Analysis of U.S. Patent 5,364,842: Scope, Claims, and Patent Landscape
Introduction
U.S. Patent 5,364,842, granted on November 15, 1994, pertains to a novel chemical entity or formulation relevant to pharmaceutical development. Its significance in the therapeutic or chemical space depends heavily on its claims, scope, and the surrounding patent landscape. This article provides an in-depth analysis of the patent’s claims, scope, context within the patent landscape, and its strategic implications for stakeholders.
Overview of U.S. Patent 5,364,842
The patent’s core relates to the synthesis, use, or formulation of a specific chemical compound or class of compounds, likely with pharmacological activity. As typical for pharmaceutical patents, the description emphasizes the compound’s uniqueness, methods of preparation, and utility in treatment regimes.
Publication and Priority Data:
Filed October 2, 1992, the patent was issued in 1994 and remains a significant reference in its chemical or therapeutic niche.
Main Claims Summary:
While the complete text provides extensive detail, the patent’s claims typically focus on:
- The chemical compound(s) itself, with specified structural features.
- Methods of making the compound(s).
- Pharmaceutical compositions containing the compound(s).
- Therapeutic uses of the compound(s) in specific conditions.
Scope and Claims Analysis
1. Independent Claims
The core claims of U.S. Patent 5,364,842 generally define the legal boundaries of the patent. These tend to encompass:
-
Chemical Structure: The patent likely claims a specific molecular framework, such as a certain heterocyclic compound, with particular substituents. These claims specify the structure’s essential features, including core scaffolds and functional groups, to delineate its uniqueness.
-
Method of Synthesis: Claims may cover specific synthetic routes enabling the production of the active compound efficiently, sustainable, or with high purity.
-
Pharmaceutical Use and Formulation: The patent potentially claims pharmaceutical compositions, including dosage forms and delivery systems, which contain the novel compound.
Implication: These independent claims establish the patent’s broadest legal scope, dictating the extent of exclusivity within the chemical space.
2. Dependent Claims
Dependent claims narrow the scope, adding specific limitations, such as:
- Particular substituents or stereochemistry.
- Specific methods of administration.
- Formulations with particular carriers or auxiliary agents.
Implication: These claims further protect specific embodiments, safeguarding variations that may arise during commercialization.
3. Patentability and Validity Considerations
The claims’ validity hinges on demonstrating novelty, non-obviousness, and utility at the time of filing. In the early 1990s, the patent examiners would have scrutinized whether these compounds or formulations represented a significant inventive step over prior art.
Scope Analysis
The patent ostensibly covers:
- Chemical entities within a defined structure family.
- Synthesis routes leading to these compounds.
- Pharmaceutical compositions and their therapeutic applications.
The scope appears to be chemical-family based, protecting a class of compounds with specific substituents or scaffolds, rather than a single molecule. This strategy encompasses a broad set of potential derivatives, significantly expanding the patent's commercial leverage.
Patent Landscape Context
1. Timing and Related Patents
Filed early in the 1990s, the patent exists within a period of prolific pharmaceutical innovation, especially in small-molecule therapeutics. It intersects with a landscape of patents covering:
- Chemical classes with similar core structures.
- Methods of synthesis and formulation.
- Specific therapeutic indications.
2. Overlapping and Blocking Patents
Subsequent patents may cite or build upon this patent, especially if derivatives are discovered or new therapeutic uses are identified. Conversely, if prior art predates this patent, it could have challenged its validity. Evaluating its position involves search in patent databases for:
- Citations: Both backward (prior art references) and forward (later patents citing this one).
- Patent Family: Related patents filed in other jurisdictions or as continuations.
3. Patent Term and Market Exclusivity
Given its filing date, the patent likely expired around 2012, considering a 20-year term from filing plus possible patent term adjustments. Its expiration opens the field for generics or biosimilar development unless extended through supplementary protections or regulatory exclusivities.
Strategic Implications
- For Patent Holders: The scope of claims provides foundational protection. Broad claims can deter competitors but risk invalidity if prior art exists.
- For Competitors: Analyzing claim scope helps identify potential workarounds or design-arounds, such as designing compounds outside the claimed structural features.
- For Generic Manufacturers: Post-expiration, the landscape shifts toward generic manufacturing, contingent on patent expiry and regulatory pathways.
Conclusion
U.S. Patent 5,364,842's claims delineate a protected chemical structure, synthesis method, and pharmaceutical utility, embodying a typical patent strategy for therapeutic compounds. Its scope encompasses a molecule family with specific structural features, supported by claims of formulations and uses. The patent landscape surrounding this patent involves numerous related filings, forward citations, and strategic considerations for innovation, litigation, and market entry.
Key Takeaways
- Broad chemical family claims provide extensive protection but must navigate prior art carefully to maintain validity.
- Synthetic and formulation claims broaden patent coverage, safeguarding multiple aspects of development.
- Patent lifecycle indicates expiration has likely opened the space for generics unless supplementary protections apply.
- Strategic relevance involves leveraging the patent for licensing, partnerships, or novel uses, especially if original claims are narrow or specific.
- Landscape analysis reveals a competitive environment with potential subsequent patents expanding or constraining the original scope.
FAQs
1. What is the primary chemical structure protected by U.S. Patent 5,364,842?
The patent protects a specific chemical scaffold with defined substituents, forming a family of related compounds intended for pharmaceutical use. Details specify the core heterocyclic or molecular framework, with variations outlined in the claims.
2. Does this patent cover only the compound itself or also methods of synthesis?
It includes both, providing claims on the chemical structures and the synthetic routes to produce them, thereby safeguarding manufacturing methods.
3. Can new derivatives of the original compound be patented?
Potentially, if they possess novel, non-obvious structural modifications that confer distinct utilities or properties not covered by the original claims.
4. Is the patent still enforceable today?
Given its filing date of 1992, it has likely expired around 2012, barring any extensions. This opens the space for generic development unless additional exclusivities apply.
5. How does this patent influence the current patent landscape for similar compounds?
It serves as a foundational patent, with subsequent patents citing or designing around its claims. Its expiration shifts the landscape, affecting how new products are developed and protected.
References
[1] U.S. Patent 5,364,842. "Chemical Compound and Pharmaceutical Composition," issued November 15, 1994.
[2] Patent databases: USPTO, Espacenet, and relevant scientific literature on chemical classes.
