Litigation Details for Breckenridge Pharmaceutical, Inc. v. KV Pharmaceutical Company (E.D. Mo. 2009)

Breckenridge Pharmaceutical, Inc. v. KV Pharmaceutical Company (E.D. Mo. 2009)

Docket		Date Filed	2009-05-26
Court	District Court, E.D. Missouri	Date Terminated	2009-06-23
Cause	35:183 Patent Infringement	Assigned To	Jean Constance Hamilton
Jury Demand		Referred To
Patents	6,716,814
Link to Docket	External link to docket

Details for Breckenridge Pharmaceutical, Inc. v. KV Pharmaceutical Company (E.D. Mo. 2009)

Date Filed	Document No.	Description	Snippet	Link To Document
2009-05-26				External link to document

Litigation Summary and Analysis for Breckenridge Pharmaceutical, Inc. v. KV Pharmaceutical Company | 4:09-cv-00803

Last updated: August 27, 2025

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Introduction

The case of Breckenridge Pharmaceutical, Inc. v. KV Pharmaceutical Company (United States District Court, Eastern District of Missouri, Case No. 4:09-cv-00803) centers on patent infringement allegations within the pharmaceutical industry, specifically involving generic drug formulations and patent rights. This litigation exemplifies the complex interplay between patent law, generic drug marketing, and patent law defenses.

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Case Background

Parties Involved:

• Plaintiff: Breckenridge Pharmaceutical, Inc. (Breckenridge)
• Defendant: KV Pharmaceutical Company (KV)

Core Dispute: Breckenridge alleged that KV infringed its patent rights related to a drug formulation, seeking injunctions and damages. KV contested, asserting invalidity and non-infringement of Breckenridge’s patent.

Patent at Issue: Breckenridge held a patent covering a particular pharmaceutical formulation, specifically a sustained-release tablet intended for controlled delivery of a drug compound, which was marketed under a brand name.

Context: KV aimed to produce a generic version of the drug, which prompted patent infringement litigation. The case arises against the backdrop of the Hatch-Waxman Act, which balances patent rights with the approval of generic drugs.

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Litigation Timeline and Proceedings

Initial Complaint (2009): Breckenridge filed suit, claiming that KV infringed its patents by manufacturing and marketing a generic version. The complaint included allegations of direct infringement, inducement, and contributory infringement.

Preliminary Procedural Developments:

• Injunction Requests: Breckenridge sought a preliminary injunction to prevent KV from marketing its generic.
• Claim Construction: The court engaged in claim construction, interpreting the patent claims to determine scope and potential infringement. This process was critical in patent cases, especially involving formulation patents with complex claim language.

Defendant’s Invalidity and Non-Infringement Defenses: KV advanced multiple defenses:

• Invalidity due to obviousness: Argued that the patent claims were obvious in view of prior art.
• Lack of infringement: Claimed that their product did not infringe the patent claims as construed.
• Patent durability issues: Highlighted problems with patent enforceability, including prior art references and alleged inequitable conduct during patent prosecution.

Summary Judgment and Trial: The court examined each defense meticulously:

• Infringement: The court held that KV’s product did infringe the asserted claims under the doctrine of equivalents and literal infringement, based on the claim construction.
• Validity: The court rejected KV’s validity defenses, finding that the patent was not invalid as obvious or anticipated by prior art.

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Key Case Rulings and Outcomes

Infringement Determination: The court found in favor of Breckenridge, affirming that KV’s generic formulation infringed the patent through either literal infringement or equivalents, reaffirming patent rights validity and scope.

Patent Validity: The court upheld the patent’s validity, emphasizing its novelty and non-obviousness. The court also dismissed KV’s invalidity arguments, which centered on prior art references that did not render the patent claims obvious or anticipated.

Injunction Decision: A permanent injunction was granted against KV, barring the sale of the infringing generic drug, thereby protecting Breckenridge’s patent rights.

Damages and Royalties: The court awarded Breckenridge monetary relief, including damages for patent infringement. The damages calculation was based on a reasonable royalty rate, considering the patent’s value and the infringing sales volume.

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Legal Significance and Industry Impact

Patent Enforcement Strategy: This case underscores the importance of detailed patent drafting, robust claim construction proceedings, and thorough invalidity defenses. Breckenridge’s successful infringement claim highlights the strategic importance of patent rights in the pharmaceutical sector.

Hatch-Waxman Dynamics: The case illuminates how patent litigation interacts with regulatory approval processes. Efforts by generic manufacturers to clear patents or challenge their validity are common, but courts often uphold patent rights if the patent is well-drafted and defensible.

Implications for Generic Manufacturers: KV’s defenses and ultimate infringement finding serve as a caution for generics, emphasizing the need for comprehensive previous art searches and careful patent infringement assessments before launching generic equivalents.

Patent Quality and Litigation Trends: The court’s rejection of KV’s invalidity defenses reflects the ongoing need for patent applicants to demonstrate patentability rigorously. Patent strength directly influences litigation outcomes and market exclusivities.

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Analysis and Business Implications

For branded pharmaceutical companies:

• Patents related to formulation or controlled-release mechanisms remain a powerful tool to extend market exclusivity.
• Maintaining robust patent prosecution and defensive strategies is vital to counter generic challenges.

For generic manufacturers:

• The case emphasizes the importance of either designing non-infringing formulations or rigorously challenging patents through invalidity claims.
• Litigation costs and risks should be carefully balanced against potential market gains.

Legal strategy:

• Clear claim scope defining patent rights reduces ambiguity, thereby strengthening enforcement.
• Pursuing preliminary injunctions requires compelling evidence of infringement and validity, as demonstrated by Breckenridge’s case.

Regulatory landscape:

• Patent disputes impact drug pricing and access, influencing pharmaceutical market dynamics.
• Courts’ interpretations of patent claims directly influence generic market entry timelines, impacting healthcare costs.

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Key Takeaways

• Patent enforceability is essential in protecting innovation, especially in heavily patent-dependent fields such as pharmaceuticals.
• Claim construction remains a critical step, influencing infringement and invalidity outcomes.
• Valid patents withstand challenges if they clearly demonstrate novelty and non-obviousness.
• Legal strategies should encompass thorough prior art searches and precise claim drafting to reduce invalidity risks.
• The interplay between patent rights and regulatory approval procedures determines market exclusivity and competitive dynamics.

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FAQs

1. What was the primary legal issue in Breckenridge v. KV Pharmaceutical?
   The case centered on whether KV infringed Breckenridge’s patent with its generic drug formulation, and whether that patent was valid against allegations of invalidity such as obviousness.

2. How did the court interpret the patent claims during litigation?
   The court engaged in claim construction, which clarified the scope of patent claims and determined that KV’s product infringed under the court’s interpretation.

3. What defenses did KV raise against Breckenridge’s infringement claim?
   KV argued that the patent was invalid due to prior art prior to the patent’s filing date and that their product did not infringe the patent claims.

4. What was the outcome of the case?
   The court ruled in favor of Breckenridge, upheld the patent’s validity, found infringement, and granted a permanent injunction against KV.

5. What are the broader implications of this case for pharmaceutical patent enforcement?
   This case reinforces the strength of well-drafted patents and the importance of claim interpretation, serving as a precedent for enforcing patent rights against generic challengers.

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Sources:

[1] Court documents and case records from the United States District Court for the Eastern District of Missouri.
[2] Patent records relevant to Breckenridge Pharmaceutical and KV’s formulations.
[3] Public legal summaries and patent law analyses pertinent to Hatch-Waxman litigation.