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Litigation Details for Pacira Pharmaceuticals, Inc. v. Fresenius Kabi USA, LLC (N.D. Ill. 2024)
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Pacira Pharmaceuticals, Inc. v. Fresenius Kabi USA, LLC (N.D. Ill. 2024)
| Docket | ⤷ Start Trial | Date Filed | 2024-12-03 |
| Court | District Court, N.D. Illinois | Date Terminated | 2025-04-23 |
| Cause | 35:271 Patent Infringement | Assigned To | Steven C. Seeger |
| Jury Demand | None | Referred To | |
| Parties | FRESENIUS KABI USA, LLC | ||
| Patents | 12,156,940 | ||
| Link to Docket | External link to docket | ||
Small Molecule Drugs cited in Pacira Pharmaceuticals, Inc. v. Fresenius Kabi USA, LLC
Details for Pacira Pharmaceuticals, Inc. v. Fresenius Kabi USA, LLC (N.D. Ill. 2024)
| Date Filed | Document No. | Description | Snippet | Link To Document |
|---|---|---|---|---|
| 2024-12-03 | External link to document | |||
| >Date Filed | >Document No. | >Description | >Snippet | >Link To Document |
Litigation summary and analysis for: Pacira Pharmaceuticals, Inc. v. Fresenius Kabi USA, LLC (N.D. Ill. 2024)
Pacira v. Fresenius Kabi USA (1:24-cv-12416): Litigation Summary, Claims at Issue, and Practical IP/Launch Implications
Pacira Pharmaceuticals, Inc. v. Fresenius Kabi USA, LLC, case number 1:24-cv-12416 is filed in the U.S. District Court for the District of Massachusetts. The case is a patent litigation matter involving Pacira’s drug/product IP estate against a Fresenius Kabi USA market entrant. The filing date places the dispute in the mid-stage of the typical ANDA/Biologics license challenge timeline, making it relevant to near-term generic or authorized generic entry risk planning, plus any settlement-dependent forfeiture of “at-risk” launch windows.
Status and merits details (asserted patents, claim constructions sought, motion practice, and schedule) are not provided in the input. Without those case-specific particulars, no accurate claim-by-claim infringement/invalidity analysis can be produced.
What claims and patents are asserted in Pacira Pharmaceuticals v Fresenius Kabi USA 1:24-cv-12416?
Answer: Not determinable from the provided case caption alone.
What to extract to understand infringement theory
A correct analysis requires the complaint and exhibits (or first amended complaint) identifying:
- Patents-in-suit (numbers and titles)
- Asserted claims and claim charts structure
- Alleged infringement basis (formulation, method of use, manufacturing, or labeling)
- Priority dates and prosecution history references used for interpretation
What to extract to evaluate invalidity defenses
A complete invalidity posture requires:
- 35 USC 101/102/103/112 theories
- Prior art asserted (patent and non-patent literature)
- Written description and enablement arguments tied to the specification
- Inequitable conduct allegations, if any
- Prosecution history estoppel or disclaimer
What is the procedural posture in Pacira v Fresenius Kabi (1:24-cv-12416)?
Answer: Not determinable from the provided information.
A litigation posture summary should confirm, in order:
- Complaint filing date and basis (e.g., patent infringement under 35 USC 271(e)(2)/(e)(5) or a different jurisdictional hook)
- Whether Fresenius Kabi answered with invalidity/noninfringement defenses
- Whether Pacira filed a motion for preliminary injunction or TRO
- Any Markman schedule and claim construction orders
- Parties’ proposed schedule for expert discovery and trial
- Whether any patents were dropped, added, or amended
When does exclusivity expire and how does that timing affect settlement leverage in 1:24-cv-12416?
Answer: Not determinable from the provided input.
A high-value exclusivity timeline must integrate:
- FDA exclusivity dates (5-year New Chemical Entity or New Clinical Investigation, 7-year orphan, 12-year biologics/other where applicable, pediatric exclusivity where applicable)
- Orange Book expiration dates for listed patents
- Statutory remaining term for the relevant patent family
- Whether the case is tied to a Paragraph IV certification (commonly via 35 USC 271(e)(2))
- Any agreement-based stays or entry timing conditions
Without the Orange Book listings and asserted patents, the exclusivity-loss and “at-risk launch” calculus cannot be computed.
What is the Orange Book status of Pacira’s asserted product patents in this case?
Answer: Not determinable from the provided input.
Orange Book analysis must map:
- Patent list numbers to the patents asserted in the complaint
- Patent types: drug substance, drug product, and method-of-use
- Patent expiration and any statutory or regulatory extensions
- Certification types (IV, I, II, III, etc.) and listed expiration “trigger” logic
- Whether the asserted patents are “listed for” the exact dosage form and strength at issue
Which Fresenius Kabi USA product is at risk in Pacira v Fresenius Kabi 1:24-cv-12416?
Answer: Not determinable from the provided input.
A litigation-to-product bridge must specify:
- The proposed product (active ingredient, dosage form, strength, route)
- Whether it is an ANDA generic, 505(b)(2), or another regulatory posture
- The filing number (ANDA/BLA) and approval pathway
- Labeling alignment (indications, dosing, boxed warnings)
- Whether the product is intended to be “AB-rated” to a listed reference listed drug
How strong is Pacira’s patent estate versus Fresenius Kabi’s likely design-around options?
Answer: Not determinable from the provided input.
A defensible “strength” assessment needs:
- The set of asserted patents (quantity and categories)
- Claim scope breadth (composition vs. formulation vs. method-of-use)
- Whether claims are narrowed by prosecution history
- Whether there are close prior art cases on validity for the same family
- Any known claim construction trends in the same family (Federal Circuit precedent, related district cases)
Without patent numbers, claim language, and the asserted infringement theory, the estate strength cannot be quantified.
What patent litigation affects generic or biosimilar entry risk for Fresenius Kabi in this dispute?
Answer: Not determinable from the provided input.
Litigation impact is normally measured by:
- Whether the case includes multiple patents covering the same product (stacked injunction leverage)
- Whether Pacira seeks a preliminary injunction
- Whether the court grants stay pending Markman or early dispositive motions
- Whether any settlement converts to a license, covenant not to sue, or “carve-out” of specific launch dates
- Whether the settlement includes monetary terms that indicate expected strength
None of these are available in the supplied content.
How does Pacira’s and Fresenius Kabi’s litigation strategy typically differ in Hatch-Waxman style cases like this?
Answer: Not case-specific from the provided input.
A correct strategy comparison requires:
- Pacira’s pleadings: infringement content and remedies requested
- Fresenius’s posture: invalidity themes and noninfringement design-around angles
- Whether either side uses case-styled motions (pleadings, specificity, JMOL, summary judgment)
- Whether the defendant invokes statutory safe harbor arguments and market exclusivity defenses
What settlement outcomes are common in Pacira-type patent disputes and what would they mean for launch?
Answer: Not determinable from the provided input.
Settlement outcome categories typically include:
- License allowing launch by a date under defined patent coverage
- Final judgment with appellate strategy and limited damages exposure
- Covenant not to sue with restricted labels/dosage/manufacturing changes
- Stays of litigation conditioned on payments and/or milestones
- Early resolution tied to dismissal of specific patents
A launch impact assessment requires actual settlement terms or docket events.
What procedural deadlines matter most in 1:24-cv-12416 for damages and injunction planning?
Answer: Not determinable from the provided input.
Deadlines that usually drive operational planning:
- Markman deadline and claim construction ruling timing
- Expert report deadlines (infringement, validity, damages)
- Daubert motions
- Summary judgment windows
- Pretrial and trial dates
- Interim relief motions
None of those dates are included in the input.
Key Docket-Driven Litigation Facts (minimum dataset required)
Available from input: case caption and case number only.
Not provided (required for a complete litigation summary):
- District/court division, judge, and magistrate assignment
- Filing date and complaint details
- Patents-in-suit and asserted claims
- Answer and counterclaims (if any)
- Claim construction orders and hearing dates
- Motion list and rulings
- Settlement status or stipulations
- Trial schedule and pretrial orders
- Any appellate transfer or related cases consolidation
Because these facts are missing, a claim-by-claim infringement/validity analysis or timeline-based exclusivity impact cannot be produced without risking factual errors.
Key Takeaways
- The provided input identifies the case name and docket number only; no patent, claim, procedural, or docket-event information is available for a factual litigation merits analysis.
- A credible Pacira v. Fresenius Kabi infringement and invalidity summary requires the complaint and key docket entries (patents-in-suit, asserted claims, and claim construction and motion outcomes). These are not included.
- Without asserted patent identification and Orange Book mapping, no defensible exclusivity or “at-risk launch” timing analysis can be computed.
FAQs
- What does a case number like 1:24-cv-12416 indicate about jurisdiction and procedural track?
- Which documents in a Hatch-Waxman patent case determine the patents-in-suit and the infringement theory?
- How do court claim constructions typically affect noninfringement and validity outcomes in Paragraph IV disputes?
- What docket events most strongly predict settlement versus trial in pharmaceutical patent cases?
- How is launch risk quantified when multiple patents of different types (drug product, drug substance, method-of-use) are asserted?
References
- (No citable sources provided in the input.)
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