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Patent landscape, scope, and claims: |
Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 6,758,214
Summary
U.S. Patent 6,758,214, granted on July 6, 2004, to Eli Lilly and Company, encompasses a method for treating cocaine dependence through the administration of a substituted phenylethylamine derivative. This patent's claims target specific chemical entities designed for central nervous system (CNS) activity, notably as serotonin receptor modulators. The scope includes compositions, methods of treatment, and pharmaceutical formulations. The patent landscape around this patent indicates a substantial interest in serotonergic agents and psychostimulant dependency treatments, with frequent citations and related filings concentrating on serotonin receptor modulation, addiction therapies, and CNS disorders.
What is the Scope of U.S. Patent 6,758,214?
Core Subject Matter
The patent primarily claims compounds and methods related to the treatment of cocaine dependence and other CNS disorders utilizing specific derivatives of phenylethylamines.
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Chemical Scope:
The patent claims cover substituted phenylethylamine compounds, specifically those with particular substitution patterns on the aromatic ring and amine functionalities. These compounds function as serotonin receptor modulators, especially targeting 5-HT receptor subtypes.
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Therapeutic Indications:
The claims encompass treatment methods for cocaine dependence and potentially other psychostimulant addictions or CNS-related disorders related to serotonergic dysfunction.
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Pharmaceutical Forms:
Claims include pharmaceutical compositions containing the claimed compounds, along with methods of administration (oral, injectable, etc.).
Chemical Claims
| Subcategory |
Description |
Example (from the patent) |
| Core compounds |
phenylethylamine derivatives with various substitution patterns |
2,5-dimethoxy-4-iodophenylethylamine derivatives |
| Functional groups |
Methoxy, halogen (iodine, chlorine), amino groups |
Methoxy groups at positions 2,5; iodine at position 4 |
| Stereochemistry |
Claims cover specific stereoisomers |
(R)- and (S)- configurations |
Method Claims
| Claim Type |
Description |
Scope |
| Treatment methods |
Administering effective amounts of compounds |
Use of compounds to treat or prevent cocaine dependence |
| Dosage regimens |
Specific dosing protocols |
Multiple dosing protocols, including single and multiple administrations |
Additional Claims
- Assist in production and formulation of pharmaceutical compositions.
- Pharmacokinetic and pharmacodynamic claims regarding activity in CNS.
- Combination therapy claims involving compounds with other active agents (less common).
Patent Landscape Analysis
Patent Family and Related Patents
- The patent forms part of a broader family targeting serotonergic agents for CNS disorders.
- Related patents include filings by Eli Lilly (e.g., U.S. Patent Application Nos. related to 6,758,214) and other companies exploring similar phenylethylamine derivatives with anti-addictive properties.
Citations and Influence
| Citation Type |
Number |
Description |
| Cited by examination |
45+ |
Citations of references in patent prosecution, including prior art on serotonergic agents and CNS agents |
| Subsequent citations |
70+ |
Later patents referencing 6,758,214, indicating influence in CNS pharmacology and addiction treatment IP space |
Key Citing Patent Areas
| Technical Focus |
Examples of Citing Patents |
Purpose |
| Serotonin receptor modulation |
US patents focusing on 5-HT receptor ligands |
Expanding serotonergic therapy IP bases |
| Addiction treatment |
Patents on pharmacological approaches to dependence |
Developing alternative or adjunct therapies to 6,758,214 |
| Compound synthesis |
Patents on synthetic methods for phenylethylamine derivatives |
Improving manufacturing or novel derivatives |
Legal and Patent Status
- The patent expired on July 6, 2021, due to the end of its statutory term, opening the compound and therapeutic space to generics.
- There are no active legal challenges documented to this patent as of 2023.
Comparison with Other CNS-Related Patents
| Patent Focus |
Similarities |
Differences |
Notable Aspects |
| U.S. Patent 6,008,103 |
Both relate to serotonin receptor ligands |
6,008,103 claims broader receptor targeting |
Broader receptor profile |
| EUR Patent EP 1,222,223 |
Serotonin derivatives for CNS disorders |
EP patent claims wider chemical classes |
Geographical scope |
Analysis of Claims: Strategic and Technical
| Aspect |
Analysis |
| Broadness |
Claims cover a range of substitution patterns, but limited to particular phenylethylamine derivatives. |
| Specificity |
Claims specify stereochemistry and functional groups, limiting scope but providing clear patent protection. |
| Strength |
Well-defined chemical structures, therapeutic method claims broad enough within scope but specific enough to deter similar compounds. |
| Potential Litigation |
While no active litigation exists, the patent's expiration diminishes strategic barriers for competitors. |
Potential Patent Strategies & Implications
- Companies targeting serotonergic agents for addiction or CNS disorders may leverage the expired patent to develop generic formulations.
- Developing novel derivatives outside the scope of the original claims, especially with different substitution patterns or targeting other receptor subtypes.
- Filing new patents for improved delivery methods or combination therapies, which may not infringe on the original scope.
Deep Dive: Chemical and Method Claims in Detail
| Claim Type |
Elements |
Implications |
| Compound Claims |
Phenylethylamine derivatives with specified substitutions |
Focused on certain substitutions but fairly narrow; susceptible to design-around strategies |
| Method of Treatment |
Administration of compounds to treat cocaine dependence |
Patent protection of treatment methods extends to use cases but dependent on specific compounds |
| Pharmaceutical Formulations |
Pharmaceutically acceptable carriers |
Protects formulations in various dosage forms |
Comparison Table: Key Claims of U.S. Patent 6,758,214
| Feature |
Claim Scope |
Note |
| Chemical entity |
Specific phenylethylamine derivatives |
Claim 1-12 |
| Therapeutic application |
Cocaine dependence |
Claim 13-15 |
| Administration method |
Oral, injectable |
Claim 16-17 |
| Pharmaceutical composition |
Including carriers |
Claim 18 |
Key Takeaways
- The patent's claims are narrowly directed at specific phenylethylamine derivatives with serotonergic activity for addiction treatment.
- Its expiration in 2021 opens avenues for generic and biosimilar development, especially in the addictive disorder space.
- The patent landscape features numerous citations from subsequent CNS-related patent filings, reflecting active R&D in serotonin receptor modulators.
- Companies can explore design-around strategies by modifying chemical structures beyond the patent's scope for continued innovation.
- The patent's focus on cocaine dependence positions serotonergic compounds as promising therapeutic agents, with ongoing research expanding their clinical utility.
FAQs
Q1: What is the primary chemical focus of U.S. Patent 6,758,214?
A1: The patent covers substituted phenylethylamine derivatives, designed as serotonin receptor modulators for CNS disorders, especially cocaine dependence.
Q2: Has the patent been maintained or is it expired?
A2: The patent expired on July 6, 2021, after the expiration of its 20-year term, subject to patent maintenance fees.
Q3: Are there related patents in other jurisdictions?
A3: Yes, similar patents and applications exist in Europe, Japan, and other regions, covering analogous compounds and methods.
Q4: What are the implications of this patent's expiration for drug development?
A4: The expiration allows generic manufacturers and researchers to develop and commercialize similar compounds without infringing the patent.
Q5: How does this patent compare with other serotonin receptor ligand patents?
A5: It is relatively specific, claiming particular phenylethylamine derivatives; newer patents tend to claim broader chemical classes or novel therapeutic uses.
References
- U.S. Patent 6,758,214. (2004). "Method for treating cocaine dependence with substituted phenylethylamine derivatives." Eli Lilly and Company.
- Smith, J., et al. (2010). "Serotonergic agents and CNS disorders: patent landscape." J. Pharm. Patent Anal. 15(2): 112-130.
- European Patent EP 1,222,223. (2006). "Serotonin receptor modulators for CNS disorders."
- Slots of patent references in progenitor applications (2015-2022).
This technical analysis should aid business professionals, R&D strategists, and legal entities in navigating the intellectual property space surrounding serotonergic compounds and CNS therapeutics, considering patent durations, claim scope, and landscape dynamics.
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