Patent 10,137,193: What the Claims Actually Cover, Where Dupilumab Fits, and the Real Competitive Patent Risk

What does US Patent 10,137,193 claim, in enforceable scope?

US Patent 10,137,193 is directed to combination treatment of persistent asthma using:

an ICS (maintenance dosing),
a LABA (maintenance dosing),
an anti-IL-4 receptor (IL-4R) antibody or antigen-binding fragment (F(ab’) or equivalent binding fragment) with specific CDR sequence identifiers, and
dosing logic that couples ICS and LABA administration duration to the duration of antibody administration.

The patent’s independent claim (Claim 1) anchors the core technical limitations: 1) Persistent asthma treatment in a subject. 2) Combination therapy includes:

one or more maintenance doses of an ICS,
one or more maintenance doses of a LABA,
a loading dose about 600 mg of an anti-IL-4R antibody/Fab with HCDR SEQ ID NOs 3, 4, 5 and LCDR SEQ ID NOs 6, 7, 8,
maintenance doses about 300 mg of the same anti-IL-4R antibody/Fab. 3) ICS and LABA are administered for the duration of antibody administration.

Claims 2-3 further tie the antibody/Fab identity to a specific sequence set and then to dupilumab:

Claim 2: the antibody has:
- HCVR SEQ ID NO: 1
- LCVR SEQ ID NO: 2
Claim 3: the antibody is dupilumab.

Claims 4-5 specify regimen timing:

q2w maintenance dosing for at least 24 weeks.

Claims 6-7 specify an alternate regimen:

q4w maintenance dosing for at least 24 weeks.

Claims 8 covers route:

systemic, subcutaneous, intravenous, or intranasal.

Claims 9 covers baseline biology:

eosinophils >=300 cells/µL, 200-299, or <200 (a broad bucketization).

Claims 10-11 provide explicit drug examples:

ICS: mometasone furoate, budesonide, fluticasone propionate
LABA: formoterol, salmeterol

Claims 12 covers age:

subject 12 years and above.

Claims 13-15 are functional equivalents:

Increasing FEV1 (liters),
improving one or more persistent asthma-associated parameters,
reducing patient dependence on ICS and/or LABA.

Claims 16-30 are materially the same construct but with different antibody dosing strengths:

loading dose about 400 mg and maintenance about 200 mg,
with the rest of the CDR sequence constraints identical.

Core identity constraints: CDR SEQ IDs and the dupilumab bridge

The enforceability hinges on whether the “anti-IL-4R antibody” is effectively limited to the antibody defined by those CDR sequence identifiers. The claims do not say “dupilumab” in the antibody definition; they say:

three HCDRs comprising SEQ ID NOs 3,4,5
three LCDRs comprising SEQ ID NOs 6,7,8

Claim 2 then provides the variable region sequence (HCVR SEQ ID NO: 1; LCVR SEQ ID NO: 2), and Claim 3/18 nails it to dupilumab.

From a landscape and freedom-to-operate (FTO) angle, the practical effect is that the claims are tight on the molecule identity when Claim 3/18 applies, but broader in the generic wording of Claims 1/16 unless SEQ ID matching limits you back to the same antibody.

What are the dosing/regimen limitations that create (or shrink) differentiation?

The patent offers multiple dosing/regimen variants that are likely to matter for both infringement and design-around.

Dose strength variants

Variant A (Claims 1-15):
- loading about 600 mg
- maintenance about 300 mg
Variant B (Claims 16-30):
- loading about 400 mg
- maintenance about 200 mg

Schedule variants

q2w (Claims 4-5, 19-20)
q4w (Claims 6-7, 21-22)

Duration coupling

A key limiting phrase appears across the independent claims:

ICS and LABA are administered for the duration of administration of the antibody/Fab.

This is not merely “co-administration.” It ties the timing relationship and could matter if:

a competitor’s protocol uses antibody but tapers ICS/LABA earlier, or
uses different treatment duration logic.

Is this claim set broad or narrow versus known asthma biologic practice?

Broad, in disease and regimen buckets:

“persistent asthma” with broad eosinophil stratification (including “<200”).
multiple ICS/LABA examples are listed.
multiple routes are listed.

Narrow, in the antibody definition:

the CDR sequence constraints are specific.
HCVR/LCVR identifiers point to a specific variable region sequence set.
dupilumab is expressly captured in dependent claims.

Taken together, the enforceable core is a dupilumab (anti-IL-4R) + ICS/LABA combination regimen for persistent asthma with defined loading/maintenance dosing patterns.

How does this overlap with dupilumab’s existing asthma patent and approval record?

Dupilumab (anti-IL-4Rα antagonist) is a known, clinically used biologic in asthma. In a patent landscape sense, that means:

the molecular identity is not novel,
the competitive question becomes whether the specific combination method, timing, and dose/schedule are already claimed elsewhere by the same or other parties.

US10,137,193 claims an asthma treatment method built around dupilumab-like CDR/variable regions. If other patents already claim dupilumab plus background controller therapy in asthma (with similar endpoints such as FEV1, exacerbations, or eosinophil-driven response), then the key risk is redundant coverage that blocks competitors but also depends on priority/date/claim scope.

Where are the main “infringement levers” for a competitor?

The claims present four operational levers that map directly to clinical protocols.

1) Drug identity (anti-IL-4R antibody with the specified CDR/variable regions)

If a competitor uses the same molecule (dupilumab) or an antibody with the same SEQ-defined CDR/variable regions, they land in-range.
If they use a different IL-4 pathway modality (anti-IL-4, anti-IL-13, different receptor binding or epitope) they likely avoid the CDR-defined limitations.

2) Dose loading and maintenance levels

Claims are anchored to “about 600 mg / 300 mg” and “about 400 mg / 200 mg.”
“About” creates tolerance, but the existence of two distinct dosing bands indicates the drafters expected specific regimen equivalence classes.

3) Schedule: q2w vs q4w

A competitor on a different schedule (e.g., other intervals) may attempt avoidance.

4) Duration coupling: ICS and LABA for the duration of antibody

If a protocol staggers controller therapy duration relative to the biologic, it may weaken literal match.
If controller therapy remains continuous during the biologic course, the coupling language is readily satisfied.

What are the claim weaknesses from a validity and design-around perspective?

Potential obviousness and prior art pressure

This patent combines:

established controller therapy (ICS/LABA) for persistent asthma,
a known IL-4R biologic agent (dupilumab),
and claimed clinical outcomes (FEV1 and parameters).

That structure is the classic target for obviousness/combination attack if prior art includes:

asthma studies or regimens using dupilumab with background therapy,
pharmacology rationales for IL-4R modulation in type 2 inflammation with controller therapies.

Potential indefiniteness risk is limited

The sequence-based limitations (SEQ IDs) and regimen dosing provide definitional clarity on what antibody is covered and what dosing patterns are required. Indefiniteness is less likely to be the dominant invalidity route.

Design-around pathways

To avoid infringement while keeping an IL-4 axis biologic program:

use a different IL-4R binding molecule with different CDRs/variable regions than the SEQ ID-defined antibody,
avoid the specific loading/maintenance dosing bands (if clinically feasible),
adopt schedule and treatment-duration logic that does not satisfy “ICS and LABA are administered for the duration of administration.”

What does the “FEV1 increase” and “asthma parameter improvement” add beyond Claim 1?

Claims 13 and 14 restate the same combination therapy and tether it to FEV1 or asthma parameters.

In method-of-treatment practice, such functional claim language often offers limited incremental protection if the underlying combination is already identical. Practically, these dependent/parallel claims strengthen the patent’s ability to argue that the claimed regimen “does” achieve the targeted efficacy endpoints, which can matter in enforcement where clinical protocol evidence is used.

What is the risk of claim overlap with related filings for dupilumab?

This patent’s broad strategy is typical for biologic combination method patents:

claim the combination explicitly,
include multiple schedules and controller choices,
include regimen duration coupling,
include efficacy endpoint wrappers.

In most biologic landscapes, overlap is common and drives complexity:

same family claims,
continuation claims,
related filings in different jurisdictions,
and method claims that track label-like administration.

Without reviewing the full family and prosecution history for US10,137,193 and its continuations, the enforceability question is best framed as: how likely is the regimen described to be label-consistent and already widely practiced? If it tracks common dupilumab background therapy paradigms, then infringement risk increases because clinicians have fewer protocol deviations.

How to read this patent as an investment or R&D constraint

Competitive implication

If you plan to commercialize an IL-4R biologic in asthma as an adjunct to ICS/LABA, this patent is a direct procedural blocker when your protocol matches the claimed dosing/schedule/duration logic and uses the SEQ-defined dupilumab-like binding regions.
If you plan a different IL-4 pathway molecule or a different dosing/adjunct strategy, the SEQ-defined antibody limitation and duration coupling become your key design handles.

Pipeline steering implication

For R&D, the immediate steering question is not “does it modulate IL-4R?” but:

does the molecule match the claimed CDR/variable regions?
does the regimen match one of the two dose bands and one of the two schedules?
does your protocol maintain ICS/LABA concurrently for the entire duration of biologic administration?

Key Takeaways

US10,137,193 is a method-of-treatment asthma combination patent tying persistent asthma therapy to anti-IL-4R antibody dosing with specific SEQ-defined CDR/variable regions, paired with ICS and LABA maintained for the entire duration of the antibody course.
The patent has two dosing strength frameworks: 600/300 mg and 400/200 mg, with controller dosing schedules q2w or q4w, and dependent claims expressly capture dupilumab via variable region sequences.
Infringement risk is highest for clinical regimens that (i) use dupilumab or an equivalent SEQ-defined antibody, (ii) use label-consistent loading/maintenance dosing in one of the claimed bands, (iii) follow q2w or q4w maintenance, and (iv) keep ICS/LABA on board throughout the biologic treatment duration.
Design-around is most feasible by altering at least one of the claim pillars: molecule identity (CDR/variable regions), dosing bands, schedule, or the duration coupling between biologic and controller therapy.
Validity pressure likely centers on prior art asthma combination regimens using IL-4 axis biology plus standard controller therapy, but sequence-defined targeting makes the antibody identity less amenable to simple generic obviousness narratives.

FAQs

Does US10,137,193 cover any IL-4R antibody, or is it sequence-limited?
It is CDR- and variable-region sequence limited via SEQ ID NO constraints; dependent claims additionally identify dupilumab by variable region sequences.
What are the two antibody dosing sets claimed?
The patent claims regimen variants using about 600 mg loading with about 300 mg maintenance and about 400 mg loading with about 200 mg maintenance.
Is q2w or q4w dosing required?
The patent includes q2w and q4w maintenance claim paths, each with at least 24 weeks language in the dependent claims.
Does the patent require ICS/LABA to be used only during initial phases?
No. The method language requires ICS and LABA administered for the duration of the antibody administration.
Do the FEV1 and “asthma parameter” claims broaden beyond Claim 1?
They wrap the same combination therapy to functional clinical endpoints, but they do not materially change the core combination limitations anchored to the antibody and dosing logic.

References

[1] US Patent 10,137,193. United States Patent and Trademark Office. (Title and bibliographic details not provided in the prompt).

Title:	Methods for treating or preventing asthma by administering an IL-4R antagonist
Abstract:	The invention provides methods for treating or preventing asthma and associated conditions in a patient. The methods featured in the invention comprise administering to a subject in need thereof a therapeutic composition comprising an interleukin-4 receptor (IL-4R) antagonist, such as an anti-IL-4R antibody.
Inventor(s):	Pirozzi; Gianluca (Berkeley Heights, NJ), Skobieranda; Franck (Flourtown, PA), Li; Yongtao (Springfield, NJ), Graham; Neil (Croton-on-Hudson, NY), Weinstein; Steven P. (Hartsdale, NY)
Assignee:	Sanofi Biotechnology (FR) Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)
Application Number:	14/627,728
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	Patent 10,137,193: What the Claims Actually Cover, Where Dupilumab Fits, and the Real Competitive Patent Risk What does US Patent 10,137,193 claim, in enforceable scope? US Patent 10,137,193 is directed to combination treatment of persistent asthma using: an ICS (maintenance dosing), a LABA (maintenance dosing), an anti-IL-4 receptor (IL-4R) antibody or antigen-binding fragment (F(ab’) or equivalent binding fragment) with specific CDR sequence identifiers, and dosing logic that couples ICS and LABA administration duration to the duration of antibody administration. The patent’s independent claim (Claim 1) anchors the core technical limitations: 1) Persistent asthma treatment in a subject. 2) Combination therapy includes: one or more maintenance doses of an ICS, one or more maintenance doses of a LABA, a loading dose about 600 mg of an anti-IL-4R antibody/Fab with HCDR SEQ ID NOs 3, 4, 5 and LCDR SEQ ID NOs 6, 7, 8, maintenance doses about 300 mg of the same anti-IL-4R antibody/Fab. 3) ICS and LABA are administered for the duration of antibody administration. Claims 2-3 further tie the antibody/Fab identity to a specific sequence set and then to dupilumab: Claim 2: the antibody has: HCVR SEQ ID NO: 1 LCVR SEQ ID NO: 2 Claim 3: the antibody is dupilumab. Claims 4-5 specify regimen timing: q2w maintenance dosing for at least 24 weeks. Claims 6-7 specify an alternate regimen: q4w maintenance dosing for at least 24 weeks. Claims 8 covers route: systemic, subcutaneous, intravenous, or intranasal. Claims 9 covers baseline biology: eosinophils >=300 cells/µL, 200-299, or <200 (a broad bucketization). Claims 10-11 provide explicit drug examples: ICS: mometasone furoate, budesonide, fluticasone propionate LABA: formoterol, salmeterol Claims 12 covers age: subject 12 years and above. Claims 13-15 are functional equivalents: Increasing FEV1 (liters), improving one or more persistent asthma-associated parameters, reducing patient dependence on ICS and/or LABA. Claims 16-30 are materially the same construct but with different antibody dosing strengths: loading dose about 400 mg and maintenance about 200 mg, with the rest of the CDR sequence constraints identical. Core identity constraints: CDR SEQ IDs and the dupilumab bridge The enforceability hinges on whether the “anti-IL-4R antibody” is effectively limited to the antibody defined by those CDR sequence identifiers. The claims do not say “dupilumab” in the antibody definition; they say: three HCDRs comprising SEQ ID NOs 3,4,5 three LCDRs comprising SEQ ID NOs 6,7,8 Claim 2 then provides the variable region sequence (HCVR SEQ ID NO: 1; LCVR SEQ ID NO: 2), and Claim 3/18 nails it to dupilumab. From a landscape and freedom-to-operate (FTO) angle, the practical effect is that the claims are tight on the molecule identity when Claim 3/18 applies, but broader in the generic wording of Claims 1/16 unless SEQ ID matching limits you back to the same antibody. What are the dosing/regimen limitations that create (or shrink) differentiation? The patent offers multiple dosing/regimen variants that are likely to matter for both infringement and design-around. Dose strength variants Variant A (Claims 1-15): loading about 600 mg maintenance about 300 mg Variant B (Claims 16-30): loading about 400 mg maintenance about 200 mg Schedule variants q2w (Claims 4-5, 19-20) q4w (Claims 6-7, 21-22) Duration coupling A key limiting phrase appears across the independent claims: ICS and LABA are administered for the duration of administration of the antibody/Fab. This is not merely “co-administration.” It ties the timing relationship and could matter if: a competitor’s protocol uses antibody but tapers ICS/LABA earlier, or uses different treatment duration logic. Is this claim set broad or narrow versus known asthma biologic practice? Broad, in disease and regimen buckets: “persistent asthma” with broad eosinophil stratification (including “<200”). multiple ICS/LABA examples are listed. multiple routes are listed. Narrow, in the antibody definition: the CDR sequence constraints are specific. HCVR/LCVR identifiers point to a specific variable region sequence set. dupilumab is expressly captured in dependent claims. Taken together, the enforceable core is a dupilumab (anti-IL-4R) + ICS/LABA combination regimen for persistent asthma with defined loading/maintenance dosing patterns. How does this overlap with dupilumab’s existing asthma patent and approval record? Dupilumab (anti-IL-4Rα antagonist) is a known, clinically used biologic in asthma. In a patent landscape sense, that means: the molecular identity is not novel, the competitive question becomes whether the specific combination method, timing, and dose/schedule are already claimed elsewhere by the same or other parties. US10,137,193 claims an asthma treatment method built around dupilumab-like CDR/variable regions. If other patents already claim dupilumab plus background controller therapy in asthma (with similar endpoints such as FEV1, exacerbations, or eosinophil-driven response), then the key risk is redundant coverage that blocks competitors but also depends on priority/date/claim scope. Where are the main “infringement levers” for a competitor? The claims present four operational levers that map directly to clinical protocols. 1) Drug identity (anti-IL-4R antibody with the specified CDR/variable regions) If a competitor uses the same molecule (dupilumab) or an antibody with the same SEQ-defined CDR/variable regions, they land in-range. If they use a different IL-4 pathway modality (anti-IL-4, anti-IL-13, different receptor binding or epitope) they likely avoid the CDR-defined limitations. 2) Dose loading and maintenance levels Claims are anchored to “about 600 mg / 300 mg” and “about 400 mg / 200 mg.” “About” creates tolerance, but the existence of two distinct dosing bands indicates the drafters expected specific regimen equivalence classes. 3) Schedule: q2w vs q4w A competitor on a different schedule (e.g., other intervals) may attempt avoidance. 4) Duration coupling: ICS and LABA for the duration of antibody If a protocol staggers controller therapy duration relative to the biologic, it may weaken literal match. If controller therapy remains continuous during the biologic course, the coupling language is readily satisfied. What are the claim weaknesses from a validity and design-around perspective? Potential obviousness and prior art pressure This patent combines: established controller therapy (ICS/LABA) for persistent asthma, a known IL-4R biologic agent (dupilumab), and claimed clinical outcomes (FEV1 and parameters). That structure is the classic target for obviousness/combination attack if prior art includes: asthma studies or regimens using dupilumab with background therapy, pharmacology rationales for IL-4R modulation in type 2 inflammation with controller therapies. Potential indefiniteness risk is limited The sequence-based limitations (SEQ IDs) and regimen dosing provide definitional clarity on what antibody is covered and what dosing patterns are required. Indefiniteness is less likely to be the dominant invalidity route. Design-around pathways To avoid infringement while keeping an IL-4 axis biologic program: use a different IL-4R binding molecule with different CDRs/variable regions than the SEQ ID-defined antibody, avoid the specific loading/maintenance dosing bands (if clinically feasible), adopt schedule and treatment-duration logic that does not satisfy “ICS and LABA are administered for the duration of administration.” What does the “FEV1 increase” and “asthma parameter improvement” add beyond Claim 1? Claims 13 and 14 restate the same combination therapy and tether it to FEV1 or asthma parameters. In method-of-treatment practice, such functional claim language often offers limited incremental protection if the underlying combination is already identical. Practically, these dependent/parallel claims strengthen the patent’s ability to argue that the claimed regimen “does” achieve the targeted efficacy endpoints, which can matter in enforcement where clinical protocol evidence is used. What is the risk of claim overlap with related filings for dupilumab? This patent’s broad strategy is typical for biologic combination method patents: claim the combination explicitly, include multiple schedules and controller choices, include regimen duration coupling, include efficacy endpoint wrappers. In most biologic landscapes, overlap is common and drives complexity: same family claims, continuation claims, related filings in different jurisdictions, and method claims that track label-like administration. Without reviewing the full family and prosecution history for US10,137,193 and its continuations, the enforceability question is best framed as: how likely is the regimen described to be label-consistent and already widely practiced? If it tracks common dupilumab background therapy paradigms, then infringement risk increases because clinicians have fewer protocol deviations. How to read this patent as an investment or R&D constraint Competitive implication If you plan to commercialize an IL-4R biologic in asthma as an adjunct to ICS/LABA, this patent is a direct procedural blocker when your protocol matches the claimed dosing/schedule/duration logic and uses the SEQ-defined dupilumab-like binding regions. If you plan a different IL-4 pathway molecule or a different dosing/adjunct strategy, the SEQ-defined antibody limitation and duration coupling become your key design handles. Pipeline steering implication For R&D, the immediate steering question is not “does it modulate IL-4R?” but: does the molecule match the claimed CDR/variable regions? does the regimen match one of the two dose bands and one of the two schedules? does your protocol maintain ICS/LABA concurrently for the entire duration of biologic administration? Key Takeaways US10,137,193 is a method-of-treatment asthma combination patent tying persistent asthma therapy to anti-IL-4R antibody dosing with specific SEQ-defined CDR/variable regions, paired with ICS and LABA maintained for the entire duration of the antibody course. The patent has two dosing strength frameworks: 600/300 mg and 400/200 mg, with controller dosing schedules q2w or q4w, and dependent claims expressly capture dupilumab via variable region sequences. Infringement risk is highest for clinical regimens that (i) use dupilumab or an equivalent SEQ-defined antibody, (ii) use label-consistent loading/maintenance dosing in one of the claimed bands, (iii) follow q2w or q4w maintenance, and (iv) keep ICS/LABA on board throughout the biologic treatment duration. Design-around is most feasible by altering at least one of the claim pillars: molecule identity (CDR/variable regions), dosing bands, schedule, or the duration coupling between biologic and controller therapy. Validity pressure likely centers on prior art asthma combination regimens using IL-4 axis biology plus standard controller therapy, but sequence-defined targeting makes the antibody identity less amenable to simple generic obviousness narratives. FAQs Does US10,137,193 cover any IL-4R antibody, or is it sequence-limited? It is CDR- and variable-region sequence limited via SEQ ID NO constraints; dependent claims additionally identify dupilumab by variable region sequences. What are the two antibody dosing sets claimed? The patent claims regimen variants using about 600 mg loading with about 300 mg maintenance and about 400 mg loading with about 200 mg maintenance. Is q2w or q4w dosing required? The patent includes q2w and q4w maintenance claim paths, each with at least 24 weeks language in the dependent claims. Does the patent require ICS/LABA to be used only during initial phases? No. The method language requires ICS and LABA administered for the duration of the antibody administration. Do the FEV1 and “asthma parameter” claims broaden beyond Claim 1? They wrap the same combination therapy to functional clinical endpoints, but they do not materially change the core combination limitations anchored to the antibody and dosing logic. References [1] US Patent 10,137,193. United States Patent and Trademark Office. (Title and bibliographic details not provided in the prompt). More… ↓ ⤷ Start Trial

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	March 28, 2017	10,137,193	2035-02-20
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	October 19, 2018	10,137,193	2035-02-20
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	June 18, 2020	10,137,193	2035-02-20
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	June 14, 2021	10,137,193	2035-02-20
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	October 20, 2021	10,137,193	2035-02-20
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 10,137,193

Summary for Patent: 10,137,193