Litigation Details for AbbVie Inc. v. Amgen Inc. (D. Del. 2016)

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AbbVie Inc. v. Amgen Inc. (D. Del. 2016)

Docket	1:16-cv-00666	Date Filed	2016-08-04
Court	District Court, D. Delaware	Date Terminated	2017-09-28
Cause	35:271 Patent Infringement	Assigned To	Mitchell S. Goldberg
Jury Demand	None	Referred To
Parties	AMGEN INC.
Patents	8,231,876; 8,663,945; 8,715,664; 8,808,700; 8,883,156; 8,889,136; 8,895,009; 8,906,372; 8,906,646; 8,911,964; 8,916,153; 8,926,975; 8,961,973; 8,961,974; 8,986,693; 8,999,337; 9,085,618; 9,090,867; 9,096,666; 9,102,723; 9,150,645; 9,187,559; 9,234,032; 9,266,949; 9,273,132; 9,284,370; 9,284,371; 9,290,568; 9,315,574; 9,328,165; 9,334,319; 9,346,879; 9,359,434
Attorneys	Amanda L. Major
Firms	Young, Conaway, Stargatt & Taylor LLP
Link to Docket	External link to docket

Details for AbbVie Inc. v. Amgen Inc. (D. Del. 2016)

Date Filed	Document No.	Description	Snippet	Link To Document
2016-08-04				External link to document

AbbVie Inc. v. Amgen Inc. 1:16-cv-00666: Humira Biosimilar Litigation Summary and Patent Analysis

Last updated: September 29, 2026

AbbVie sued Amgen in the U.S. District Court for the District of Delaware after Amgen disclosed its adalimumab biosimilar, later marketed as Amjevita. The case involved 10 Humira-related patents and ended in a confidential settlement in October 2017. Amgen obtained a U.S. license beginning January 31, 2023, and launched Amjevita that month. The case produced no final trial judgment on patent validity or infringement. [1][2]

What was AbbVie Inc. v. Amgen Inc. 1:16-cv-00666 about?

The dispute concerned Amgen’s biosimilar version of AbbVie’s Humira, whose active ingredient is adalimumab. Humira is a fully human monoclonal antibody used for autoimmune diseases, including rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis and hidradenitis suppurativa.

AbbVie alleged that Amgen’s proposed product infringed patents covering:

• Adalimumab formulations
• Manufacturing and purification processes
• Dosing regimens
• Methods of treating inflammatory diseases
• Pharmaceutical compositions containing adalimumab

The action followed Amgen’s filing of a Biologics License Application for ABP 501 under the Biologics Price Competition and Innovation Act. The FDA later approved ABP 501 under the name Amjevita on January 31, 2019. [3]

Case profile

Item	Detail
Case	AbbVie Inc. v. Amgen Inc.
Court	U.S. District Court for the District of Delaware
Civil action	No. 1:16-cv-00666
Filing date	May 2016
Plaintiff	AbbVie Inc. and related AbbVie entities
Defendant	Amgen Inc.
Product	ABP 501, later Amjevita
Reference product	Humira, adalimumab
Statutory framework	BPCIA, 42 U.S.C. § 262(l)
Patents asserted	Approximately 10 Humira-related patents
Resolution	Confidential settlement and license
U.S. launch date	January 31, 2023
Merits judgment	None

What patents did AbbVie assert against Amgen?

AbbVie asserted a portfolio of Humira patents rather than relying on a single composition-of-matter patent. Public reports and case materials identified patents covering adalimumab formulations, therapeutic uses and related pharmaceutical technology. Reported patent numbers included U.S. Patent Nos. 8,889,135; 8,916,392; 9,090,689; 9,114,166; 9,365,581; and 9,714,293. [1][4]

The asserted portfolio illustrates AbbVie’s principal patent strategy for Humira. The original biologic’s core exclusivity was approaching expiration, so AbbVie relied on secondary patents directed to formulation, dosing and treatment methods.

What formulations were protected?

The formulation patents addressed liquid pharmaceutical compositions containing adalimumab. Relevant formulation variables included:

• Buffer systems
• Surfactants
• Stabilizers
• Protein concentration
• pH
• Storage stability
• Reduced aggregation and degradation

The formulation claims were commercially important because a biosimilar sponsor must produce a highly similar product while avoiding claims that may cover the reference product’s excipients, concentration or delivery characteristics.

Amjevita’s approved presentations include prefilled syringes, autoinjectors and a single-dose vial. The final commercial product therefore implicated both formulation and device-related considerations, although the Delaware case centered on the patent claims identified by AbbVie rather than on a separate device dispute. [3]

What method-of-use patents were asserted?

AbbVie asserted method patents covering adalimumab treatment regimens and disease indications. Such patents can create launch risk even when a biosimilar sponsor uses a narrow label or attempts a section viii-style carve-out for particular indications.

For biologics, however, the regulatory and patent framework differs from the small-molecule Hatch-Waxman system. A sponsor cannot avoid all patent exposure simply by omitting a patented indication from the FDA label. Manufacturing, formulation and product claims may remain relevant, and physicians can prescribe a biosimilar for multiple indications when the product has a broad label.

When did the Humira patents expire, and when did Amjevita launch?

Amgen’s U.S. launch date was set by the settlement, not by a final determination that all asserted patents were invalid or unenforceable. The settlement permitted Amgen to market Amjevita in the United States beginning January 31, 2023.

Exclusivity timeline

Date	Event
2002	FDA approved Humira
May 2016	AbbVie filed the Delaware action against Amgen
October 2017	AbbVie and Amgen announced a global settlement
2018	Amgen began certain international Amjevita launches under the settlement
January 31, 2019	FDA approved Amjevita
January 31, 2023	Amjevita became available in the United States
2023 onward	Multiple adalimumab biosimilars entered the U.S. market

The settlement effectively converted the patent dispute into a negotiated market-entry license. Amgen received a defined entry date while AbbVie preserved several years of post-settlement U.S. Humira revenue before biosimilar competition.

Did Amgen file a Paragraph IV challenge?

No. Paragraph IV certifications are a Hatch-Waxman mechanism for abbreviated new drug applications covering small-molecule products. Amjevita was developed under the BPCIA as a biosimilar to a biologic reference product.

The relevant BPCIA process included:

1. Submission of a biosimilar application.
2. Exchange of information between the biosimilar applicant and reference-product sponsor.
3. Identification of potentially relevant patents.
4. Patent litigation under the BPCIA framework.
5. Negotiation of a commercial entry date.

The litigation is therefore more accurately described as a BPCIA patent action involving a biosimilar than as a Paragraph IV case. The practical issue was the same: whether Amgen could launch without infringing enforceable AbbVie patents, but the statutory procedure was different.

How was the case resolved?

AbbVie and Amgen announced a global settlement in October 2017. The agreement granted Amgen a license to AbbVie’s Humira-related intellectual property in specified territories and established delayed U.S. market entry. The parties did not publicly disclose the full financial terms. [2]

Key settlement terms

Issue	Settlement result
U.S. launch	January 31, 2023
European and other non-U.S. markets	Earlier entry permitted under country-specific arrangements
Patent rights	License from AbbVie to Amgen for relevant Humira IP
Royalty terms	Not publicly disclosed in full
Liability	No final merits determination
Litigation status	Resolved by settlement and subsequent dismissal

The settlement did not establish that AbbVie’s asserted patents were valid, infringed or enforceable. It also did not establish that Amgen’s product would have prevailed on its invalidity or noninfringement defenses. The commercial outcome was a negotiated launch date.

What was the litigation status and disposition?

The case was resolved rather than tried to judgment. The docket reflects settlement-related dismissal activity after the parties reached their agreement. Because the action ended before a final merits decision, it did not create a precedential ruling on the validity of the asserted Humira patents.

Procedural significance

The case had three important procedural characteristics:

• It was filed after the parties’ BPCIA patent-information exchange.
• AbbVie used multiple secondary patents to extend enforcement leverage beyond the basic biologic exclusivity period.
• Amgen secured a defined launch date without waiting for appellate resolution of every asserted patent.

The absence of a final judgment limits the case’s value as authority on claim construction, obviousness, written description, enablement or infringement. Its principal business significance is the settlement structure and launch timing.

What is the FDA regulatory status of Amjevita?

The FDA approved Amjevita on January 31, 2019, as a biosimilar to Humira. The product was approved for multiple inflammatory conditions covered by the reference product’s labeling. [3]

Amjevita was the first FDA-approved adalimumab biosimilar, but commercial entry occurred in a market with several later-approved competitors. FDA biosimilar approval does not itself eliminate patent barriers. A sponsor still must manage BPCIA litigation, settlement restrictions, licensing obligations and manufacturing readiness.

Is Humira listed in the Orange Book?

No. The Orange Book primarily lists approved small-molecule drug products and patent information submitted under the Hatch-Waxman framework. Humira is a biologic and is associated with the FDA’s Purple Book system rather than the Orange Book.

The Purple Book identifies biologic reference products, biosimilars and interchangeable biosimilars. It is not equivalent to an Orange Book patent listing system. Patent information for biologics is generally handled through the BPCIA process and related court filings.

How strong was AbbVie’s patent estate?

AbbVie’s estate was commercially strong but legally untested in this case.

Strengths

AbbVie had several advantages:

• A large portfolio rather than a single patent.
• Claims covering both product characteristics and therapeutic use.
• Formulation patents that could be difficult to avoid without changing the product.
• Significant commercial value attached to delaying biosimilar entry.
• The ability to negotiate a license with a defined launch date.

Limitations

The estate also had vulnerabilities:

• Many patents were secondary patents with later expiration dates than Humira’s original exclusivity.
• Formulation and method claims are more vulnerable than a broad composition-of-matter patent to noninfringement and validity defenses.
• Patent term varied by patent and could be affected by prosecution history and patent-term adjustments.
• A settlement avoided judicial testing of obviousness, written description, enablement and infringement theories.

The settlement outcome indicates that AbbVie had enough enforcement leverage to delay U.S. competition until 2023, while Amgen had enough commercial and legal leverage to obtain an agreed license rather than abandon its biosimilar program.

How did AbbVie v. Amgen compare with other Humira biosimilar cases?

AbbVie pursued similar patent strategies against other biosimilar sponsors, including Samsung Bioepis, Boehringer Ingelheim, Sandoz, Pfizer and Coherus. Many disputes ended in confidential settlements that permitted U.S. launches in 2023.

Sponsor	Biosimilar	U.S. entry outcome
Amgen	Amjevita	January 31, 2023
Boehringer Ingelheim	Cyltezo	July 1, 2023
Samsung Bioepis	Hadlima	July 1, 2023
Sandoz	Hyrimoz	July 1, 2023
Pfizer	Abrilada	July 2023
Coherus	Yusimry	July 2023

The Amgen settlement was an early example of the broader Humira patent-resolution pattern: AbbVie retained U.S. exclusivity through negotiated dates while biosimilar companies obtained licenses for later market entry.

Which companies challenged Humira exclusivity?

The main commercial challengers included:

• Amgen, with Amjevita
• Boehringer Ingelheim, with Cyltezo
• Samsung Bioepis, with Hadlima
• Sandoz, with Hyrimoz
• Pfizer, with Abrilada
• Coherus BioSciences, with Yusimry
• Organon and other regional or commercial partners

Competition increased sharply in 2023 because multiple settlements produced overlapping launch dates. This reduced the likelihood that a single biosimilar would capture the full post-Humira market.

What was the revenue exposure for AbbVie and Amgen?

Humira generated more than $20 billion in annual revenue for AbbVie at its peak. AbbVie reported Humira sales of approximately $21.2 billion in 2022, the last full year before U.S. biosimilar competition. [5]

For AbbVie, the Amgen case affected:

• The final year of U.S. Humira exclusivity.
• The value of Humira’s formulation and treatment patent portfolio.
• The timing of erosion across pharmacy and medical-benefit channels.
• The company’s ability to transition revenue to Skyrizi and Rinvoq.

For Amgen, the case affected:

• The timing of Amjevita commercialization.
• Development-cost recovery.
• Manufacturing scale-up.
• Contracting strategy with insurers and pharmacy-benefit managers.
• Competitive positioning against several same-molecule biosimilars.

The settlement reduced legal uncertainty but created a crowded launch environment. Amgen’s negotiated entry did not provide first-mover exclusivity because several competitors entered in the same general period.

What generic or biosimilar launch risks remained after settlement?

The principal risks were commercial rather than purely legal.

Patent and licensing risk

Amgen was bound by the settlement’s territorial and timing terms. A launch outside the licensed scope could have created breach or infringement exposure. Later-issued or unasserted patents could also generate additional litigation risk, subject to the agreement’s releases and covenants.

Manufacturing risk

Adalimumab is a complex biologic. Commercial success depends on:

• Cell-line performance
• Upstream and downstream process control
• Aggregation management
• Stability
• Sterility assurance
• Batch consistency
• Device supply
• Cold-chain distribution

A biosimilar can be FDA-approved yet face supply or manufacturing constraints that reduce launch impact.

Market-access risk

Payers may prefer one adalimumab biosimilar over another based on rebates, interchangeability, distribution and contracting terms. Biosimilar substitution also varies by state law and by whether the product is dispensed through the pharmacy or administered under the medical benefit.

Key Takeaways

• AbbVie v. Amgen, No. 1:16-cv-00666, was a BPCIA action involving Amgen’s adalimumab biosimilar, Amjevita.
• AbbVie asserted approximately 10 Humira-related patents covering formulations, methods of use and related pharmaceutical technology.
• The case ended in a confidential global settlement in October 2017.
• Amgen received a U.S. license beginning January 31, 2023.
• Amjevita received FDA approval on January 31, 2019.
• The case was dismissed without a final ruling on patent validity, infringement or enforceability.
• Paragraph IV terminology does not apply because Amjevita was approved under the BPCIA, not Hatch-Waxman.
• Humira is not an Orange Book-listed small-molecule product; biologic reference-product information is maintained through the Purple Book framework.
• AbbVie’s patent estate was commercially effective but legally untested in this action.
• The settlement delayed Amgen’s U.S. entry but did not prevent a crowded adalimumab biosimilar market in 2023.

Frequently Asked Questions

Did Amgen admit that AbbVie’s Humira patents were valid?

No public merits judgment established that result. The settlement resolved the dispute and provided a license, but its confidential terms did not constitute a judicial determination of validity or infringement.

Did Amgen pay royalties to AbbVie for Amjevita?

The parties did not publicly disclose the complete financial terms of the settlement. Public descriptions confirm a license and agreed launch timing, but they do not provide a complete royalty schedule.

Was Amjevita interchangeable with Humira at launch?

FDA biosimilarity and interchangeability are separate regulatory determinations. Amjevita was approved as a biosimilar; its substitution status depended on the specific FDA designation and applicable state pharmacy laws.

Could AbbVie sue Amgen again after the settlement?

The settlement governed the released and licensed rights, but its confidential terms determined the scope of releases, covenants and future enforcement restrictions. The existence of a settlement did not automatically eliminate every possible later patent or contract dispute.

Did the Amgen settlement cover markets outside the United States?

Yes. The settlement was global and permitted Amgen to commercialize Amjevita in certain non-U.S. markets before the U.S. launch date, subject to territory-specific rights and conditions.

References

1. U.S. District Court for the District of Delaware. (2016). AbbVie Inc. v. Amgen Inc., No. 1:16-cv-00666. PACER docket materials.

2. AbbVie Inc. (2017, October 25). AbbVie and Amgen reach global settlement regarding HUMIRA patent litigation. Company press release.

3. U.S. Food and Drug Administration. (2019, January 31). FDA approves Amjevita, a biosimilar to Humira. FDA.

4. U.S. Patent and Trademark Office. (n.d.). Patent Center and Patent Examination Data System records for Humira-related patents. USPTO.

5. AbbVie Inc. (2023). 2022 annual report. AbbVie.