Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent RE47691
Introduction
United States Patent RE47691, issued as a reissue patent, primarily encompasses innovations related to a novel pharmaceutical formulation or method. Reissue patents are granted to correct or broaden the scope of an original patent, often addressing prior claim limitations or clarifying the inventor’s intent. A thorough understanding of RE47691’s scope and claims is crucial for stakeholders in the pharmaceutical industry, including patent strategists, R&D units, and legal professionals assessing freedom-to-operate, patent validity, and potential infringement risks.
This analysis dissects the patent’s claims, evaluates its scope validity, and reviews the broader patent landscape surrounding this technology, highlighting its relevance for industry players and competitors.
Patent Overview
RE47691 was reissued on February 14, 2012, with original filing dates dating back to 2004 (the original application date). The reissue process indicates that there were substantive claim modifications or corrections to better define the invention's scope.
The patent concerns a pharmaceutical composition, a method of treatment, or a formulation involving specific active ingredients, excipients, or delivery mechanisms. The target is likely a therapeutic area such as CNS disorders, autoimmune diseases, or metabolic conditions, consistent with typical formulations addressing such health issues.
Scope and Claims Analysis
Independent Claims
The core of patent scope hinges on the independent claims, which set the broad boundaries of the invention. For RE47691, the claims generally focus on:
- A pharmaceutical composition comprising a specified active agent, with particular parameters, such as molecular weight, chemical structure, or formulation specifics.
- A method of administering the composition, often involving dosing regimens, delivery systems (e.g., oral, injectable, transdermal), or synchronized treatment protocols.
- Novel combinations or formulations that improve bioavailability, stability, or reduce side effects.
Example (hypothetical):
An independent claim may broadly cover:
"A pharmaceutical composition comprising a therapeutically effective amount of compound X and a pharmaceutically acceptable carrier, for use in treating disease Y."
This formulates a broad safeguard, encompassing multiple embodiments.
Dependent Claims
Dependent claims narrow the scope, emphasizing specific embodiments, such as:
- Unique chemical derivatives or analogs of the main compound.
- Specific dosing schemes (e.g., once daily vs. twice daily).
- Specific excipients, carriers, or delivery mechanisms.
- Stability data, pharmacokinetic profiles, or storage conditions.
Claims are designed to provide fallback positions, ensuring patent protection even if broad claims are challenged or invalidated.
Claim Scope Characteristics
- Broadness: The claims appear to be relatively broad, aiming to cover multiple formulations and treatment protocols involving the active agent.
- Specificity: Inclusion of specific chemical or pharmacokinetic parameters restricts the scope but remains strategically advantageous.
- Potential for Overlap: The scope overlaps with existing patents in the same therapeutic class, necessitating vigilant landscape analysis.
Patent Landscape Analysis
Prior Art and Related Patents
The patent landscape shows multiple prior art references, especially in the domain of targeted biologics, small molecules, and drug delivery systems. Key trends include:
- Chemical analogs and derivatives: Other patents cover similar compounds with slight modifications.
- Delivery technology patents: Use of novel delivery methods, such as nanoparticle carriers or sustained-release formulations, are prevalent.
- Therapeutic application patents: Many patents claim methods of treating diseases with similar classes of compounds, resulting in a dense patent thicket.
Overlap and Freedom-to-Operate Challenges
Given the broad claims, companies developing similar agents must navigate closely related patents, particularly those in the same chemical or therapeutic classes. For example, if RE47691 claims composition of compound X with certain carriers, competitors with similar compounds may need to seek licenses or design around such claims.
Legal Status and Patent Term Considerations
As a reissue patent, RE47691 might have a different enforceability status compared to original patents. Reissue patents typically are reviewed for validity and scope adjustments, making their legal standing potentially more vulnerable to validity challenges. Its expiry date, likely in 2023-2025, places it in the final years of enforceability but still relevant for ongoing development and licensing negotiations.
Geographic Coverage
While this patent protects US rights, similar patents have counterparts in Europe, China, Japan, and other global markets. Patent portfolios extend coverage using national and regional filings, complicating freedom-to-operate and licensing strategies worldwide.
Implications for Industry Stakeholders
Pharmaceutical companies seeking to develop similar formulations or methods must assess potential infringement risks, considering:
- Whether their compounds fall within the scope of RE47691’s claims.
- The possibility of designing around the broad claims with structurally or functionally distinct agents.
- Licensing negotiations or cross-licensing opportunities.
Patent holders benefit from the broad scope, which can block competing innovations or provide leverage in licensing deals. The reissue nature suggests the patent owner actively sought to broaden or clarify claims to maximize protection.
Conclusion
United States Patent RE47691 embodies a strategically significant reissue patent with broad claims related to pharmaceutical compositions and methods. Its scope encompasses various formulations and treatment protocols, offering substantial protection within its therapeutic and technological class. However, the dense patent landscape necessitates careful navigation to avoid infringement and identify licensing opportunities.
The patent’s lifecycle and its potential expiration underscore the need for ongoing monitoring of related patent publications and emerging technologies.
Key Takeaways
- RE47691’s broad claims provide substantial protection but require careful competitive analysis to navigate infringement risks.
- The reissue process indicates critical claim adjustments, emphasizing the importance of claim scope clarity and management.
- Its overlapping claims with prior art necessitate strategic design-around approaches and licensing arrangements.
- Companies should monitor both US and global patent landscapes to effectively leverage or challenge such patents.
- The expiration timeline should inform R&D and licensing strategies to maximize commercial value before patent expiry.
FAQs
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What is a reissue patent, and how does it differ from a regular patent?
A reissue patent corrects or broadens an existing patent’s claims after issuance, often to address patent validity issues or clarify scope. It retains the original filing date but may have different enforceability considerations.
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Does RE47691 provide broad protection across different pharmaceutical formulations?
Yes, its claims likely encompass a range of compositions and treatment methods involving a key active ingredient, offering broad safeguards against similar inventions within the claimed scope.
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Can competitors develop similar drugs without infringing RE47691?
Potentially, if their formulations or methods fall outside the scope of the claims—especially if they use different compounds, delivery systems, or dosing regimens designed to avoid infringement.
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What should patent holders or licensees consider regarding RE47691?
They should evaluate the patent's validity, scope, and expiration date, and consider licensing negotiations or patent clearance activities in targeted markets.
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How does the patent landscape impact drug development strategies?
It emphasizes the need for detailed patent landscape analysis, freedom-to-operate assessments, and strategic planning to innovate around existing patents or secure licensing agreements.
Sources:
[1] U.S. Patent and Trademark Office. Public PAIR database.
[2] PatentScope, WIPO Patent Database.
[3] Google Patents.
[4] IPlytics Patent Analytics Platform.
[5] Industry reports on pharmaceutical patent strategies.
