014). As such,
courts “are duty bound to examine facts and law in every lawsuit before them to ensure
that they possess subject matter jurisdiction.” Wilderness Soc’y v. Kane Cnty., 632 F.3d
1162, 1179 n.3 (10th Cir. 2011) (Gorsuch, J., concurring). 	Indeed, courts have an
independent obligation to determine whether subject matter jurisdiction exists, even in the
absence of a challenge from any party. 	1mage Software, Inc. v. Reynolds & Reynolds,
Co., 459 F.3d 1044, 1048 (10th Cir. 2006) (citing Arbaugh v. Y & H Corp., 546 U.S. 500,
514 (2006)). A court may not simply presume jurisdiction to reach the substantive issues
before it. See Colo. Outfitters Ass’n v. Hickenlooper, 823 F.3d 537, 543 (10th Cir. 2016).
Rather, a federal court must resolve jurisdictional issues before reaching the merits.
United States v. Springer, 875 F.3d 968, 973 (10th Cir. 2017).
The doctrine of standing serves as “[o]ne of those landmarks” in identifying “the
‘Cases’ and ‘Controversies’ that are of the justiciable sort referred to in Article III.” Lujan
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v. Defs. of Wildlife, 504 U.S. 555, 560 (1992); see also Citizen Ctr. v. Gessler, 770 F.3d
900, 906 (10th Cir. 2014) (standing is jurisdictional). Under Article III, standing requires
three elements: injury in fact, causation, and redressability. Colo. Outfitters, 823 F.3d at
544. These three elements of standing are “an indispensable part of the plaintiff’s case,”
and thus the plaintiff must support each element “with the manner and degree of evidence
required at the successive stages of the litigation.” 	Lujan, 504 U.S. at 561 (quotation
omitted). 	At the summary judgment stage, a plaintiff’s standing must be supported by
specific evidentiary facts and not by mere allegations. Id.
“[T]he proof required to establish standing increases as the suit proceeds.” 	Rio
Grande Found. v. Oliver, 57 F.4th 1147, 1162 (10th Cir. 2023) (quotation omitted). 	“At
the pleading stage, general factual allegations of injury resulting from the defendant’s
conduct may suffice, while on summary judgment, the plaintiff must set forth by affidavit
or other evidence specific facts which for purposes of the summary judgment motion will
be taken to be true.” Id. (cleaned up).
II. 	Rule 56 of the Federal Rules of Civil Procedure
Under Rule 56 of the Federal Rules of Civil Procedure, summary judgment is
warranted “if the movant shows that there is no genuine dispute as to any material fact
and the movant is entitled to judgment as a matter of law.” 	Fed. R. Civ. P. 56(a). 	“A
dispute is genuine if there is sufficient evidence so that a rational trier of fact could resolve
the issue either way. A fact is material if under the substantive law it is essential to the
proper disposition of the claim.” 	Crowe v. ADT Sec. Servs., Inc., 649 F.3d 1189, 1194
(10th Cir. 2011) (citation and quotations omitted).
“Cross-motions for summary judgment are treated as two individual motions for
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summary judgment and held to the same standard.” Banner Bank v. First Am. Title Ins.
Co., 916 F.3d 1323, 1326 (10th Cir. 2019); see also Buell Cabinet Co. v. Sudduth, 608
F.2d 431, 433 (10th Cir. 1979) (“Cross-motions for summary judgment are to be treated
separately; the denial of one does not require the grant of another.”). 	However, the
summary-judgment burden slightly differs depending on which party bears the ultimate
burden at trial. 	A movant that does not bear the ultimate burden of persuasion at trial
does not need to disprove the other party’s claim; rather, the movant must only point the
Court to a lack of evidence for the other party on an essential element of that party’s
claim. 	Adler v. Wal-Mart Stores, Inc., 144 F.3d 664, 671 (10th Cir. 1998). 	Once this
movant has met its initial burden, the burden then shifts to the nonmoving party to “set
forth specific facts showing that there is a genuine issue for trial.” 	Anderson v. Liberty
Lobby, Inc., 477 U.S. 242, 250 (1986). But “if the moving party has the burden of proof
[at trial], a more stringent summary judgment standard applies.” 	Pelt v. Utah, 539 F.3d
1271, 1280 (10th Cir. 2008). A moving party who bears the burden at trial “must establish,
as a matter of law, all essential elements of the issue before the nonmoving party can be
obligated to bring forward any specific facts alleged to rebut the movant’s case.” Id.
When considering the evidence in the record, the Court cannot and does not weigh
the evidence or determine the credibility of witnesses. See Fogarty v. Gallegos, 523 F.3d
1147, 1165 (10th Cir. 2008). At all times, the Court views each motion in the light most
favorable to the nonmoving party. Banner Bank, 916 F.3d at 1326.
ANALYSIS
In Defendants’ Motion for Summary Judgment, Defendants argue, inter alia, that
this Court lacks subject matter jurisdiction because Amgen does not have standing and
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the case is not ripe. 	[Doc. 29 at 28]. 	The Court begins with Defendants’ standing
argument, because it may not reach the merits of the action without first assuring itself
that it has subject matter jurisdiction over each of the claims. 	See Colo. Outfitters, 823
F.3d at 543.
I. 	Subject Matter Jurisdiction
A. 	Applicable Law
A 	plaintiff’s 	“burden 	to 	demonstrate 	standing 	for 	each 	form 	of 	relief
sought . . . exists at all times throughout the litigation.” Collins v. Daniels, 916 F.3d 1302,
1314 (10th Cir. 2019) (quotations omitted). To establish standing, a plaintiff must show it
(1) suffered an injury in fact that (2) is fairly traceable to the defendant’s conduct and (3)
can be redressed by a favorable judicial decision. 	See Baker v. USD 229 Blue Valley,
979 F.3d 866, 871 (10th Cir. 2020). However, because causation and redressability are
often “flip sides of the same coin,” Sprint Commc’ns Co. v. APCC Servs., Inc., 554 U.S.
269, 288 (2008), “the two key questions in most standing disputes are injury in fact and
causation,” FDA v. All. for Hippocratic Med., 602 U.S. 367, 380–81 (2024).
An injury in fact must be “concrete, meaning that it must be real and not abstract,”
and the injury must be “actual or imminent, not speculative,” meaning that it “must have
already occurred or be likely to occur soon.” 	All. for Hippocratic Med., 602 U.S. at 381
(quoting Clapper v. Amnesty Int’l USA, 568 U.S. 398, 409 (2013)). Where, as here,2 “a
2 Amgen seeks, inter alia, (1) a declaratory judgment that the Affordability Program is
facially unconstitutional; and (2) an injunction against the establishment and enforcement
of a UPL for Enbrel. 	[Doc. 1 at 36–37]. 	A declaratory judgment and an injunction are
both forms of prospective relief. See, e.g., Collins, 916 F.3d at 1314 (declaratory relief);
Colo. Cross Disability Coal. v. Abercrombie & Fitch Co., 765 F.3d 1205, 1211 (10th Cir.
2014) (injunctive relief).
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plaintiff seeks prospective relief,” the plaintiff must establish “a sufficient likelihood of
future injury.” Id.; see also Colo. Cross Disability Coal. v. Abercrombie & Fitch Co., 765
F.3d 1205, 1211 (10th Cir. 2014) (“When prospective relief . . . is sought, the plaintiff must
be suffering a continuing injury or be under a real and immediate threat of being injured
in the future.” (quotation omitted)). 	With respect to causation, a plaintiff must also
establish that its injury “likely was caused or likely will be caused by the defendant’s
conduct.” All. for Hippocratic Med., 602 U.S. at 382.
Standing is “usually easy to establish” in cases challenging regulations that
“require or forbid some action by the plaintiff”—i.e., where the government is directly
regulating the plaintiff. Id. Conversely, standing is “ordinarily substantially more difficult
to establish” where an unregulated plaintiff challenges the government’s “unlawful
regulation . . . of someone else.” 	Id. at 382–83 (collecting cases). 	The Court’s inquiry
thus begins with whether Amgen is subject to direct regulation under the Act.
B. 	Amgen is Not Subject to Direct Regulation.
Defendants contend that Amgen is not subject to direct regulation under the Act
because UPLs do not apply at the pharmaceutical manufacturer’s point of sale; instead,
UPLs apply only to downstream actors. 	[Doc. 29 at 28–30]. 	Amgen argues that the
statute contains no such express limitation. [Doc. 35 at 12–13]. The Court finds that both
the statutory language and legislative history of the Act support the conclusion that a UPL
does not directly apply to a wholesaler’s purchase from a manufacturer at the top of the
supply chain. 	Instead, a UPL applies directly only to downstream transactions for the
actual sales and reimbursements of the prescription drug dispensed to Colorado
consumers.
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The Act defines a UPL as “the maximum amount that may be paid or billed for a
prescription drug that is dispensed or distributed in Colorado in any financial transaction
concerning the purchase of or reimbursement for the prescription drug.” Colo. Rev. Stat.
§ 10-16-1401(23) (emphasis added). 	A UPL applies to “all purchases of and payer
reimbursements for a prescription drug that is dispensed or administered in the state,” id.
§ 	10-16-1407(5), 	including a 	consumer’s purchase 	from 	a 	pharmacy or 	provider,
reimbursements by certain insurance payers, and pharmacies and providers’ purchases
of the prescription drug, see 3 C.C.R. § 702-9:4.2.C.3 	Amgen reads this language to
include “‘any financial transaction’” along the supply chain. [Doc. 35 at 12 (quoting Colo.
Rev. Stat. § 10-16-1401(23))]. But the Court respectfully agrees with Defendants insofar
as the statute’s use of the definite article “the” in the phrase “the prescription drug”
demonstrates the General Assembly’s intent to cabin application of UPLs to financial
transactions in which “the” prescription drug is “dispensed or distributed in Colorado.”
Colo. Rev. Stat. § 10-16-1401(23); see also Nielsen v. Preap, 586 U.S. 392, 408 (2019)
(“[G]rammar and usage establish that ‘the’ is ‘a function word . . . indicat[ing] that a
following noun or noun equivalent is definite or has been previously specified by
context.”).
Moreover, the statute instructs the Board, in establishing a UPL, to consider the
costs of “administering,” “dispensing,” and “distributing” the prescription drug, see Colo.
3 The Court is respectfully unpersuaded by Amgen’s argument that the Board’s regulation,
C.C.R. § 702-9:4.2.C, is inconsistent with the statutory language, Colo. Rev. Stat. § 10-
16-1401(23). See [Doc. 35 at 12–13 (citing Canyon Fuel Co. v. Sec’y of Labor, 894 F.3d
1279, 1291 (10th Cir. 2018); McCool v. Sears, 186 P.3d 147, 151 (Colo. App. 2008))].
That the regulation provides further clarity to the statutory text does not render the two
inconsistent and, for the reasons discussed above, the statute also supports Defendants’
interpretation of the Act.
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Rev. Stat. § 10-16-1407(2), i.e., the costs associated with providers, pharmacies, and
wholesalers, respectively. In passing the Act, the General Assembly expressly stated its
intent for UPLs to apply specifically to the state and municipalities, contractors and
vendors, commercial health plans, providers, and pharmacies. 	See 2021 Colo. Sess.
Laws 1256, 1257. The UPLs contemplated by the Act do not apply to a prescription drug
manufacturer’s point of sale; instead, UPLs apply to downstream transactions in the
pharmaceutical supply chain.
Thus, the Court concludes based on the unambiguous statutory text that Amgen
is not subject to direct regulation under the Act.4 Accordingly, Amgen cannot challenge
the constitutionality of the Act under this theory of standing.
C. 	Amgen Fails to Establish Standing as an Unregulated Party.
According to Amgen, even if UPLs apply only downstream, “common sense and
basic economics” support standing here because a price cap downstream will reduce
prices upstream. [Doc. 35 at 13–17]. Thus, the Court next considers whether Amgen, as
an unregulated party asserting various challenges to the Affordability Program, has
satisfied the standard set forth in FDA v. Alliance for Hippocratic Medicine, 602 U.S. 367
(2024). For the following reasons, the Court finds that Amgen’s asserted future injury is
simply too speculative to be “concrete” and “imminent.” 	See id. at 386–93 (claims of
future injury are insufficient where plaintiffs cannot show that the harm is likely to occur).
To 	establish 	standing 	as 	an 	unregulated 	party, 	“the 	plaintiff 	must 	show 	a
predictable chain of events leading from the government action to the asserted injury—in
4 The Court notes that, even if it did find ambiguity in the statutory text, the canon of
constitutional avoidance supports the Court’s interpretation of the Act. See F.C.C. v. Fox
Television Stations, Inc., 556 U.S. 502, 516 (2009).
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other words, that the government action has caused or likely will cause injury in fact to
the plaintiff.” Id. at 385. The Supreme Court has repeatedly emphasized that an Article
III injury must be “actual or imminent, not speculative.” Id. at 381; see also Clapper, 568
U.S. at 409; Lujan, 504 U.S. at 560.
“In cases of alleged future injuries to unregulated parties from government
regulation, the causation requirement and the imminence element of the injury in fact
requirement can overlap” because both causation and imminence “target the same issue:
Is it likely that the government’s regulation . . . of someone else will cause a concrete and
particularized injury in fact to the unregulated plaintiff?” 	All. for Hippocratic Med., 602
U.S. at 385 n.2. 	“Although imminence is concededly a somewhat elastic concept, it
cannot be stretched beyond its purpose, which is to ensure that the alleged injury is not
too speculative for Article III purposes—that the injury is certainly impending.” Clapper,
568 U.S. at 409 (quoting Lujan, 504 U.S. at 565 n.2).
Here, relying on “basic economics and common sense” and the Declaration of
Patrick Costello, an Associate Vice President of United States Value and Access, Amgen
argues that it has standing to challenge the Act because “a price cap on Amgen’s drug
will result in less revenue for Amgen’s wholesalers and distributors, who will in turn
demand lower prices or other compensation from Amgen, reducing Amgen’s profits.”
[Doc. 35 at 9, 15–16 (citing [Doc. 35-1 (the “Costello Declaration”)])]. 	The Court
respectfully disagrees with Amgen’s argument for at least two reasons.
First, the Court finds Amgen’s appeal to “basic economics and common sense”
unpersuasive. 	Nothing in the record defines what the amorphous concepts of “basic
economics and common sense” entail, or if such “basic economics and common sense”
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even 	apply 	to 	the 	pharmaceutical 	industry. 	Amgen’s 	position 	assumes, 	without
establishing as an undisputed fact, that any UPL established will necessarily fall below
the WAC, or what Amgen’s customers currently pay. Furthermore, it does not consider
the undisputed complexity of the supply chain and the various rebates, reimbursements,
chargebacks, and discounts that are exchanged at various levels of the supply chain. To
the extent that Amgen suggests that it will necessarily be injured regardless of whether,
when, or what UPL may be set due to “basic economics and common sense,” this Court
respectfully declines to conclude that Amgen has carried its summary judgment burden
of establishing injury-in-fact on such speculation. Indeed, Amgen’s CEO testified before
Congress that the pharmaceutical market is driven by “counterintuitive pricing behavior.”
[Doc. 29 at 24 & n.21 (quoting Bradway Written Statement at 7–8)].
Second, and more fundamentally, Mr. Costello has not articulated a specific and
concrete injury to Amgen under the Affordability Program—particularly in light of the fact
that no UPL for Enbrel has been set and it is unclear when and if such a UPL will be set.
Instead, Mr. Costello’s Declaration is based on two unfulfilled conditions precedent: (1)
“if an upper payment limit is imposed on wholesalers’ sales of Enbrel,” then “there is no
realistic chance that wholesalers will absorb the discount required to comply with the
upper payment limit without passing cost on to Amgen,” [Doc. 35-1 at ¶ 12 (emphasis
added)]; and (2) “if Colorado dictates that wholesalers must sell the products for less than
WAC,” then “Amgen cannot reasonably expect wholesalers to purchase products at
WAC, without any discount or reimbursement from Amgen,” [id. at ¶ 13 (emphasis
added)]. 	But, at this juncture, Colorado has not fulfilled either of these prerequisites.
Moreover, Mr. Costello’s statement that “[t]here is no scenario in which an upper payment
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limit for Enbrel would not negatively impact Amgen,” necessarily relies on both foregoing
conditions and is conclusory in nature. [Id. at ¶ 14].
The Costello Declaration reinforces the speculative nature of Amgen’s theory of
standing. Amgen might be able to demonstrate harm if the Board sets a UPL for Enbrel;
if that UPL is set lower than the WAC for Enbrel; and if wholesalers react by demanding
that Amgen absorb any costs associated with the same. 	Unless and until a UPL is set
for Enbrel and at a price lower than WAC, however, Amgen’s alleged future injuries are
hypothetical at best. 	In other words, Amgen’s theory of standing is premised on “the
predictable effect” of a hypothetical UPL on the decisions of wholesalers.
Notably, Amgen fails to cite any authority for the proposition that an unregulated
plaintiff can establish standing based on hypothetical government action. Compare [Doc.
35 at 13–17 (collecting cases)], with Kane Cnty. v. United States, 928 F.3d 877, 888–89
(10th Cir. 2019) (finding environmental group had standing to challenge government
plans to “double the width of [two] roads” in scenic areas because widening the roads in
a scenic area “would almost inevitably increase traffic”); Carpenters Indus. Council v.
Zinke, 854 F.3d 1, 5 (D.C. Cir. 2017) (finding standing based on future economic injury
where lumber companies challenged an existing “critical habitat designation” that would
reduce their timber supply); Wedges/Ledges of Calif., Inc. v. City of Phoenix, 24 F.3d 56,
60–61 (9th Cir. 1994) (manufacturer and operator of crane arcade game had standing to
challenge city policies where manufacturer demonstrated that city had “succeeded in
destroying the market for crane games”); Energy Future Coal. v. EPA, 793 F.3d 141, 144
(D.C. Cir. 2015) (ethanol producers had standing to challenge EPA’s test fuel regulation
prohibiting the producers’ product from being used as a test fuel); Maine Lobstermen’s
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Ass’n v. Nat’l Marine Fisheries Serv., 70 F.4th 582, 592 (D.C. Cir. 2023) (finding
lobstermen 	had 	standing 	to 	challenge 	already-promulgated 	rule 	that 	would 	“cost
lobstermen $50 to $90 million”); Dep’t of Com. v. New York, 588 U.S. 752, 764–68 (2019)
(holding that “respondents have met their burden of showing that third parties will likely
react in predictable ways to the citizenship question” that agency sought to reinstate in
census where “evidence at trial established that noncitizen households have historically
responded to the census at lower rates than other groups, and the . . . discrepancy is
likely attributable at least in part to noncitizens’ reluctance to answer a citizenship
question”).5 Even if the Board may one day establish a below-list-price UPL for Enbrel,
the Court is not at liberty to assume or predict one of several possible outcomes to find
Article III standing at this time. Cf. Clapper, 568 U.S. at 413–14 (declining to “abandon”
the Supreme Court’s “usual reluctance to . . . endorse standing theories that require
guesswork as to how independent decisionmakers will exercise their judgment”); Garcia
v. Texas, 564 U.S. 940, 941 (2011) (“Our task is to rule on what the law is, not what it
might eventually be.”).
The economic injuries alleged by Amgen are too speculative and too attenuated
to support standing in this case. Because Amgen’s “allegations of possible future injury
are not sufficient,” the Court concludes that Amgen has failed to satisfy the requirement
that “threatened injury must be certainly impending to constitute injury in fact.” 	See
Clapper, 568 U.S. at 409 (cleaned up). 	And it is clear that the Court cannot presume
subject matter jurisdiction in order to reach the merits of this case. Cf. DaimlerChrysler
5 Two cases cited by Amgen do not address standing whatsoever. 	See Caldwell
Wholesale Co. v. R J Reynolds Tobacco Co., 781 F. App’x 289, 291 (5th Cir. 2019) (per
curiam); Money Mailer, LLC v. Brewer, 449 P.3d 258, 264 (Wash. 2019).
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Corp. v. Cuno, 547 U.S. 332, 348 (2006) (holding that a taxpayer litigant cannot assume
a particular disposition of government funds in order to establish standing); Colo.
Outfitters, 823 F.3d at 543 ( “[A] federal court can’t ‘assume’ a plaintiff has demonstrated
Article III standing in order to proceed to the merits of the underlying claim, regardless of
the claim’s significance.” (citing Steel Co. v. Citizens for a Better Env’t, 523 U.S. 83, 94
(1998) (explaining that “such an approach . . . carries the courts beyond the bounds of
authorized judicial action and thus offends fundamental principles of separation of
powers”))). 	Accordingly, Amgen has failed to meet its burden at summary judgment to
establish standing, and this Court must dismiss Amgen’s Complaint without prejudice for
lack of subject matter jurisdiction.
CONCLUSION
For the reasons set forth above, IT IS ORDERED that:
(1) 	Defendants’ Motion for Summary Judgment [Doc. 29] is GRANTED;
(2) 	Plaintiffs’ Complaint [Doc. 1] is DISMISSED without prejudice for lack of
subject matter jurisdiction;
(3) 	Plaintiffs’ Motion for Summary Judgment [Doc. 24] is DENIED as moot; and
(4) 	The Clerk of Court is directed to TERMINATE this matter accordingly.
DATED: March 28, 2025 	BY THE COURT:
_________________________
Nina Y. Wang
United States District Judge
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