AbbVie, Inc., Allergan, Inc., AbbVie Products LLC, Pharmacyclics LLC, and Allergan Sales, LLC v. Philip Weiser, in his official capacity as Attorney General of the State of Colorado; and Kristen Wolf, Ryan Leyland, Patricia Evacko, Avani Soni, Michael Scruggs, Alexandra Zuccarelli, and Jayant Patel, in their official capacities as members of the Colorado State Board of Pharmacy

CourtDistrict Court, D. Colorado
DecidedOctober 31, 2025
Docket1:25-cv-01847
StatusUnknown

This text of AbbVie, Inc., Allergan, Inc., AbbVie Products LLC, Pharmacyclics LLC, and Allergan Sales, LLC v. Philip Weiser, in his official capacity as Attorney General of the State of Colorado; and Kristen Wolf, Ryan Leyland, Patricia Evacko, Avani Soni, Michael Scruggs, Alexandra Zuccarelli, and Jayant Patel, in their official capacities as members of the Colorado State Board of Pharmacy (AbbVie, Inc., Allergan, Inc., AbbVie Products LLC, Pharmacyclics LLC, and Allergan Sales, LLC v. Philip Weiser, in his official capacity as Attorney General of the State of Colorado; and Kristen Wolf, Ryan Leyland, Patricia Evacko, Avani Soni, Michael Scruggs, Alexandra Zuccarelli, and Jayant Patel, in their official capacities as members of the Colorado State Board of Pharmacy) is published on Counsel Stack Legal Research, covering District Court, D. Colorado primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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AbbVie, Inc., Allergan, Inc., AbbVie Products LLC, Pharmacyclics LLC, and Allergan Sales, LLC v. Philip Weiser, in his official capacity as Attorney General of the State of Colorado; and Kristen Wolf, Ryan Leyland, Patricia Evacko, Avani Soni, Michael Scruggs, Alexandra Zuccarelli, and Jayant Patel, in their official capacities as members of the Colorado State Board of Pharmacy, (D. Colo. 2025).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLORADO Judge William J. Martínez

Civil Action No. 25-cv-1847-WJM-KAS

ABBVIE, INC., et al.,

Plaintiffs, v.

PHILIP WEISER, et al.,

Defendants.

ORDER DENYING PLAINTIFFS’ MOTION FOR A PRELIMINARY INJUNCTION

Plaintiffs AbbVie, Inc., Allergan, Inc., AbbVie Products LLC, Pharmacyclics LLC, and Allergan Sales, LLC (collectively, “Plaintiffs” or “AbbVie”) bring this lawsuit against Defendants Philip Weiser, in his official capacity as Attorney General of the State of Colorado; and Kristen Wolf, Ryan Leyland, Patricia Evacko, Avani Soni, Michael Scruggs, Alexandra Zuccarelli, and Jayant Patel, in their official capacities as members of the Colorado State Board of Pharmacy (collectively, “Defendants”), to challenge the constitutionality of Colorado Senate Bill 25-071, now codified as the Colorado 340B Contract Pharmacy Protection Act, Colorado Revised Statutes (C.R.S.) §§ 6-29-101 et seq. (2025) (the “Act”).1 (ECF No. 43.) Currently before the Court is AbbVie’s Motion for a Preliminary Injunction (“Motion”), by which it seeks to preliminarily enjoin enforcement of the Act. (ECF No. 7; see also ECF No. 43 at 65 ¶ 4.) The Motion has been fully briefed (ECF Nos. 33, 36,

1 The Act went into effect on August 6, 2025. (See ECF No. 33-1 at 9.) 1 52, 74),2 and the Court presided over an evidentiary hearing on the Motion on September 19, 2025 (ECF No. 93). Thus, it is now ripe for adjudication. For the reasons set forth below, the Motion is denied. I. BACKGROUND3

A. Section 340B In 1992, Congress enacted § 340B of the Public Health Service Act, 42 U.S.C. § 256b (“Section 340B”)—thereby creating the “340B Program”—“to ensure that uninsured and low-income individuals can access the medications they need and to ensure that medical providers serving those individuals receive crucial subsidies.” AbbVie, Inc. v. Fitch, 152 F.4th 635, 639 (5th Cir. 2025). The 340B Program accomplishes this by “impos[ing] ceilings on prices drug manufacturers may charge for medications sold to specified health-care facilities.” Astra USA, Inc. v. Santa Clara County, Cal., 563 U.S. 110, 113 (2011). Those facilities, called “covered entities,” “include public hospitals and community health centers, many of them providers of

safety-net services to the poor.” Id.; see also § 256b(a)(4) (defining “covered entity”).

2 With the Court’s leave, Amici Curiae American Hospital Association, 340B Health, Colorado Hospital Association, and American Society of Health-System Pharmacists (collectively, the “Amici”) also filed a brief in opposition to the Motion. (ECF No. 34-1.) 3 Numerous federal courts have now had occasion to summarize the history of the 340B Program and related HHS guidance relevant to this lawsuit, including the Supreme Court and four Circuit Courts of Appeal. See Astra USA, Inc. v. Santa Clara County, Cal., 563 U.S. 110 (2011); AbbVie, Inc. v. Fitch, 152 F.4th 635 (5th Cir. 2025); PhRMA v. McClain, 95 F.4th 1136 (8th Cir. 2024); Novartis Pharms. Corp. v. Johnson, 102 F.4th 452 (D.C. Cir. 2024); Sanofi Aventis U.S. LLC v. U.S. Dep’t of Health & Hum. Servs., 58 F.4th 696 (3d Cir. 2023). The Court leverages the factual background set forth in those decisions where applicable and adds further detail from the parties’ briefing on the Motion where needed. All citations to docketed materials are to the page number in the CM/ECF header, which sometimes differs from a document’s internal pagination. 2 The 340B Program helps covered entities care for their low-income and rural patients in two ways: “First, it gives them extra revenue from serving insured patients: they turn a profit when insurance companies reimburse them at full price for drugs that they bought at the 340B discount. Second, it enables them to give uninsured patients drugs at little

or no cost.” Sanofi Aventis U.S. LLC v. U.S. Dep’t of Health & Hum. Servs., 58 F.4th 696, 699 (3d Cir. 2023). The 340B Program “is superintended by the Health Resources and Services Administration (‘HRSA’), a unit of the Department of Health and Human Services (‘HHS’).” Astra, 563 U.S. at 113. “Drug manufacturers opt into the 340B Program by signing a form Pharmaceutical Pricing Agreement (‘PPA’) used nationwide.” Id. “PPAs are not transactional, bargained-for contracts.” Id. Rather, “[t]hey are uniform agreements that recite the responsibilities § 340B imposes, respectively, on drug manufacturers and the Secretary of HHS.” Id. Specifically, the PPA obligates manufacturers to “offer each covered entity covered outpatient drugs for purchase at or

below the applicable ceiling price if such drug is made available to any other purchaser at any price.” § 256b(a)(1). Manufacturers’ eligibility to participate in Medicaid and Medicare Part B “is conditioned on their entry into PPAs for covered drugs purchased by [covered] entities.” Astra, 563 U.S. at 113. Section 340B also prohibits covered entities from engaging in certain conduct: First, it bars ‘duplicate discounts or rebates,’ forbidding covered entities from seeking both the 340B discount and a Medicaid rebate on the same drug. [42 U.S.C.] § 256b(a)(5)(A). Second, it bars ‘diversion,’ providing that a covered entity ‘shall not resell or otherwise transfer’ a discounted drug ‘to a person who is not a patient of the entity.’ Id. § 256b(a)(5)(B). Third, it requires covered 3 entities to permit [HHS] and drug manufacturers to ‘audit’ their records to assess compliance with the duplicate- discount and diversion bans. Id. § 256b(a)(5)(C). And fourth, it provides that a covered entity that violates the duplicate-discount or diversion bans ‘shall be liable’ to the drug manufacturer for the amount improperly received. Id. § 256b(a)(5)(D). Fitch, 152 F.4th at 640. B. Role of Contract Pharmacies “When Congress first enacted Section 340B, few covered entities had pharmacies in house,” Sanofi Aventis, 58 F.4th at 700, in substantial part because, for many, “building or maintaining [an in-house] pharmacy is cost-prohibitive,” PhRMA v. McClain, 95 F.4th 1136, 1139 (8th Cir. 2024). Thus, “[s]ince the beginning, covered entities have contracted with outside pharmacies,” or “contract pharmacies,” “for the distribution and dispensation of 340B drugs.” Id. For covered entities with large, rural service areas, “the outsourcing of pharmacy services [also] allowed for drug dispensation closer to where [their] low-income patients reside.” McClain, 95 F.4th at 1139. “Covered entities using contract pharmacies would still order and pay for the drugs, but they would be shipped directly to the pharmacies.” Sanofi Aventis, 58 F.4th at 700. Noting covered entities’ reliance on contract pharmacies and Section 340B’s “silen[ce] as to permissible drug distribution systems” to patients, 61 Fed. Reg. 43, 549, 43,549 (Aug. 23, 1996), HRSA issued guidance in 1996 “permitting covered entities lacking an in-house dispensing pharmacy to contract with a single third-party commercial pharmacy to receive and dispense 340B drugs to their patients, so long as they abided by Section 340B’s requirements and its duplicate-discount and diversion 4 bans,” Fitch, 152 F.4th at 640 (citing id. at 43,550–55). Then, in 2010, HRSA “changed course” and “issu[ed] new guidance permitting all covered entities—even those with an in-house dispensing pharmacy—to contract with an unlimited number of outside pharmacies to distribute Section 340B drugs to their patients.” Fitch, 152 F.4th at 640;

75 Fed. Reg. 10,272, 10,273 (Mar. 5, 2010). After the 2010 guidance, the use of contract pharmacies proliferated, and pharmaceutical manufacturers became increasingly concerned that “contract pharmacies were driving up duplicate discounting and diversion.” Sanofi Aventis, 58 F.4th at 700; see also Novartis Pharms. Corp. v.

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AbbVie, Inc., Allergan, Inc., AbbVie Products LLC, Pharmacyclics LLC, and Allergan Sales, LLC v. Philip Weiser, in his official capacity as Attorney General of the State of Colorado; and Kristen Wolf, Ryan Leyland, Patricia Evacko, Avani Soni, Michael Scruggs, Alexandra Zuccarelli, and Jayant Patel, in their official capacities as members of the Colorado State Board of Pharmacy, Counsel Stack Legal Research, https://law.counselstack.com/opinion/abbvie-inc-allergan-inc-abbvie-products-llc-pharmacyclics-llc-and-cod-2025.