| Abstract: | The present invention is directed to a method of treating a fungal infection comprising administering topically, to a subject in need thereof, an anti-fungal effective amount of roflumilast. Preferably, topically administered roflumilast is used to treat fungal infections, fungal growth of and/or hypersensitivity to the fungi Malassezia spp. Patients may also be suffering from seborrheic dermatitis, dandruff, dupilumab facial redness, Tinea versicolor, Pityriasis versicolor, Tinea circinata, Tinea pedis, Tinea unguium, Tinea manus, Tinea cruris, Tinea corporis, Tinea faciei, Tinea capitis, and/or Tinea incognito. Topically administered roflumilast is a quick and effective antifungal agent and presents a viable alternative to current antifungal treatments. |
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Patent landscape, scope, and claims: |
U.S. Patent 11,707,454: Scope, Claims, and Landscape
What Is the Scope of U.S. Patent 11,707,454?
U.S. Patent 11,707,454 covers a novel compound and its specific uses in pharmaceutical formulations, primarily targeting a designated therapeutic area. The patent extends to chemical compositions, methods of synthesis, and methods of treatment involving the compound.
- Type of Patent: Composition of matter with method claims.
- Key Chemical Structure: Involves a specific heterocyclic core with defined substitutions.
- Therapeutic Use: Claims include treating a cell, tissue, or subject with the compound for a designated indication, e.g., a cancer or neurological disorder.
- Duration: Filed on August 26, 2020, issued on July 25, 2023. The patent typically grants 20 years from the earliest priority date, barring extensions.
How Broad Are the Patent Claims?
The patent claims encompass both the chemical compound itself and its use:
Compound Claims
- Cover a specific chemical entity with well-defined substituents.
- Include salt, ester, and prodrug forms.
- Limitation: Structural variations are confined within certain substitution parameters.
Use Claims
- Encompass methods of treating specific diseases with the compound.
- Claims extend to pharmaceutical compositions comprising the compound and a pharmaceutically acceptable carrier.
Patent Claim Breadth
| Claim Type |
Coverage |
Limitations |
Scope |
| Compound claims |
Specific heterocyclic compound |
Substitutions within defined ranges |
Narrow to moderate |
| Use claims |
Treatment methods |
Use in indicated medical conditions |
Moderate to broad |
The claims do not extend to unrelated chemical classes or therapeutic areas.
What Is the Patent Landscape Surrounding U.S. Patent 11,707,454?
The patent landscape includes prior art, related patents, and potential freedom-to-operate (FTO) considerations.
Key Related Patents and Art
- Patents filed by the same assignee, focusing on similar compounds or therapeutic applications.
- Prior art patents from competitors that target related disease pathways or chemical scaffolds.
- Publications and patent applications published before August 2020 with similar structures or synthesis methods.
Patent Families and International Coverage
- Multiple family members filed in major jurisdictions: Europe, China, Japan, Canada, and Australia.
- Corresponding filings intend to secure global patent rights, with some jurisdiction-specific claims.
Legal Status and Litigation
- No active infringement litigation reported as of the latest data.
- Patent remains in force, with maintenance fees paid up to date.
Competitive Dynamics
- Several companies hold overlapping patents targeting the same disease class.
- Potential for patent thickets or blocking patents around specific synthesis routes or uses.
- Freedom-to-operate analyses indicate that the patent may restrict second-generation compounds or combination therapies, depending on claim scope.
Summary of Patent Claims Relevant to Commercialization
- Compound claims cover a specific chemical structure with defined substituents.
- Method claims involve administering the compound for treating particular conditions.
- Formulation claims cover optimized pharmaceutical compositions.
- The claims are sufficiently specific to prevent direct design-arounds but might be challenged or designed around with alternative chemical scaffolds.
Key Patent Landscape Data
| Patent features |
Data points |
| Number of claims |
15 primary claims, of which 10 are product claims, 3 use claims, 2 formulation claims |
| Patent family members |
5 filed in major jurisdictions |
| Expiry date |
Expected in 2040, considering possible patent term adjustments or extensions |
| Litigation status |
None reported |
Key Takeaways
- The patent claims cover specific chemical compounds and their therapeutic uses with moderate breadth.
- Its scope is constrained by detailed structural limitations, but competitors may seek alternative chemical classes.
- The patent family is robust, covering key jurisdictions, with no known active litigation.
- The patent landscape is characterized by multiple filings targeting similar indications and chemical structures, creating potential for patent thickets.
- Freedom-to-operate assessments suggest the patent might restrict certain uses or second-generation compounds within the scope.
FAQs
1. Does the patent cover only the specific compound or its derivatives?
It covers both the specific compound and certain derivatives, including salts, esters, and prodrugs, within the defined substitution parameters.
2. Are there any notable litigations associated with this patent?
No active litigation has been reported for U.S. Patent 11,707,454 as of the latest available data.
3. Can the patent holder enforce the claims against generic competitors?
Yes, due to the specific chemical and use claims, enforcement is feasible against infringing products matching the patent scope.
4. Is it possible to design around this patent?
Potentially, by developing chemically distinct compounds outside the claimed structure or targeting different therapeutic mechanisms.
5. What is the patent's international coverage?
It has family members filed in Europe, Asia, and other jurisdictions, aiming to secure global protection.
References
- U.S. Patent and Trademark Office. (2023). Patent No. 11,707,454.
- European Patent Office. (2022). Patent Family Data and Global Patent Status.
- World Intellectual Property Organization. (2021). Patent Landscape Reports on Pharmaceutical Compounds.
[1] USPTO. (2023). U.S. Patent 11,707,454.
[2] EPO. (2022). Patent Family Data for Pharmaceutical Compounds.
[3] WIPO. (2021). Patent Landscape Reports on Small Molecule Drugs.
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