Executive summary
US Drug Patent 9,364,485 claims a propellant-free, alcohol-free (incl. propylene glycol–free) sprayable topical steroid composition that uses a non-polymeric emulsifying system anchored on sorbitan stearate plus a specific polymer class (cellulose/gum/alginate/phthalate), with droplet formation, substantially non-foaming, and substantially non-occlusive skin performance. The independent claim is drafted broadly across (i) steroid identity, (ii) penetration enhancer selection, and (iii) water-immiscible substance selection, while narrowing via composition constraints (no propellant; no alcohol; no propylene glycol) and functional spray/skin behavior (droplets, non-foaming, non-occlusive). The patent’s commercial and litigation relevance will largely track whether competitors’ sprays use propellant/alcohol/propylene glycol, and whether they meet the same emulsifier+polymer architecture and performance constraints.
What does US Patent 9,364,485 claim: sprayable topical steroid composition with sorbitan stearate and non-occlusive droplets?
What is the independent claim scope (Claim 1)
Claim 1 covers:
- Dosage form / administration
- “sprayable topical pharmaceutical composition”
- Forms droplets upon application
- Substantially non-foaming and substantially non-occlusive to skin
- Active ingredient
- A steroid (the claim itself is generic; dependent claim 3 enumerates examples)
- Emulsifying system and excipients
- Non-polymeric emulsifying agent comprising:
- sorbitan stearate
- a polymer selected from:
- cellulose
- gum
- alginate
- phthalate
- water
- a water-immiscible substance
- a penetration enhancer
- Composition exclusions
- Composition is substantially free of:
- a propellant
- an alcohol
- propylene glycol
- Implicit claim structure
- The claim is not limited to a particular device (spray mechanism) beyond “sprayable,” but the functional droplet/non-foaming/non-occlusive limitations create a performance-based infringement hook.
Functional limitations that matter for infringement
- Droplet formation: targets sprays that create droplets rather than misting/foam.
- Substantially non-foaming: excludes or narrows formulas that generate foam on actuation or upon contact.
- Substantially non-occlusive: narrows against thick occlusive films or strongly barrier-occluding vehicles.
In practice, these are typically assessed by product behavior tests (foam generation, skin film/occlusion, visual wetting and residue).
What is narrowed vs what remains open
Broad (open)
- Steroid identity: broad class in claim 1; narrowed only in dependent claim 3.
- Penetration enhancer: broad class via multiple dependent layers (claims 4 and 5).
- Water-immiscible phase: broad via dependent claim 6.
- Polymer: constrained to a defined class (cellulose/gum/alginate/phthalate), but the list is still sizable (claim 7).
Narrow (hard constraints)
- Exclusions: no propellant, no alcohol, no propylene glycol (substantially free).
- Architecture: must include sorbitan stearate plus non-polymeric emulsifying agent with the listed components.
- Performance: droplets, non-foaming, non-occlusive.
Which steroids and penetration enhancers are covered by US 9,364,485?
Which steroids are explicitly listed (Dependent Claim 3)
Claim 3 lists:
- alclometasone dipropionate
- beclomethasone dipropionate
- betamethasone dipropionate
- betamethasone valerate
- fluocinolone acetonide
- halobetasol propionate
- hydrocortisone aceponate
- hydrocortisone acetate
- hydrocortisone valerate
- hydrocortisone butyrate
- mometasone furoate
- triamcinolone acetonide
- clocortolone pivalate
- clobetasol propionate
- desoximetasone
- fluticasone propionate
Claim 1’s steroid element is not limited to this list, but claim 3 provides clear coverage for many market-relevant corticosteroids. If the asserted product uses one of these steroids, the patent’s dependent claims strengthen the case for a straightforward literal match.
Which penetration enhancers are explicitly listed (Dependent Claims 4 and 5)
This creates a defense and design-around map: penetration enhancers outside these enumerated examples may still fall under Claim 4’s broader categories, but the enumerated list provides higher certainty for products that use the named agents.
Penetration enhancer concentration constraint (Claim 2 and Claim 10)
This is a classic infringement boundary. If a competitor uses a penetration enhancer above or below range, it may avoid dependent-claim coverage, but still potentially infringe Claim 1 unless the concentration is a necessary feature of Claim 1 as construed.
What polymers and emulsifying components are required under US 9,364,485?
Polymer class limitation (Claim 1 via Claim 7)
The “polymer” is selected from:
- cellulose
- gum
- alginate
- phthalate
Dependent claim 7 enumerates:
- ethyl cellulose
- methyl cellulose
- hydroxyethyl cellulose
- hydroxypropylcellulose
- hydroxypropyl methylcellulose
- hydroxybutyl methyl cellulose
- xanthan gum
- tragacanth
- guar gum
- locust bean gum
- acacia
- alginate
- cellulose acetate phthalate
- cellulose acetate butyrate
- hydroxypropyl methylcellulose phthalate
- and combinations
The polymer requirement is structural, not performance-only, so proving presence and identity is central to infringement and freedom-to-operate.
Sorbitan stearate is the anchor
Claim 1 requires sorbitan stearate in the non-polymeric emulsifying agent. This is a key narrowing feature.
Design-around typically focuses on:
- substituting emulsifiers away from sorbitan stearate, or
- changing the emulsifier system so it no longer “compris[es] sorbitan stearate” in the relevant emulsifying agent.
Because the claim uses “comprising,” adding sorbitan stearate likely preserves infringement risk even if additional emulsifiers exist.
What water-immiscible substance and excipient phase is covered?
Water-immiscible substance examples (Claim 6)
Selected from:
- vegetable oil
- saturated paraffin oil
- mineral oil
- fatty acid
- fatty ester of a natural fatty acid
- triglyceride of animal or vegetable origin
- medium chain triglyceride
- mixture of mono-, di-, and/or triglycerides
- wax
- hydrogenated vegetable oil
- or any combination thereof
This is broad coverage for the oil/immiscible phase. If a competitor uses a defined hydrocarbon or ester oil outside these examples, infringement could still occur depending on claim construction, but Claim 6 increases clarity for common dermatologic vehicles.
Is there a betamethasone-specific claim and does it change the landscape?
Betamethasone-specific independent claim (Claim 9)
Claim 9 is parallel to Claim 1 with an active-material substitution:
- sprayable topical pharmaceutical composition comprising a betamethasone compound
- 0.025% to 0.1% by weight betamethasone base
- same emulsifying system architecture
- same exclusions: no propellant, no alcohol, no propylene glycol
- same performance: droplets, substantially non-foaming, substantially non-occlusive
Betamethasone compound examples (Claim 11)
- betamethasone benzoate
- betamethasone dipropionate
- betamethasone sodium phosphate
- betamethasone valerate
Landscape impact
Claim 9 strengthens the patent estate against generic or reformulated betamethasone sprays that keep the excipient system but change only the steroid identity. If a product contains betamethasone in the specified strength range, Claim 9 provides a second independent infringement pathway distinct from Claim 1’s broader steroid coverage.
What method-of-use / indication coverage is claimed?
Therapeutic use claims (Claims 12 and 13)
Claim 12: for treating:
- atopic dermatitis
- seborrhoeic dermatitis
- eczema
- plaque psoriasis
- erythroderma psoriasis
- psoriasis of the scalp
- steroid responsive dermatoses
- erythema
- contact sensitivity reactions
- and other associated diseases/disorders
Claim 13: the same indication set tied to Claim 9’s betamethasone composition.
Landscape impact
Indication claims can create exposure even if a competitor targets a slightly different drug strength or steroid salt within the same family, but only if the asserted use aligns with the claimed composition and the product is used for the listed indications (often relevant in FDA labeling and marketing).
What viscosity and physical property limitations exist?
Viscosity range (Claims 14 and 16)
This is a manufacturing constraint that can become important where competitors attempt to engineer around droplet behavior by changing rheology. However, viscosity is a dependent claim limitation, so it strengthens coverage rather than fully defining Claim 1.
How strong is the patent estate likely to be based on claim structure (scope vs design-around)?
Key claim features that tend to be hard to design around
- No propellant
- No alcohol and no propylene glycol
- Sorbitan stearate + polymer class
- Functional performance: droplets, non-foaming, non-occlusive
Any formulation that keeps a propellant or uses alcohol/propylene glycol likely avoids at least portions of the claim. But if the formulation is designed as a propellant-free spray using sorbitan stearate and similar polymer/fatty systems, it faces higher risk.
Key design-around levers
- Replace sorbitan stearate with a different emulsifier system so the emulsifying agent no longer includes sorbitan stearate.
- Reintroduce an excluded component (alcohol or propylene glycol) so the composition is not “substantially free.”
- Change the spray behavior so it becomes foaming or occlusive, avoiding the “substantially non-foaming” or “substantially non-occlusive” performance limitations.
- Use a different penetration enhancer category and/or concentration outside the dependent ranges.
Litigation leverage points
- Proving the presence of sorbitan stearate, the polymer identity, and compliance with “substantially free” exclusions typically relies on formulation documents and lab testing.
- “Substantially non-foaming” and “non-occlusive” can become factual battlegrounds and may require expert-tested metrics.
What competitors are most exposed under this claim set (without naming parties)?
Based strictly on the claim elements, highest exposure is concentrated in:
- propellant-free spray topicals for dermatologic steroids using a sorbitan stearate emulsifying system with a cellulose/gum/alginate/phthalate polymer, and
- compositions built to be non-foaming and non-occlusive, and
- that avoid alcohol and propylene glycol while maintaining penetration enhancer inclusion.
Competitors using aerosol canisters with propellants, or vehicles containing propylene glycol, are structurally separated from the claim’s core constraints.
How do these claims intersect with typical spray topical technology (technical claim themes)
Spray droplet formation without foam
The claim targets a balance: sprayable delivery and user-friendly application while limiting foam. This aligns with formulation systems that are microemulsion-type or emulsion/dispersion-type rather than foaming propellant systems.
Non-occlusive skin behavior
“Non-occlusive” is a performance constraint tied to oil load, film formation, and polymer/film-former characteristics. Even with a water-immiscible phase present, the system is claimed to avoid an occlusive film.
Emulsifier + polymer architecture
Requiring both:
- sorbitan stearate (a surfactant/emulsifier)
- and a specific polymer class
suggests the claim was drafted to capture a defined physical dispersion mechanism and stability profile.
Key claim-to-exposure matrix for infringement assessment
| Claim element |
What must be present / satisfied |
Typical evidence |
Main design-around |
| Sprayable topical |
Sprayable dosage form |
Product composition + device compatibility |
Use different dosage form (cream/ointment/gel) |
| Droplets upon application |
Droplet formation |
Application testing |
Change atomization to mist/stream pattern |
| Substantially non-foaming |
No foam or minimal foaming |
Foaming tests (qual/quant) |
Use foaming excipients or propellant-related foam |
| Substantially non-occlusive |
No occlusive film |
Skin occlusion proxies, film tests |
Increase film-forming/oily load to occlude |
| Steroid |
Any steroid in claim 1; enumerated set in claim 3 |
Label/composition |
Choose non-covered steroid only affects dependent claims; claim 1 is broad |
| Non-polymeric emulsifying agent |
Includes sorbitan stearate + polymer class + water + oil phase + penetration enhancer |
Formulation & specs |
Remove sorbitan stearate; change polymer class |
| Penetration enhancer |
Must be one in category; concentration range in dependent claims |
Lab assay |
Use enhancer outside enumerated categories or range |
| Exclusions |
Substantially free of propellant, alcohol, propylene glycol |
Formulation COAs, lab assays |
Add propylene glycol or alcohol; use propellant |
| Viscosity (dependent) |
10 to 15,000 cP |
Rheology measurements |
Move outside range |
What is the regulatory and labeling exposure mechanism (US context)
While the provided prompt does not include an FDA product identifier, these claims align with the typical FDA-Orange-Book infringement model: if a spray topical corticosteroid product is approved and listed, the scope of protection will hinge on whether the Orange Book lists a patent with these exact claims and whether a generic applicant’s composition matches the claim limitations.
Indication claims (Claims 12 and 13) can matter for “carve-out” labeling in settlements, where a product might be launched with narrower indications to reduce exposure.
Key Takeaways
- US Patent 9,364,485 centers on a propellant-free, alcohol-free (propylene glycol–free) sprayable topical steroid composition that makes droplets, is substantially non-foaming, and is substantially non-occlusive.
- The emulsifying architecture is anchored on sorbitan stearate plus a polymer selected from cellulose, gum, alginate, and phthalate classes, with water and a water-immiscible phase and a penetration enhancer.
- Dependent claims materially tighten scope by specifying penetration enhancer ranges, steroid exemplars, betamethasone concentration and salts, viscosity, and polymer exemplars.
- The highest infringement risk scenario is a competitor that keeps the propellant/alcohol/propylene glycol exclusions while using sorbitan stearate + one of the claimed polymer classes and achieving the same non-foaming/non-occlusive droplet performance.
- Design-around is most feasible by removing sorbitan stearate from the emulsifying system, or by reintroducing propylene glycol or alcohol, or by changing droplet/foam/occlusion behavior.
FAQs
- How do “substantially non-foaming” and “substantially non-occlusive” get tested in infringement disputes?
- Does Claim 1 cover all corticosteroids or only the enumerated list in Claim 3?
- If a competitor uses betamethasone outside 0.025% to 0.1% by weight, do they still risk Claim 1 infringement?
- What is the most direct design-around to avoid the emulsifier limitation involving sorbitan stearate?
- Can a launch avoid indication claims by limiting FDA label use even if composition matches the patent?
References (APA)
- United States Patent No. 9,364,485. (n.d.). United States Patent and Trademark Office.
