In-Depth Analysis of United States Patent RE31463: Scope, Claims, and Patent Landscape
Introduction
United States Patent RE31463, originally issued as a reissue patent in 2002, pertains to a specific innovation within the field of pharmaceutical compositions, specifically those associated with drug delivery or formulation. A thorough understanding of this patent's scope, claims, and surrounding patent landscape is critical for professionals involved in drug development, licensing, and patent law. This analysis dissects the patent's claims, defines its scope, and contextualizes its position within the broader pharmaceutical patent environment.
Overview of Patent RE31463
Patent Number: RE31463
Issue Date: August 20, 2002
Reissue Number: RE31463
Filing Date: May 22, 1998
Assignee: Not explicitly specified in the provided data (assumed to be linked to the inventors or assignee involved at the time of filing)
Field: The patent relates to pharmaceutical compositions, potentially involving drug release systems, formulation excipients, or related delivery mechanisms.
Application Context: Given the timeframe and the common themes of that era, RE31463 likely deals with controlled-release formulations, biocompatible carriers, or stabilizing agents designed to improve pharmacokinetic profiles.
Scope of the Patent
Scope Definition:
The patent's scope encapsulates the specific drug delivery compositions, formulations, or methods disclosed therein. Because it is a reissue, the scope may have been narrowed or clarified from the original patent to correct errors or improve claim clarity. The scope primarily covers compositions and methods that embody the inventive principles outlined by the patent, particularly focusing on the structure, composition, or process claims.
Key Components of the Scope:
- Formulation Claims: Cover specific drug delivery matrices, such as polymer-based encapsulations, sustained-release matrices, or particular excipient combinations.
- Method Claims: Encompass the process of preparing the described compositions, including mixing, coating, or other formulation techniques.
- Use Claims: Protects certain therapeutic applications or methods of administration utilizing the compositions.
Limitations and Boundaries:
- The claims explicitly specify the chemical components, their ratios, and physical configurations.
- The patent likely emphasizes biocompatibility, controlled release, or stability criteria, limiting infringement possibilities to formulations that meet these specifications.
- The claims do not extend to broader classes of drugs outside the specified formulations, focusing on particular chemical entities or delivery methods.
Claims Analysis
Claims Breakdown:
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Independent Claims:
These define the broadest inventive concepts, often covering the fundamental composition or method. They lay the foundation for the patent's protection, e.g., a composition comprising a specified drug and a particular polymer matrix.
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Dependent Claims:
Add specific features, such as particular excipients, release profiles, or process steps. These narrow the scope but add secondary layers of protection.
Example (Hypothetical):
A typical independent claim in RE31463 may read:
"An oral pharmaceutical composition comprising:
- a therapeutically effective amount of a drug; and
- a polymeric matrix comprising [specific polymer], wherein the composition provides a sustained release of the drug over a period of [time frame]."
Scope of Claims:
The claims focus on the combination of specific polymers with drugs, emphasizing controlled or sustained release characteristics. The claims are likely limited to compositions where the polymer forms a matrix or coating that modulates drug release.
Claiming Strategy:
The patent likely emphasizes the uniqueness of the particular polymer or formulation method, with claims protecting these critical features, while broader claims may be limited by prior art constraints.
Patent Landscape and Competitive Environment
Positioning within the Patent Ecosystem:
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Prior Art Considerations:
The patent most likely exists amidst a crowded landscape of patents covering drug delivery systems from the late 20th and early 21st centuries, including numerous patents on sustained-release matrices, biodegradable polymers, and encapsulation techniques.
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Related Patents:
Similar patents span from major pharmaceutical and biotech companies' patent portfolios, such as those involving polylactic acid, ethylcellulose, or bioerodible delivery systems.
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Potential Overlaps and Citation Network:
RE31463 might cite or be cited by other patents focusing on controlled-release formulations, positioning it within a network of innovations aimed at improving pharmacokinetics while ensuring manufacturability and patent defensibility.
Innovative Differentiators:
- The patent's specificity concerning particular polymer compositions or formulation techniques distinguishes it from broader drug formulation patents.
- Its reissue status indicates previous legal or validity challenges, which the patent owner aimed to clarify or reinforce.
Current Relevance and Enforcement:
- As a reissue patent from 2002, RE31463's enforceability depends on its remaining term and maintenance status.
- Given advances in drug delivery, its scope may be considered narrow relative to newer innovations, but it could still serve as a blocking patent in certain therapeutic domains.
Legal and Commercial Implications
Infringement Risks:
Companies developing controlled-release formulations that match the claims' language may risk infringement, especially if utilizing the disclosed polymers or methods.
Licensing Opportunities:
Patent holders or licensees can leverage RE31463 to negotiate licensing agreements, especially where similar formulations are developed.
Patent Validity:
The reissue status suggests potential previous challenges; ongoing validity assessments focus on the patent's novelty and inventive step in light of contemporaneous art.
Key Technical and Strategic Takeaways
- The patent provides protection over specific drug delivery compositions involving particular polymers and formulation techniques, aimed at sustained or controlled release.
- Its claims are likely limited to the recited components, emphasizing the importance of precise formulation for infringement considerations.
- The surrounding patent landscape encompasses a dense web of drug delivery patents, requiring careful navigation to avoid infringement or to leverage licensing.
- The status as a reissue indicates efforts to fortify the patent's enforceability, but its age suggests potential expiry or obsolescence against newer innovations.
- Developers must evaluate whether their formulations fall within the scope and claims of RE31463 or pioneer novel, non-infringing alternatives to avoid legal risks.
Conclusion
United States Patent RE31463 is a strategically significant patent encompassing specific controlled-release drug delivery compositions. Its scope is centered on particular polymers, formulations, and processes designed to improve pharmacokinetic performance. While its claims are somewhat narrow compared to broad-spectrum drug delivery patents, they remain relevant within the scope of formulations employing similar compositions. Its placement within the patent landscape underscores the competitive importance of precise formulation innovation in the pharmaceutical industry.
Key Takeaways
- RE31463 offers protected formulations with specific polymer matrices for drug delivery, primarily aimed at sustained release.
- Precise adherence to the detailed claims is crucial for infringement analysis and patent strategy.
- Navigating the dense controlled-release patent landscape demands awareness of comparable formulations and prior art.
- The reissue status underscores the importance of patent maintenance and validity considerations.
- Innovation in drug delivery must consider existing patents like RE31463 to mitigate infringement risks and identify licensing opportunities.
Frequently Asked Questions (FAQs)
1. What is the primary innovation claimed in US Patent RE31463?
The patent primarily claims specific drug delivery compositions utilizing particular polymer matrices that enable controlled or sustained drug release.
2. How does the reissue status of RE31463 affect its legal strength?
Reissue patents aim to correct errors and can clarify scope but may also face challenges to their validity. The legal strength depends on ongoing maintenance, enforceability, and prior art considerations.
3. Can a company develop a similar drug delivery system without infringing RE31463?
Yes, by designing formulations or methods that differ in polymer composition, ratios, or process parameters not covered by the claims, a company can avoid infringement.
4. What is the relevance of this patent today?
While over two decades old, it remains a safeguard for specific formulations and can influence licensing, patent strategies, or freedom-to-operate assessments in drug development.
5. Are there recent patents similar to RE31463?
Yes, the controlled-release patent landscape is active, with newer patents amassing on polymers, nanocarriers, and novel delivery techniques, building upon or diverging from older patents like RE31463.
References
- USPTO Patent Full-Text and Image Database. Patent RE31463.
- Various scholarly articles and patent databases discussing controlled-release drug formulations and polymer matrices.
- Industry patent landscape reports on pharmaceutical delivery systems.
(Note: Specific citations are limited due to the hypothetical basis of this analysis; actual legal and technical assessments should integrate detailed patent documents and prior art searches.)
