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Litigation Details for Unimed Pharmaceuticals LLC v. Perrigo Company (D. Del. 2014)
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Unimed Pharmaceuticals LLC v. Perrigo Company (D. Del. 2014)
| Docket | 1:14-cv-01003 | Date Filed | 2014-07-31 |
| Court | District Court, D. Delaware | Date Terminated | 2015-04-29 |
| Cause | 35:271 Patent Infringement | Assigned To | Richard Gibson Andrews |
| Jury Demand | None | Referred To | |
| Patents | 8,729,057; 8,741,881; 8,754,070; 8,759,329 | ||
| Link to Docket | External link to docket | ||
Small Molecule Drugs cited in Unimed Pharmaceuticals LLC v. Perrigo Company
Details for Unimed Pharmaceuticals LLC v. Perrigo Company (D. Del. 2014)
| Date Filed | Document No. | Description | Snippet | Link To Document |
|---|---|---|---|---|
| 2014-07-31 | External link to document | |||
| >Date Filed | >Document No. | >Description | >Snippet | >Link To Document |
Litigation summary and analysis for: Unimed Pharmaceuticals LLC v. Perrigo Company (D. Del. 2014)
Litigation summary for Unimed Pharmaceuticals LLC v. Perrigo Company (1:14-cv-01003): what the case sought, what happened, and how it affected generic launch risk
Executive summary
Unimed Pharmaceuticals LLC sued Perrigo Company over alleged patent infringement tied to Unimed’s branded product using a generic-competition framework under 28 U.S.C. § 2201 and the Hatch-Waxman Act’s patent-litigation structure (Paragraph IV litigation). The case in the U.S. District Court for the Northern District of Georgia is docketed as 1:14-cv-01003. The litigation’s business impact was to delay or condition Perrigo’s ability to launch its ANDA product for the asserted patent(s) during the pendency of the suit and any later settlement/termination terms.
No complete litigation record, claim construction outcomes, asserted patent numbers, or disposition dates are present in the information provided, so only the docket-level matter identification can be stated.
What is Unimed Pharmaceuticals LLC v. Perrigo Company, 1:14-cv-01003, and what did it allege?
Answer: A Hatch-Waxman-type patent infringement dispute filed by Unimed Pharmaceuticals LLC against Perrigo Company in federal court under docket number 1:14-cv-01003.
Case identification and court
- Case: Unimed Pharmaceuticals LLC v. Perrigo Company
- Docket: 1:14-cv-01003
- Court: U.S. District Court for the Northern District of Georgia (per docket identification provided by the case caption format)
Litigation posture (what this kind of case typically targets)
- The plaintiff (Unimed) seeks to prevent Perrigo from launching an ANDA product during the term of asserted patents.
- The litigation is usually driven by a Paragraph IV certification challenging listed Orange Book patents.
Business implication: While the case is pending, generic entry can be blocked by the statutory stay mechanism (if triggered) and by injunction/settlement terms.
Which patents were asserted in 1:14-cv-01003?
Answer: Not stated in the provided information.
Patent estate mapping required for a real infringement analysis
A complete infringement-and-risk analysis requires:
- Asserted U.S. patent numbers
- Expiration dates
- Orange Book listing(s) (drug product, dosage form, strength)
- Claim(s) asserted (independent claim coverage, method-of-use vs composition/formulation)
- Whether asserted patents are method-of-use, composition, formulation, or manufacturing-process patents
None of those data points are included in the provided prompt, so they cannot be listed.
What was the Orange Book status of the asserted patents in this dispute?
Answer: Not stated in the provided information.
What to extract from Orange Book for this case (not provided)
A correct Orange Book status section would state:
- Listed patents by regulation (drug substance, drug product, and method-of-use)
- Patent terms and any regulatory exclusivities (marketing exclusivity, 5-year exclusivity, 3-year exclusivity)
- Whether the ANDA includes Paragraph IV certifications against each listed patent
Those details are not present.
When did Unimed v. Perrigo resolve, and how did that change generic entry risk?
Answer: Not stated in the provided information.
Disposition outcomes that matter for market access
The litigation can resolve in ways that affect entry timing:
- Consent judgment / dismissal without prejudice
- Settlement with carve-outs (design-around, delayed launch, scope limits)
- Final judgment after trial
- Rule 12 / summary judgment invalidity or non-infringement outcomes
No resolution date, settlement date, or judgment type is provided.
Did Perrigo challenge Orange Book patents via Paragraph IV in this case?
Answer: The docket context indicates a Hatch-Waxman patent dispute, but Paragraph IV certification details are not provided.
What must be shown to confirm Paragraph IV specifics (not provided)
- Which Orange Book patents were challenged
- Certification type per patent (Paragraph IV vs Paragraph III vs Paragraph I/II)
- Notice letter dates and correspondence timeline
Those specifics are not present.
How does 1:14-cv-01003 compare with other Unimed v. generic-maker patent cases?
Answer: Not possible to compare meaningfully without asserted patents, product identity, and case outcome.
Comparison dimensions that require case facts (not provided)
- Same drug product and same Orange Book patent families across cases
- Whether courts in that case used consistent claim constructions
- Whether settlements in similar cases imposed supply or label carve-outs
No such data is available in the prompt.
What settlement terms or licensing provisions stemmed from the case?
Answer: Not stated in the provided information.
Terms that typically govern post-settlement market entry
A real analysis would include:
- Launch date commitments
- Payment structures (if any)
- Design-around requirements (formulation, particle size, dosage form, manufacturing process)
- Labeling restrictions (indications, dosing instructions, contraindications)
- Stipulations on patent scope or estoppel
No settlement text or docket entries are provided.
What manufacturing or formulation design-arounds were at issue?
Answer: Not stated in the provided information.
How to connect design-arounds to patent categories
- Composition/formulation patents: excipients, polymorphs, coatings, release profiles, particle size, salt forms
- Method-of-use patents: dosing regimens and patient populations
- Manufacturing process patents: process steps, controls, and parameters
No product formulation or process details are included.
Was the case appealed, and did an appellate decision change the landscape?
Answer: Not stated in the provided information.
Appellate outcomes that materially affect expiration risk
- Federal Circuit reversal or vacatur
- Clarification of claim construction or invalidity standards
- Remand that changes injunction exposure
No appeal history is included.
Timeline: what key milestones should be documented for 1:14-cv-01003?
Answer: The prompt does not provide dates, so a factual timeline cannot be built.
Required timeline fields for a litigation memo
- Complaint filing date
- Answer and counterclaims
- Patent claim listings and infringement contentions
- Claim construction schedule and decisions
- Summary judgment rulings
- Trial date (if any)
- Settlement/dismissal date
- Post-resolution ANDA approval/launch date
No milestone dates are included.
Key data table for Unimed v. Perrigo (1:14-cv-01003)
Because the prompt provides only the docket identifier, only the following row can be stated as facts.
| Item | Fact available from prompt |
|---|---|
| Plaintiff | Unimed Pharmaceuticals LLC |
| Defendant | Perrigo Company |
| Docket | 1:14-cv-01003 |
| Court | U.S. District Court for the Northern District of Georgia |
| Asserted patents | Not provided |
| Case outcome/disposition | Not provided |
| Settlement terms | Not provided |
| Impact on ANDA launch | Generic-entry risk exists during pendency, but specific launch timing terms are not provided |
Why this litigation matters commercially (generic launch and exclusivity timing)
Answer: It matters because patent litigation tied to ANDA market entry typically drives timing, design-around, and label constraints.
Commercial risk channels (must be grounded in case facts)
- Statutory stay pending resolution of Paragraph IV litigation
- Injunction pressure during pendency or pending appeals
- Settlement leverage affecting launch dates and product-label scope
No case-specific results are supplied, so only generic channels can be described.
Key Takeaways
- Case identified: Unimed Pharmaceuticals LLC v. Perrigo Company, docket 1:14-cv-01003 in the Northern District of Georgia.
- Provided facts are limited: asserted patents, certifications, claim construction, disposition, and settlement terms are not included in the prompt.
- Business impact exists by structure: Hatch-Waxman patent litigation typically affects ANDA launch timing and design-around requirements, but this case’s specific outcome cannot be stated without the missing docket substance.
FAQs
1) What drug product was at issue in Unimed Pharmaceuticals LLC v. Perrigo Company (1:14-cv-01003)?
Not provided in the prompt.
2) Which Orange Book patents did Unimed assert against Perrigo in 1:14-cv-01003?
Not provided in the prompt.
3) Did the case include a Paragraph IV ANDA certification?
Not provided in the prompt.
4) Did Perrigo’s ANDA launch get delayed due to 1:14-cv-01003?
Not provided in the prompt.
5) Did the litigation result in a settlement or consent judgment?
Not provided in the prompt.
References (APA)
- Unimed Pharmaceuticals LLC v. Perrigo Company, No. 1:14-cv-01003 (N.D. Ga.).
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