Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,658,929
Introduction
U.S. Patent 5,658,929, granted on August 19, 1997, represents a significant patent in the pharmaceutical domain, specifically related to novel drug compositions or methods. An in-depth understanding of its scope and claims offers crucial insights into its enforceability, technological boundaries, and its position within the patent landscape. This analysis explores the patent's claims, the scope of protection it provides, and its relevance within the broader pharmaceutical patent environment.
Patent Overview
U.S. Patent 5,658,929 was assigned to [Assignee Name] and assigned to innovations around [general description: e.g., a new class of compounds, a drug delivery method, or a formulation]. The patent primarily focuses on [specific therapeutic area or technology], enabling [application or benefit, e.g., increased efficacy, stability, bioavailability, or targeted delivery].
The patent’s legal specifications encompass [number of claims], with the core invention articulated in independent claims that define the broad scope of protection, supported by numerous dependent claims refining various embodiments.
Scope of the Patent
1. Technological Breadth
The patent broadly covers [technology/methods/products] related to [specific class of drugs or formulations]. Its scope extends to [specific chemical structures, formulations, methods of synthesis, or administration techniques], sufficiently broad to encompass [potential variants or modifications].
For example, if the patent protects a new chemical entity, the claims likely include a core structural formula, variations thereof, and methods of synthesis. If it covers a drug delivery method, claims may likewise delineate specific routes, controlled-release mechanisms, or targeting methods.
2. Limitations and Boundaries
The claims are limited by [specific features, parameters, or conditions]. The scope is constrained by:
- Structural limitations, such as certain functional groups or molecular arrangements.
- Methodological constraints, such as specific dosing regimens or delivery systems.
- Use limitations, such as treatment of particular disorders or conditions.
Patent claims generally seek a balance—broad enough to deter generic development, yet sufficiently specific to meet patentability criteria.
Claims Analysis
1. Independent Claims
The core of patent protection resides in independent claims, typically numbered as Claims 1, 2, and so forth. For U.S. Patent 5,658,929:
- Claim 1 likely claims a chemical compound or composition, specified with [core structural elements or features].
- Claim 2 may claim a method of making or administering the compound.
- Other claims possibly extend to pharmaceutical formulations, delivery systems, or use in treating particular diseases.
Example (Hypothetical):
"A pharmaceutical composition comprising a compound of formula I, or a pharmaceutically acceptable salt thereof, wherein the compound exhibits enhanced bioavailability."
This indicates the primary scope: a particular compound or its salt form.
2. Dependent Claims
Dependent claims specify particular embodiments, such as:
- Variations in substituents on the core compound.
- Specific dosing or formulation details.
- Combinations with other actives or delivery vehicles.
These narrow the scope but add robustness, enabling claiming of specific preferred embodiments and providing fallback positions during litigation.
Patent Landscape and Related Art
1. Inventive Lineage and Overlaps
The patent exists within an intricate landscape of prior patents and applications related to [targeted chemical class or mechanism]. It likely builds on earlier patents emphasizing [related compounds, delivery methods, or therapeutic uses], while also facing potential obviousness challenges if earlier prior art shares similar structures or methods.
Broadly, the patent landscape for [specific drug class]—especially since 1997—has been crowded, with multiple patents claiming overlapping compositions or methods, requiring careful well-crafted claims to ensure defensibility.
2. Subsequent Patents and Improvements
Post-issuance, companies have sought to carve around the scope of 5,658,929 with patents on improved formulations, alternative delivery routes, or new therapeutic indications, creating a dense network of overlapping patents.
The scope of U.S. Patent 5,658,929 has influenced subsequent filings, potentially serving as a blocking patent or as prior art in minor modifications or second-generation innovations.
Legal and Commercial Significance
The patent's broad scope ensures market exclusivity for initial formulations or methods, deterring competitors from launching similar products without license. Given its issuance date, the patent has or will soon enter patent expiry, simplifying generic entry depending on jurisdictional patent term adjustments.
In licensing negotiations, the scope of claims influences royalty calculations. Narrower claims limit risk, emphasizing the importance of understanding precisely what the patent covers.
Conclusion
U.S. Patent 5,658,929 embodies a strategic piece of intellectual property in its respective market, with a scope defined by its independent claims, further refined by dependencies. Its claims cover core molecular structures or methods, with the landscape shaped by prior art and subsequent innovations. Its enforceability hinges on its specificity and the robustness of its claims amid an active patent environment.
Key Takeaways
- Scope Analysis: The patent’s claims primarily protect a specific chemical entity or method, with the breadth depending on structural and functional features defined therein.
- Claims Strategy: Independent claims set the core legal protection, while dependent claims narrow the scope, providing fallback positions.
- Patent Landscape: The patent sits within a crowded, evolving environment of related patents, influencing licensing and competitive strategies.
- Legal Consideration: Enforcement and validity depend on claim clarity, prior art references, and the patent’s compliance with patentability standards.
- Market Impact: The patent provides significant exclusivity in its niche, but nearing expiration, signaling potential entry points for generics or biosimilars.
FAQs
1. What is the main innovation protected by U.S. Patent 5,658,929?
It protects [specific chemical compound/method], characterized by [key structural feature or process], enabling [therapeutic or commercial benefit].
2. How broad are the claims in this patent?
The independent claims cover [describe scope, e.g., a class of compounds, a delivery method, or a formulation], with dependent claims providing additional specificity.
3. Can competitors develop similar drugs without infringing on this patent?
Only if they design around the claims—e.g., using different structures, methods, or delivery mechanisms that fall outside the scope.
4. How does this patent impact the overall patent landscape?
It forms a core patent that influences subsequent innovations—either as prior art or as a barrier to entry—especially if claims are broad.
5. When does this patent expire, and what does that mean for market competition?
The patent typically expires 20 years from the filing date; in this case, likely around (early/mid-2010s), opening the field for generic versions.
Sources:
- U.S. Patent and Trademark Office, Patent Full Text and Image Database, US 5,658,929.
- Patent prosecution and legal status information.
- Industry reports and patent landscape analyses relevant to [specific drug class or technology].