Scope and Claims Analysis of US Patent 10,106,503: Nebulized Inhaled Biphenyl-2-ylcarbamic Acid for COPD and Asthma (10–200 μg/day)

US Patent 10,106,503 claims a narrow inhalation dosing and formulation-driven method for treating chronic obstructive pulmonary disease (COPD) and asthma using an inhalable pharmaceutical composition containing a specific active compound (biphenyl-2-ylcarbamic acid 1-(2-{[4-(4-carbamoylpiperidin-1-ylmethyl)benzoyl]methylamino}ethyl)piperidin-4-yl ester) and optional salts, delivered in a defined 10 to 200 μg/day exposure range. The claims also lock in administration modes (inhalation, nebulizer), dosing cadence (single daily dose), and aqueous solution/formulation attributes (pH 3–8; isotonic aqueous solution; optional sodium chloride/citric acid buffer), with optional combination add-ons (β2 adrenergic receptor agonists; steroidal anti-inflammatory agents).

What is the active ingredient and what does US 10,106,503 claim for inhaled COPD and asthma?

Featured snippet answer: US 10,106,503 claims treating COPD and/or asthma by inhaling a pharmaceutical composition containing a specific biphenyl-2-ylcarbamic acid piperidine ester compound (or salt) administered to deliver ~10 μg/day to ~200 μg/day of the active, typically via nebulizer and often as a single daily dose aqueous formulation with defined pH and isotonic properties.

Claim 1: Core method-of-treatment with dose window

Independent claim 1 covers:

Use condition: “treating chronic obstructive pulmonary disease or asthma in a mammal”
Administration: via administering a pharmaceutical composition
Active: biphenyl-2-ylcarbamic acid 1-(2-{[4-(4-carbamoylpiperidin-1-ylmethyl)benzoyl]methylamino}ethyl)piperidin-4-yl ester or salt
Dose requirement: pharmaceutical composition administered in an amount sufficient to provide about 10 μg/day to about 200 μg/day
Carrier: includes “pharmaceutically acceptable carrier” (broad; dependent claims add constraints)

This claim is the foundation. Every other claim either restricts the treated disease, the delivery device/route, the dosing cadence, or the formulation characteristics, or adds co-therapies.

Claims 2–3: Disease restriction

Claim 2: COPD
Claim 3: asthma
These are dependent carve-outs of claim 1, which already covers “COPD or asthma.” Practically, they increase enforceability against defendants that only practice one indication.

Claims 4–6: Delivery modality and dosing schedule

Claim 4: administration by inhalation
Claim 5: inhalation using a nebulizer inhaler
Claim 6: administered as a single daily dose

These narrow the independent claim into device and regimen-specific practice. Device and schedule are common litigation pressure points because an accused product may use dry powder inhalation or multiple daily doses.

Claims 7–12: Aqueous formulation constraints

Claim 7: pharmaceutically acceptable aqueous carrier
Claim 8: pH 3 to 8
Claim 9: further comprises a buffer
Claim 10: buffer is sodium chloride citric acid buffer
Claim 11: isotonic aqueous solution
Claim 12: isotonic aqueous solution comprises ~0.05 μg/mL to ~10 mg/mL active (or salt)

These dependent claims materially narrow to a specific solution-type formulation space:

pH band (3–8)
isotonicity
specific buffer system (NaCl + citric acid)
wide concentration window (from microgram per mL to milligram per mL)

Claims 13–14: Optional combination therapy

Claim 13: adds a β2 adrenergic receptor agonist
Claim 14: adds a steroidal anti-inflammatory agent

These support combination-product enforcement scenarios, but they are still tethered to the same inhalation and dosing window of the claimed active.

What does US 10,106,503 cover for humans vs mammals?

Featured snippet answer: Claims 15–25 replicate the mammal claims but require a human patient, with the same 10–200 μg/day active dose window and similar inhalation and formulation/device dependencies.

Claim 15: Human method-of-treatment with identical dose window

Treated indication: COPD in a human patient (not asthma)
Active and dosing window: same compound (or salt), 10–200 μg/day
Route: inhalation
Carrier: pharmaceutically acceptable

Claims 16–17: Nebulizer and single daily dose

Claim 16: nebulizer inhaler
Claim 17: single daily dose

Claims 18–23: Aqueous pH/buffer/isotonic concentration limits

Claim 18: aqueous carrier
Claim 19: pH 3–8
Claim 20: buffer
Claim 21: sodium chloride citric acid buffer
Claim 22: isotonic aqueous solution
Claim 23: concentration ~0.05 μg/mL to ~10 mg/mL

Claims 24–25: Optional add-ons

Claim 24: β2 agonist
Claim 25: steroidal anti-inflammatory agent

Practical scope difference

Independent claim coverage: claim 1 is broader on the treated conditions (COPD or asthma) and on target species (“mammal”).
Enforcement focus: claim 15 strengthens human COPD-specific infringement theory and can be more persuasive to a court due to reduced uncertainty over patient class.

How narrow is the dosing scope (10–200 μg/day) and how does it impact design-around risk?

Featured snippet answer: The claims require that dosing be “sufficient to provide about 10 μg/day to about 200 μg/day” of the specific active (or salt). A product that falls outside this exposure band is outside the claim dose requirement, but “about” creates a tolerance band governed by intrinsic record and expert claim construction.

Key claim constraint: exposure expressed in μg/day

This dosing metric is not concentration-only; it is exposure over time. That means infringement analysis should evaluate:

administered active amount per day
actual delivered dose to the lungs (depending on device and formulation)
whether the accused product’s regimen yields daily active exposure within the claim window

Design-around pathways likely tested in litigation

Lower-than-10 μg/day regimens: reduce exposure below claimed lower bound.
Higher-than-200 μg/day regimens: increase exposure above upper bound.
Different dosing cadence: move from single daily dose to BID/TID while keeping daily total above/below range.
Different device class: dry powder inhalers may still be “inhalation” (claim 4/15) but may avoid nebuilizer inhaler limitations (claim 5/16).
Non-aqueous delivery: claim 7/18 require aqueous carrier for narrower dependent claims.

How “about” affects certainty

The claim language uses “about” for both the daily and concentration limits. That expands the practical infringement footprint compared to rigid numerical cutoffs, but it still constrains the useful design space.

Which delivery and formulation features create the most enforceable “claim hooks”?

Featured snippet answer: The most enforceable claim hooks are the combination of (1) daily μg exposure window, (2) inhalation route, (3) optionally nebulizer inhaler and single daily dose, and (4) for dependent claims, aqueous isotonic pH 3–8 with sodium chloride/citric acid buffer and the 0.05 μg/mL to 10 mg/mL concentration range.

High-leverage claim elements for infringement mapping

Active compound identity
The claims are tied to a specific chemical structure; any “equivalent” substitution would be a validity/claim construction fight, not a simple formulation change.
Daily dosing window (10–200 μg/day)
This is quantitative and often decisive.
Route (inhalation)
If a defendant switches to systemic dosing, it avoids all inhalation claims.
Device (nebulizer inhaler)
Narrower dependent claims provide stronger infringement leverage only for nebulizer-type administration.
Aqueous isotonic + pH 3–8 + buffer type
These dependent constraints are meaningful for formulation competitors.

Combination therapy claims are additive

Claims 13–14 and 24–25 add co-therapies but do not remove any other limitations. A generic/alternate formulation would still have to practice the underlying inhalation method and dosing window.

What patent estate gaps exist if a competitor uses a different device or regimen?

Featured snippet answer: A competitor can reduce exposure to dependent claim infringement by changing one of the narrowest elements: device type (avoid “nebulizer inhaler”), dosing schedule (avoid “single daily dose”), and formulation carrier system (avoid “aqueous carrier,” or alter buffer/isotonic/pH). However, independent claims 1 and 15 still require inhalation and the daily dose window.

Dependence structure

Independent claim 1 captures inhalation + compound + daily μg range.
Dependent claims layer device and formulation constraints.
Even if a competitor avoids dependent claims, independent claim risk remains if inhalation and dosing window are met.

Typical infringement outcome pattern

If a competitor stays within 10–200 μg/day and uses inhalation, independent claim coverage remains.
If the competitor alters dose outside range, claim avoidance is strongest.
If the competitor uses non-nebulizer inhalation, dependent claim risks (claims 5 and 16) drop, but independent risks persist.

How strong is the claim set likely to be without knowing the specification?

Featured snippet answer: The claim set is strong in specificity: defined compound identity, defined daily dose band, and dependent constraints that cover common inhalation solution regimens. Strength in litigation will hinge on whether the specification supports broad interpretations of “about,” isotonicity, pH range application to manufactured product, and device classification as “nebulizer inhaler.”

Claim breadth scorecard (based on language provided)

Indication breadth: moderate (COPD and asthma for mammal; COPD only for human)
Route breadth: limited to inhalation
Device specificity: limited (only in dependent claims)
Carrier/formulation specificity: limited to aqueous carrier in dependent claims
Numerical certainty: high for dose window and pH band; moderate for “about”
Combination coverage: moderate (dependent additions)

What generic or biosimilar entry risks exist for US 10,106,503?

Featured snippet answer: Entry risk is driven by whether an abbreviated pathway applicant must match an inhalation regimen delivering the same active exposure (10–200 μg/day) and route. “Generic” entry would depend on whether the active is already approved and substitutable; biosimilar logic generally does not apply unless the drug is biologic, which the claim language does not indicate.

Practical risk pathways

If the branded drug uses the same compound, inhalation method, and daily μg exposure: high risk of Paragraph IV-style infringement allegations tied to claim 1/15.
If the branded dose is within the claim window but the competitor uses a different device/regimen: independent claim risks persist if inhalation and daily exposure match.
If the competitor reformulates to keep daily exposure outside 10–200 μg/day: stronger avoidance of claim 1/15.

Where infringement fights concentrate

daily exposure calculations and dosing regimen matching
inhalation classification and whether the product is “nebulizer inhaler”
isotonicity, pH measurement standards, and buffer composition for dependent claims

What is the likely litigation map given the claim structure (single compound, multiple dependent ladders)?

Featured snippet answer: The most likely infringement theory bundles revolve around claim 1/15 (core dose + inhalation), with dependent fallbacks for nebulizer, single daily dosing, and aqueous isotonic pH/buffer formulation parameters.

Infringement “ladder” approach in practice

Assert independent claim 1 (mammal, COPD or asthma) or claim 15 (human COPD).
Add dependent claims as alternative grounds:
- device (nebulizer inhaler)
- regimen (single daily dose)
- aqueous isotonic pH and buffer
- concentration range
- combination add-ons

Validity attack points typical for this architecture

chemical scope support (whether the exact compound is enabled and tied to the claimed dosing/formulation)
“about” construction
whether isotonicity and pH constraints are supported and meaningful
obviousness based on prior art inhalation solution formulations and dose ranges
enablement and written description for salt forms and buffers

Comparison: How do claims 1–14 (mammal, COPD or asthma) compare with claims 15–25 (human COPD)?

Featured snippet answer: The mammal claims cover both COPD and asthma, while the human claims narrow to COPD. Both share the same compound and the same daily dosing band, with the human set providing an additional human-specific infringement pathway that can simplify enforcement.

Side-by-side scope

Element	Claims 1–14	Claims 15–25
Patient class	Mammal	Human
Indications	COPD or asthma	COPD only
Route	Inhalation (dependent)	Inhalation (independent)
Device	Nebulizer in dependent	Nebulizer in dependent
Dosing cadence	Single daily dose in dependent	Single daily dose in dependent
Formulation	Aqueous in dependent; pH/buffer/isotonic in dependents	Same dependents
Combination therapy	β2 agonist or steroidal anti-inflammatory in dependents	Same dependents
Quantitative anchor	10–200 μg/day in independent	10–200 μg/day in independent

Patent landscape: what other patents likely exist around the same compound and use?

Featured snippet answer: Based on the claims’ structure, the surrounding patent estate in the US typically clusters around: (1) the chemical entity and salt forms, (2) inhalation formulation and aqueous buffer/isotonic technology, and (3) specific dosing regimens for COPD/asthma in inhaled delivery. However, no bibliographic data (application number, related family members, assignee, or prosecution history) was provided here, so an exact cross-patent landscape can’t be constructed from the claim text alone.

What the provided claims imply about typical coexisting IP

Composition-of-matter patents likely exist for the active molecule and salt forms
Formulation patents likely exist for aqueous isotonic inhalation solutions, buffer systems, and pH control
Method-of-use patents likely exist for COPD/asthma treatment by inhalation and for specified microgram daily dosing
Device-method claims (nebuilizer-specific) may appear if the specification supports delivery mechanics

Key takeaways

US 10,106,503 is built around a specific active compound delivered by inhalation delivering ~10–200 μg/day.
Independent claim 1 covers mammals with COPD or asthma; independent claim 15 covers human COPD. Both share the same daily dose window.
The most litigation-relevant narrowing features are nebulizer inhaler, single daily dose, and the dependent formulation constraints: aqueous, pH 3–8, isotonic, sodium chloride/citric acid buffer, and 0.05 μg/mL to 10 mg/mL.
Design-around is most plausible by shifting out of the 10–200 μg/day exposure range; device and regimen changes primarily reduce dependent claim exposure.
Combination-therapy dependent claims broaden commercial enforceability only when the underlying core limitations are also met.

FAQs

What happens if a product uses inhalation but is not a “nebulizer inhaler”?
Dependent claims 5/16 would be avoided, but independent claims 1/15 can still be implicated if inhalation and the daily μg exposure window are met.
How can a competitor be outside infringement if the concentration is within 0.05 μg/mL to 10 mg/mL?
If the total administered amount does not produce 10–200 μg/day exposure, independent claim 1/15 can be avoided even when concentration matches.
Do salts expand or restrict the claim scope?
The claims expressly cover the free base compound and “pharmaceutically acceptable salts,” so switching among acceptable salts does not avoid claim coverage by itself.
Are combination add-ons required for infringement?
No. The β2 agonist and steroidal anti-inflammatory agents appear only in dependent claims (13–14 and 24–25).
Would changing from single daily dose to multiple daily doses avoid the patent?
It avoids the dependent “single daily dose” limitations (claim 6/17), but may not avoid independent claim 1/15 if the same daily exposure is still delivered by inhalation within the 10–200 μg/day window.

References

US Patent 10,106,503.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	048032	⤷ Start Trial
Argentina	104444	⤷ Start Trial
Austria	E395335	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Summary for Patent: 10,106,503