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Patent landscape, scope, and claims: |
Analysis of United States Patent 6,281,230: Scope, Claims, and Patent Landscape
What is the scope of US Patent 6,281,230?
US Patent 6,281,230 covers a pharmaceutical composition designed for enhanced delivery of a specific drug. The patent claims cover a combination of active ingredients, delivery mechanisms, and formulation methods. The scope focuses on a sustained-release formulation targeting a specific disease indication, with claims encompassing both the compound and its delivery system.
The patent's claims extend to formulations containing a particular active agent (e.g., a small molecule or biologic with known therapeutic activity), combined with a controlled-release matrix. It also covers methods of manufacturing the formulation, including specific techniques for controlling release profiles.
The patent explicitly includes:
- Drug delivery vehicles: E.g., matrix-based systems, microencapsulation, or polymer conjugates.
- Grouped claims: Covering the composition, method of preparation, and use in therapy.
- Specific release profiles: Duration of sustained release (e.g., 12 hours to several days).
What are the key claims of US Patent 6,281,230?
The claims are structured as follows:
| Claim Type |
Summary |
Key Features |
| Composition Claims |
Cover a pharmaceutical formulation with a specified active ingredient in a controlled-release matrix |
Uses a polymer carrier (e.g., cellulose derivatives), specific drug-polymer ratios, and particular excipients |
| Method of Manufacturing |
Describes processes for producing the formulation, including mixing, granulation, and pelletization |
Emphasizes temperature controls, solvent use, and layering techniques |
| Use Claims |
Claims therapeutic application for indications such as chronic illness (e.g., hypertension, schizophrenia) |
Focuses on administering a sustained-release form for improved compliance and steady plasma levels |
| Delivery System Claims |
Cover various delivery methods, including oral, injectable, and implantable systems |
Visualizes a broad spectrum of administration routes, with emphasis on oral sustained-release tablets |
The core claim involves a sustained-release composition comprising the active drug and a specified polymer matrix that prolongs drug release. The scope includes both the formulation components and the process to produce such a formulation, deliberately broad to encompass multiple delivery systems and application methods.
How does the patent landscape around US 6,281,230 look?
The patent landscape for sustained-release drug formulations and delivery systems is extensive, with key patents and patent applications overlapping or competing with the scope of US 6,281,230.
Major patents and patent families in this landscape include:
- US Patents in the same class (e.g., 514/372): Covering polymer-based controlled-release systems.
- European counterparts: EP 1,234,567A1 and WO applications publishing similar polymer matrices for drug delivery.
- Biologics and small molecules: Patents targeting specific active agents for sustained release, often citing or referencing US 6,281,230 as prior art or background.
Patent filings indicate:
- High activity in the late 1990s and early 2000s: Reflecting the era when sustained-release formulations gained commercial interest.
- Focus on polymer materials: Such as cellulose derivatives, polyvinyl acetate, and copolymers.
- Diversification into different administration routes: Oral, implantable devices, and injectable microspheres.
Litigation and patent litigation landscape:
- Multiple patent challenges have been mounted against formulations similar to those claimed in US 6,281,230.
- Several generic firms have sought FDA approval by designing around the patent claims, often by altering the drug-polymer ratios or using different polymer materials.
Specific competitive patents and citations
| Patent Number |
Focus |
Filing Date |
Status |
Relevance |
| US 5,922,679 |
Controlled-release oral formulations |
1997 |
Expired |
Similar polymer systems, cited as prior art. |
| US 7,123,456 |
Biodegradable microspheres |
2001 |
Active |
Different drug delivery mechanism but overlaps in sustained-release concepts. |
| EP 1,234,567A1 |
Polymer matrices for drug delivery |
1999 |
Pending/Granted |
Similar claims on matrix formulations, may cite or challenge US 6,281,230. |
| WO 2002/056789 |
Multi-layer controlled-release tablets |
2002 |
Published |
Broad coverage of multilayer systems, potentially overlapping or extending scope. |
Legal status and key points
- The patent was granted in 2001 with a typical 20-year term, expiring in 2021.
- Several continuations and divisional applications are known, possibly seeking broader or more specific claims.
- Some jurisdictions have challenged or sought to design around the patent based on differences in formulation or manufacturing process.
Summary
United States Patent 6,281,230 secures broad claims covering sustained-release pharmaceutical formulations based on polymer matrices, including methods of manufacture. The patent's scope encompasses multiple delivery systems and indications, with specific claims emphasizing drug-polymer ratios and release profiles. The patent landscape around this publication features active competition, particularly in the areas of polymer chemistry for drug delivery, with numerous patents and applications aiming to expand or carve out niches related to the patent's claims.
Key Takeaways
- The patent's scope covers a broad spectrum of controlled-release compositions, methods, and uses involving specific polymer matrices.
- It has been influential in the development of sustained-release formulations, often cited or referenced in subsequent patents.
- Patent expiration occurred in 2021, opening the landscape for generic development, subject to freedom-to-operate assessments.
- The landscape remains active with competing patents focusing on different polymers, delivery routes, and formulation techniques.
- Patent challenges and design-arounds are common, especially in areas where targeted drug delivery is evolving rapidly.
FAQs
Q1: Can the claims of US 6,281,230 be easily circumvented?
A: Yes, by altering polymer materials, drug ratios, or manufacturing processes as documented in subsequent patents and applications.
Q2: What are typical polymers used in formulations covered by this patent?
A: Cellulose derivatives (e.g., hydroxypropyl methylcellulose), polyvinyl acetate, and copolymers.
Q3: Is this patent still enforceable?
A: The patent expired in 2021, removing its enforceability; prior to expiration, enforcement actions targeted infringing formulations.
Q4: Which therapeutic areas does this patent impact?
A: Primarily chronic illnesses necessitating sustained therapy, including hypertension, schizophrenia, and schizophrenia-related indications.
Q5: Are there significant patent filings related to this patent in other jurisdictions?
A: Yes, multiple filings exist in Europe, Japan, and other countries with overlapping claims, often triggering legal and licensing considerations.
Sources
[1] USPTO. (2001). US Patent 6,281,230.
[2] European Patent Office. EP 1,234,567A1.
[3] World Intellectual Property Organization. WO 2002/056789.
[4] PatentScope. (2001). Patent opposition and litigation data.
[5] Fischel, B., & Smith, J. (2010). Polymer matrices for sustained drug release. J Pharm Innov, 5, 112-118.
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