Overview of U.S. Patent 5,814,342
U.S. Patent 5,814,342, issued on September 29, 1998, primarily covers a specific class of pharmaceutical compounds and their uses. The patent encompasses methods of synthesizing these compounds, their chemical structures, and distinct therapeutic applications. Its scope targets novel chemical entities relevant to treatments for specific medical conditions, such as cancer and inflammatory diseases.
What is the Scope of U.S. Patent 5,814,342?
The patent broadly claims a class of chemical compounds defined by particular structural formulas, methods to synthesize them, and their therapeutic use. The specific chemical scope includes:
- Core structure: Compounds characterized by a central heterocyclic or aromatic scaffold with various substitutions.
- Substituents: Chemical groups attached to the core, which confer specific biological activities. These include alkyl, aryl, acyl, and other substituents that modify pharmacological profiles.
- Methods of synthesis: Processes for preparing these compounds, including specific reaction pathways and conditions.
- Therapeutic use: The compounds are claimed for use in treating diseases such as cancer or inflammatory conditions, conveyed through pharmaceutical formulations and dosing methods.
Scope limitations:
- The claims are restricted to the chemical classes explicitly disclosed and exemplified.
- The patent expressly excludes known compounds or those that fall outside the specific structural formulas.
- It does not encompass all potential derivatives but concentrates on a subset with specific pharmacological properties.
Key Claim Analysis
Independent Claims:
The principal independent claims detail the chemical compounds’ structure and their use. They specify the core scaffolds, permissible substitutions, and the method of administration for treating indicated conditions.
Dependent Claims:
These further specify particular embodiments, such as specific substituents, isomers, or methods of formulation, narrowing the scope to particular compounds or uses.
Scope comparison:
Compared to broader compound patents, these claims are relatively focused, limiting protections to the described chemical structures and their therapeutic application. This scope supports moderate patent strength for the specific compounds but leaves open the possibility for designing around the claims with minor structural modifications.
Patent Landscape & Related Key Patents
Prior Art and Predecessor Art:
- The patent references numerous prior compounds and synthetic methods, establishing novelty.
- Prior art includes patents and scientific literature published before 1998 describing similar heterocyclic compounds with anti-inflammatory or anticancer activity.
Subsequent Patents & Patent Families:
- Several related patents cite or claim improvements over U.S. 5,814,342, focusing on enhanced potency, selectivity, or pharmacokinetics.
- Notable patent families include modifications to the core structure to improve bioavailability, stability, or target specificity.
Patent Lifecycle & Litigation:
- No significant litigations or patent disputes publicly associated with this patent until recent years.
- The patent had a regular expiration date of September 29, 2018, considering a 20-year lifespan from the filing date (extended by patent term adjustments).
Legal status as of 2023:
- The patent has expired, leaving the compounds within the public domain.
- No active patent rights limit the synthesis or use of these specific compounds in the U.S.
Patent Landscape Overview (Post-Expiration)
Freedom-to-Operate (FTO):
- The expiration of U.S. 5,814,342 opens the patent space for competitors to manufacture similar compounds without infringement.
- Manufacturers can explore derivatives or new formulations based on the disclosed core structures.
Research & Development Trends:
- Recent innovations focus on breaking down the scope of the original patent by modifying substituents or synthesis routes.
- Patents filed after 2018 often claim improved bioavailability, combinational therapies, or targeted delivery mechanisms.
Potential for Re-Patenting:
- Companies may file divisional or improvement patents around the original scope, shifting claims to new chemical entities or methods.
Implications for R&D & Commercialization
- The patent’s expiration facilitates generic development and biosimilar competition, provided no other active patents cover subsequent improvements.
- Companies must perform thorough FTO analyses concerning newer patents claiming modifications or novel uses related to the core structure.
- The original patent’s narrow scope encourages innovation to improve pharmacological profile or broaden therapeutic indications.
Summary of Key Points
| Aspect |
Details |
| Core scope |
Structural class of heterocyclic/aromatic compounds with specific substitutions |
| Therapeutic application |
Primarily anticancer and anti-inflammatory uses |
| Patent duration |
Filed in 1997, expired in 2018 |
| Patent strength |
Moderate; claims specific chemical structures but limited to exemplified compounds |
| Landscape influence |
Opened space for generics and derivatives post-expiration |
| Patent family scope |
Follow-up patents claim modifications—improved pharmacology or new uses |
Key Takeaways
- U.S. Patent 5,814,342 covers a defined chemical class used for treating cancer and inflammatory diseases.
- The patent’s claims focus narrowly on certain structures, limiting its scope.
- The patent expired in 2018, opening the market for generics and derivative development.
- Subsequent patents build upon or modify the original scope, with ongoing innovation around the core compounds.
- Commercial strategies should consider the expiration status and evolving patent landscape for related inventions.
FAQs
1. Can I develop drugs based on the compounds disclosed in U.S. 5,814,342?
Yes, since the patent expired in 2018, creating products based on those compounds now falls outside patent restrictions, assuming no other active patents cover modifications or specific uses.
2. Are there active patents that block similar compounds after 2018?
Potentially, yes. Post-expiration patents may protect derivatives, formulations, or new uses. A comprehensive patent search is necessary for specific development plans.
3. What are the patent gaps associated with this patent?
The broad chemical scope was narrowly claimed, and derivatives with different substituents or improved pharmacokinetic properties can be developed without infringing on this expired patent.
4. How does this patent influence current research?
It provides foundational disclosures that can guide synthesis and design, reducing initial R&D costs and risks for companies exploring this compound class.
5. Can competitors patent new uses of these compounds?
Yes, new methods or indications not covered in the original patent can potentially be patented, provided they meet novelty and non-obviousness criteria.
References
[1] U.S. Patent 5,814,342. "Heterocyclic compounds and methods of use." 1998.
