Last updated: April 25, 2026
What is the case and what court has jurisdiction?
Fresenius Kabi USA, LLC v. Custopharm, Inc. is a federal patent infringement case docketed as 1:18-cv-00665.
- Court: U.S. District Court for the District of Delaware
- Case number: 1:18-cv-00665
- Parties:
- Plaintiff: Fresenius Kabi USA, LLC
- Defendant: Custopharm, Inc. (docketed as Custopharm, Inc.)
What triggered the litigation?
The action is a typical Hatch-Waxman era structure: a brand or reference manufacturer sues an ANDA filer (or related generic manufacturer) for infringement of asserted patents covering a drug product and/or formulation used in the defendant’s proposed generic product.
The docket title and case posture indicate the lawsuit is about patent infringement tied to commercialization of a generic product by the defendant. (Court and docket identification: [1].)
What claims and patents were asserted?
The specific asserted patent numbers, claim construction targets, and infringement theories are not included in the information available in the provided record context here. Without the asserted-patent list and the claim chart or final infringement contentions, a complete, accurate claim-level litigation analysis cannot be produced.
What procedural milestones shaped the timeline?
The case is filed in 2018 under Delaware’s patent docket. The filing date, responsive pleadings, Markman schedule, claim construction outcome, dispositive motion rulings, and any injunction or settlement terms are not provided in the input context, so the procedural timeline cannot be reconstructed accurately here. Court identification remains the only verifiable fact: [1].
What happened in the merits stage?
No merits disposition details (summary judgment grants, jury verdict, or bench decision) are provided in the input context. Without a disposition order or final judgment document in the available material, a merits outcome summary would risk inaccuracy.
Was there a settlement, dismissal, or consent judgment?
The existence and terms of any settlement or dismissal are not included in the provided context. A litigation outcome statement would require a dismissal order, stipulation, or settlement filing that is not present here.
What is the likely dispute architecture (based on the case type and docket posture)?
Given the party types and case nature, the typical architecture is:
- Plaintiff alleges direct infringement (and often one or more of induced/contributory) of one or more patents related to:
- drug substance or composition
- formulation or dosage form
- manufacturing process
- or method-of-treatment claims, depending on the patent family
- Defendant challenges:
- non-infringement
- invalidity under § 102/103 and/or § 112
- and sometimes unenforceability (inequitable conduct) or prosecution history-based defenses
But the asserted patent categories and specific defenses used in this matter cannot be confirmed from the provided record context.
What did the litigation likely mean strategically for Fresenius Kabi?
Without asserted patents and outcomes, the only defensible strategic read is structural:
- Fresenius Kabi positions itself to enforce IP covering a marketed product while leveraging Delaware’s patent expertise and the case’s early-phase schedules.
- The litigation likely sought one or more of the following end-states:
- delayed generic launch via injunction pressure
- leverage for licensing
- or elimination of specific asserted claims through claim construction or invalidity motions
This is consistent with how these disputes run, but it cannot be mapped to this case’s exact asserted patents, rulings, or leverage points without record details.
What did the litigation likely mean strategically for Custopharm?
Again, without the patent list, outcomes, and product details tied to infringement contentions, the only defensible strategy framing is generic-dispute standard:
- Custopharm would typically aim to:
- narrow claim scope through claim construction
- prevail on non-infringement for specific product features
- or attack validity with prior art and enablement/description arguments
No product- or patent-specific analysis can be stated as fact.
What are the investment-relevant risk factors to monitor from this docket?
To make risk-monitoring actionable, the docket needs at least one of: (a) an asserted-patent list, (b) a final judgment, (c) a key claim construction ruling, or (d) a timeline of injunction-related motions. None of these are included in the supplied context here. The only verified data point remains the case identity. [1].
Key Takeaways
- Case identity is established: Fresenius Kabi USA, LLC v. Custopharm, Inc., 1:18-cv-00665 in the District of Delaware. [1]
- Claim-level and outcome-level analysis cannot be completed from the provided material because the asserted patents, rulings, and final disposition are not present.
- Any business conclusions tied to specific patent scope, infringement theories, invalidity posture, or launch timing would require orders and documents not available in the current context.
FAQs
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What is the case number for Fresenius Kabi v. Custopharm?
1:18-cv-00665. [1]
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Where is the case filed?
U.S. District Court for the District of Delaware. [1]
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Who are the parties?
Fresenius Kabi USA, LLC (plaintiff) and Custopharm, Inc. (defendant). [1]
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Is this a patent infringement case?
The docket identifies it as a federal case consistent with patent litigation between these parties. [1]
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What is the litigation outcome?
The outcome is not provided in the available context here.
References
[1] CourtListener. Fresenius Kabi USA, LLC v. Custopharm, Inc. Case No. 1:18-cv-00665 (D. Del.). https://www.courtlistener.com/ (search results and docket page for case number 1:18-cv-00665).
