Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 5,213,804
Introduction
United States Patent 5,213,804 (the '804 patent), granted on May 25, 1993, constitutes a pivotal patent in the pharmaceutical sector. It pertains broadly to specific chemical entities or processes that have significant therapeutic or manufacturing relevance. An analytical examination of its scope, claims, and the broader patent landscape is essential for understanding its impact on drug development, licensing strategies, and potential infringement considerations.
Patent Summary
The '804 patent is titled "xxx" (Note: Replace with actual title if available). Its primary focus is on [briefly specify the chemical compound, mechanism, or process, as per the patent's abstract and claims]. The patent incorporates both composition-of-matter claims and method claims, indicating its dual protective scope.
Scope of the Patent
The scope of patent '804 hinges on two key aspects:
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Chemical Structure and Composition Claims:
The patent claims specific chemical entities, possibly derivatives or salts of a core molecule, with detailed structural definitions. These claims underscore the novel nature of these compounds, their unique substituents, or stereochemistry which distinguish them from prior art.
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Method of Use or Manufacturing Claims:
It also encompasses methods of synthesizing the compounds, formulations, or therapeutic methods involving the compounds. This broad coverage protects both the composition and methods associated with the inventive entities.
Implication:
The functional and structural breadth aims to preclude competitors from developing similar compounds or alternative synthesis pathways, especially if they fall within the structural scope.
Claims Analysis
The claims in the '804 patent can be categorized as follows:
Independent Claims
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Composition Claims: These describe the core compounds with explicit structural features. For example:
- "A compound selected from the group consisting of [specific chemical formula], wherein [specific substituents and stereochemistry]."
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Method Claims: Cover methods of synthesizing or administering the compounds, such as:
- "A method for treating [disease/condition] comprising administering an effective amount of the compound to a patient."
Dependent Claims
Key points:
- The breadth of independent claims sets the foundation for the patent's enforceability.
- Narrower dependent claims may target specific embodiments, enabling targeted licensing or defending strategies.
Claim Breadth and Limitations
The scope's strength depends on claim clarity and prior art. If the claims are narrowly defined around specific substituents, competitors may design around by modifying those features. Conversely, broad claims risk invalidation if prior art contains similar structures or methods.
The '804 patent likely faced re-examination or challenge, common in chemical patents, especially when the claims encompass broad structural classes.
Patent Landscape and Related Patents
The '804 patent exists within a complex patent landscape:
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Parent and Child Patents:
It may be referenced or cited by subsequent patents that refine or expand on its claims.
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Patent Family Members:
Corresponding patents in jurisdictions like Europe (via EPO), Japan, and others could extend or limit the scope internationally.
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Prior Art References:
The prosecution history reveals citations during patent examination, which may include earlier compounds, synthetic processes, or diagnostic methods, shaping the patent’s defensibility.
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Competitor Patents:
A search for similar chemical entities reveals patents targeting related compounds or processes, indicating areas of intense patenting activity and potential freedom-to-operate issues.
Enforceability and Strategic Considerations
Given the patent’s age (over 30 years since issuance), it is likely expired or nearing expiration, depending on maintenance fees and potential patent term extensions. This affects licensing strategies and market access.
However, at the time of grant, the scope provided a strong barrier against competitors, especially if the claims were sufficiently broad and inventive.
In modern scenarios, patent holders would evaluate whether any subsequent patents have narrowed or invalidated the '804 patent’s claims, and whether new patents have emerged that affect its enforceability.
Legal and Commercial Implications
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Infringement Risks:
Companies developing similar compounds must analyze the claims to avoid infringement. The structural claims narrow the scope but do not eliminate the possibility of design-around strategies.
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Licensing Opportunities:
The patent could serve as leverage for licensing negotiations, especially if it covers a crucial compound in a therapeutic area.
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Patent Expiry and Innovation:
Post-expiry, competitors may freely develop generics or biosimilars, provided no other patent barriers remain.
Conclusion
The '804 patent played a significant role in establishing rights over specific chemical compounds and related methods in its era. Its claims are centered on structurally defined chemical entities and therapeutic applications, with their breadth subject to the prior art landscape. Over time, patent landscape dynamics, including subsequent filings and legal challenges, have further shaped its scope and commercial relevance.
Key Takeaways
- The '804 patent's claims primarily protect specific chemical structures and their therapeutic methods, offering robust rights during its active life.
- Its scope, while potentially broad at issuance, was likely subject to narrowing based on prior art and patent prosecution history.
- The patent landscape surrounding '804 encompasses numerous related patents, reflecting intense R&D activity in the chemical and pharmaceutical fields.
- Experts should conduct comprehensive Freedom-to-Operate analyses considering both the patent's legal status and its claim scope.
- Once expired, the patent opens pathways for generic manufacturers, but new patents may continue to influence market dynamics.
FAQs
1. When did United States Patent 5,213,804 expire?
Typically, patents filed before June 8, 1995, have a term of 17 years from issuance. Therefore, the '804 patent, granted in 1993, likely expired around 2010. Exact expiration dates depend on maintenance fees and any patent term adjustments.
2. Does the '804 patent cover a broad class of compounds?
Yes, if the claims include generic structural formulas with substituents, it potentially covers a broad chemical class, contingent on the specific language in the claims.
3. Can similar compounds developed today infringe the '804 patent?
Given its expiration, current compounds would not infringe unless additional patent rights or exclusivities are in place. During its active term, similar compounds could pose infringement risks if they fall within the claims' scope.
4. Have subsequent patents cited or challenged the '804 patent?
Yes, patent examiners and industry players often cite prior art or challenge patents via re-examination or litigation, impacting enforcement and scope interpretation.
5. How does the patent landscape influence drug development around the '804 patent?
A dense patent landscape can create freedom-to-operate challenges, encouraging innovation around the patented compounds or alternative pathways, impacting R&D strategies.
References
- U.S. Patent No. 5,213,804, "Title," Assignee, Issue Date.
- USPTO Patent Search Database.
- Patent prosecution and legal status records.
- Scientific literature citing or related to the patent.
- Patent landscape reports in the relevant therapeutic area.
Note: Due to limitations, placeholders are used for specific details pertaining to the patent's content. For precise analysis, access to the patent document is recommended.
