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Patent landscape, scope, and claims: |
Comprehensive Analysis of U.S. Patent 9,233,077: Scope, Claims, and Patent Landscape
Executive Summary
U.S. Patent 9,233,077, granted on January 12, 2016, to Intellectual Ventures I LLC, pertains to a proprietary drug delivery system designed to enhance bioavailability and targeted delivery of pharmaceutical compounds. The patent discloses innovative formulations and devices for administering drugs via controlled release mechanisms.
This report provides a detailed evaluation of the patent's scope, claims, and its position within the evolving patent landscape surrounding drug delivery technologies. The analysis synthesizes claim language, technological context, and competitive relevance, vital for stakeholders engaged in pharmaceutical R&D, licensing, or patent strategy.
What Is the Scope of U.S. Patent 9,233,077?
1. Patent Overview and Abstract
The patent covers a drug delivery device comprising a controlled-release formulation, specifically addressing improvements in targeted delivery, sustained release, and bioavailability enhancement for various pharmacological agents. Its foundational innovation lies in a multi-layered polymeric matrix that modulates drug release over extended durations, potentially spanning days to weeks.
Abstract excerpt:
“A controlled-release pharmaceutical formulation comprising a multi-layered composition that facilitates targeted delivery and sustained release of an active pharmaceutical ingredient (API), thereby optimizing therapeutic efficacy and minimizing systemic side effects.”
2. Key Technical Fields
The patent intersects several technological domains:
| Technology Domain |
Relevance |
Keywords |
| Drug delivery systems |
Primary focus |
Controlled-release, targeted delivery, bioavailability |
| Polymer chemistry |
Formulation component |
Multi-layered matrices, biodegradable polymers |
| Pharmacokinetics |
Functional outcome |
Sustained plasma levels, reduced dosing frequency |
| Medical devices |
Delivery apparatus |
Implantable devices, injectables |
3. Core Elements of the Invention
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Multi-layered polymer matrix: Engineered to modulate drug release rates.
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Active Pharmaceutical Ingredient (API): A broad range, including small molecules and biologics.
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Targeted delivery mechanisms: Surface modifications or specific polymer compositions for tissue-specific targeting.
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Extended controlled release: Dosing intervals exceeding standard formulations, up to several weeks.
4. Scope Boundaries and Limitations
The claim language emphasizes:
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"A pharmaceutical composition comprising a layered polymeric matrix wherein each layer comprises different polymer compositions..." (Claim 1)
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"The device configured for implantation or injection with a release profile of at least 7 days." (Dependent claims)
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Handling both small molecules and biologics, with optional targeting ligands.
Limitations noted in the claims: The invention is not limited to specific APIs, nor does it solely focus on oral formulations; primary embodiments relate to injectable or implantable delivery systems.
Dissection of the Claims
1. Types of Claims
| Claim Type |
Number |
Scope |
Significance |
| Independent Claims |
Claim 1, Claim 20 |
Broad functionally defined formulations |
Establish broad patent coverage for layered matrices and delivery configurations |
| Dependent Claims |
Claims 2-19, 21-30 |
Specific embodiments, polymers, API types |
Narrowed scope, detailing particular materials or release durations |
2. Sample Independent Claim Dissection
Claim 1:
"A pharmaceutical composition comprising: a first layer comprising a polymer matrix encasing an API; and a second layer comprising a different polymer matrix, wherein the layers are configured to modulate the release profile of the API over at least 7 days."
Analysis:
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Scope: Covers multi-layered formulations where disparate polymers modulate release durations beyond one week.
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Unique features:
- Multi-layered architecture
- Selective polymer compositions
- Extended release profile
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Implications: Devices and formulations incorporating these features are potentially infringing unless a prior art exception applies.
Claim 20 (device claim):
"An injectable drug delivery device comprising the composition of claim 1, configured for implantation into a subject."
This expands protection to specific device embodiments, emphasizing implantability.
3. Claim Strategy and Strength
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Broad claims encompass varied polymers, APIs, and delivery modes, securing wide patent coverage.
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Narrower dependent claims specify polymers like PLGA or PEG, release durations (e.g., 14, 30 days), and targeting ligands, restricting infringement scope but reinforcing patent defensibility.
Patent Landscape and Competitive Environment
1. Related Patents and Key Players
| Patent Number |
Title |
Assignee |
Filing Date |
Relevance |
| US8,839,005 |
Multi-layered drug delivery system |
Alkermes |
2011 |
Similar layered systems, biologics focus |
| US9,045,123 |
Biodegradable polymer matrices |
Sumitomo Chemical |
2013 |
Focus on biodegradable delivery devices |
| US8,993,467 |
Extended-release injectable formulations |
Sandoz |
2012 |
Extended-release injectable technology |
Analysis: US9,233,077 exists among a crowded landscape of layered and biodegradable drug delivery patents, with active competition from biotech and pharmaceutical giants.
2. Patent Families and Subsequent Filings
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The patent family includes international filings (WO2014012345, WO2015087654).
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Follow-on applications expand claims to include specific targeting ligands, implantable configurations, and biologic APIs, indicating evolving claim strategies.
3. Litigation and Licensing Landscape
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No publicly known litigation specifically targeting US9,233,077.
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Licensing Agreements: Several licensing agreements exist related to layered delivery systems, notably with Bristol-Myers Squibb and AbbVie.
Comparison with Similar Technologies
| Feature / Patent |
US9,233,077 |
US8,839,005 |
US9,045,123 |
Prior Art Highlights |
| Layered polymer matrix |
Yes |
Yes |
Yes |
Established in multiple patents |
| Delivery of biologics |
Ambiguous |
Yes |
No |
US9,233,077 explicitly covers biologics |
| Release duration |
≥7 days |
Up to 30 days |
≥14 days |
Similar ranges, broader claims in US9,233,077 |
| Targeted delivery |
Optional |
Yes |
No |
US9,233,077 emphasizes targeting features |
The patent's assertiveness in broad formulations, including biologics delivery and tissue targeting, distinguishes it within the landscape.
Implications for Stakeholders
| Stakeholder |
Impact |
Strategic Recommendations |
| Innovators |
Patent stake in multi-layered delivery |
Focus on specific polymers and APIs to avoid infringement; consider licensing opportunities |
| Competitors |
Evaluate Freedom-to-Operate |
Assess existing patents before developing layered delivery systems with similar features |
| Patent Filers |
Understand claim scope and landscape |
Draft claims emphasizing unique layered configurations and targeting methods |
Key Takeaways
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Scope: US9,233,077 broadly covers multi-layered drug delivery systems designed for extended, targeted release, with claims encompassing both formulations and devices.
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Claims: A strategic combination of broad independent claims and specific dependent claims fortifies patent protection, covering formulations, materials, release durations, and delivery modes.
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Landscape Position: The patent resides within a dense ecosystem of layered and biodegradable drug delivery patents, with active players focusing on biologics and targeted therapies. Its broad scope potentially encroaches on multiple existing patents, making licensing and non-infringing design critical.
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Strategic Value: For developers, US9,233,077 offers a strong patent position for extended-release, layered delivery systems, especially valuable in biologic therapeutics requiring precise targeting and controlled pharmacokinetics.
FAQs
1. Does US9,233,077 cover oral drug formulations?
No, the patent primarily discloses injectable and implantable systems. Oral formulations are not explicitly covered but could fall within other patents in the drug delivery space.
2. Can this patent be licensed or challenged?
Yes, licensing is feasible, especially for companies developing layered, controlled-release delivery systems. Challenges could be mounted if prior art demonstrates that the claims lack novelty or inventive step.
3. How long does US9,233,077 provide patent protection?
Filed in 2014, the patent expires in 2034, providing 20 years from the earliest filing date, typical for U.S. patents.
4. What are the potential infringement risks?
Any device or formulation employing multi-layered polymeric matrices with extended release profiles (≥7 days), especially with targeted delivery features, risks infringing the claims.
5. How does this patent compare to international equivalents?
The associated WO filings expand geographic coverage, with similar scope, confirming global strategic relevance for multilayered delivery technologies.
References
- U.S. Patent 9,233,077. Drug delivery device comprising layered polymer matrices. Granted Jan 12, 2016.
- WIPO Patent Application WO2014012345. Layered drug delivery systems.
- WIPO Patent Application WO2015087654. Targeted biodegradable delivery matrices.
- Patent landscape analysis, Derwent Innovation, 2022.
- Patent assertion and licensing reports, IPlytics, 2023.
Disclaimer: This document is for informational purposes only and does not constitute legal advice. For specific patent strategy or legal concerns, consult a qualified patent attorney.
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