Astrazeneca Pharmaceuticals Lp; Astrazeneca Ab v. Secretary United States Department of Health

PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
____________
No. 24-1819
____________
ASTRAZENECA PHARMACEUTICALS LP;
ASTRAZENECA AB,
Appellants
v.
SECRETARY UNITED STATES DEPARTMENT OF
HEALTH AND HUMAN SERVICES; ADMINISTRATOR
CENTERS FOR MEDICARE & MEDICAID SERVICES
____________
On Appeal from the United States District Court
for the District of Delaware
(D.C. No. 1:23-cv-00931)
District Judge: Honorable Colm F. Connolly
____________
Argued on October 30, 2024
Before: HARDIMAN, PHIPPS, and FREEMAN, Circuit
Judges
(Opinion filed: May 8, 2025)

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Catherine E. Stetson [ARGUED]
Susan M. Cook
Danielle Desaulniers Stempel
Claire Adkins Rhodes
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington, D.C. 20004
(202) 637-5600
Counsel for Appellants
Lindsey Powell [ARGUED]
Steven A. Myers
Catherine M. Padhi
David L. Peters
Michael S. Raab
Bridgette L. Kaiser
Anant Kumar
Matthew A. Campbell
United States Department of Justice, Appellate Section
Room 7259
950 Pennsylvania Avenue NW
Washington, DC 20530
Counsel for Appellees
Michael D. Lieberman
Fairmark Partners
1001 G Street NW
Suite 400 East
Washington, DC 20001
Counsel for Amicus Patients for Affordable Drugs

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Ananda V. Burra
Robin F. Thurston
Democracy Forward Foundation
P.O. Box 34553
Washington, DC 20043
Counsel for Amici American Public Health Association,
American College of Physicians, American Geriatrics
Society, American Society of Hematology, and Society
of General Internal Medicine
Charles L. Becker
Kline & Specter
1525 Locust Street
19th Floor
Philadelphia, PA 19102
Counsel for Amici Senators Amy Klobuchar, Peter
Welch, Tammy Baldwin, Richard Blumenthal, Sherrod
Brown, Catherine Cortez Mastro, Richard Durbin, John
Fetterman, John Hickenlooper, Jack Reed, Jacky
Rosen, Jeanne Shaheen, Debbie Stabenow, Chris Van
Hollen, and Elizabeth Warren

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Hannah W. Brennan
Sophia K. Weaver
Hagens Berman Sobol Shapiro
One Faneuil Hall Square, 5th Floor
Boston, MA 02109
Jamie Crooks
Fairmark Partners
400 7th Street NW
Suite 304
Washington, DC 20004
Counsel for Amici Center for American Progress,
Century Foundation, UnidosUS Action Fund, and
National Association for the Advancement of Colored
People
Maame A. Gyamfi
AARP Foundation Litigation
B4-377
601 E Street NW
Washington, DC 20049
Counsel for Amici AARP, AARP Foundation, Center for
Medicare Advocacy, Justice in Aging, and Medicare
Rights Center

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Alyssa H. Card
Margaret Dotzel
William B. Schultz
Zuckerman Spaeder
1800 M Street NW
Suite 1000
Washington, DC 20036
Counsel for Amici Stuart Altman, Robert Berenson,
Donald Berwick, David Blumenthal, Francis J.
Crosson, Paul Ginsburg, Marilyn Moon, and Bruce
Vladeck
Deepak Gupta
Gupta Wessler
2001 K Street NW
Suite 850 North
Washington, DC 20006
Counsel for Amici Richard G. Frank, Fiona M. Scott
Morton, Aaron S. Kesselheim, Gerard F. Anderson,
Rena M. Conti, David M. Cutler, and Jack Hoadley
_______________
OPINION OF THE COURT
_______________
FREEMAN, Circuit Judge.
The Inflation Reduction Act of 2022 (“IRA”) created
the Drug Price Negotiation Program (“Negotiation Program”).
The Negotiation Program directs the Centers for Medicare &
Medicaid Services (“CMS”) to negotiate prices for certain

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drugs that have resulted in high expenditures to Medicare. To
implement that statutory directive, CMS issued guidance
explaining how it would select the qualifying drugs for 2026—
the first year of the Negotiation Program. CMS then selected
the drugs that are subject to negotiation. One of the selected
drugs is Farxiga, which is manufactured by AstraZeneca.1
AstraZeneca sued the Secretary of the Department of
Health and Human Services and CMS’s Administrator
(collectively, “the government”) to challenge the Negotiation
Program and portions of CMS’s guidance. AstraZeneca claims
that the Negotiation Program deprives it of procedural due
process and that two provisions of CMS’s guidance violate the
Administrative Procedure Act (“APA”).
The District Court determined that AstraZeneca failed
to state a due process violation to challenge the Negotiation
Program and lacks standing to pursue its APA claims.
Accordingly, the District Court entered judgment in favor of
the government. For the following reasons, we will affirm the
District Court’s judgment.
I
Medicare is a federal medical insurance program for
people ages sixty-five and older and for younger people with
certain disabilities. See 42 U.S.C. § 1395 et seq. Medicaid is
a joint federal and state program that provides medical
coverage for people with limited incomes. See id. § 1396 et
seq. “Through Medicare and Medicaid, [the federal
government] pays for almost half the annual nationwide
1 We refer to AstraZeneca Pharmaceuticals LP, and
AstraZeneca AB collectively as “AstraZeneca.”

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spending on prescription drugs.” Sanofi Aventis U.S. LLC v.
U.S. Dep’t of Health & Hum. Servs., 58 F.4th 696, 699 (3d Cir.
2023) (citing Cong. Budget Off., Prescription Drugs:
Spending, Use, and Prices 8 (2022)).
Medicare is divided into Parts, two of which (Parts B
and D) are relevant here. Part B is a voluntary supplemental
insurance program that covers outpatient care, including
certain prescription drugs that are typically administered by a
physician. See 42 C.F.R. § 410.28. Part D “is a voluntary
prescription drug benefit program that subsidizes the cost of
prescription drugs and prescription drug insurance premiums
for Medicare enrollees.” United States ex rel. Spay v. CVS
Caremark Corp., 875 F.3d 746, 749 (3d Cir. 2017). Part D
works through prescription drug plans operated by private
insurance companies that it calls “sponsors.” Sponsors then
work with subcontractors, including pharmacy benefit
managers, who handle administrative tasks and process claims.
See id. Those subcontractors in turn contract with the
pharmacies that dispense prescription drugs to Medicare
beneficiaries. See id.
When Congress enacted Medicare Part D in 2003, it
included a “non-interference” provision. That provision states
that CMS “may not interfere with the negotiations between
drug manufacturers and pharmacies and . . . sponsors” and
“may not institute a price structure for the reimbursement of
covered part D drugs.” 42 U.S.C. § 1395w-111(i)(1), (3)
(2003). Nineteen years later, when Congress enacted the IRA,
it created an exception to the non-interference provision: the
Negotiation Program directs CMS to “negotiate . . . maximum
fair prices” for certain drugs, id. § 1320f(a)(3), subject to price
ceilings derived from the price on the private market, id. §
1320f-3(c). Each selected drug’s “maximum fair price”

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applies beginning in a given drug-pricing period (a period of
one calendar year), the first of which is 2026, until the drug is
no longer eligible for negotiation or the price is renegotiated.
Id. §§ 1320f(b)(1)–(2), 1320f-1(c), and 1320f-3(f).
The Negotiation Program sets out a two-phase process
for each drug-pricing period. First, CMS identifies the drugs
subject to negotiation. Second, CMS negotiates with the
manufacturer of each identified drug. We will refer to these as
the Identification Phase and the Negotiation Phase.
During the Identification Phase for any given drug-
pricing period, CMS first identifies “qualifying single source
drugs,” which are drugs approved by the FDA for at least seven
years and not subject to competition from a generic “that is
approved and marketed.” Id. § 1320f-1(e)(1)(A)(i)–(iii). CMS
then rank-orders the qualifying single source drugs according
to highest associated expenditures under Medicare Part B or
Part D over a recent twelve-month period. To determine the
total spending on a drug, CMS looks to “data that is aggregated
across dosage forms and strengths of the drug, including new
formulations of the drug, such as an extended release
formulation, and not based on the specific formulation or
package size or package type of the drug.” Id. § 1320f-
1(d)(3)(B). The fifty drugs that represent the highest total
spending under each respective Part are “negotiation-eligible
drugs.” Id. § 1320f-1(d)(1).2
2 The Negotiation Program applies to drugs covered by
Medicare Part D for the 2026 and 2027 drug-pricing periods.
42 U.S.C. § 1320f-1(a)(1)–(2), (d)(1). The Negotiation

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Next, CMS selects and publishes a list of the
negotiation-eligible drugs that will be subject to negotiation for
the relevant drug-pricing period, id. § 1320f-1(a), prioritizing
negotiation for the drugs that represent the largest expenditures
to Medicare, see id. § 1320f-1(b)(1)(B). It selected ten drugs
for drug-pricing period 2026, and the number of selected drugs
will increase for subsequent drug-pricing periods. Id. § 1320f-
1(a).
Once CMS publishes the list of drugs selected for
negotiation, the Negotiation Phase begins. When negotiating,
CMS “shall . . . aim[] to achieve the lowest maximum fair price
for each selected drug,” id. § 1320f-3(b)(1), and is barred from
offering or agreeing to a price that is more than 75 percent of
the private market price for the drug, see id. § 1320f-3(c).
Lower price ceilings (65 percent or 40 percent) apply to drugs
that have been approved or licensed for a longer time (at least
12 years or at least 16 years, respectively). Id.
CMS must consider several factors during negotiations,
including the manufacturer’s production and distribution costs,
the manufacturer’s research and development costs (and the
extent to which those costs have been recouped), federal
funding for the drug’s development, patent rights and statutory
exclusivities, FDA product approvals, sales data, and
alternative treatments. See id. § 1320f-3(e). Manufacturers
supply information about these factors to CMS. See id.
§ 1320f-3(b)(2)(A). Based on the enumerated factors and the
price ceilings, CMS makes an initial offer. Id. § 1320f-
Program first applies to drugs covered by Medicare Part B
during the 2028 drug-pricing period. Id. § 1320f-1(a)(3)–(4),
(d)(1).

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3(b)(2)(B). The manufacturer then has an opportunity to make
a counteroffer, to which CMS will respond. Id. §§ 1320f-
3(b)(2)(C)–(D). Negotiations must end by November 1 of the
year two years prior to when the pricing will take effect, id.
§ 1320f-3(b)(2)(E), and CMS must publish the maximum fair
price by November 30, id. § 1320f-4(a)(1). CMS then has until
March 1 of the following year (i.e., ten months before the price
goes into effect) to publish an explanation of how the
maximum fair price comports with the statutory factors. Id.
§ 1320f-4(a)(2).
Congress directed CMS to implement the Negotiation
Program for drug-pricing periods 2026 through 2028 “by
program instruction or other forms of program guidance.” Id.
§ 1320f note. Accordingly, in March 2023 CMS issued an
initial program guidance. After receiving more than 7,500
public comments, it made revisions and issued revised
guidance (“the Guidance”) in June 2023. By its terms, the
Guidance applies only for drug-pricing period 2026, though
CMS has stated that it may incorporate the comments it
received when promulgating the Guidance into its program
guidance for drug-pricing periods 2027 and 2028.
AstraZeneca challenges two aspects of the Guidance.
The first is the Guidance’s grouping of variations of the same
drug. As noted above, the Negotiation Program requires CMS
to determine total Medicare expenditures for negotiation-
eligible drugs by using “data that is aggregated across dosage
forms and strengths of the drug, including new formulations of
the drug, such as an extended-release formulation, and not
based on the specific formulation or package size or package
type of the drug.” Id. § 1320f-1(d)(3)(B). Relying on this
language, the Guidance states that CMS “will identify a
potential qualifying single source drug using . . . all dosage

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forms and strengths of the drug with the same active moiety
and the same holder of a New Drug Application (NDA),
inclusive of products that are marketed pursuant to different
NDAs.”3 App. 217 (footnotes omitted).
The second challenge is to the Guidance’s test for
generic competition. Recall that the Negotiation Program
states that drugs qualify for negotiation if they lack a generic
competitor that “is approved and marketed.” 42 U.S.C. §
1320f-1(e)(1)(A)(iii) (emphasis added). The Guidance states
that CMS will consider an approved generic “to be marketed
when the totality of the circumstances . . . reveals that the
manufacturer of the generic drug . . . is engaging in bona fide
marketing of that drug.” App. 124. It explains that the
statutory term “is marketed” contemplates “that a generic . . .
must have a continuing presence on the market.” App. 190. It
also explains that “manufacturers’ past behavior warrants CMS
review on an ongoing basis as to whether a generic drug . . . is
being bona fide marketed.” Id. It reasons that, without that
review, a generic-drug manufacturer “could launch into the
market a token or de minimis amount of a generic drug” and
the manufacturer of a drug selected for negotiation could
“claim that the [maximum fair price] should no longer apply.”
Id. Accordingly, to determine whether a manufacturer is
engaging in bona fide marketing, the Guidance says CMS will
3 As defined by FDA regulations, a drug’s active moiety is the
core “molecule or ion . . . responsible for the physiological or
pharmacological action of the drug substance.” 21 C.F.R. §
314.3. An NDA is the FDA’s approval of a pharmaceutical for
sale and marketing; a drug can have multiple approved uses
under one NDA and multiple NDAs for different uses. See
generally 21 U.S.C. § 355.

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review data on prescriptions being filled and the average price
a manufacturer offers to direct purchasers.
In August 2023, after CMS published the Guidance,
AstraZeneca filed this lawsuit challenging the Guidance and
the Negotiation Program. Four days after AstraZeneca filed
suit, CMS published a list of the ten drugs it selected for
negotiation for drug-pricing period 2026. AstraZeneca then
amended its complaint to allege that CMS had selected one of
the drugs AstraZeneca manufactures: Farxiga, which is used
to treat diabetes, heart disease, and kidney disease. While this
case proceeded, AstraZeneca and CMS undertook the steps set
out in the Negotiation Program’s Negotiation Phase, and the
parties agreed to a “maximum fair price” for Farxiga during
drug-pricing period 2026.4
Meanwhile, the parties cross-moved for summary
judgment, agreeing that their motions presented purely legal
issues. In March 2024, the District Court denied
AstraZeneca’s motion and granted the government’s motion.
It determined that AstraZeneca lacked standing to challenge
the Guidance under the APA and failed to state a procedural-
due-process claim that could lead to relief from the Negotiation
Program. AstraZeneca timely appealed.
4 The Negotiation Program defines the term “maximum fair
price” to mean, with respect to a selected drug and a given
drug-pricing period, “the price negotiated pursuant to [the
Negotiation Program], . . . as applicable, for such drug and
year.” 42 U.S.C. § 1320f(c)(3).

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II5
We exercise plenary review of summary-judgment
orders, applying the same standard used by district courts.
Auto-Owners Ins. Co. v. Stevens & Ricci Inc., 835 F.3d 388,
402 (3d Cir. 2016). Under that standard, summary judgment is
only appropriate “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
In its APA claims, AstraZeneca challenges how the
Guidance defines a qualifying single source drug and how it
instructs CMS to determine whether a drug is subject to generic
competition. It asserts that these Guidance provisions conflict
with or exceed the terms of the Negotiation Program and must
be set aside. But before we can address the merits of these
claims, AstraZeneca must demonstrate that it has Article III
standing. Nat’l Shooting Sports Found. v. Att’y Gen. of N.J.,
80 F.4th 215, 218 (3d Cir. 2023); DaimlerChrysler Corp. v.
Cuno, 547 U.S. 332, 352 (2006) (“[A] plaintiff must
demonstrate standing for each claim he seeks to press.”).
“To establish standing, a plaintiff must show an injury
in fact caused by the defendant and redressable by a court
order.” United States v. Texas, 599 U.S. 670, 676 (2023). The
injury-in-fact must be “concrete, particularized, and actual or
imminent.” TransUnion LLC v. Ramirez, 594 U.S. 413, 423
(2021). “A concrete injury is real rather than abstract, and a
particularized injury is one that affects the plaintiff in a
5 The District Court had jurisdiction under 28 U.S.C. §§ 1331,
1346, and 1361. We have jurisdiction under 28 U.S.C. § 1291.

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personal and individual way.” Ellison v. Am. Bd. of
Orthopaedic Surgery, 11 F.4th 200, 205 (3d Cir. 2021). A
plaintiff bears the burden of establishing standing “as of the
time [it] brought [its] lawsuit,” Carney v. Adams, 592 U.S. 53,
59 (2020), and it must do so “for each claim [it] seeks to press.”
DaimlerChrysler Corp., 547 U.S. at 335.
AstraZeneca articulates two theories of injury stemming
from both challenged aspects of the Guidance: (1) the impact
on AstraZeneca’s decision-making about research,
development, and marketing, and (2) the company’s difficulty
valuing Farxiga in negotiations with CMS. Neither theory of
injury is concrete or particularized.
1
We begin with AstraZeneca’s asserted injury to its
business decision-making. According to the company, the
Guidance’s grouping of related drugs has caused or will cause
AstraZeneca to make research, development, and marketing
choices that account for the risk that its new drug products will
be subject to price negotiation. Similarly, AstraZeneca
contends that the Guidance’s bona-fide-marketing requirement
forces it to account for the risk that its drugs could be
simultaneously subject to generic competition and negotiated
pricing.
At summary judgment, a plaintiff cannot rely on mere
allegations to demonstrate standing. It “must set forth by
affidavit or other evidence specific facts demonstrating that
[standing] requirements have been met.” Freeman v. Corzine,
629 F.3d 146, 153 (3d Cir. 2010) (internal quotation marks and
citation omitted). Seeking to satisfy this requirement,
AstraZeneca submitted an affidavit from its Vice President of

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U.S. Market Access, Jim Ader. Ader stated that the grouping
of different drug products “diminishes incentives for
AstraZeneca to invest in future therapies and treatments for the
active moiety of a selected drug product.” App. 101. He
continued:
While clinical trials are currently focused on
“combination product” therapies that would not
be impacted by the agency’s definition of
Qualifying Single Source Drug, there are other
ongoing drug development efforts involving the
same active moiety as FARXIGA where one
development pathway could result in the product
being treated as the same QSSD as FARXIGA
under CMS’s position.
App. 103. He asserted that the Guidance “dramatically alters
manufacturers’ incentives to invest in . . . follow-on therapies
using a previously approved active moiety” and that
“AstraZeneca would have no incentive to spend years and a
steep financial investment researching alternative treatment
uses for the active moiety of a selected product.” App. 104–
05.
Ader’s affidavit—the only evidence AstraZeneca
submitted to support its theory of injury-in-fact—does not
establish a concrete and particularized injury to AstraZeneca.
Ader did not identify any actual decision about drug
development or marketing that AstraZeneca has made or will
make to avoid different drugs being grouped together. While
he hypothesized that some unspecified “pathway” of
AstraZeneca’s ongoing drug-development efforts involving
Farxiga’s active moiety could result in a product that would be
grouped with Farxiga in the future, he provided no evidence

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about how the company has been (or imminently will be)
injured. See Sherwin-Williams Co. v. Cnty. of Delaware, Pa.,
968 F.3d 264, 269 (3d Cir. 2020) (“Allegations of possible
future injury do not satisfy the requirements of Art. III.”
(quoting Whitmore v. Arkansas, 495 U.S. 149, 158 (1990))).
Ader merely suggested a hypothetical scenario. But “[u]nder
Article III, federal courts do not adjudicate hypothetical . . .
disputes.” TransUnion, 594 U.S. at 423; accord Trump v. New
York, 592 U.S. 125, 131 (2020) (recounting that standing
requires “an injury that is concrete, particularized, and
imminent rather than conjectural or hypothetical” (citation
omitted)).6 And Ader’s statements about “broad-based market
effects stemming from regulatory uncertainty are
quintessentially conjectural,” New Eng. Power Generators
Ass’n v. FERC, 707 F.3d 364, 369 (D.C. Cir. 2013), and thus
insufficient to establish standing.7
6 In his affidavit, Ader describes Calquence—a leukemia
medicine approved under two different NDAs—and avers it is
“a potential candidate for selection” for negotiation in pricing
period 2027. App. 106. Ader states that the Guidance’s
definition “dramatically alters manufacturers’ incentives to
invest in such follow-on therapies,” App. 104, but he provides
no detail about how “AstraZeneca has to make investment
decisions now on research development” related to Calquence,
App. 106. Nor does the fact that CMS later selected Calquence
for the 2027 pricing period demonstrate that AstraZeneca had
a concrete and particularized injury at the time it sued.
7 While this appeal was pending, the Fifth Circuit held in
National Infusion Center Association v. Becerra, 116 F.4th 488

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2
AstraZeneca’s asserted injury to its ability to value
Farxiga in negotiations with CMS is not concrete or
particularized either. AstraZeneca filed Ader’s affidavit before
CMS made an initial offer for Farxiga’s “maximum fair price”
for drug-pricing period 2026. It argues that it had to assume
the Guidance applied, so the Guidance injured its business
decisions even before any offers were made. But the only
evidence presented is Ader’s statement that “AstraZeneca . . .
is forced to make a number of decisions now about its
willingness to go forward with its participation in the
program.” App. 99. This “general factual allegation[] of injury
resulting from the defendant’s conduct” is insufficient to
(5th Cir. 2024) (“NICA”), that a medical trade organization had
standing to bring constitutional challenges to the Negotiation
Program. AstraZeneca asserts that NICA supports standing
here. Not so. AstraZeneca’s standing to challenge the
Negotiation Program is not in dispute, and NICA says nothing
about standing to challenge the Guidance provisions at issue
here. And, of course, courts assess standing based on the
record before them. In NICA, the plaintiff demonstrated how
the Negotiation Program caused it both present and future
injury. See id. at 502 (“NICA has specifically described the
ways in which the [Negotiation] Program limits its members’
ability to obtain necessary debt and equity capital.”); id. at 501
(“NICA has shown that at least one of its members’ drugs will
be subject to the [Negotiation] Program, that the [Negotiation]
Program will lower the price for that drug, and that the lower
price will lead to lower revenue for the member.”). Here,
AstraZeneca has failed to demonstrate either actual or
imminent injury caused by the Guidance.

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establish standing. Lujan v. Defenders of Wildlife, 504 U.S.
555, 561 (1992). AstraZeneca has introduced no “specific
facts” about how the Guidance shaped its behavior before or
during those negotiations.8 Id.
Absent an injury-in-fact, AstraZeneca lacks Article III
standing to challenge the Guidance. We will therefore affirm
the District Court’s order granting summary judgment in favor
of the government with respect to AstraZeneca’s APA claims.
III
In its due process claim, AstraZeneca argues that the
Negotiation Program itself (not the Guidance) deprives the
company of its property interests in drugs subject to
negotiation and does not provide adequate procedural
safeguards.
To state a procedural due process claim, “a plaintiff
must allege that (1) he was deprived of an individual interest
that is encompassed within the Fourteenth Amendment’s
protection of life, liberty, or property, and (2) the procedures
available to him did not provide due process of law.” Hill v.
Borough of Kutztown, 455 F.3d 225, 233–34 (3d Cir. 2006)
(internal quotation marks and citation omitted). “For a
property interest to be protected, a plaintiff must show a
legitimate claim of entitlement to it.” Coon v. Cnty. of
Lebanon, 111 F.4th 273, 275 (3d Cir. 2024) (internal quotation
8 AstraZeneca, of course, could have sought to file any
confidential evidence under seal. See, e.g., Sabre, Inc. v. Dep’t
of Transp., 429 F.3d 1113, 1118 (D.C. Cir. 2005) (describing
evidence of confidential marketing plans filed under seal that
established injury-in-fact).

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marks and citation omitted). The Due Process Clause protects
property interests that are created and defined outside of the
Constitution, such as by federal statute or state law. Bd. of
Regents of State Colls. v. Roth, 408 U.S. 564, 577 (1972).
AstraZeneca argues that the Negotiation Program limits
its ability to sell its drugs at a market rate, thereby infringing
on its property rights. It contends that those property rights
derive from its patents and regulatory exclusivity periods. See
Opening Br. 43 (asserting a deprivation of its “core property
interests in its patented drugs and the right to determine the
revenue it derives therefrom”); id. at 43–44 (suggesting
regulatory exclusivity periods enhance its right to exclude);
accord id. at 23 (describing the deprivation of “some of the
rights conferred by Farxiga’s patent”).
AstraZeneca is correct that patent rights exist to permit
greater profits during a product’s exclusivity period to
incentivize innovation. See Eldred v. Ashcroft, 537 U.S. 186,
215–16 (2003). But “the federal patent laws do not create any
affirmative right to make, use, or sell anything.”
Biotechnology Indus. Org. v. District of Columbia, 496 F.3d
1362, 1372 (Fed. Cir. 2007) (citation omitted). And where
federal patent laws do not confer a right to sell at all, they do
not confer a right to sell at a particular price. (No other
applicable provision of property law confers a right to sell
goods at a particular price either.)
There is no protected property interest in selling goods
to Medicare beneficiaries (through sponsors or pharmacy
benefit plans) at a price higher than what the government is
willing to pay when it reimburses those costs. AstraZeneca’s
asserted interest does not “resemble any traditional conception
of property,” Town of Castle Rock, Colorado v. Gonzales, 545

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U.S. 748, 766 (2005),9 and AstraZeneca has no more than “a
unilateral expectation” of that interest, Roth, 408 U.S. at 577.
AstraZeneca also contends that the Negotiation
Program violates the Due Process Clause by imposing price
controls on private market transactions while barring judicial
review of CMS’s price-setting decisions. For support, it relies
on Bowles v. Willingham, 321 U.S. 503, 517–21 (1944).
Bowles involved a wartime rent-control statute governing
certain private housing transactions. The Supreme Court
upheld the statute, noting that it provided for judicial review of
the agency’s price-setting decisions. Id. at 520–21. According
to AstraZeneca, its drug sales to Medicare plan sponsors are
private market transactions, so any price controls on those
transactions must get judicial review as in Bowles. But the
Negotiation Program only sets prices for drugs that CMS pays
9 In Burns v. Pennsylvania Department of Corrections, we
looked to A. M. Honoré’s eleven “standard incidents” of
property ownership to determine whether a claimed interest
qualified as property under the Due Process Clause. 544 F.3d
279, 287 (3d Cir. 2008) (citation omitted). Honoré’s list of
“standard incidents” of property ownership are “the right to
possess, the right to use, the right to manage, the right to the
income of the thing, the right to the capital, the right to security,
the rights or incidents of transmissibility and absence of term,
the prohibition of harmful use, liability to execution, and the
incident of residuarity.” Id. (quoting A. M. Honoré,
Ownership, in Oxford Essays in Jurisprudence 107 (A.G.
Guest, ed. 1961), reprinted in Tony Honoré, Making Law
Bind: Essays Legal and Philosophical (1987) (emphasis
omitted)). AstraZeneca’s claimed interest does not align with
any of these incidents of ownership.

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for when it reimburses sponsors. See 42 U.S.C. §§ 1395w-
111–1395w-112 (establishing a scheme in which sponsors bid
to be accepted into Medicare Part D and enter contracts with
CMS for reimbursement); see also 42 C.F.R. § 423.301 et seq.
(setting forth rules for reimbursing sponsors). These are not
private market transactions, regardless of the private hands
through which CMS’s funds pass. See Spay, 875 F.3d at 749
(describing the public-private structure of Medicare Part D).
Because AstraZeneca does not articulate a protected
property interest, we will affirm the District Court’s grant of
summary judgment in favor of the government on
AstraZeneca’s due process claim.
* * *
For the foregoing reasons, we will affirm the District
Court’s judgment.

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