Litigation Details for AbbVie Inc. v. Fresenius Kabi USA, LLC (N.D. Ill. 2024)

AbbVie Inc. v. Fresenius Kabi USA, LLC (N.D. Ill. 2024)

Docket	1:24-cv-04914	Date Filed	2024-06-13
Court	District Court, N.D. Illinois	Date Terminated	2025-03-03
Cause	35:271 Patent Infringement	Assigned To	John Robert Blakey
Jury Demand	None	Referred To
Patents	7,612,087; 8,471,025; 8,835,455; 8,969,566; 9,284,314; 9,695,122
Link to Docket	External link to docket

Details for AbbVie Inc. v. Fresenius Kabi USA, LLC (N.D. Ill. 2024)

Date Filed	Document No.	Description	Snippet	Link To Document
2024-06-13				External link to document

Litigation summary and analysis for: AbbVie Inc. v. Fresenius Kabi USA, LLC (N.D. Ill. 2024)

Last updated: July 15, 2026

AbbVie v. Fresenius Kabi USA LLC (1:24-cv-04914) patent litigation summary, claims at issue, and exclusivity risk

AbbVie Inc. v. Fresenius Kabi USA LLC, No. 1:24-cv-04914 (filed 2024), is a US patent infringement dispute that targets Fresenius Kabi’s proposed generic launch of an AbbVie drug product covered by AbbVie’s patent estate and listed in the FDA Orange Book. The case posture, asserted patent numbers, claim construction, and settlement status determine whether Fresenius Kabi faces an injunction risk, carve-out licensing terms, or delayed entry versus a design-around that avoids final judgment exposure.

What is the AbbVie v. Fresenius Kabi USA LLC 1:24-cv-04914 case about?

Filed action: AbbVie Inc. v. Fresenius Kabi USA, LLC, 1:24-cv-04914 (US District Court, jurisdiction within the federal district system per docketing).

Core allegation: infringement of AbbVie-listed Orange Book patents tied to an AbbVie marketed product by a Fresenius Kabi “proposed” drug, typically driven by an ANDA Paragraph IV certification or related FDA approval path (generic or abbreviated approval pathway). This case format aligns with Hatch-Waxman patent litigation: a brand owner sues the first ANDA filer (or another FDA applicant) after a Paragraph IV notice.

Typical Hatch-Waxman structure in this fact pattern:

• AbbVie holds Orange Book-listed patents covering at least one of: drug substance, drug product/formulation, or method of use.
• Fresenius Kabi files an FDA submission that triggers a patent certification.
• AbbVie files suit within the statutory window after receiving the notice.

Which AbbVie product is implicated in 1:24-cv-04914?

The implicated AbbVie product, the asserted patent list, and the specific Orange Book listing(s) are the highest-impact inputs for any litigation analysis. Those details are not present in the provided prompt.

Which patents does AbbVie assert in 1:24-cv-04914, and what do they cover?

In Hatch-Waxman cases, the practical analysis depends on whether AbbVie asserts:

• Composition-of-matter or process patents (hard to design around)
• Formulation or fill-finish patents (design-around possible via different excipients or manufacturing route, depending on claim scope)
• Method-of-use patents (easier to avoid with a different label, but only if FDA labeling can be changed and infringement cannot occur through off-label use)
• Combination claims (more difficult to avoid if the generic includes all claimed components)

How strong is an AbbVie Orange Book patent estate in this posture?

Strength is assessed from:

• Patent age and remaining life
• Claim breadth and number of independent claims
• Whether patents are layered (drug substance + formulation + method of use)
• Prior litigation history of the same patents
• Whether the case is at early-stage pleadings or near trial

But the case-specific patent numbers and remaining term are required to quantify strength.

What procedural stage is 1:24-cv-04914 in, and how does that affect outcomes?

Hatch-Waxman timelines often reach one of three stages that materially change litigation risk:

1. Early motion practice

   • Motions to dismiss, transfer, venue challenges, pleading sufficiency.
   • Early signals of whether infringement and validity theories are likely to survive.

2. Claim construction and summary judgment

   • Claim construction can narrow infringement analysis and drive settlement.
   • Summary judgment often decides design-around feasibility and certain invalidity grounds.

3. Trial and post-trial proceedings

   • Highest cost phase, greatest leverage for settlement or injunction.

For an actionable litigation summary, the docket dates (e.g., amended complaint, answer, claim construction order, expert schedule, trial setting) are required. Those dates are not included in the prompt.

What is the expected infringement theory for Fresenius Kabi in 1:24-cv-04914?

In Paragraph IV cases, infringement theories typically track one of these claims approaches:

• Direct infringement based on the proposed generic product meeting all claim limitations
• Induced infringement based on intended/label instructions
• Contributory infringement based on components used in an infringing combination or method

For IV challenges, the key infringement question is whether Fresenius Kabi’s proposed formulation/manufacturing process and intended use satisfy the construed claims.

How do design-around options usually work in this fact pattern?

Common design-around routes include:

• Different excipient system that avoids formulation claim limitations
• Different particle size profile or stability-preserving composition
• Different dosing regimen or labeling carve-out to avoid method-of-use claims
• Alternate manufacturing process that avoids process claim elements

The likelihood of success depends entirely on which claim types AbbVie asserted.

When does AbbVie’s exclusivity expire, and when can Fresenius Kabi launch?

The decision clock is typically driven by a combination of:

• Patent expiration dates of the asserted Orange Book patents
• Statutory exclusivity (3-year, 5-year, and any pediatric exclusivity where applicable)
• Hatch-Waxman 30-month stay triggered by a Paragraph IV filing, if applicable
• Any settlement terms that cap launch dates, limit claims, or require non-infringing product changes

Without the asserted patent list, Orange Book listing dates, and the asserted patents’ expiries, launch timing cannot be stated.

What is the Orange Book status of the AbbVie product involved in 1:24-cv-04914?

Orange Book status analysis requires:

• Listed patents’ numbers
• Patent expiration dates (including pediatric extension)
• Whether patents are drug substance vs drug product vs method-of-use
• Whether the same patents appear in multiple listing entries

Those data are not included in the prompt.

What happens if Fresenius Kabi wins on invalidity or non-infringement in 1:24-cv-04914?

If the court finds:

• Invalidity of key asserted patents, Fresenius Kabi may obtain an earlier path to FDA approval and launch (subject to other unadjudicated patents)
• Non-infringement, AbbVie may pivot to remaining patents, if any; otherwise it may be effectively blocked for this asserted patent set
• No injunction, Fresenius may still launch if it avoids covered claims or if the court does not order entry prohibition tied to a specific patent

If settlement occurs, typical outcomes include:

• An agreed “at-risk” or delayed launch date
• Monetary payments and/or covenant not to sue conditioned on product changes
• License terms allowing manufacture/sale under certain design constraints

Settlement terms cannot be summarized without docket entries and case documents.

What patent invalidity and non-infringement defenses are likely in 1:24-cv-04914?

Common defenses in Hatch-Waxman suits:

• Invalidity for lack of novelty, obviousness, or indefiniteness
• Written description and enablement challenges under 35 USC 112
• Prosecution history estoppel or claim scope arguments
• Non-infringement based on differences in formulation/process and intended use

The probability distribution depends on which patents are asserted and claim categories. The prompt does not provide patent numbers or claim language.

How does 1:24-cv-04914 compare with other AbbVie vs generic challenges?

Abundant patterns across AbbVie-driven generic defenses include:

• Aggressive pursuit of formulation and method-of-use layered patents
• Multiple asserted patents to extend leverage across design-around attempts
• Settlement frameworks that delay launch while preserving brand market share

A reliable comparison requires:

• Identification of the AbbVie drug and patent estate in this case
• Which court has jurisdiction and any parallel cases involving the same patents

These cannot be grounded from the prompt.

What does this litigation imply for competitive landscape and revenue exposure?

Revenue exposure for AbbVie depends on:

• The size of the affected product’s US revenue
• The number of effective patents left to block generic entry
• Whether Fresenius Kabi is the first filer and whether another filer can enter sooner if this case delays

Without identifying the product and patents, revenue impact cannot be quantified.

Key case-critical items that must be tracked on the docket for 1:24-cv-04914

To evaluate injunction risk and launch timing in a Paragraph IV posture, the following docket events are decisive:

• Complaint and Amended Complaint: asserted patent numbers and claim counts
• Answer: defenses, including invalidity grounds and non-infringement positions
• Early claim construction order (Markman) and disputed terms
• Expert report dates and summary judgment motions
• Daubert rulings and evidentiary rulings
• Settlement order or dismissal with prejudice (if applicable)

Those docket events are not provided in the prompt.

Key Takeaways

• Case identity: AbbVie Inc. v. Fresenius Kabi USA LLC, 1:24-cv-04914, is a patent infringement dispute consistent with Hatch-Waxman “proposed generic” litigation tied to Orange Book-listed AbbVie patents.
• What drives the outcome: asserted patent scope (drug substance vs formulation vs method of use), claim construction, and validity challenges determine whether Fresenius Kabi faces an injunction or a delayed launch.
• What is missing for an actionable analysis: asserted patent numbers, the AbbVie product, Orange Book listing expiries, and current docket posture are required to summarize claims at issue, estimate remaining blocking power, and compute launch exposure.

FAQs

What is the basis of AbbVie’s lawsuit against Fresenius Kabi USA under 1:24-cv-04914?

The suit is a US patent infringement action in a Hatch-Waxman setting tied to Orange Book-listed patents covering an AbbVie marketed product and a Fresenius Kabi proposed generic.

Does 1:24-cv-04914 involve Paragraph IV certifications?

The case pattern and parties are consistent with Paragraph IV-driven Hatch-Waxman litigation, but the specific FDA certification type cannot be confirmed from the provided prompt.

Can Fresenius Kabi launch during the litigation if it designs around the asserted patents?

In theory yes if it avoids all asserted claim limitations and/or if key patents are invalidated or found non-infringed. Case-specific design-around feasibility depends on asserted claim types and construction.

What court outcomes most directly determine whether a generic launches at risk?

A final judgment of invalidity or non-infringement for all blocking asserted patents is the most direct enabler; partial judgments often leave remaining patents that still block or delay entry.

How do settlements typically resolve cases like this?

Settlements often include agreed launch dates, product modifications, covenants not to sue, and sometimes monetary consideration. The terms for 1:24-cv-04914 cannot be summarized without docket/settlement filings.

References

No sources were provided in the prompt, and no case docket details, patent numbers, or filings were included, so no inline citations or APA reference list can be generated.