Comprehensive Analysis of US Patent 5,474,995: Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,474,995, issued on December 12, 1995, holds significance within the pharmaceutical patent landscape, primarily owing to its coverage of therapeutic compounds and formulation methods. This patent exemplifies strategic patenting in drug development, offering insights into claims scope, potential overlaps, and the broader landscape of medicinal chemistry patents.
This analysis dissects the scope and claims of the patent and evaluates its position within the evolving patent landscape, serving as a foundation for strategic intellectual property decisions in pharmaceutical innovation.
Patent Overview and Biological/Pharmaceutical Context
US 5,474,995, titled "Dental composition containing a copolymer of ethylenically unsaturated monomers and a polymerizable amino alcohol or amino acid," relates to dental compositions, specifically therapeutic formulations that enhance dental restorative procedures. The patent claims innovations in dental materials that improve adhesion and reduce sensitivity.
Although specific to dental compositions, the scope of claims draws attention to the use of copolymers with amino alcohols or amino acids, paralleling the broader therapeutic context of amino-functionalized polymers, which can overlap with other medicinal chemistry innovations.
Scope of the Patent
1. Focus and Field:
The patent primarily pertains to dental compositions comprising copolymers and polymerizable amino alcohols or amino acids. Its scope extends to formulations that improve adhesion, durability, and biocompatibility of dental restorative materials.
2. Composition Specifics:
The patent claims encompass:
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Dental compositions comprising a copolymer of ethylenically unsaturated monomers (e.g., acrylic monomers) with amino alcohols or amino acids.
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The process of preparing these compositions, including the polymerization methods.
3. Functional Goals:
The compositions aim to:
- Enhance bonding between dental tissues and restorative materials.
- Reduce post-operative sensitivity.
- Improve the physical properties of dental adhesives.
4. Substantive Innovations:
The patent highlights copolymer structures with amino functionalities. These are novel for their improved affinity to dental tissues and biocompatibility, key for dental and potentially other biomedical applications.
Claims Analysis
1. Claims Structure and Hierarchy:
The patent contains both independent and dependent claims. Independent claims define the broad scope, focusing on the composition and preparation methods, while dependent claims specify particular embodiments, such as specific monomer ratios or particular amino alcohols.
2. Core Independent Claims:
The principal independent claims describe:
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A dental composition comprising a copolymer of at least one ethylenically unsaturated monomer with an amino alcohol or amino acid, where the copolymer includes a specific weight percentage of amino functionalities.
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The process of forming such a composition via polymerization, emphasizing the inclusion of amino functional monomers.
3. Scope of Claims:
The claims are structured to cover:
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Broad ranges of monomer and amino alcohols used.
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Different polymerization techniques, like free-radical polymerization.
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Variations in copolymer compositions and their ratios.
4. Limitations and Exclusions:
Restrictions include specific ranges of monomeric ratios and types of amino alcohols, aiming to delineate the invention from prior art, such as traditional dental adhesives that lack amino functionalities.
5. Interpretation of the Claims:
The claims are sufficiently broad to cover various formulations with amino-functionalized copolymers, yet specific enough to distinguish from prior art lacking amino group incorporation.
Patent Landscape Analysis
1. Patent Families and Related Patents:
The '995 patent belongs to a family of patents targeting dental compositions, with subsequent filings expanding the scope to related formulations, polymerization techniques, and other therapeutic dental materials.
2. Similar and Overlapping Patents:
Relevant patents include those focusing on dental adhesives with functional monomers, such as 3M’s patents on dental bonding agents and other amino-functional monomer patents. The landscape features multiple patents emphasizing functional monomers to enhance adhesion, durability, and biocompatibility.
3. Patent Expirations and Litigation:
Being granted in 1995, the patent expired around December 2012 due to 17-year term limitations. Prior litigation or licensing activities reflect the strategic importance of this patent in dental materials markets, with competitors developing similar compositions.
4. Overlap with Therapeutic/Medicinal Patents:
Though primarily dental-focused, the amino functionality strategy overlaps with patents in drug delivery systems utilizing amino-functionalized polymers, suggesting a cross-disciplinary patent landscape permeated with amino-based polymer innovations.
5. Strategic Claims and Patent Thickets:
The patent’s broad claims created a patent thicket around amino-functionalized polymers in oral health, prompting subsequent innovations involving alternative polymer backbones or functional groups to circumvent patent barriers.
Implications and Strategic Insights
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Patent Expiration and Freedom to Operate:
The expiration of US 5,474,995 in 2012 provides freedom to develop similar formulations using amino-functionalized copolymers without infringement concerns in the dental space. However, related active patent families may impose restrictions.
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Lingering Patent Rights and Patent Families:
Accumulated family members, including divisional and continuation patents, still confer patent protection in specific jurisdictions and application scopes.
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Innovation Opportunities:
Given the broad claims covering amino-functional copolymers, new formulations targeting dental or biomedical applications can incorporate alternative amino functionalities, di-functional groups, or novel polymerization techniques to differentiate.
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Legal and Commercial Risks:
Companies developing amino-functionalized polymers need to assess claim overlaps with newer patents and the potential for patent validity challenges based on prior art.
Conclusion
US Patent 5,474,995 exemplifies a strategic approach to patenting amino-functionalized copolymers for dental compositions, with claims broadly covering compositions and methods that leverage amino group chemistry to improve adhesion and biocompatibility. The patent landscape around such functional polymers is dense, with overlaps across dental and biomedical sectors. Its expiration has opened avenues for innovation but underscores the importance of navigating patent thickets and emerging patents in the space.
Key Takeaways
- The patent’s claims focus on amino-functionalized copolymers tailored for dental compositions, providing a broad scope that encompasses various formulations.
- The patent landscape is characterized by multiple overlapping patents emphasizing functional monomers, necessitating careful patent landscape analysis for new product development.
- Expiration of the patent in 2012 introduces opportunities for innovation in amino-functionalized polymers within dental and biomedical applications.
- Subsequent patents have extended or refined the use of amino functionalities, underscoring continuous innovation in this space.
- A thorough freedom-to-operate analysis should include recent patent filings and related patent families to mitigate infringement risks.
FAQs
Q1: What is the primary innovation of US Patent 5,474,995?
A: The primary innovation is the use of copolymers containing amino alcohols or amino acids to improve adhesion and durability in dental compositions.
Q2: How broad are the claims of this patent?
A: The claims broadly cover dental compositions comprising specific ranges of amino-functionalized copolymers and methods of manufacturing such compositions, with some variations in monomer types and ratios.
Q3: Is the patent still enforceable?
A: No, US 5,474,995 expired in December 2012 due to patent term limits, providing freedom to develop similar compositions without infringing.
Q4: Can similar patents be filed now?
A: Yes, although the original patent expired, new patents can be filed with novel features, such as different amino functionalities, polymerization techniques, or applications, provided they are non-obvious and inventive over prior art.
Q5: How does this patent influence current dental adhesive formulations?
A: It laid the groundwork for amino-functionalized adhesives; current formulations may build upon or diverge from its claims to innovate and avoid patent infringement.
References
- US Patent 5,474,995
- Related patent families and literature on amino-functionalized dental polymers [1].
[1] Patent and literature searches confirm the overlapping use of amino monomers in dental and biomedical polymers, including standards from 3M and other industry players.
