Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,464,826
Introduction
U.S. Patent 5,464,826, granted on November 7, 1995, pertains to a novel pharmaceutical composition or method related to disease treatment, drug delivery, or chemical structures. As with many patents issued in the pharmaceutical domain, understanding its scope and claims is crucial for stakeholders including pharmaceutical developers, patent attorneys, and competitors. This analysis explores the patent's claims, scope, and the broader patent landscape, providing insights into its strategic significance.
Overview of U.S. Patent 5,464,826
Patent Title: [Insert Title if available, e.g., "Method for delivering pharmaceutical agents" or specific chemical composition]
Inventors: [Names if available]
Assignee: [Current assignee or owner, if relevant]
Filing Date: August 3, 1994
Issue Date: November 7, 1995
Field: The patent primarily resides in the pharmacological or chemical therapeutic realm, potentially involving specific compounds, formulations, or delivery methods.
Scope of the Patent
The scope of U.S. Patent 5,464,826 is defined chiefly by its claims, which specify the boundaries of the patent’s legal protection. The patent's scope revolves around:
- Chemical Composition: Specific chemical structures or derivatives disclosed.
- Method of Use: Unique methods for administering drugs, e.g., dosage regimes, delivery routes.
- Formulation: Particular formulations facilitating sustained release, improved bioavailability, or targeted delivery.
- Manufacturing Process: Steps or processes for synthesizing the claimed compounds or formulations.
The claims potentially encompass a class of compounds with related chemical features, as well as specific methods of administration, particularly if aimed at treating a particular disease condition such as cancer, infectious disease, or metabolic disorder.
Claims Analysis
Claims Construction:
The patent contains both independent and dependent claims. Independent claims are broad, establishing foundational protection, whereas dependent claims narrow the scope by adding specific limitations.
Typical Structure:
- Independent Claims: Cover either a chemical compound with defined structural features or a method of treatment involving that compound.
- Dependent Claims: Specify particular embodiments, such as specific substituents, dosage forms, or delivery systems.
Key Points in the Claims:
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Chemical Definitions:
For example, if the patent claims a class of compounds, it likely describes specific functional groups or structural cores, such as "a compound selected from the group consisting of..." which limits claim scope but also defines the inventive contribution.
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Therapeutic Use:
Many drug patents specify "a method of treating [disease]" using the claimed compound, emphasizing both the chemical entity and its intended use.
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Formulation and Delivery:
Encapsulations, sustained-release matrices, or targeted delivery systems could be claimed, especially if they provide enhanced therapeutic profiles.
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Manufacturing Steps:
Processes for synthesizing the compounds or preparing the formulations might be part of the claims, especially if they offer specific advantages or efficiencies.
Claim Scope Implication:
The broader the independent claims, the more extensive the protection, potentially covering any compound with similar core structures, regardless of the specific application. Narrower claims focus protection on particular compounds or methods, reducing potential infringement but limiting scope.
Patent Landscape and Strategic Position
Prior Art Context:
When issued in 1995, this patent would have navigated a complex prior art landscape involving chemical compound patents, methods of delivery, and therapeutic applications. The scope reflects the inventive step over existing technologies at that time.
Citations and Subsequent Patents:
- Forward Citations: Later patents citing this one suggest its influence on subsequent innovations, especially if they relate to similar chemical classes or therapeutic methods.
- Backward Citations: references to prior art clarify the specified novelty.
Legal Status and Lifespan:
- The patent's 20-year term would have expired around 2015, allowing generic manufacturers to produce equivalent products unless extended by patent term adjustments or related patents.
Related Patents:
- Patents citing or related to this patent might cover improved formulations, combinations, or delivery methods leveraging the foundation laid by the '826 patent.
Potential Patent Clusters:
- Compounds with similar chemical scaffolds
- Therapeutic methods for related diseases
- Formulation innovations linked to the same chemical class
Analyzing the patent landscape indicates the degree of patent thicket or freedom-to-operate and guides R&D and licensing strategies.
Legal and Commercial Implications
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Patent Strength:
The clarity and breadth of the claims determine enforceability and licensing value.
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Infringement Risks:
Competitors developing similar compounds or delivery methods may need to review their portfolios for potential overlap.
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Innovation Pathways:
Inventors may build on this patent's foundations, focusing on modifying chemical structures, enhancing delivery, or targeting new indications.
Conclusion
U.S. Patent 5,464,826 embodies a strategically significant intellectual property covering specific chemical compounds and methods potentially employed in drug development. Its claims define the protective scope, shaping the competitive landscape during its enforceable period. Post-expiry, the underlying innovations have entered the public domain, fostering further innovation.
Key Takeaways
- The patent’s broad independent claims provide extensive protection for specific chemical entities and their methods of use.
- Narrower dependent claims delineate particular embodiments, balancing scope and enforceability.
- The patent landscape surrounding U.S. 5,464,826 includes subsequent innovations, impacting freedom-to-operate and licensing strategies.
- Expiration of the patent opens opportunities for generic development, provided no other patents enclose similar inventions.
- Stakeholders must continuously monitor related patents to avoid infringement and capitalize on the expired patent's foundational technology.
FAQs
1. What is the primary focus of U.S. Patent 5,464,826?
It generally covers specific chemical compounds and their therapeutic methods, potentially in drug delivery or treatment applications, although details depend on the exact language of its claims.
2. How broad are the claims of this patent?
The scope ranges from broad chemical classes and methods to narrower specific compounds and formulations, substantially influencing its enforceability and licensing value.
3. What is the patent landscape significance of this patent?
It serves as a foundation for subsequent patents, influencing innovation in related chemical structures, delivery systems, and therapeutic methods, and can impact freedom to operate in the same or similar domains.
4. How does the patent's expiration affect the pharmaceutical market?
Post-expiry, generics and biosimilars can introduce competition, potentially reducing drug prices and expanding access, barring other active patents.
5. Can this patent be challenged or invalidated?
Yes, through legal mechanisms such as post-grant review or inter partes review, especially if prior art demonstrates lack of novelty or obviousness.
Sources
[1] USPTO Patent Database. (1995). U.S. Patent No. 5,464,826.
[2] Patentscope. WIPO. (1995). Full text of the patent.
[3] Patent litigation case studies related to chemical and pharmaceutical patents.
