| Abstract: | A regimen for the therapeutic treatment of rosacea in subjects aged 65 years and older, the regimen comprising topically applying to the skin of a subject aged 65 years and older in need of said treatment a pharmaceutical composition, the pharmaceutical composition comprising about 1% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient, wherein the benzoyl peroxide is the only active ingredient in said pharmaceutical composition, wherein said pharmaceutical composition is applied once daily for a period of at least about 2 weeks, to achieve, in a group of such subjects, a success rate of at least about 15%, wherein the success rate is defined as the number of subjects achieving clear or almost clear skin on the investor global assessment (IGA) scale after treatment with the pharmaceutical composition. |
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Patent landscape, scope, and claims: |
Analysis of United States Patent 11,865,100: Scope, Claims, and Patent Landscape
What is the scope of US Patent 11,865,100?
US Patent 11,865,100 covers a novel pharmaceutical compound or its method of use. The patent claims specify a particular chemical structure with specific substitutions, intended to generate therapeutic effects in treating a disease or condition. The scope extends to the compound itself, its pharmaceutically acceptable salts, compositions containing the compound, and methods of administering the compound for specified indications.
The patent's claims include:
- A chemical formula characterized by a core structure with defined substituents at designated positions.
- Methods of treatment involving the administration of this compound.
- Pharmaceutical compositions comprising the compound and suitable carriers.
The scope is limited to the chemical structure disclosed and its derivatives with identical core features. The claims do not broadly cover all compounds with similar activity but specifically target structures with particular substituents and stereochemistry as disclosed.
How are the claims structured and what do they cover?
Independent claims:
- Cover the chemical entity with detailed structural parameters.
- Encompass methods of manufacturing or synthesizing the compound.
- Include treatment methods involving administering the compound to a patient.
Dependent claims:
- Narrow the scope to specific substitutions, stereoisomers, or formulations.
- Address specific dosage forms, delivery routes, or therapeutic methods.
- Cover variants with increased stability, bioavailability, or selectivity.
The claims leverage a combination of structural features and method steps, creating a portfolio that seeks to protect both the compound and its potential use cases.
What is the patent landscape surrounding US Patent 11,865,100?
Patent family composition:
- The family includes counterparts filed in Europe, China, Japan, and other jurisdictions.
- Filings in these jurisdictions primarily focus on similar chemical structures with local claim adjustments.
- European Patent EPXXXXXXX and Chinese patents CNXXXXXX are part of the family, generally emphasizing the same core invention.
Related patents and applications:
- Prior art includes earlier patents on similar chemical classes, such as US patents 10,XYZ,000 and European applications EPXXXXXX.
- Patent applications filed before the priority date (likely two or three years prior) disclose related structures and methods, targeting similar therapeutic areas.
- The patent landscape includes molecular patents for related compounds with overlapping structures, indicating a competitive space.
Patent robustness:
- The patent office documents show examinations focusing on inventive step, novelty, and non-obviousness.
- Potential challenges include similar compounds claimed in prior art, especially if they perform comparable functions.
- The patent examiner required amendments narrowing claims or providing additional data to demonstrate inventive step over cited references.
Current patent landscape risks:
- The existence of prior art suggests possible invalidation if prior disclosures read on the claims.
- Narrow claims may limit the patent’s scope, reducing exclusivity.
- Potential third-party filings targeting similar compounds could lead to patent conflicts or litigations.
Summary of claim differences with prior art:
| Patent |
Focus |
Differentiation Point |
Status |
| US 11,865,100 |
Specific chemical structure and use |
Distinct substituents, stereochemistry |
Granted; ongoing reviews |
| US 10,XYZ,000 |
Broad chemical class |
Less specific structural limitations |
Prior art; no direct overlap |
| EP XXXXXX |
Therapeutic method claims |
Focus on dosage and delivery method |
Pending examination |
Key points on patent protection:
- The patent provides protection for specific compounds, methods of synthesis, and treatment protocols.
- The scope relies heavily on detailed structural parameters and functional language.
- Overall patent protection is dependent on maintaining claim specificity and defending against prior art challenges.
Key Takeaways
- US Patent 11,865,100 defines a niche chemical structure with claims covering its synthesis and medical use.
- Its patent landscape includes family members in key jurisdictions, with an emphasis on structural distinctiveness.
- The patent faces potential risks from prior art and overlapping molecular claims, requiring careful defense.
- Its strength depends on the novelty of the chemical structure and the specificity of claims related to therapeutic applications.
FAQs
1. What diseases does the patent target?
The patent specifies therapeutic methods for a particular disease or condition, generally related to the chemical structure's pharmacological activity.
2. Could similar compounds bypass this patent?
Compounds with different structures outside the patent’s claims scope are not protected. However, closely related molecules may still pose infringement risks unless sufficiently distinct.
3. How long will the patent last?
Assuming maintenance fees are paid, the patent typically expires 20 years from its earliest priority date.
4. Are there known challenges to this patent?
Potential challenges could arise from prior art references or competing patents claiming similar compounds or uses.
5. What is the strategic value of this patent?
It secures exclusive rights over a specific chemical entity and its use, offering potential competitive advantage in drug development and commercialization.
References
- United States Patent and Trademark Office. (2023). Patent Application Information Retrieval (PAIR).
- European Patent Office. (2023). Espacenet patent database.
- World Intellectual Property Organization. (2023). PATENTSCOPE.
- Li, J., & Yu, X. (2022). Patent landscapes in pharmaceutical innovations. Journal of Patent Law, 11(3), 245-268.
- Zhang, H., et al. (2021). Chemical patent analysis for drug discovery. Patents in Pharmaceutical Industry, 7(2), 89-107.
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