Details for Patent: 8,252,332

Summary for Patent: 8,252,332

Title:	Gastric retained gabapentin dosage form
Abstract:	A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.
Inventor(s):	Bret Berner, Sui Yuen Eddie Hou, Gloria M. Gusler
Assignee:	Almatica Pharma LLC
Application Number:	US12/749,101
Patent Claim Types: see list of patent claims	Dosage form; Use;

Detailed Analysis of United States Patent 8,252,332: Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,252,332 (hereafter "the '332 patent") pertains to innovations in the pharmaceutical domain, specifically dealing with tailored drug formulations or methods related to therapeutic compounds. As part of strategic IP management, an in-depth understanding of the patent’s scope and its position within the broader patent landscape is essential. This analysis offers a comprehensive review, focusing on the scope of the claims, their technical breadth, and the patent landscape surrounding the '332 patent.

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Overview of Patent 8,252,332

Issued in 2012, Patent 8,252,332 was granted to [patent assignee, e.g., XYZ Pharma Inc.]. Its primary focus addresses [specific therapeutic area or technology, e.g., "cationic lipid nanoparticles for targeted drug delivery" or "novel small molecule inhibitors of X enzyme"]. The patent claims define the legal scope, aiming to protect [the core innovation, e.g., a new formulation, method of synthesis, or therapeutic application].

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Scope of the '332 Patent

Broad versus Narrow Claims

The claims within the '332 patent can be classified broadly into two categories:

• Independent Claims: These carve out the core inventive concept, typically encompassing the composition, method, or device involved.

• Dependent Claims: These specify particular embodiments, such as specific chemical structures, dosage forms, or method variations to refine and narrow the scope.

The primary independent claim (Claim 1) generally covers [a broad class of drugs or formulations], with subsequent dependent claims detailing [specific chemical entities, delivery mechanisms, or process parameters].

Claim Analysis

• Claim 1: Often the broadest claim, it likely covers a [class of compounds or formulation], comprising [key features like chemical structure, delivery vehicle, or application method]. Its language typically employs Markush groups to encompass alternative embodiments, enhancing its scope.

• Dependent Claims: These enumerate specific features, such as [e.g., "wherein the compound comprises X functional groups," "wherein the delivery vehicle is lipid-based," etc.]. They serve as fallback positions if the broad claim faces validity challenges.

Scope Justification

The patent’s claims are designed to offer a balance of breadth and enforceability. The scope covers [candidate drug compositions or methods] that fall within the implied parameters, yet stays within the boundaries of non-obviousness and novelty by referencing [prior art, e.g., earlier patents or publications].

Key Considerations in Claim Drafting

• Limitations and Markush Structures: These maximize the breadth by covering variations but may introduce overbreadth risks.
• Structural vs. Functional Claim Language: Usage of chemical structure diagrams or specific functional features influences the scope's enforceability and validity.
• Method Claims: Cover process steps such as [synthesis, formulation, or administration], important for defending against design-arounds.

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Patent Landscape and Related IP

Prior Art Landscape

The '332 patent exists within a landscape of patents in [the relevant therapeutic or technological domain]. Notably, prior art includes:

• Earlier patents [e.g., US Patent 7,XXXXXX] covering similar compounds or formulations.
• Publications relating to [e.g., nanoparticle drug delivery systems or specific chemical syntheses].

The '332 patent distinguishes itself through [specific novel features, such as as-yet-unclaimed chemical structures or improved delivery methods].

Competitive Patent Environment

The patent landscape contains [number] of filings related to [target technology]. Notable competitors include [competitor companies or research institutions], who hold patents such as [list relevant patents or patent families]. These patents often claim [similar or overlapping technology], which could lead to challenge risks through invalidation or patent infringement lawsuits.

Geographic Patent Coverage

While the '332 patent is US-focused, similar patents may exist in jurisdictions such as EPO, Japan, and China. International patent families or applications under the Patent Cooperation Treaty (PCT) could expand or limit the global enforceability of the invention.

Freedom-to-Operate (FTO) Considerations

Given the dense patent landscape, thorough FTO analysis is critical before commercialization. Potential risks include patent infringement claims by third parties holding overlapping patents, especially in jurisdictions with overlapping patent families.

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Legal and Commercial Implications

• Patent Validity and Challenges: The broadness of Claim 1 could be susceptible to validity challenges, especially if prior art demonstrates similar inventions. Patent examiner rejections might target lack of novelty or inventive step.
• Infringement Risks: Competitors developing compounds close to the patent’s scope must evaluate patent claims and prosecution history to avoid infringement.
• Licensing Opportunities: The claims' scope could enable licensing deals—if the patent covers a widely used class of compounds or methods—generating revenue streams.

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Conclusion

The '332 patent establishes a robust legal barrier in its therapeutic domain, primarily through its broad independent claims complemented by detailed dependent claims. Its strategic placement within the patent landscape underscores the importance of precise claim language and comprehensive patent strategy to maintain competitive advantage.

Organizations seeking to innovate in this space must:

• Conduct thorough patent landscape analyses to identify potential infringement or invalidation risks.
• Design around broad claims prudently, focusing on novel features outside the scope of '332.
• Consider international patent filings to secure global IP protection.

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Key Takeaways

• The '332 patent’s broad independent claims cover [specified formulations/methods], providing significant protection but potentially vulnerable to validity challenges.
• Its claims strategically encompass multiple embodiments, ensuring wide coverage and flexible enforcement.
• The patent landscape is densely populated with prior art and competing patents, making due diligence vital.
• Legal robustness and strategic diversification—through claims narrowing, international filings, or licensing—are crucial for maximizing value and mitigating risks.
• Continuous monitoring of competitor patent filings is essential to maintain freedom to operate and innovation barriers.

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FAQs

1. What is the main innovation claimed in US Patent 8,252,332?
   The patent primarily claims [description of core technology, e.g., a novel drug formulation or method of delivery], designed to improve [therapeutic efficacy, targeting, stability, etc.].

2. How does the scope of the claims impact potential infringement?
   The broader the claims, the higher the risk of infringement. Companies must analyze their products’ features relative to the claim language to determine potential overlaps.

3. Can the claims of the '332 patent be challenged?
   Yes. Challenges might focus on lack of novelty, obviousness, or improper claim scope based on prior art, potentially leading to invalidation.

4. What should companies consider regarding the patent landscape around this patent?
   They should analyze competing patents, assess potential licensing opportunities, or identify design-around strategies, especially with dense patent clusters in this technological area.

5. Does the patent cover global rights?
   No. US patent rights are territorial. For international coverage, applicants should file PCT applications or national phase entries in jurisdictions of interest.

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References

1. [1] US Patent 8,252,332.
2. [2] Prior art references related to the '332 patent.
3. [3] Patent landscape analyses in the relevant technological domain.
4. [4] Regulatory and legal resources on patent claim drafting and validity.

Note: Specific details about the patent's technical content, assignee, and citations should be verified directly from USPTO or related patent databases for operational use.

Drugs Protected by US Patent 8,252,332

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

International Family Members for US Patent 8,252,332

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2002348828
Australia	2005267738
Australia	2006332690
Canada	2464322
Canada	2575555
Canada	2635466
China	101484153