United States Patent 11,484,531: Scope, Claim Scope Map, and COPD Nebulized Revefenacin Landscape
What does U.S. Patent 11,484,531 claim in enforceable terms?
U.S. Patent 11,484,531 claims a specific COPD treatment method tied to (1) patient selection criteria using objective lung function metrics and (2) a specific nebulized dose/formulation of revefenacin administered once daily.
Independent claim (Claim 1) sets the core scope
Claim 1 recites a method for treating COPD that includes all of the following elements:
-
Patient selection based on both:
- Peak inspiratory flow rate (PIFR): < about 60 L/min
- Percent predicted FEV1: < about 50%
-
Drug and formulation:
- Administer a pharmaceutical composition comprising about 175 μg revefenacin (or pharmaceutically acceptable salt)
-
Concentration/volume:
- In 3 mL of an aqueous solution
-
Dosing regimen and device:
- Once daily
- Administered using a nebulizer
The independent claim is therefore a method-of-treatment claim with enforceability anchored on a combination of eligibility criteria plus a tight product-and-admin regimen.
Dependent claims narrow scope via patient thresholds and formulation/device features
Claims 2 to 10 narrow or add limitations:
- Claim 2: PIFR < about 50 L/min
- Claim 3: % predicted FEV1 < about 40%
- Claim 4: Both in stated ranges:
- PIFR 20 to <60 L/min
- % predicted FEV1 20% to <50%
- Claim 5: formulation pH 4.5 to 5.5
- Claim 6: formulation pH 4.8 to 5.2
- Claim 7: formulation isotonic
- Claim 8: further comprises sodium chloride, citric acid, sodium citrate
- Claim 9: formulation is sterile, isotonic, pH 4.8 to 5.2
- Claim 10: administration by jet nebulizer
Net effect: claim scope can be characterized as (a) constrained by a dosing product definition and (b) constrained by an eligibility rule set tied to inspiratory flow capacity and airflow limitation severity.
How to read this claim as a “scope map” for infringement and design-around
A practical way to structure analysis for this patent is as a logical “AND” matrix. Infringement requires meeting every limitation in Claim 1 for independent infringement, and additional subsets for dependent claims.
Scope matrix for Claim 1 (must all be satisfied)
| Element |
Claim wording concept |
What must be true in accused activity |
| Indication |
Treating COPD |
Used in COPD patients |
| Patient selection |
PIFR criterion |
PIFR < 60 L/min (approx.) |
| Patient selection |
FEV1 criterion |
% predicted FEV1 < 50% (approx.) |
| Dose |
Revefenacin amount |
~175 μg revefenacin (or salt) |
| Form/Concentration |
aqueous solution volume |
3 mL aqueous solution |
| Regimen |
dosing frequency |
once daily |
| Delivery |
device class |
nebulizer |
Dependent claim overlay (additional limitations)
| Dependent claim |
Extra limitation |
Infringement impact |
| Claim 2 |
PIFR < 50 L/min |
narrows eligible PIFR subgroup |
| Claim 3 |
% predicted FEV1 < 40% |
narrows eligible severity subgroup |
| Claim 4 |
both PIFR and FEV1 in ranges |
narrows to moderate-to-severe window |
| Claim 5 |
pH 4.5 to 5.5 |
narrows formulation identity |
| Claim 6 |
pH 4.8 to 5.2 |
tighter formulation pH |
| Claim 7 |
isotonic |
excipient condition |
| Claim 8 |
specific excipient trio |
specific formulation composition |
| Claim 9 |
sterile + isotonic + pH |
tight formulation profile |
| Claim 10 |
jet nebulizer |
tighter device limitation |
Where is the claim “most fragile” for competitors attempting design-arounds?
From a design-around standpoint, the patent’s enforceability concentrates in three high-leverage areas.
1) Patient selection rules (PIFR and % predicted FEV1)
The patent does not claim “revefenacin nebulization for COPD” broadly. It claims nebulized revefenacin once daily for a selected subgroup defined by:
- PIFR < ~60 L/min
- % predicted FEV1 < ~50%
Any competitive strategy that avoids the selection rule, or avoids treating within that subgroup, can reduce method-of-claim exposure. Practically, this is harder because real-world COPD populations include such patients and clinicians may not follow a rigid PIFR screen unless a label or guideline requires it.
2) Dose/formulation specificity (175 μg in 3 mL)
The method ties to:
- about 175 μg revefenacin
- in 3 mL
- as an aqueous solution
This is a tight drug product definition for a nebulized regimen. A different dose strength, different solution volume, or non-3 mL regimen is a direct lever against Claim 1.
3) Formulation micro-parameters and device type in dependent claims
Claims 5 to 9 narrow formulation using:
- pH ranges (4.5 to 5.5; 4.8 to 5.2)
- isotonicity
- excipient composition (NaCl, citric acid, sodium citrate)
- sterility
Claim 10 narrows device class to jet nebulizer.
These dependent limitations matter for “cover” if an accused activity matches Claim 1 but not Claim 1’s dependent refinements. They also matter for prosecution history narrowing effects if later arguments tie enablement or inventiveness to these particulars.
What is the scope relationship to typical COPD inhaled therapies?
This patent’s scope is narrower than typical COPD method claims because it is:
- device and regimen constrained (neb/nebulizer; once daily; 3 mL aqueous solution)
- molecular and dose constrained (revefenacin 175 μg)
- patient selection constrained (PIFR and % predicted FEV1)
By contrast, many COPD patents are drafted around:
- compositions broadly (fixed-dose LAMA/LABA/LAMA+LAMA) without PIFR eligibility screens
- general “improve lung function” endpoints without dosing volume constraints
- inhaler types without prescribing nebulizer subclass
This patent is therefore a mechanism plus logistics claim: it links who gets treated and how the drug is delivered to a specific nebulized revefenacin composition.
What does the claim set imply about the patent’s likely protected product profile?
Although the prompt only provides the claims, the dependent claims describe a very specific formulation envelope:
- pH: about 4.8 to about 5.2 (with broader option 4.5 to 5.5)
- isotonic
- sterile
- excipients: sodium chloride, citric acid, sodium citrate
- administered via jet nebulizer (Claim 10)
- 3 mL aqueous solution
- about 175 μg revefenacin once daily
This clustering points to a formulation architecture that is likely aligned with a marketed nebulized revefenacin product profile rather than a general compounding approach.
How does this constrain the “patent landscape” for COPD nebulized revefenacin in the U.S.?
Even without full citations for the rest of the portfolio, the claim structure dictates what types of adjacent patents and litigation-relevant documents will be most consequential.
Likely intersecting patent categories around this claim
- Revefenacin composition/pH/isotonicity/vehicle patents
- Expect overlapping protection around solution volume and pH windows.
- Revefenacin dosing regimen patents
- Once-daily dosing methods are a typical claim target.
- Nebulizer-specific administration method patents
- Jet nebulizer vs other nebulizer types (mesh, vibrating plate) often separate claim domains.
- Patient selection / inspiratory flow capability patents
- PIFR screening and severity thresholds are a less common category, but when present they can create “medical method” barriers to competing prescriptive regimens.
Practical competitive implications
- A generic or biosimilar developer may be able to copy the active pharmaceutical ingredient but still face exposure if clinician-directed administration is designed to match the same eligibility criteria and delivery specifics.
- A different dose regimen (not 175 μg per 3 mL) likely avoids Claim 1, but could still trigger dependent claim coverage if the range interpretation (“about”) pulls the alternative into the claimed tolerance band.
- A different nebulizer class (non-jet) may avoid Claim 10 but not necessarily Claim 1, because Claim 1 only requires “a nebulizer.”
What are the “claim breadth” implications for litigation strategy?
For enforcement
This patent is enforcement-friendly where:
- PIFR and FEV1 are documented in medical records
- dosing corresponds to 175 μg in 3 mL aqueous solution once daily
- care team prescribes nebulized therapy to a population consistent with the selection thresholds
Method patents often hinge on evidence of patient selection. Here, the selection criteria are objective and likely captured in pulmonary function tests, improving evidentiary clarity.
For invalidity or non-infringement posture
Key non-infringement angles are:
- different dose strength or different dosing volume
- different regimen frequency (not once daily)
- different formulation profile that avoids dependent claim features (pH, isotonicity, specific excipients)
- different device type (to target Claim 10 at minimum)
- treating patients outside the PIFR/FEV1 selection window
Claim chart (condensed) for quick infringement screening
| Accused treatment activity |
Matches Claim 1? |
Matches dependent? |
| COPD treatment with nebulized revefenacin |
Needed |
Needed |
| Patient PIFR measured and found < ~60 L/min |
Must be true |
narrows further for Claims 2 and 4 |
| Patient % predicted FEV1 < ~50% |
Must be true |
narrows further for Claims 3 and 4 |
| Dose is ~175 μg in 3 mL aqueous solution |
Must be true |
independent anchor |
| Given once daily |
Must be true |
no dependent override |
| Delivered using a nebulizer |
Must be true |
jet nebulizer hits Claim 10 |
| If pH and excipients match (Claims 5-9) |
not needed for Claim 1 |
required only for dependent claims |
Key Takeaways
- U.S. Patent 11,484,531 is a method-of-treatment patent with enforceability anchored on a two-part patient selection rule (PIFR < ~60 L/min and % predicted FEV1 < ~50%) plus a tight nebulized revefenacin regimen (about 175 μg in 3 mL aqueous solution once daily).
- Dependent claims further constrain pH, isotonicity, specific excipients, sterility, and jet nebulizer delivery, creating layered fallback coverage if Claim 1 is met.
- The most leverage for design-around is avoiding at least one Claim 1 element: dose/volume, once-daily regimen, nebulizer administration, or the patient selection criteria. The most leverage against dependent claims is formulation and device specifics (pH/isotonicity/excipients/jet nebulizer).
FAQs
1) Does Claim 11,484,531 cover all COPD patients treated with nebulized revefenacin?
No. Claim 1 limits coverage to COPD treatment where the patient selection criteria are met: PIFR < ~60 L/min and % predicted FEV1 < ~50%.
2) Is jet nebulizer required for independent infringement?
Not under Claim 1. Claim 1 requires “a nebulizer.” Jet nebulizer is an additional limitation in Claim 10.
3) What exact dose and volume does Claim 1 require?
Claim 1 requires a pharmaceutical composition comprising about 175 μg revefenacin in 3 mL of an aqueous solution, administered once daily.
4) Can a different formulation pH avoid the patent?
It may avoid dependent-claim coverage (Claims 5 to 9) if pH and other formulation constraints are not met. It does not by itself avoid Claim 1 unless the alternative also breaks Claim 1’s required elements (dose/volume/regimen/patient selection/nebulizer).
5) Which additional patient subgroups are explicitly covered?
Claims 2 to 4 add narrower selection conditions: PIFR < ~50 L/min, % predicted FEV1 < ~40%, and a defined combined range (PIFR 20 to <60 L/min and % predicted FEV1 20% to <50%).
References
[1] U.S. Patent 11,484,531 (claims as provided in prompt).
