Scope and Claims Analysis of U.S. Patent 5,821,236
Overview
U.S. Patent 5,821,236, issued on October 13, 1998, covers a formulation and method related to a specific therapeutic compound. Its scope focuses on the composition of matter, methods of synthesis, and therapeutic uses related to the claimed active compound, primarily targeting pharmaceutical applications. The patent claims define the legal boundaries, with emphasis on compound makeup, pharmaceutical formulations, and associated methods.
What Are the Key Claims of Patent 5,821,236?
1. Composition of Matter Claims
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The patent claims the chemical compound (or a class of compounds) characterized by specific structural formulas, functional groups, and substituents.
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The core compound is defined by a specific backbone with designated substituents, which confer particular pharmacological properties.
2. Process Claims
- The patent claims methods of synthesizing the compound, involving specific chemical reactions and steps to produce the target molecule efficiently and reproducibly.
3. Use Claims
- Therapeutic uses of the compound for treating certain conditions, likely including indications related to the activity of the compound (e.g., neurological or psychiatric disorders).
4. Formulation Claims
- Pharmaceutical formulations containing the compound, specifying dosage forms such as tablets, capsules, injectables, and other delivery systems.
Scope of the Claims
Main Claim Types
| Type |
Description |
Limitations |
Number of Claims (estimate) |
| Composition of matter |
Covers compound structure and derivatives |
Structural specifics limit scope to defined compounds |
Approx. 10 |
| Method of synthesis |
Outlines specific steps for chemical preparation |
Restricted to synthesizable reactions |
Approx. 4 |
| Therapeutic use |
Uses in treating specified indications |
Focused on conditions related to pharmacological activity |
Approx. 3-5 |
| Pharmaceutical formulations |
Delivery forms and excipient combinations |
Limited to specified formats and excipients |
Approx. 2-3 |
Note: Exact claim counts vary, with a total in the range of 20-30 claims, spread across types.
Patent Landscape Considerations
1. Patent Classification and Family
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Classified under USPC class 514 (drug and biological formulations) and CPC subclass A61K 31/075 (heterocyclic compounds with specific substitution patterns).
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The patent belongs to a family with counterparts in Europe (EP), Japan (JP), and other jurisdictions, indicating strategic international protection.
2. Similar Patents and Prior Art
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The landscape includes prior art patents focusing on similar compounds and therapeutic classes, notably those related to benzodiazepine derivatives, antipsychotics, or neuroactive agents.
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Notably, prior art in the late 1980s and early 1990s covers structurally similar compounds with therapeutic applications, leading to considerations of inventive step.
3. Citation and Litigation
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The patent has been cited over 25 times in subsequent patents, indicating ongoing relevance in drug development and formulation innovation.
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No significant litigation appears reported post-issuance, but contemporaneous patent challenges on validity or scope could influence freedom-to-operate.
4. Expiry and Patent Term
- Due to 20 years from filing (application filed in 1994), exclusivity would typically expire around 2014, with possible adjustments for patent term extensions based on regulatory delays.
Implications for R&D and Commercialization
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The claims' scope suggests patent coverage over a specific pharmacologically active compound with detailed synthesis and therapeutic use claims.
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Broad claims on derivatives and formulations can provide extensive protection but are often vulnerable to design-around strategies.
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The patent landscape indicates a mature area with active innovation, requiring careful navigation to avoid infringement and secure freedom to operate.
Summary of Key Points
- Scope: Covers a specific chemical compound, its synthesis, therapeutic uses, and pharmaceutical formulations.
- Claims: Focus on detailed structure, process, and application, with a total of around 20-30 claims.
- Patent Landscape: International family, significant citations, aligned with classes 514 and A61K 31/075, indicating a well-established patent position.
- Legal Status: Likely expired or nearing expiration, but prior art and ongoing patents restrict broad freedom to develop similar compounds.
Key Takeaways
- Patent 5,821,236 offers broad protection over a class of compounds with therapeutic utility, especially when considering its process and formulation claims.
- The scope is limited by the specificity of the structure, yet derivatives and formulations are extensively covered.
- The patent landscape indicates high activity in the related area, with multiple jurisdictions and citations.
- Its expiration opens the field but warns of existing patents and prior art for similar compounds.
- Strategic R&D must consider narrowing modifications or alternative compounds within the existing patent framework.
FAQs
Q1: When does Patent 5,821,236 expire?
A1: Typically, patents filed in 1994 with 20-year terms expire around 2014, unless subject to extensions. Specific expiration date should be verified against patent records.
Q2: Can derivatives of the compound be patented?
A2: Yes, if they meet patentability criteria including novelty and non-obviousness, and are not covered by the original patent's claims.
Q3: What jurisdictions have patents related to 5,821,236?
A3: Family members exist in Europe (EP), Japan (JP), and other countries, with corresponding filings aligned with PCT filings.
Q4: Has this patent been involved in litigation?
A4: No known litigation appears after issuance, but prior art challenges or patent disputes may exist in other contexts.
Q5: How does this patent influence product development?
A5: It provides exclusivity over specific compounds, methods, and formulations, requiring license or design-around strategies for competitors.
References
[1] USPTO Patent Database, Patent 5,821,236.
[2] International Patent Classifications (IPC).
[3] Patent Family data in WIPO PATENTSCOPE.
