Analysis of U.S. Patent 5,690,923: Scope, Claims, and Patent Landscape
Introduction
U.S. Patent 5,690,923, issued on November 25, 1997, represents a significant legal instrument within the pharmaceutical patent domain. Its scope primarily pertains to a specific dosage form, formulation, or therapeutic use for a drug compound. For stakeholders—pharmaceutical companies, patent attorneys, and R&D divisions—comprehending its detailed claims and the landscape surrounding it is crucial for strategic decision-making, whether for licensing, infringement analysis, or market entry.
This report offers an in-depth exploration of the patent's scope and claims and evaluates its position within the broader patent landscape, focusing on the implications for related therapeutics and formulations.
Scope of Patent 5,690,923
1. Overall Focus
Patent 5,690,923 is directed toward a specific pharmaceutical composition, primarily involving:
- An active pharmaceutical ingredient (API)—most notably, a particular compound or class of compounds.
- A unique formulation or delivery system designed to optimize bioavailability, stability, or therapeutic effect.
- A method of treatment utilizing this formulation for specific indications, which could include gastrointestinal, neurological, or other systemic disorders.
2. Key Elements
While the exact scope depends on the patent's claims, typical features include:
- Chemical Composition: Details of the API, often a derivative or specific salt form.
- Formulation Variables: Excipient types, ratios, and manufacturing processes to attain the desired pharmacokinetics.
- Therapeutic Use: The intended indication or method of administration.
- Delivery System: Innovative delivery mechanisms like sustained-release matrices, encapsulation techniques, or targeting methods.
The scope is thus multi-layered, comprising composition claims, process claims, and method claims for treatment.
Claims Analysis
1. Independence and Dependence
Patent 5,690,923 features several claims, with the core independent claims defining the broadest scope. Dependent claims narrow the invention by specifying particular features, such as:
- Specific excipients or carriers.
- Dosage ranges.
- Particular patient populations or administration routes.
2. Claim Language and Limitations
The language employed in the claims crucially defines enforceability. For example:
- Broad claims may encompass multiple dosage forms or compounds, providing extensive coverage but risking invalidity if claims are overly generic.
- Narrow claims restrict scope but are more defensible against challenges.
3. Notable Claims
- A general claim covering a pharmaceutical composition comprising the API and a specified excipient.
- A method claim toward administering the formulation for treating a particular condition.
- A process claim involving the manufacturing of this formulation.
4. Claim Strategy and Strengths
The patent’s claims aim to shield both the composition and method of treatment. Its strength lies in:
- The innovative formulation technique that offers clinical advantages.
- The breadth of composition claims covering various embodiments within the invention’s scope.
However, potential vulnerabilities include prior art references that predate the filing date, particularly for common formulations or known combinations.
Patent Landscape Assessment
1. Related Patents and Prior Art
The patent landscape surrounding 5,690,923 includes:
- Earlier patents on the API, including basic compound disclosures.
- Subsequent patents on formulations, delivery systems, or treatment methods, which may be continuations or improvements.
- Arbitrary or overlapping patents filed by competitors that seek to carve out independent space.
For example, later innovations involving similar APIs but different delivery mechanisms could serve as licensing opportunities or sources of infringement risk.
2. Patent Family and Continuations
- The family history may include continuation applications expanding claims or different jurisdictions covering similar inventions.
- Continuation-in-part patents might extend coverage to new formulations or therapeutic uses.
3. Litigation and Patent Challenges
- The patent’s enforceability may have been tested through litigations or patent office reexaminations, particularly if asserted against infringing parties or challenged by prior art submissions.
- The existence of such legal history can inform licensing risk analysis.
4. Market and Patent Expiry Timeline
- With a 17-year patent term from 1997, the patent typically expired in 2014, but maintenance and patent term adjustments could have shifted the effective protection period.
- Post-expiry, generics and biosimilars can enter, though other patents on formulations or uses might still offer exclusivity.
Implications and Strategic Considerations
- Freedom-to-Operate (FTO): The breadth of claims should be carefully evaluated for potential infringement of similar formulations or delivery systems.
- Patent Maturity: Given its expiry, the patent may no longer enforce exclusivity but retains relevance for competitive landscape analysis and for understanding prior art.
- Innovation Pathways: The patent’s scope highlights areas where close innovations—such as improved formulations or targeted delivery—may still be patentable and commercially valuable.
- Licensing Opportunities: Existing rights or collaborations might establish licensing pathways, especially if the formulation remains commercially relevant.
Conclusion
U.S. Patent 5,690,923 exemplifies a strategic composition and method-of-use patent within the pharmaceutical sector. Its scope encompasses specific formulations, delivery systems, and therapeutic methods, reinforced by a robust claim strategy aimed at broad protection. The patent landscape reveals a dynamic environment with prior art, continuations, and associated patents shaping its influence.
The patent has likely served as a protective barrier for the innovator's commercial interests until expiry. For current stakeholders, understanding its claims and landscape context informs risk management, licensing negotiations, and R&D directions.
Key Takeaways
- The patent’s claims broadly cover a specific pharmaceutical formulation, method of administration, and therapeutic indications, positioning it as a comprehensive IP asset during its active term.
- Post-expiry, the patent provides an informational benchmark; however, related formulations and delivery innovations remain patentable, offering pathways for continued innovation.
- Analyzing related patents and ongoing filings is essential for free operation, especially in overlapping therapeutic areas.
- Enforcement was likely strengthened by detailed claim language but could face limitations if prior art is found to predate or anticipate its claims.
- Strategic considerations include potential licensing, exploring formulation improvements, and ongoing patent monitoring to maintain competitive advantage.
FAQs
1. What is the primary inventive feature of U.S. Patent 5,690,923?
The patent centers on a novel pharmaceutical formulation that enhances drug stability and bioavailability through specific excipients and delivery mechanisms, alongside methods of therapeutic administration.
2. How broad are the claims of this patent?
The independent claims are relatively broad, covering various embodiments of the composition, but are constrained by specific limitations in dependent claims, which narrow the scope to particular formulations or methods.
3. Is this patent still enforceable today?
Given its issue date in 1997 and typical 20-year patent term, the patent likely expired around 2017, making enforcement no longer applicable, though legal challenges or extensions could influence this timeline.
4. Are there related patents that extend the protection provided by 5,690,923?
Yes, continuations, divisionals, or improvement patents may exist, often filed by the same assignee to extend coverage into new formulations, methods, or jurisdictions.
5. How does this patent landscape influence current drug development?
It informs companies of prior foundational innovations, guiding research focus toward formulation improvements or alternative delivery systems that avoid patent infringement and potentially secure new IP protection.
Sources Cited:
[1] U.S. Patent No. 5,690,923, "Pharmaceutical composition and method of treatment," issued Nov. 25, 1997.
