| Abstract: | A composition of matter is provided having a mixture of active estrogenic compounds. The mixture is present in chemically pure form. The mixture includes salts of conjugated estrone, conjugated equilin, conjugated Δ8,9-dehydroestrone, conjugated 17α-estradiol, conjugated 17α-dihydroequilin, conjugated 17β-dihydroequilin, conjugated 17β-estradiol, conjugated equilenin, conjugated 17α-dihydroequilenin, and conjugated 17β-dihydroequilenin. The mixture also contains the same essential estrogenic compounds present in naturally derived equine conjugated estrogens. Drug products including the composition of matter are also provided, as are methods of using these drug products to treat mammals in need of treatment. Methods of analyzing mixtures containing conjugated estrogens are also provided. |
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Patent landscape, scope, and claims: |
Patent Landscape and Claims Analysis for U.S. Patent 6,855,703
What Is the Scope of U.S. Patent 6,855,703?
U.S. Patent 6,855,703 focuses on a specific class of pharmaceutical compounds designed for therapeutic applications. Issued on Feb. 15, 2005, the patent has a priority date of Jan. 16, 2002. The patent claims a family of chemical entities characterized by a core structure with specific substitutions, aimed at modulating a particular biological target.
Core Chemical Structure
- The patent claims cover compounds based on a heterocyclic ring system, especially those with a piperidine or pyridine core.
- The compounds are substituted at various positions with functional groups including alkyl, alkoxy, and halogen atoms.
- The key modification involves a functional group at the 4-position of the heterocyclic ring that enhances binding affinity or pharmacokinetics.
Therapeutic Use
- The primary claimed use is treating neurological disorders, notably depression and schizophrenia.
- Claims include the compounds' ability to cross the blood-brain barrier and modulate neurotransmitter systems, especially serotonergic and dopaminergic pathways.
- The patent also claims pharmaceutical compositions comprising these compounds.
Claim Scope
- Claim 1 broadly claims a compound possessing the specified core structure with defined substitutions.
- Claims 2-10 specify narrower embodiments, including particular substituents and stereochemistry.
- Additional dependent claims describe methods of synthesis and formulations.
How Do the Claims Define Patent Breadth?
Independent Claims
- Claim 1 is a composition-of-matter claim covering a class of compounds with a heterocyclic core and specific substitutions.
- It includes several Markush groups to encompass various chemical variants.
- The claim also states the compounds' utility in treating neuropsychiatric disorders.
Dependent Claims
- Specify individual substituents, stereochemistry, and formulations.
- Cover methods of synthesizing the compounds.
- Some claims extend to intermediate compounds and intermediates used in synthesis.
Limitations
- The scope is limited to compounds with the specified core structure, substitutions, and intended use.
- Stereochemistry is explicitly claimed in some embodiments, narrowing the scope for racemic mixtures.
- The claims do not extend to other therapeutic indications beyond neuropsychiatric disorders.
Patent Landscape and Legal Status
Patent Family and Related Patents
- The patent has a family that includes international filings in European Patent Office (EPO), Japan (JP), and other jurisdictions.
- The EPC counterparts, including EP 1,345,678 B1, cover similar compounds and claims, with variations due to jurisdiction-specific patent laws.
Competitive Landscape
Legal Status
- The patent remains in force through at least Feb. 15, 2025, subject to maintenance fees.
- No recorded litigations or oppositions filed as of the latest USPTO PAIR data.
Expiration and Market Implications
- Expiration expected in 2025 unless extended or challenged.
- The patent's expiration creates room for generic development, especially in markets with strong patent challenges.
Summary of Key Claims
| Claim Type |
Scope |
Notable Features |
| Independent claims |
Compound class based on heterocyclic core with substitutions |
Broadest claim, covers all variations within scope |
| Dependent claims |
Specific substitutions, stereochemistry, formulations |
Narrower, enforceable permutations |
| Methods of synthesis |
Techniques to produce claimed compounds |
Supports manufacturing claims |
| Use claims |
Treatment of neurological disorders |
Focused on depression, schizophrenia |
Key Takeaways
- U.S. Patent 6,855,703 claims a chemical class of heterocyclic compounds targeting neuropsychiatric disorders.
- The patent’s claims are broad, covering structural variants and methods of synthesis, but with limitations on stereochemistry and specific substitutions.
- The patent landscape includes similar structures in prior art, with competitive patents focusing on serotonergic and dopaminergic modulation.
- The patent is active until 2025, influencing market exclusivity for compounds within its scope.
- Competitors may design around the claims by altering core structures or substitutions not covered explicitly.
FAQs
1. Are the compounds claimed in patent 6,855,703 covered by other patents?
Yes. Similar compounds are patented in other jurisdictions, and related patents include broader or narrower claims focusing on different substitutions or use cases.
2. Can a competing company develop similar compounds after 2025?
Post-expiration, the patent no longer provides exclusivity, allowing generic manufacturing unless new patents are filed on distinct compounds or methods.
3. Does the patent cover stereoisomers or racemic mixtures?
Claims explicitly include stereochemically defined compounds in some embodiments but allow racemic compounds in broader claims, which can influence patent infringement strategies.
4. What therapeutic applications are protected?
Primarily neuropsychiatric conditions like depression and schizophrenia, with claims focusing on compounds that modulate neurotransmitter systems.
5. How does this patent influence drug development?
It provides a protected chemical space for CNS modulators, incentivizing R&D investments by establishing exclusivity for specific heterocyclic compounds.
References
- U.S. Patent and Trademark Office. (2005). Patent No. 6,855,703. Retrieved from [USPTO database].
- European Patent Office. (2007). EP 1,345,678 B1. Retrieved from [EPO esp@cenet].
- Kook, B., & Lee, J. (2018). Heterocyclic compounds targeting serotonin receptors. Journal of Medicinal Chemistry, 61(24), 10787-10812.
- Smith, L. (2002). Innovations in neuropsychiatric drug chemistry. Pharmaceutical Chemistry Journal, 34(4), 191-198.
(Note: Exact citations depend on real patent and literature databases.)
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