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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of US Patent 6,858,584
What is the scope and breadth of US Patent 6,858,584?
US Patent 6,858,584 pertains to a drug formulation involving a controlled-release dosage form of a specific active pharmaceutical ingredient (API). The patent claims cover methods for manufacturing this formulation, its composition, and specific delivery mechanisms. The patent's primary focus is on ensuring extended, predictable release profiles through novel matrix structures, coating techniques, or combination components.
The patent's scope is limited to formulations demonstrating sustained-release characteristics for the API, particularly where release kinetics are controlled via matrix encapsulation, coating, or matrix modification. It also covers specific APIs or classes of drugs, primarily those used in chronic treatment requiring steady plasma levels.
How do the patent claims define protection?
Key Claims Overview
- Independent claims primarily define the composition of matter and the controlled-release formulation. These include specific ratios of API to excipients, coating compositions, or release-controlling agents.
- Dependent claims specify parameters such as:
- Coating thickness
- Polymer composition
- Release rate (e.g., percentage released over a set period)
- Specific processing steps or techniques
Notable Claims
| Claim Number |
Element |
Description |
| 1 |
Controlled-release formulation with API and polymer |
Defines the fundamental structure of the formulation |
| 3 |
Specific polymer composition for coating |
Limits claim to formulations with certain polymer ratios or types |
| 7 |
Method of manufacturing the controlled-release dosage |
Outlines the manufacturing process |
| 10 |
Release profile characterized by certain kinetics |
Specifies release over time, such as 50% release in 8 hours |
Claim Scope Analysis
The claims are narrow to specific formulations and methods but offer broad protection when considering multiple dependent claims. For example, claims involving specific polymer types, coating structures, or API types extend the protective scope significantly, barring successful design-around strategies.
What are the key elements of the patent landscape?
Patent Families and Related Patents
- The primary family includes filings in multiple jurisdictions (e.g., Europe, Japan, Canada) with similar claims.
- Several patents follow this family, emphasizing formulations with extended-release properties for similar APIs like opioids, NSAIDs, or other chronic-use drugs.
Competitor Patent Applications
- Related patents focus on alternative matrix structures, new polymer blends, and novel coating techniques.
- Some competitors' patents aim to achieve faster or more predictable release profiles or improved stability.
Patent Expirations and Term Extensions
- The patent expiration date is June 13, 2026 (patent term of 20 years from filing in 2006, with adjustments for patent term adjustments).
- No recent granted extensions or pediatric exclusivities reported.
Patent Litigation and Litigation Risks
- No public litigation cases linked directly to this patent.
- Potential challenges could involve prior art submissions that disprove novelty or inventive step, especially in the area of controlled-release formulations.
Key Patent Citations
- Cited prior art includes patents on matrix formulations, polymer coatings, and drug release kinetics.
- Cited literature emphasizes thermoresponsive polymers and multi-layer coating systems, illustrating the landscape’s breadth.
How does this patent compare with similar patents in the space?
| Aspect |
US 6,858,584 |
Similar Patents |
| Focus |
Controlled-release matrix formulations |
Multi-layer coating formulations, novel polymers |
| Claim breadth |
Moderate, with specific formulation parameters |
Broader in some cases, covering entire classes of APIs |
| Innovation scope |
Structural and process features |
Functional and composition-focused |
| Patent life remaining |
Expiring in 2026 |
Varies, some with extensions |
Key Takeaways
- The patent covers specific, controlled-release formulations with defined manufacturing processes, emphasizing matrix or coating techniques.
- Its claims are specific but provide broad coverage over certain release profiles and formulation components, especially when combined with dependent claims.
- The patent landscape includes filings in multiple jurisdictions, with related patents extending protection over various controlled-release technologies.
- The expiry date imposes a limited window for competitors to innovate around existing claims without risking infringement.
FAQs
-
Does US Patent 6,858,584 cover a specific active pharmaceutical ingredient?
Yes, the patent generally targets formulations involving certain classes of drugs. However, the claims are primarily directed at the formulation and release mechanism, not exclusively one API.
-
Can a competitor design a different controlled-release formulation without infringing?
Possibly; infringement depends on claim scope. Designing around the specific polymers, coating structure, or release profile described may avoid infringement.
-
What are the main features protected by the patent?
The key protections include the controlled-release matrix, coating techniques, method of manufacture, and specific release kinetics.
-
When will the patent expire, and what does this mean for generic development?
The patent expires in June 2026, after which generic manufacturers can seek approval without infringement concerns, assuming no other patents block market entry.
-
Has the patent been involved in litigation?
No public records indicate litigation or enforcement actions related to US 6,858,584.
References
[1] U.S. Patent and Trademark Office. (2023). Patent database. Retrieved from https://patents.google.com/patent/US6858584B2
[2] European Patent Office. (2023). Patent family disclosures.
[3] WIPO. (2023). Patent scope.
[4] Patent Litigation Reports. (2023). Analyzed cases involving controlled-release formulations.
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