United States Patent 11,986,527: Scope, Claims, and U.S. Landscape
US Drug Patent 11,986,527 claims a specific low-strength topical corticosteroid formulation and a treatment method tied to (i) an oil-phase composition, (ii) a defined corticosteroid concentration range, (iii) a solubilization threshold measured at a specified temperature, and (iv) an explicit formulation exclusion (no white petrolatum). The claims are structured to capture both general corticosteroids and a fallback to halobetasol propionate, while anchoring the technical novelty to the oil esters + mineral oil / light mineral oil system and solubilization performance.
What is claimed at a high level?
The independent claim is method-of-treatment (topical administration) where the marketed product is constrained by formulation parameters:
- Indication scope (broad): “dermatological or mucosal disorder or condition” including, in dependent claim, common inflammatory dermatoses (psoriasis variants, atopic/contact dermatitis, eczema, seborrheic dermatitis, rashes).
- Drug scope (broad, within list): corticosteroids selected from a defined group including clobetasol propionate and halobetasol propionate and others (betamethasone dipropionate/valerate, diflorasone diacetate, desoximetasone, mometasone furoate, halcinonide, budesonide, fluocinonide, amcinonide).
- Concentration constraint: corticosteroid at about 0.01% to about 0.030% or less.
- Solubilization constraint (performance/definition): at least 25% of the corticosteroid must be solubilized in the liquid oil component at 22° C. ± 2° C.
- Oil-phase composition constraint: the “liquid oil component” contains:
- one or more monocarboxylic acid esters and/or dicarboxylic acid esters, and
- mineral oil and/or light mineral oil (including a combination).
- Carrier constraint: an aqueous component comprising water.
- Exclusion: pharmaceutical composition is free of white petrolatum.
- Dosage form constraint: lotion or cream.
Claim 2-18 build on the same scaffold with narrower drug selection (halobetasol) and explicit example-level parameters (0.01% halobetasol; optional specific esters).
Claim-by-Claim Scope Analysis
Claim 1: Independent method-of-treatment with formulation-defined limitations
Claim 1 captures a therapeutic method only when all formulation limitations are met.
Core elements:
- Method type: “method of treating” by topically administering to the skin of an individual with a dermatological or mucosal disorder.
- Active: topical corticosteroid from a defined list:
- clobetasol propionate
- betamethasone dipropionate
- halobetasol propionate
- diflorasone diacetate
- desoximetasone
- mometasone furoate
- betamethasone valerate
- halcinonide
- budesonide
- fluocinonide
- amcinonide
- Corticosteroid concentration: about 0.01% to about 0.030% or less
- Oil-phase: “liquid oil component” contains:
- one or more monocarboxylic acid esters and/or dicarboxylic acid esters
- plus mineral oil and/or light mineral oil
- Solubilization threshold: ≥25% solubilized in the liquid oil component at 22° C. ± 2° C.
- Aqueous phase: includes water
- No white petrolatum: composition is free of white petrolatum
- Form: lotion or cream
Practical claim breadth (what it captures):
- Broad on indications (when not limited by dependents).
- Broad on which corticosteroid (within the enumerated set).
- Medium-to-broad on ester selection (any monocarboxylic or dicarboxylic acid esters satisfying the solubilization and formulation constraints).
- Narrow by:
- quantitative solubilization requirement,
- defined concentration band,
- explicit petrolatum exclusion,
- oil-phase requirement to include mineral oil/light mineral oil in the “liquid oil component.”
Claims 2-4: Halobetasol propionate fallback and concentration specifics
- Claim 2: corticosteroid is halobetasol propionate.
- Claim 3: concentration is about 0.03%.
- Claim 4: concentration is about 0.01%.
Scope effect: These claims tighten the drug identity and concentration. From an infringement perspective, products using halobetasol at ~0.01% or ~0.03% fall into these dependent layers only if the same formulation and solubilization constraints of Claim 1 are also met.
Claims 5-8: Ester-type specificity (example anchoring)
- Claim 5: liquid oil component comprises a dicarboxylic acid ester
- Claim 6: dicarboxylic ester = diethyl sebacate
- Claim 7: liquid oil component comprises a monocarboxylic acid ester
- Claim 8: monocarboxylic ester = isopropyl myristate
Scope effect: Claims 5-8 provide additional coverage for at least two named ester options. They do not limit Claim 1’s ester universe but create extra claim paths for formulations built around these specific esters.
Claims 9-12: Oil composition and optional formulation auxiliaries
- Claim 9: liquid oil component comprises light mineral oil.
- Claim 10: liquid oil component further comprises an emulsifying agent.
- Claim 11: aqueous component further comprises one or more of: humectants, preservatives, chelating agents, emulsifying agents, thickening agents, or combinations.
- Claim 12: composition further comprises a pH adjusting agent.
Scope effect: These dependents expand coverage for typical topical lotion/cream excipient selections. They generally do not restrict beyond standard formulation choices, except that the independent constraints remain binding.
Claims 13-17: Dosage form, indication exemplars, dosing regimen, and treatment duration
- Claim 13: formulation is a lotion (not cream).
- Claim 14: disorder/condition is one of:
- psoriasis, plaque psoriasis
- atopic dermatitis
- contact dermatitis
- hand dermatitis
- eczema
- seborrheic dermatitis
- rash
- poison ivy dermatitis
- Claim 15: condition is plaque psoriasis
- Claim 16: administered once daily or twice daily.
- Claim 17: treatment longer than two weeks
Scope effect: This set expands method coverage into specific clinical contexts and practical use patterns, while leaving the formulation definition intact.
Claim 18: Fully specified halobetasol example claim
Claim 18 restates a method with halobetasol propionate and nails down more specifics:
- liquid oil component: monocarboxylic and/or dicarboxylic acid esters + mineral oil/light mineral oil
- halobetasol propionate concentration = 0.01%
- at least 25% solubilized at 22° C. ± 2° C.
- free of white petrolatum
- formulated as lotion or cream
Scope effect: Claim 18 functions like an explicit, tighter “center of gravity” claim around the halobetasol 0.01% embodiment that aligns with the solubilization condition.
What is the patent’s real claim “hook”?
The novelty is not just “low-dose topical corticosteroid lotion/cream.” The independent claim is written so that formulation performance defines the scope:
1) Solubilization threshold at a fixed temperature
- At least 25% of corticosteroid must be solubilized in the liquid oil component at 22° C. ± 2° C.
- This turns the claim into a measurable formulation property, which is harder to design around than a vague “enhances solubility” statement.
2) Oil system defined by ester class + mineral oil/light mineral oil
- The oil component must include:
- monocarboxylic acid esters and/or dicarboxylic acid esters
- mineral oil and/or light mineral oil
3) Exclusion of white petrolatum
- Many topical bases incorporate petrolatum fractions. Here, the claim requires free of white petrolatum, which limits typical occlusive bases.
4) Active concentration band
- The claim is bounded by ~0.01% to ~0.030% or less corticosteroid concentration.
Implication: A generic or follow-on product that changes the oil base, solubilization behavior, or uses a different vehicle that does not meet the “≥25% solubilized at 22° C.” condition can reduce (or eliminate) literal coverage.
Infringement Mapping: What must a product do to fall within scope?
A product using the listed corticosteroids will only satisfy Claim 1 if all of the following are true simultaneously:
| Limitation in Claim 1 |
Product requirement for literal coverage |
| Topical method treating dermatological/mucosal disorder |
Labeled/used for the claimed condition, applied topically |
| Corticosteroid is from enumerated list |
Uses one of the specified actives |
| Lotion or cream |
Dosage form must be lotion or cream |
| Corticosteroid concentration |
In the 0.01% to 0.030% or less range |
| Oil phase includes esters + mineral oil/light mineral oil |
Liquid oil component must contain those ester types and mineral oil or light mineral oil |
| Solubilization |
≥25% of the corticosteroid solubilized in liquid oil at 22° C. ± 2° C. |
| Aqueous phase present |
Contains water (aqueous component) |
| No white petrolatum |
White petrolatum-free formulation |
Dependent claims add further conditions (halobetasol only, specific concentrations, specific esters, light mineral oil requirement, dosing regimen, etc.).
Patent Landscape: U.S. competitive and design-around logic
1) Likely claim target: low-strength superpotent steroid creams/lotion platforms
The asserted scaffold is aligned with the commercial reality that clobetasol/halobetasol and other high-potency corticosteroids are often formulated as creams, ointments, or lotions at low strengths. The claim’s distinctive constraints suggest a focus on vehicle-driven solubilization rather than pure active concentration.
2) Design-around vectors
Because the claims hinge on a solubilization property tied to a defined oil system and an explicit petrolatum exclusion, the main practical design-around levers are:
- Change oil-phase composition so that the corticosteroid is not ≥25% solubilized at 22° C. ± 2° C. in the “liquid oil component” as defined by the claim.
- Remove mineral oil/light mineral oil from the claimed “liquid oil component” system, or change ester selection such that the solubilization threshold is not met.
- Use a vehicle that is still petrolatum-free but changes solubilization behavior.
- Move outside the concentration window (below ~0.01% or above ~0.030% or less), though that may be clinically constrained.
- Dose form change: if a product were not lotion/cream (for example, different dosage format), it could fall outside “formulated as a lotion or a cream.” The claim is explicit, so changing dosage form can matter.
3) Litigation relevance of performance-defined claim elements
The solubilization requirement is likely to be a center of dispute:
- It can require expert measurement and formulation comparison.
- It also creates a stronger argument for non-infringement by demonstrating solubilization below the threshold under the specified conditions.
4) Landscape positioning vs. typical topical steroid reformulations
In a competitive landscape, many product variations change:
- emulsifier type
- humectant/preservative selection
- thickening system
- pH adjustments
These are addressed by dependent claims (Claims 10-12, 11) and typically will not avoid coverage if the core solubilization/vehicle constraints remain met.
Freedom-to-Operate (FTO) screening checklist for product teams
A product development or licensing decision can be screened against the claim language using the following deterministic questions:
- Does the active match? One of the listed corticosteroids, including halobetasol/clobetasol family and others enumerated.
- Is the concentration within 0.01% to 0.030% or less?
- Is the product lotion or cream?
- Is the composition white petrolatum-free?
- Does the oil phase include mineral oil and/or light mineral oil plus mono-/di-carboxylic acid esters?
- Does measured solubilization of the corticosteroid in the claimed “liquid oil component” meet ≥25% at 22° C. ± 2° C.?
- If halobetasol-specific: is the concentration ~0.01% or ~0.03% (Claims 3-4) and does the solubilization threshold still hold?
- If ester-specific: is the formulation using diethyl sebacate or isopropyl myristate (Claims 6 and 8), or light mineral oil (Claim 9)?
- For method claims: does the intended use map to covered conditions and dosing regimen or duration (Claims 14-17)?
If any of items 5 or 6 fail, Claim 1 coverage becomes substantially harder to establish.
Key Takeaways
- US 11,986,527 is a formulation-defined method-of-treatment patent where infringement depends on vehicle performance, not just drug identity and potency.
- The independent claim requires a topical corticosteroid (0.01% to ~0.030% or less) in a lotion or cream that is:
- free of white petrolatum
- contains an oil phase with esters + mineral oil/light mineral oil
- and meets a measurable property: ≥25% solubilization of the corticosteroid in the liquid oil component at 22° C. ± 2° C.
- Dependent claims narrow to halobetasol propionate and to specific concentrations, esters, excipient types, and use patterns (conditions, dosing frequency, treatment duration).
- For competitive strategy, the most effective design-around levers are to break the solubilization threshold and/or change the oil-phase architecture such that the corticosteroid is not ≥25% solubilized in the claimed oil system at the specified temperature.
FAQs
1) Does the patent cover any topical corticosteroid?
No. It covers topical treatment using corticosteroids only from the enumerated group in Claim 1 and within the stated concentration window.
2) Is the claim driven by the corticosteroid concentration alone?
No. Concentration is necessary but not sufficient. Claim 1 additionally requires the solubilization threshold (≥25% at 22° C. ± 2° C.) in the defined oil component.
3) What is the significance of “free of white petrolatum”?
It is an explicit negative limitation. Any formulation using white petrolatum would not satisfy the “free of white petrolatum” requirement for Claim 1.
4) Do common formulation excipients create infringement risk by themselves?
No. Excipients like emulsifiers, humectants, preservatives, pH adjusters, and thickening agents are addressed in dependent claims and do not avoid coverage if the core vehicle and solubilization requirements are met.
5) What is the narrowest claim position?
Claim 18 is the tightest structure in the set, fixing halobetasol propionate at 0.01% with the same solubilization and vehicle constraints, plus petrolatum exclusion and lotion/cream form.
References
- US Patent 11,986,527. Claims as provided in the prompt.
