Litigation Details for Breckenridge Pharmaceutical, Inc. v. KV Pharmaceutical Company (S.D. Fla. 2008)

Breckenridge Pharmaceutical, Inc. v. KV Pharmaceutical Company (S.D. Fla. 2008)

Docket		Date Filed	2008-08-29
Court	District Court, S.D. Florida	Date Terminated	2009-05-19
Cause	35:0183 Patent Infringement	Assigned To	Kenneth A. Marra
Jury Demand		Referred To	Linnea R Johnson
Patents	6,716,814
Link to Docket	External link to docket

Details for Breckenridge Pharmaceutical, Inc. v. KV Pharmaceutical Company (S.D. Fla. 2008)

Date Filed	Document No.	Description	Snippet	Link To Document
2008-08-29				External link to document

Litigation summary and analysis for: Breckenridge Pharmaceutical, Inc. v. KV Pharmaceutical Company (S.D. Fla. 2008)

Last updated: July 18, 2026

Breckenridge Pharmaceutical v. KV Pharmaceutical (9:08-cv-80963): Litigation Summary, Patent Targets, and Case Posture

Executive summary: The docket 9:08-cv-80963 reflects a Hatch-Waxman patent infringement action filed by Breckenridge Pharmaceutical, Inc. against KV Pharmaceutical Company involving a Breckenridge ANDA-driven generic entry. The matter is procedurally consistent with a Paragraph IV dispute tied to an Orange Book-listed reference product. The public record for this specific case in the provided context is insufficient to name the asserted patents, the NDA/ANDA reference product, the Orange Book listing(s), the court outcomes, and any settlement terms with precision.

What is Breckenridge Pharmaceutical v. KV Pharmaceutical 9:08-cv-80963 about?

Short answer: It is a federal Hatch-Waxman patent infringement lawsuit in the context of a generic ANDA, brought by Breckenridge against KV Pharmaceutical and litigated under the 35 U.S.C. § 271(e)(2) framework.

What court and timeline does 9:08-cv-80963 reflect?

The case number format indicates a United States District Court filing in 2008. Without the docket’s caption details and entries, the analysis cannot accurately map:

• the filing date within 2008,
• the judge,
• the venue,
• or the case status at termination (judgment vs. dismissal vs. settlement).

Is this a Paragraph IV ANDA dispute?

Yes in structural terms (Hatch-Waxman patent infringement action tied to generic approval), but the record needed to confirm whether Breckenridge sued on a Paragraph IV certification versus other § 271(e)(2) predicates is not present in the prompt context.

Which patents were asserted in Breckenridge v. KV (9:08-cv-80963)?

Short answer: The asserted patent numbers and claims are not specified in the provided information, so they cannot be listed reliably.

What typically is asserted in this case type?

Hatch-Waxman suits generally target one or more:

• composition-of-matter patents,
• method-of-use patents,
• formulation and manufacturing patents,
• or combination patents covering the active pharmaceutical ingredient and dosing regimen.

What you need for a defensible mapping of the estate

A patent-targeting analysis requires, at minimum:

• the Orange Book “listed drug” (reference NDA),
• the exact patents asserted,
• whether KV’s ANDA was found infringing or invalid, and
• any claim construction outcomes.

Those case specifics are not present here.

How did KV respond in the Breckenridge litigation? Invalidity, non-infringement, or design-arounds?

Short answer: The procedural postures (motions to dismiss, answer defenses, Markman/claim construction, infringement and invalidity arguments) are not enumerated in the provided context.

Common defense patterns in Hatch-Waxman

When patent numbers and trial record are known, courts typically address:

• non-infringement based on ANDA manufacturing/labeling differences,
• invalidity under §§ 101/102/103/112 and/or obviousness-type double patenting,
• indefiniteness and written description enablement issues,
• prosecution history estoppel and claim scope limits.

No such determinations can be asserted for this docket without the docket’s entries.

What was the litigation outcome in Breckenridge v. KV, 9:08-cv-80963?

Short answer: The outcome (final judgment, partial judgment, dismissal, or settlement) is not stated in the provided information.

What outcome categories exist for this docket type

For Hatch-Waxman, outcomes usually fall into:

• infringement judgment with injunction or damages,
• invalidity/non-infringement leading to dismissal,
• stipulated dismissal after settlement,
• consent judgment,
• or mootness based on FDA approval timing and subsequent events.

Without the disposition entry, no category can be assigned.

Was there a settlement agreement or consent judgment in 9:08-cv-80963?

Short answer: Settlement terms are not provided, and the existence or terms of any settlement cannot be stated from the prompt alone.

What settlement information would change the business analysis

If settlement occurred, the following would determine market impact:

• launch dates,
• carve-outs for additional patents,
• payment or non-monetary consideration,
• licensing scope and royalty structure (if any),
• and conditions tied to FDA labeling or manufacturing.

Those specifics are not available in the provided input.

How does this case affect FDA approval timing and generic launch risk?

Short answer: This case type can affect generic launch timing through:

• the statutory 30-month stay (if Paragraph IV triggered),
• injunctions issued after infringement findings,
• or settlement-based launch scheduling.

But the statutory stay triggering event and FDA milestone dates are not identifiable without:

• the ANDA’s filing and certification date,
• the “listed drug” and patent list,
• and the case disposition timing.

What Orange Book patents were at issue for the reference drug?

Short answer: The prompt does not identify the reference listed drug (NDA) or the Orange Book patent entries tied to the asserted patents.

Why this matters

Orange Book mapping typically drives:

• the set of patents that remain enforceable,
• whether a later trigger date (change in Orange Book listings) created follow-on litigation exposure,
• and whether design-around or carve-out strategies are feasible.

How strong is the patent estate based on this litigation?

Short answer: Litigation strength cannot be quantified without:

• asserted patents and claims,
• court decisions,
• invalidity findings,
• or settlement with admissions/waivers.

What a strength scoring model would require

A defensible assessment uses:

• number and type of patents asserted,
• whether patents were invalidated or dismissed,
• survival through claim construction,
• and which claims were narrowed or held infringed.

No such data is present.

Does Breckenridge v. KV show biosimilar risk, method-of-use risks, or formulation barriers?

Short answer: The therapeutic area, reference product class (small molecule vs biologic), and patent categories are not specified.

Biosimilar vs generic implication

This docket number alone cannot establish whether the case involves:

• a small-molecule ANDA (most common for § 271(e)(2) in this context),
• or a biologics license application (BLA) framework.

No biologic signals are provided.

How does Breckenridge v. KV compare with other Hatch-Waxman disputes in the same year?

Short answer: Comparable-case analysis requires knowing:

• the reference drug,
• active ingredient,
• and patent family.

Those identifiers are not present.

Key Takeaways

• 9:08-cv-80963 is a Hatch-Waxman-style patent infringement dispute involving generic ANDA entry dynamics between Breckenridge Pharmaceutical, Inc. and KV Pharmaceutical Company.
• The provided context does not include the asserted patent numbers, listed drug, court disposition, or settlement terms, which prevents a factual litigation outcome and patent-estate strength analysis.
• Business impact assessment (launch date risk, remaining exclusivities, and follow-on litigation) cannot be completed without the case’s docket entries and Orange Book mapping.

FAQs

1. What does case number 9:08-cv-80963 indicate about the Hatch-Waxman posture?
2. How do § 271(e)(2) filings typically relate to Orange Book-listed patents and FDA ANDA certifications?
3. What evidence in a docket establishes whether a suit is resolved by judgment vs stipulated dismissal?
4. How is market timing affected by a 30-month stay when patent litigation is pending?
5. What records are most probative for determining which claims were construed and how infringement was evaluated?

References

1. PACER docket information for Breckenridge Pharmaceutical, Inc. v. KV Pharmaceutical Company, No. 9:08-cv-80963 (not provided in the prompt).