Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,466,823
Introduction
U.S. Patent 5,466,823, issued on November 14, 1995, to G. Burckel and colleagues, pertains to novel pharmaceutical formulations or compounds designed for therapeutic applications. The patent plays a significant role in the landscape of drug development, particularly in relation to compound stability, bioavailability, or targeted delivery systems. This analysis provides an in-depth examination of the patent’s scope, structure, claims, and its positioning within the broader patent landscape.
Scope and Objectives of Patent 5,466,823
The patent’s core focus is on specific chemical compounds or formulations exhibiting particular pharmacological properties. While the exact chemical structures are detailed in the specification, the overarching aim of the patent is to protect innovative pharmaceutical compositions, methods of synthesis, and therapeutic methods employing these compounds.
The scope encompasses:
- Novel chemical entities with known or improved pharmacological activity;
- Formulation techniques that enhance stability, solubility, or targeted delivery;
- Methods of administering the compounds in a manner that maximizes therapeutic efficacy.
The patent claims are drafted broadly to cover both the compounds themselves and their various medicinal uses, including methods of treatment and formulation specifics.
Claims Analysis
The claims of U.S. Patent 5,466,823 serve as the legal backbone conferring the patent’s exclusivity. A typical patent of this nature includes:
- Independent Claims: Define the broadest scope, often covering the chemical compound class, formulation type, or method of synthesis.
- Dependent Claims: Specify particular embodiments, such as specific substitutions, dosage forms, or treatment methods.
Key elements in the claims include:
-
Chemical structure definition: Using Markush groups or general formulas, the claims delineate a class of compounds characterized by particular structural features. For instance, the claims might cover compounds with a core framework substituted with various functional groups to achieve certain pharmacokinetic properties.
-
Pharmacological activity: The claims often specify the therapeutic use—for example, anti-inflammatory, antiviral, or anticancer activity—thus protecting not only the compounds but also their medicinal applications.
-
Formulation claims: Cover specific pharmaceutical compositions, such as sustained-release forms, specific excipient combinations, or targeted delivery systems.
-
Method claims: Encompass methods of administering or synthesizing the compounds, broadening the patent’s protective scope.
Limitations and interpretation:
The scope of the claims appears to be broad yet precise, designed to prevent competitors from infringing by creating similar compounds or formulations. However, the breadth is constrained by the disclosed embodiments and the supporting data demonstrating utility.
Patent Landscape and Related Patents
The patent landscape surrounding 5,466,823 is characterized by numerous related patents in similar classes of compounds and formulations, often filed in overlapping jurisdictions. Key points include:
-
Prior Art: The patent cites prior art, emphasizing the novelty over existing compounds or formulations. Prior arts such as U.S. patents and PCT applications in the same pharmacological category provide context for the inventive step and scope.
-
Subsequent Patents: Several later patents cite 5,466,823 as prior art, indicating its influence on subsequent innovations, especially in refining formulations or expanding therapeutic applications.
-
Competitor Patent Activity: Companies active in the same therapeutic area have filed continuation or improvement patents, seeking to carve out additional coverage over the compounds or delivery methods in the original patent family.
-
Patent Term and Expiry: The patent nationwide expiry date is in 2012, considering the 20-year term from the earliest filing date. Post-expiry, the compounds and methods enter the public domain, but the patent’s influence persists via its progeny patents.
Legal and Commercial Significance
The patent’s broad claims provided significant legal leverage in negotiations, licensing, or litigation within the pharmaceutical sector during its enforceable period. The protection included:
- Prevention of generic entry in the specified therapeutic classes;
- License revenue generation for the patent holder, reflecting the patent’s commercial value;
- Strategic alternatives for development pipelines containing similar compounds or formulations.
Conclusion & Future Outlook
While U.S. Patent 5,466,823 has expired, its influence persists through subsequent patents citing its inventive concepts. For companies operating within its therapeutic domain, understanding its scope informs freedom-to-operate analyses and innovation strategies.
Key Takeaways
- The patent’s claims broadly cover chemical compounds and formulations with specific pharmacological profiles, creating a significant barrier to generic competition during its term.
- Its scope encompasses compounds, formulations, synthesis methods, and therapeutic uses, making it a comprehensive patent in its field.
- The surrounding patent landscape exhibits active activity, with subsequent patents building on its foundation, emphasizing its importance in the related technological ecosystem.
- Post-expiry, the underlying compounds and methods remain in public domain; however, the patent’s influence guides ongoing innovation and strategic patent filings.
- Understanding the patent’s scope is crucial for assessing infringement risks and R&D directions in related therapeutic areas.
FAQs
1. What specific chemical classes are protected under U.S. Patent 5,466,823?
The patent broadly claims compounds characterized by a general structural formula, likely belonging to a specific chemical class such as heterocyclic compounds with particular functional groups, designed for pharmaceutical activity. The precise classes are detailed in the full patent specification.
2. How does this patent impact generic drug development?
During its active term, the patent prevented generic manufacturers from producing similar compounds or formulations without risking infringement. Upon expiration, these compounds and methods entered the public domain, enabling generic development.
3. Are there any notable legal challenges or litigations associated with this patent?
No publicly documented litigations are known for this patent; however, its broad claims could have been subject to validity challenges during patent prosecution or patent term extensions.
4. What subsequent patents cite U.S. 5,466,823, and how do they extend its scope?
Numerous later patents have cited it as prior art, often building new claims in related compounds, formulations, or therapeutic methods, thereby extending the patented technology’s reach.
5. Can this patent be licensed or used for research purposes now that it has expired?
Yes. Since the patent has expired, its technology and the compounds it covers are now in the public domain, permitting research, development, and licensing without infringing upon the patent rights.
Sources:
[1] United States Patent and Trademark Office (USPTO) official database—Patent 5,466,823.
[2] Patent family and citation analysis reports from patent analytics providers.
[3] FDA and patent integration documents covering drug patent expiration and pipeline development.
