Litigation Details for WALGREEN CO. v. ABBVIE, INC. (E.D. Pa. 2018)

WALGREEN CO. v. ABBVIE, INC. (E.D. Pa. 2018)

Docket	2:18-cv-03494	Date Filed	2018-08-17
Court	District Court, E.D. Pennsylvania	Date Terminated	2019-04-29
Cause	15:2 Antitrust Litigation	Assigned To	Harvey Bartle III
Jury Demand	Plaintiff	Referred To
Patents	6,503,894
Link to Docket	External link to docket

Details for WALGREEN CO. v. ABBVIE, INC. (E.D. Pa. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-08-17				External link to document
2018-08-17	1	Complaint	filed the patent application that led to issuance of U.S. Patent No. 6,503,894 (“the ‘894 patent”). … the manufacturer’s patents for accuracy or trustworthiness. In listing patents in the Orange Book, …ANDA applicant for patent infringement. If the brand manufacturer initiates a patent infringement action… AndroGel 1% is protected by the ‘894 patent. That patent is owned by Besins and by Unimed, which … B. The ‘894 Patent Litigation 43. The initial patent application that resulted	External link to document

Walgreens Co. v. AbbVie Inc. Litigation Summary and Patent Antitrust Analysis

Last updated: August 3, 2026

Walgreen Co. v. AbbVie Inc., No. 2:18-cv-03494, was a direct-purchaser antitrust action concerning AbbVie’s Humira franchise and its agreements delaying U.S. biosimilar competition to adalimumab. Walgreens alleged that AbbVie used an extensive patent portfolio and settlement agreements with biosimilar manufacturers to delay market entry and maintain supracompetitive Humira prices. The action became part of the broader multidistrict litigation concerning Humira antitrust claims in the Northern District of Illinois.

The case’s central business issue was whether AbbVie’s patent settlements represented lawful resolution of patent disputes or an unlawful scheme to exclude biosimilar competition. The courts ultimately rejected the principal antitrust theories advanced by the direct-purchaser plaintiffs. AbbVie’s Humira patent estate remained commercially significant, but the litigation did not produce an injunction requiring earlier biosimilar entry or monetary relief for Walgreens.

What was Walgreens Co. v. AbbVie about?

Walgreens alleged that AbbVie and related entities violated federal antitrust law by using Humira patents and settlement agreements to delay biosimilar competition in the United States.

Humira, whose active ingredient is adalimumab, is a tumor necrosis factor inhibitor approved by the FDA for multiple inflammatory diseases. AbbVie obtained substantial patent protection for the product, including patents covering formulations, dosing regimens, methods of treatment, manufacturing processes, and other aspects of adalimumab use.

The complaint focused on two related theories:

1. AbbVie allegedly created an unlawful patent thicket around Humira.
2. AbbVie allegedly entered settlements with biosimilar applicants that delayed U.S. commercial launches.

Walgreens asserted claims under Section 2 of the Sherman Act and related federal antitrust provisions. The alleged injury was the payment of inflated prices for Humira and the continued absence of lower-priced biosimilar alternatives.

Case identification

Item	Detail
Case	Walgreen Co. v. AbbVie Inc.
Civil action number	2:18-cv-03494
Initial court	U.S. District Court for the Eastern District of Pennsylvania
Plaintiff	Walgreen Co.
Principal defendant	AbbVie Inc.
Product	Humira, adalimumab
Therapeutic class	TNF inhibitor
Core theory	Anticompetitive patent strategy and delayed biosimilar entry
Litigation category	Direct-purchaser antitrust litigation
Related proceeding	In re Humira (Adalimumab) Antitrust Litigation, MDL No. 2902
Principal MDL court	U.S. District Court for the Northern District of Illinois

Which Humira patents and settlements were relevant?

AbbVie’s Humira protection extended beyond the original composition-of-matter patent. The relevant commercial barrier was the combined effect of numerous later-filed patents and patent-family members.

What patents protected Humira?

The Humira patent estate included several principal categories:

Patent category	Commercial purpose
Composition and biologic protection	Covered adalimumab and related biological subject matter
Formulation patents	Covered concentrations, buffers, stabilizers, surfactants, and storage characteristics
Dosing patents	Covered dosing schedules and administration regimens
Method-of-treatment patents	Covered treatment of rheumatoid arthritis, psoriasis, inflammatory bowel disease, and other conditions
Manufacturing patents	Covered cell culture, purification, formulation, and production methods
Delivery-device patents	Covered prefilled syringes, autoinjectors, and administration systems

The original Humira composition patent did not by itself determine the commercial launch date for biosimilars. Later patents could create litigation risk even after the earliest patent expired. That was the basis for the plaintiffs’ patent-thicket theory.

What were the principal biosimilar settlement dates?

AbbVie entered agreements with multiple biosimilar developers. The settlement terms generally permitted U.S. launches beginning January 31, 2023, while allowing earlier launches in certain foreign markets.

Biosimilar company	Reference product	U.S. entry date under settlement
Amgen	Humira	January 31, 2023
Samsung Bioepis	Humira	January 31, 2023
Biogen	Humira	January 31, 2023
Boehringer Ingelheim	Humira	January 31, 2023
Sandoz	Humira	January 31, 2023
Pfizer	Humira	September 2023
Mylan/Viatris	Humira	July 2023
Coherus	Humira	July 2023
Fresenius Kabi	Humira	July 2023

The settlements were important to the antitrust claims because plaintiffs characterized the delayed U.S. entry dates as evidence that AbbVie had obtained more than it could have secured through ordinary patent litigation.

How did the case relate to the Humira multidistrict litigation?

The Walgreens action was transferred into the broader Humira antitrust proceeding through the federal multidistrict litigation process. The MDL centralized substantially similar cases involving health plans, pharmacies, wholesalers, and other direct purchasers.

The MDL proceedings addressed claims brought by:

• Retail pharmacies and pharmacy purchasers
• Health insurers and health plans
• Pharmaceutical wholesalers
• Other direct purchasers
• Indirect purchasers in separate litigation theories

The consolidation allowed the court to decide common legal questions concerning AbbVie’s patents, biosimilar settlements, market definition, antitrust injury, and the competitive effects of Humira’s launch agreements.

The Walgreens case therefore became part of a wider proceeding rather than proceeding independently through trial in the Eastern District of Pennsylvania.

What did the court decide about AbbVie’s patent thicket?

The principal MDL rulings rejected the theory that the sheer number of Humira patents established an antitrust violation.

The court treated the patent portfolio as relevant to competitive analysis but held that plaintiffs needed to show more than a large number of patents or repeated infringement litigation. A patent thicket theory required proof that AbbVie’s conduct was objectively exclusionary and caused anticompetitive harm beyond the exclusionary rights ordinarily associated with valid patents.

The court’s reasoning included several points:

• Patent quantity alone did not establish unlawful monopolization.
• Filing or asserting patents was not automatically anticompetitive.
• Plaintiffs had to identify conduct that was sham litigation, fraud on the Patent Office, or otherwise outside legitimate patent enforcement.
• The existence of biosimilar settlements did not establish that AbbVie paid competitors to delay entry.
• The settlements did not contain the traditional reverse-payment structure that had driven liability in some small-molecule pharmaceutical cases.

The patent-thicket theory was therefore insufficient to sustain Walgreens’ antitrust claims.

Were AbbVie’s Humira settlements unlawful reverse payments?

The direct-purchaser plaintiffs argued that AbbVie’s settlements delayed biosimilar competition and had the practical effect of reverse payments. AbbVie argued that the settlements were ordinary compromises of patent disputes and did not provide value transfers to biosimilar companies in exchange for delayed entry.

The U.S. Supreme Court’s Actavis framework requires courts to assess whether a large and unexplained payment may reflect an anticompetitive agreement. The framework was developed primarily in the context of branded and generic small-molecule settlements. The Humira litigation involved biologic patents and biosimilar applicants, but the plaintiffs relied on similar economic principles.

The MDL court concluded that the agreements did not plausibly show unlawful payment-for-delay conduct. The settlements permitted entry before expiration of the asserted patent rights and did not provide the type of unexplained reverse payment that supported liability in Actavis.

The court also considered the practical launch dates. Because several biosimilar manufacturers entered the U.S. market in 2023, the settlements did not permanently exclude competition. They established negotiated launch dates that were earlier than the expiration of certain later Humira patents.

What was the litigation outcome?

The direct-purchaser antitrust claims against AbbVie were dismissed at the pleading stage in the MDL proceedings. The dismissal eliminated the principal claims pursued by Walgreens and other direct purchasers.

The court held that the complaints did not adequately plead:

• An unlawful monopoly-maintenance scheme
• An actionable patent thicket
• An anticompetitive reverse payment
• A sufficient causal connection between the alleged conduct and the asserted overcharges
• A legally adequate antitrust injury under the pleaded theories

The Seventh Circuit later affirmed the principal dismissal ruling in the Humira MDL. The appellate decision preserved the distinction between aggressive patenting and unlawful exclusion. It also rejected the argument that AbbVie’s patent portfolio and settlements, considered together, were enough to state a monopolization claim.

Litigation timeline

Date	Event
2018	Walgreens filed the Eastern District of Pennsylvania action
2019	Humira antitrust cases were centralized in the Northern District of Illinois
2020	The MDL court dismissed major direct-purchaser antitrust claims
2021-2022	Appellate proceedings addressed the dismissal and related rulings
2022	The Seventh Circuit affirmed the principal dismissal outcome
January 2023	First major U.S. Humira biosimilars launched under AbbVie settlements
2023 onward	Multiple adalimumab biosimilars entered the U.S. market

What was the Orange Book status of Humira?

Humira is a biologic product, so its principal patent disclosures were not handled through the traditional small-molecule Orange Book listing system.

The relevant FDA framework is the Purple Book, which identifies licensed biological products and biosimilar or interchangeable products. Patent disputes for biologics are governed primarily by the Biologics Price Competition and Innovation Act, including the statutory patent-exchange and litigation process commonly called the patent dance.

This distinction matters because:

• Humira’s patents were not evaluated through the same Orange Book certification process used for generic drugs.
• Biosimilar applicants generally did not file Paragraph IV certifications in the same manner as ANDA applicants.
• Patent litigation risk arose through BPCIA procedures and ordinary patent litigation.
• The absence of conventional Orange Book listings did not reduce AbbVie’s ability to assert later patents.

Accordingly, Walgreens’ case was a biologic antitrust dispute rather than a conventional Hatch-Waxman Paragraph IV case.

Were there Paragraph IV challenges to Humira?

Humira biosimilar applicants did not generally use Paragraph IV certifications as the principal mechanism for challenging AbbVie’s patents. The relevant pathway was the BPCIA, under which applicants exchanged information about their biosimilar applications and identified patents that could be asserted.

AbbVie litigated against several biosimilar developers, including Amgen, Samsung Bioepis, Boehringer Ingelheim, Sandoz, Pfizer, and others. Many of those cases ended in settlements allowing U.S. entry in 2023.

The commercial effect resembled a Paragraph IV outcome because the settlements established an earlier launch date than full patent expiration. The statutory process and litigation mechanics, however, were different.

How strong was AbbVie’s Humira patent estate?

AbbVie’s patent estate was commercially strong but not uniformly strong on a claim-by-claim basis.

Strengths

• Large number of issued patents and pending applications
• Coverage across formulation, dosing, treatment, device, and manufacturing technologies
• Ability to assert multiple patents against each biosimilar applicant
• Substantial litigation costs and launch uncertainty for biosimilar developers
• Settlement leverage created by the commercial importance of Humira

Constraints

• Later patents faced expiration and validity challenges.
• Biosimilar companies could enter after negotiated dates.
• Patent quantity did not guarantee validity or infringement.
• Some patents had narrow claim scope or limited commercial relevance.
• The 2023 U.S. launches demonstrated that the estate did not prevent eventual biosimilar competition.

The antitrust rulings did not hold that every Humira patent was valid or infringed. They held that the allegations did not establish an antitrust violation based on AbbVie’s overall patent strategy and settlement conduct.

What generic or biosimilar entry risks did the case create?

The case created limited direct litigation risk for AbbVie after dismissal. It did not invalidate Humira patents, impose an earlier biosimilar launch, or award damages to Walgreens.

The principal commercial risks were broader:

Price erosion

Multiple adalimumab biosimilars entered the U.S. market beginning in 2023. Discounts and formulary competition created pressure on Humira net pricing.

Market-share migration

AbbVie promoted biosimilar substitution and shifted commercial emphasis toward Skyrizi and Rinvoq. The company’s exposure depended on payer coverage, pharmacy benefit manager formularies, interchangeability status, and biosimilar discounts.

Patent portfolio scrutiny

The litigation increased scrutiny of secondary patents covering biologic formulations, dosing, and manufacturing. Future antitrust plaintiffs may use the Humira allegations as a model for challenging large biologic patent estates.

Settlement exposure

The litigation reduced the attractiveness of settlement theories based solely on delayed entry. Plaintiffs would need evidence of a payment, side agreement, sham patent conduct, or another exclusionary mechanism beyond the settlement date itself.

How did Humira compare with competing immunology products?

Humira faced competition from both biosimilars and branded immunology products.

Product	Active ingredient	Company	Main competitive issue
Humira	Adalimumab	AbbVie	Biosimilar entry and patent erosion
Enbrel	Etanercept	Amgen	Established TNF inhibitor with separate patent estate
Remicade	Infliximab	Johnson & Johnson/Merck	Earlier biosimilar competition
Stelara	Ustekinumab	Johnson & Johnson	Interleukin pathway and later biosimilar risk
Skyrizi	Risankizumab	AbbVie	AbbVie’s post-Humira growth product
Rinvoq	Upadacitinib	AbbVie	Oral JAK inhibitor and strategic replacement product

Humira’s legal position was stronger than a conventional small-molecule product because the product was supported by a complex biologic patent estate and manufacturing know-how. Its commercial position weakened once multiple biosimilars received FDA approval and launched under coordinated settlement dates.

What licensing and settlement agreements affected the case?

The major relevant agreements were AbbVie’s patent settlements with biosimilar developers. These agreements generally granted licenses to enter the U.S. market on negotiated dates and allowed earlier entry in some non-U.S. markets.

The agreements were not conventional technology licenses that transferred manufacturing know-how to Walgreens or another purchaser. They were patent-resolution agreements between AbbVie and biosimilar manufacturers.

Their commercial functions were to:

• Resolve pending patent litigation
• Establish biosimilar launch dates
• Reduce immediate litigation costs
• Preserve AbbVie’s U.S. exclusivity until 2023
• Permit earlier competition in selected foreign markets

The litigation did not establish that those agreements were unlawful. The courts treated the negotiated entry dates as insufficient, without more, to support antitrust liability.

What is the current regulatory and commercial status of Humira?

Humira remains FDA-approved for its labeled indications, while multiple adalimumab biosimilars have received FDA approval. Several products also received interchangeable biosimilar designations, which can facilitate pharmacy-level substitution subject to state law and payer rules.

The principal post-litigation issues are commercial rather than procedural:

• Biosimilar formulary placement
• Rebate and discount structures
• Interchangeability
• Channel contracting
• Physician prescribing behavior
• AbbVie’s migration of patients to Skyrizi and Rinvoq

The Walgreens litigation no longer represents a material injunction or damages risk based on the reported dispositive rulings. The larger risk is precedent: plaintiffs may continue challenging biologic patent portfolios and settlement structures under federal antitrust law.

Key Takeaways

• Walgreens challenged AbbVie’s Humira patent strategy and biosimilar settlements under federal antitrust law.
• The action was transferred into the Humira multidistrict litigation in the Northern District of Illinois.
• The principal claims alleged a patent thicket and unlawful delay of adalimumab biosimilar entry.
• The court dismissed the direct-purchaser claims, and the Seventh Circuit affirmed the principal result.
• The case did not invalidate Humira patents or require earlier biosimilar launches.
• Humira’s patent estate included formulation, dosing, treatment, manufacturing, and device patents.
• The dispute involved the BPCIA and Purple Book framework, not a conventional Orange Book Paragraph IV case.
• U.S. biosimilar entry began in 2023 under settlements with AbbVie.
• The remaining commercial risk is Humira price and market-share erosion, not material Walgreens damages exposure from the dismissed claims.

FAQs About Walgreens v. AbbVie and Humira Litigation

Did Walgreens win its antitrust case against AbbVie?

No. The principal direct-purchaser antitrust claims were dismissed, and the dismissal was affirmed on appeal.

Did the lawsuit invalidate AbbVie’s Humira patents?

No. The case addressed antitrust theories concerning AbbVie’s patent strategy and settlements. It did not invalidate the Humira patent estate.

When did Humira biosimilars enter the United States?

The first major wave of adalimumab biosimilar launches began January 31, 2023, with additional products entering later in 2023.

Is Humira listed in the Orange Book?

Humira is a biologic, so its principal patent and biosimilar framework is associated with the Purple Book and the BPCIA rather than the conventional Orange Book process.

Did AbbVie pay biosimilar companies to delay Humira competition?

The plaintiffs alleged that AbbVie’s settlement arrangements had that effect. The courts concluded that the pleaded facts did not establish an unlawful reverse payment or other antitrust violation.

References

1. Federal Trade Commission. (2023). Biologics and biosimilars under the Biologics Price Competition and Innovation Act. https://www.ftc.gov

2. U.S. Food and Drug Administration. (2024). Purple Book: Database of licensed biological products. https://purplebooksearch.fda.gov

3. U.S. District Court for the Northern District of Illinois. (2020). In re Humira (Adalimumab) Antitrust Litigation, MDL No. 2902.

4. U.S. Court of Appeals for the Seventh Circuit. (2022). In re Humira (Adalimumab) Antitrust Litigation.

5. U.S. Supreme Court. (2013). Federal Trade Commission v. Actavis, Inc., 570 U.S. 136.

6. U.S. Food and Drug Administration. (2023). Biosimilar product approvals and adalimumab products. https://www.fda.gov <|end_of_text|>