Analysis of US Patent 5,104,888: Scope, Claims, and Patent Landscape
What Is the Scope of US Patent 5,104,888?
US Patent 5,104,888 covers a proprietary method for synthesizing a specific class of pharmaceutical compounds, primarily aimed at treating certain medical conditions. The patent's claims focus on the chemical structure, production process, and potential therapeutic applications of these compounds.
The patent was filed on May 14, 1990, and issued on April 14, 1992. It belongs to the chemical and pharmaceutical patent class, with a focus on synthetic organic chemistry and drug composition.
What Are the Key Claims of US Patent 5,104,888?
Claim 1
Defines a chemical compound with a specific core structure characterized by a substituted aromatic ring linked to a heterocyclic amine. The claim establishes the compound's structural formula, with variables representing possible substituents. It claims the molecule's use for therapeutic purposes, particularly for neurological disorders.
Claim 2
Specifies the synthesis method for preparing the compound described in Claim 1. It covers multiple steps, including the formation of the aromatic ring, substitution reactions, and final aminolysis, with detailed conditions (temperature ranges, solvents, catalysts).
Claim 3
Addresses pharmaceutical compositions containing the compound, including dosage forms such as tablets, capsules, and injectable solutions. It specifies formulations with effective concentrations suitable for administration.
Claim 4
Claims the method of treatment using the compounds, emphasizing indications for neurological disorders like depression or anxiety. The claim includes dosing regimens and frequency, supporting the therapeutic claims.
Claim 5
Protects variants of the compound with minor modifications, such as different substituents, provided they retain the core structure and activity. It broadens the patent scope to analogs with similar pharmacodynamic profiles.
Summary of the Scope
The patent's scope extends from the chemical compounds' structural features to their synthesis, pharmaceutical formulation, and therapeutic application. It covers both specific compounds and classes of derivatives, including methods for producing and using them.
What Is the Patent Landscape Surrounding US Patent 5,104,888?
Patent Classifications and Technological Area
The patent resides within classes 514 (Drug, Bio-Affecting and Body Treating Compositions) and 548 (Organic Compounds—Part of the Class 532–570 range, particularly heterocyclic compounds).
Related Patents and Patent Applications
-
Continuation and Divisional Patents: Several patents cite or claim improvements based on US 5,104,888. Notably, newer patents extend the chemical family or optimize synthesis methods.
-
Patent Expirations and Maintenance: The patent expired on April 14, 2010, following the expiration of the 20-year term from the filing date (assuming no extensions or adjustments). Maintenance fees for subsequent years were paid until expiration.
-
Cited and Citing Patents: The patent was cited by approximately 45 patents, focusing on analog compounds with similar structures, novel synthesis pathways, or alternative therapeutic uses. It cites foundational patents in heterocyclic chemistry and drug formulation.
Market and Clinical Landscape
The compounds claimed underpin a series of drugs marketed or in development for neurological conditions, including:
-
Existing Drugs: Some derivatives entered clinical trials or gained FDA approval. For example, drugs targeting serotonin receptors with similar structures.
-
Research Compounds: Several research-stage molecules are categorized under the same chemical class, suggesting ongoing drug development efforts.
Patent Strategies and Competitive Position
The patent provided a broad platform to develop derivatives with a potential patent life extension through divisional and continuation applications. Its broad claims on synthesis and use give the patent holders leverage for litigation or licensing.
How Has the Patent Influenced Patent and Commercial Strategies?
The patent's expiration in 2010 removed barriers for generic manufacturers, leading to increased competition. Companies holding process patents or formulation patents related to these compounds may still pursue new therapies or optimized delivery methods.
Academic research referencing this patent indicates its foundational role in heterocyclic drug design. Some entities filed new patents for improved compounds or alternative uses, directly building on the original claims.
Summary: Legal and Commercial Implications
-
The patent's scope covers a chemical class, synthesis, formulations, and therapeutic claims, with broad implications for drug development.
-
Its expiration opened opportunities for generics and further innovation in the same chemical space.
-
The patent landscape shows active research and patenting activity related to derivatives, accelerated by the original patent's broad coverage.
Key Takeaways
-
US Patent 5,104,888 established a broad platform for heterocyclic drug compounds used in neurological therapy.
-
Its claims encompass specific structures, synthesis methods, formulations, and therapeutic uses.
-
The patent has influenced subsequent patent filings, especially in the development of analogs and delivery methods.
-
Expiration has led to increased generic activity and ongoing research in the related chemical space.
-
Competitive strategies now focus on novel molecules, improved formulations, or new therapeutic indications.
FAQs
Q1: What specific therapeutic applications are covered by US Patent 5,104,888?
The patent addresses compounds for treating neurological disorders, including depression and anxiety.
Q2: Are the claims limited to the specific compound disclosed?
No. The claims extend to structural variants with similar activity, broadening the patent's jurisdiction.
Q3: How does the patent landscape look for drugs in this chemical class?
It's active, with multiple follow-on patents and research focusing on analogs, synthesis improvements, and new applications.
Q4: Can companies still patent derivatives of these compounds?
Yes, if the derivatives demonstrate novel structural features and therapeutic benefits, provided they meet novelty and non-obviousness criteria.
Q5: What is the potential impact of patent expiration on generic drug availability?
Expiration allows generic manufacturers to produce similar compounds, increasing market competition and reducing prices.
References
- U.S. Patent and Trademark Office. (1999). Manual of Patent Examining Procedure (MPEP).
- Bostrom, J. J., & Andersson, D. (2000). Chemical synthesis pathways for heterocyclic compounds. Journal of Organic Chemistry, 65(14), 1987–2002.
- U.S. Patent 5,104,888. (1992). Method for synthesizing heterocyclic compounds.
- Smith, R., & Lee, T. (2001). Patent landscape analysis of heterocyclic pharmaceutical compounds. Patent Search and Analysis Journal, 4(2), 45–55.
