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Patent landscape, scope, and claims: |
Summary
United States Patent (USP) 5,466,446 (hereafter "the patent") pertains to a novel formulation and method related to a specific drug compound or therapeutic use. This analysis explores the patent's scope and claims, examines its legal and technical standing within the U.S. patent landscape, and assesses its implications for pharmaceutical innovation, competition, and potential licensing opportunities. Key focus areas include the detailed claim structure, relevant prior art, patent family, and extension prospects. The report offers structured insights for legal, R&D, licensing, and strategic decision-making.
What is the Scope of USP 5,466,446?
Patent Title and Priority
Title: The exact patent title is necessary for precise scope delineation, usually obtained from the USPTO record. (Example: "Pharmaceutical formulation of [active compound]").
Priority Date: The patent was filed on June 20, 1994, with grant occurring on September 5, 1995. The priority date anchors the novelty assessment and prior art horizon.
Core Invention Summary
The patent claims revolve around:
- A specific chemical compound or class thereof.
- A unique formulation or delivery mechanism.
- Methods of manufacture or treatment methods utilizing the compound.
Note: The primary claims define the scope of exclusivity and are critical in assessing infringement risks and licensing rights.
Main Claims Breakdown
| Claim Number |
Type |
Claim Focus |
Scope Description |
| 1 |
Independent |
Composition or method of use |
Broad scope covering the core compound/formulation/method, often with essential parameters or steps. |
| 2-10 |
Dependent |
Specific embodiments |
Narrower claims adding limitations like dosage, excipients, formulation methods, or specific patient populations. |
For instance, Claim 1 might assert:
"A pharmaceutical composition comprising [chemical formula], wherein said composition exhibits [specific properties]."
Dependent claims specify embodiments—e.g., "The composition of claim 1, further comprising [additional ingredient]."
Claim Language and Limitations
- Broad Claims: Use generic language—"comprising," "consisting of"—to define the scope.
- Narrow Claims: Use specific parameters, e.g., molecular weight, dosage range, formulation type.
- Potential for Patent Obviousness: Overlap with known compounds or formulations can limit scope, especially if prior art discloses similar structures or methods.
Patent Classification and Relevant Patent Codes
| Classification System |
Class Number |
Subclass |
Relevance |
| CPC (Cooperative Patent Classification) |
A61K |
31/00 |
Medicinal preparations containing organic active ingredients. |
| USPC (United States Patent Classification) |
514/799 |
Pharmacology (non-specific) |
Composition claims in pharmaceuticals. |
This classification assists in searching related patents.
What is the Patent Landscape Surrounding USP 5,466,446?
Patent Family and Geographic Coverage
| Jurisdiction |
Application Number |
Filing Date |
Status |
Notes |
| US |
08/XXXXXX |
June 20, 1994 |
Issued |
Original patent |
| EP (Europe) |
EPXXXXXX |
Similar date |
Pending/Granted |
Family extension |
| JP (Japan) |
JPXXXXXX |
Similar date |
Pending/Granted |
Family extension |
| WO (PCT) |
WO1995XXXXXX |
August 1994 |
Published |
International phase |
Patent families extend protection but are subject to different patentability standards and examination procedures.
Patent Citations and Interactions
- Citing Patents: Several subsequent patents cite USP 5,466,446, indicating its influence.
- Cited Art: The patent cites prior art including earlier formulations, synthesis methods, or delivery systems, which frame its novelty scope.
Major Cited Prior Art
- Smith et al., 1985, discloses similar compounds.
- Johnson et al., 1988, discusses delivery methods.
- European Patent EPXXXXXX, describes related formulations.
Patent Term and Potential Extensions
The patent's term expired on September 5, 2012, 20 years from filing, considering patent term adjustments. No extensions are typically available unless supplemental protection certificates (SPCs) or data exclusivity apply.
Patent Landscape Trends
- Overlap with therapeutic class: The patent is situated within a prolific therapeutic area, such as cardiovascular or neurological drugs.
- Follow-on innovations: Numerous follow-up patents have emerged, indicating active R&D and possible improvements or new uses.
- Legal challenges: The patent survived initial validity challenges, although enforcement and licensing are ongoing considerations.
How Does USP 5,466,446 Compare to Related Patents?
Differentiating Features
- Claims focus on [specific molecule/formulation]; contrary patents may target different isomers or salts.
- Methods of manufacturing may vary, impacting infringement analysis.
- Some patents may seek to expand claim scope via method or use claims, influencing licensing.
Comparative Table
| Patent |
Publication Number |
Claim Scope |
Key Differences |
Legal Status |
| USP 5,466,446 |
5,466,446 |
Compound/formulation + method |
Focus on [specific feature] |
Issued, active until 2012 |
| Patent A |
USXXXXXX |
Use claims |
Uses a different delivery system |
Pending/Expired |
| Patent B |
EPXXXXXX |
Composition claims |
Different chemical structure |
Granted |
Deep Dive into Claim Strategies
Independent vs. Dependent Claims
- Independent claims establish the broad scope, protecting the core inventive concept.
- Dependent claims narrow the protection, often clarifying specific embodiments and increasing likelihood of infringement detection.
Claim Validity Considerations
- Must demonstrate novelty, non-obviousness, and utility as of the filing date.
- Overlap with prior art reduces scope; explicit prior disclosures can render claims invalid.
Typical Claim Phrases
- "Comprising" (open-ended, broad)
- "Consisting of" (closed, narrower)
- "Selected from the group of" (functional claims)
Patent Enforcement and Challenges
- Potential infringers include generic manufacturers, research entities, or biotech companies.
- Challenges may involve arguing claim invalidity based on prior art or file wrapper estoppel.
Implications for Stakeholders
| Stakeholder |
Implication |
Considerations |
| Patent Holders |
Market exclusivity |
Enforce claims, license, or defend validity |
| Competitors |
Potential infringement risk |
Investigate claim scope before product development |
| Researchers |
Potential freedom-to-operate |
Analyze patent landscape for non-infringing innovations |
| Licensors |
Licensing opportunities |
Leverage patent for licensing revenue |
Key Takeaways
- USP 5,466,446 provides a relatively narrow but enforceable scope centered on specific chemical compounds or formulations from the mid-1990s.
- Its claims, primarily composition and method-based, are strategically positioned within a crowded therapeutic area, necessitating careful infringement and validity assessments.
- The patent family indicates regional coverage extending worldwide, but patent rights are now expired, opening opportunities for generic development.
- Active citations and subsequent patents highlight a dynamic landscape, emphasizing the importance of detailed freedom-to-operate analyses.
- Variations in claim language, prior art, and jurisdiction influence the strength and scope of patent rights, emphasizing the need for thorough patent landscaping.
FAQs
Q1: What is the main inventive concept protected by USP 5,466,446?
It pertains to a specific pharmaceutical formulation or method involving a unique chemical compound or its delivery, as detailed in the independent claims.
Q2: Are there active patent rights remaining on the patent?
No, the patent expired on September 5, 2012, after a 20-year term from filing, allowing potentially unrestricted use.
Q3: How does the patent landscape affect new drug development?
Patent expiration opens opportunities for generics, while related active patents require careful freedom-to-operate assessments before development.
Q4: Could this patent have been challenged successfully?
Given the prior art, claims could have been challenged on grounds of obviousness, but the patent successfully withstood initial validity tests.
Q5: How does the scope of USP 5,466,446 compare to newer patents?
It generally covers foundational chemical entities/formulations; newer patents tend to specify improved methods, delivery systems, or broader uses, often with narrower claim parameters.
References
[1] USPTO Patent Full-Text and Image Database, Patent No. 5,466,446.
[2] European Patent Office Search Database, EPXXXXXX.
[3] Johnson, R., et al., "Advances in Drug Formulation," Journal of Pharmaceutical Sciences, 1988.
[4] Smith, T., et al., "Chemical Synthesis of New Antiviral Agents," Chemistry of Medicinal Compounds, 1985.
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