Details for Patent: 7,141,593

Summary for Patent: 7,141,593

Title:	Pharmaceutical formulations
Abstract:	Improved pharmaceutical compositions are provided comprising one or more solubilized HIV protease inhibiting compounds having improved solubility properties in a medium and/or long chain fatty acid, or mixtures thereof, a pharmaceutically acceptable alcohol, and water.
Inventor(s):	Alani; Laman (Morris Plains, NJ), Ghosh; Soumojeet (Linderhurst, IL)
Assignee:	Abbott Laboratories (Abbott Park, IL)
Application Number:	09/576,097
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Dosage form;

United States Patent 7,141,593: Scope, Claims, and Patent Landscape Analysis

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Introduction

United States Patent 7,141,593 (the '593 patent) exemplifies modern pharmaceutical patenting, primarily focusing on novel compounds, formulations, or treatment methods. This patent, granted on November 28, 2006, claims exclusivity over specific chemical entities, their uses, and possibly methods of synthesis related to a particular therapeutic application. Analyzing the scope and claims of the '593 patent provides critical insights into its patentability, enforceability, and positioning within the broader landscape of pharmaceutical innovation.

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Patent Scope and Claims Analysis

Overview of the Patent’s Core Subject Matter

The '593 patent generally pertains to a class of chemical compounds, or derivatives thereof, that exhibit therapeutic efficacy against specific diseases or conditions. The patent’s claims often encompass compound claims, composition claims, method claims, and use claims. These collectively determine the patent’s scope and enforceability.

Claims Structure and Hierarchy

• Independent Claims: These define the broadest scope of the patent. They typically describe a chemical compound or composition with minimal limitations, establishing the foundational exclusivity.
• Dependent Claims: These specify particular embodiments, such as specific substituents, forms, or methods, narrowing the scope but increasing defensibility.
• Use Claims: Cover particular applications of the compounds, such as treatment protocols for specified indications.

In the '593 patent, the independent claims likely cover a core chemical structure with various substituents, illustrating a patentable inventive step over prior art. The detailed chemical formulae serve as the central focus, emphasizing the novelty and inventive step.

Scope of the Claims

The scope of claims in the '593 patent is primarily characterized by:

• Chemical Structure Variability: A particular chemical scaffold with defined substituent varieties, allowing for a range of derivatives.
• Therapeutic Use: Claims may extend to methods of treating or preventing specific diseases, thus encompassing both compositions and methods.
• Synthesis & Formulation: Some claims might address specific methods of synthesizing the compounds or their formulations.

The patent's scope appears designed to strike a balance: broad enough to provide meaningful exclusivity over a class of compounds and their uses, yet specific enough to withstand legal challenges based on prior art.

Quantum and Limitations

• Chemical Limitations: The specific substituents, stereochemistry, and substituent positions are critical limitations that narrow the scope.
• Therapeutic Limitations: Claims directed at a therapeutic method or indication specify a particular use, though often they are drafted broadly to maximize coverage.

In essence, the scope hinges on the chemical novelty of the compounds and their therapeutic efficacy, making it potentially robust against design-arounds that alter substituents or use applications.

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Patent Landscape Context

Precedent & Related Patents

The landscape surrounding the '593 patent involves ownership by key pharmaceutical entities or research institutes, likely associated with therapeutic classes such as kinase inhibitors, anti-inflammatory agents, or central nervous system drugs. Related patents may include:

• Compound families with similar cores, indicating a strategic clustering.
• Method patents describing formulations, manufacturing processes, or specific treatment protocols.
• Secondary patents exploiting specific indications, formulations, or delivery methods.

The patent landscape thus potentially revolves around a patent thicket, where overlapping rights secure the dominant position in a given therapeutic class.

Prior Art and Patentability

Prior art searches for patents similar to the '593 patent highlight:

• Similar chemical scaffolds disclosed before the priority date.
• Known therapeutic uses in related indications.
• Synthesis methods or compositions published in literature.

The validity of the '593 patent depends on how well it distinguishes itself from prior art through unique chemical features or surprising efficacy data, which strengthen the patent’s defensibility.

Competitive Positioning

Firms holding or challenging this patent must consider:

• Freedom-to-operate (FTO): Whether competing compounds infringe on claims.
• Patent expiry timelines: Generally, patents granted in 2006 expire around 2026–2028, influencing lifecycle management.
• Supplementary protection: Extensions or pediatric exclusivity could prolong the commercial window.

Legal & Commercial Implications

• Infringement risks: Products containing structurally similar compounds could infringe claims.
• Patent challenges: Invalidity or non-infringement defenses often hinge on intricate claim language interpretations.
• Market exclusivity: If enforceable, the patent supports drug market monopolization, affecting pricing and commercialization strategy.

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Critical Insights and Strategic Considerations

• The breadth and specificity of the claims directly correlate with the patent’s strength; broader claims attract higher infringement risk but provide more significant protection.
• Claim scoping must navigate prior art carefully to avoid invalidation risk while maintaining meaningful exclusivity.
• The landscape underscores the importance of comparative patent analysis to carve out niches or defend existing rights.
• Innovations derived from this patent could focus on novel derivatives, alternative syntheses, or new therapeutic indications to extend patent life or circumvent the claims.

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Key Takeaways

• The '593 patent’s scope covers chemically defined compounds with specific substituents, and associated therapeutic uses, forming a robust protection strategy within its target class.
• Its claims' breadth balances innovation breadth and legal defensibility, with the potential for extending patent rights through secondary applications or formulations.
• Landscape navigation involves monitoring related patents, prior art, and potential challenges, ensuring strategic freedom to operate.
• Given expiration approaching, subsequent patenting strategies should focus on derivatives, formulations, or new therapeutic uses to prolong exclusivity.
• Clear understanding and precise drafting are pivotal for maximizing enforceability and commercial value within the competitive pharmaceutical sector.

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FAQs

1. What is the primary innovation protected by U.S. Patent 7,141,593?
The patent primarily protects a chemical class of compounds with specific structural features and their use in treating particular diseases, as defined in the independent claims.

2. How broad are the claims in the '593 patent?
Claims are structured to cover a range of compounds within a chemical scaffold, and their therapeutic application, balancing broad protection with specificity to withstand prior art challenges.

3. What risks exist for infringement or invalidation?
Risks include infringing compounds that fall within the claim scopes and invalidation arising from prior art disclosures that predate the patent or fail inventive steps.

4. How does this patent fit within the broader landscape of pharmaceutical patents?
It likely exists within a cluster of related patents targeting similar chemical classes or indications, contributing to a patent thicket that secures market exclusivity.

5. Can the lifespan of patent protection beyond 2026 be achieved?
Yes, through secondary patents on derivatives, formulations, or new therapeutic uses, or via regulatory exclusivities, to extend market protection.

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References

1. US Patent 7,141,593. United States Patent Office, 2006.
2. [Related literature or patent family data as applicable.]

Drugs Protected by US Patent 7,141,593

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate