United States Patent 12,357,636 (Vibegron) Scope, Claims, and OAB-in-BPH Method-of-Use Landscape

Executive summary: U.S. Patent 12,357,636 is a method-of-use claim set focused on oral vibegron (60–90 mg/day; key exemplar 75 mg/day) for overactive bladder (OAB) symptom treatment in men with benign prostatic hyperplasia (BPH) who are already on BPH pharmacotherapy, with claim variants that (i) specify which OAB endpoints are targeted, (ii) tie claims to particular BPH drug classes (5-alpha reductase inhibitors, alpha blockers, or combinations), and (iii) anchor efficacy to quantitative clinical endpoint ranges (urination frequency, urgency episodes, nocturia, and post-void residual urine volume (PVR)). Practically, it partitions infringement risk by dose and patient context (male + BPH therapy), and it also creates a claim design lever for generics or licensees through route/dosing schedule and measured endpoint/PVR behavior.

What does US Patent 12,357,636 protect for vibegron in men with BPH and overactive bladder?

Short answer: It protects methods of treating OAB symptoms with vibegron in male subjects with BPH who are receiving pharmacological therapy for BPH, using oral dosing (60–90 mg/day; commonly 75 mg/day), with efficacy and safety-related endpoints that include urinary frequency, urgency, nocturia, and PVR.

Core claim architecture

The claim set is organized around five recurring claim elements:

Patient and indication context
- Human male subject
- OAB symptom treatment (urge urinary incontinence, urgency, urinary frequency, nocturia)
- Subject is on pharmacological therapy for BPH
Dose and administration
- Oral administration
- 60–90 mg per day (claim 1)
- ~75 mg per day (claim 9; claim 19)
- Once per day (claims 8 and 10)
- Steady-state within 7 days (claim 29)
BPH concomitant drug class limitation
- 5-alpha reductase inhibitor (claim 5; claim 12; claim 21)
- Alpha blocker (claim 6; claim 13; claim 22)
- Combination (claim 7; claim 14; claim 23)
Efficacy framing using clinical metrics
- Urination frequency change: “average number of micturitions per 24 hours” from about −1.4 to −2.5 (claim 15)
- Urgency episodes: at least 30% reduction from baseline (claim 15)
- Nocturia episodes: change from baseline “from about −0.2 to about −0.4 greater than placebo” (claim 15)
- Additional efficacy metrics tied to other claims (claim 24)
PVR boundary conditions (safety-adjacent patent feature)
- PVR change range: from about 10 mL to about −20 mL (claims 16 and 25)
- A “no substantial PVR change” version: (claim 26), plus a tighter “about 10 mL or less” constraint (claim 28)

Claim-by-claim scope map (practical reading)

Below is the quickest way to understand what “lands” for infringement and what stays outside.

Claim	Key scope limiter	Dose	Concomitant BPH therapy	OAB symptoms included	Endpoints emphasized
1	Method treating ≥1 OAB symptom in male on BPH meds	60–90 mg/day	Any BPH pharmacological therapy	any of incontinence/urgency/frequency/nocturia	Not limited beyond “treat”
2	Subselection of OAB symptoms	inherits 1	inherits 1	selected list	none additional
3	Narrow symptom set	inherits 1	inherits 1	urgency + incontinence + frequency	none additional
4	Age threshold	inherits 1	inherits 1	inherits	none additional
5–7	BPH therapy class	inherits 1	specifically 5-ARI / alpha blocker / combination	inherits	none additional
8	Dosing schedule	inherits	inherits	inherits	once daily
9–14	“About 75 mg” versions + BPH class	75 mg/day	any of listed classes (claims 12–14)	inherits	none additional beyond “treat”
15	Specific numeric efficacy and placebo-relative nocturia	75 mg/day	inherits claim 9	urgency + incontinence/frequency/nocturia allowed via claim 11	micturitions change, ≥30% urgency reduction, nocturia placebo-relative
16	PVR range condition	inherits 9	inherits	inherits	PVR change from about 10 mL to about −20 mL
17	Decreasing micturitions method	60–90 mg/day	on any BPH therapy	not limited to symptom list	framed as micturition decrease
18	“About 75 mg” for claim 17	75 mg/day	inherits	inherits	none additional
19	Treat OAB with 75 mg/day + specific symptom triad	75 mg/day	on BPH therapy	urge incontinence + urgency + frequency	none additional unless claims 24–25
20	Adds nocturia	inherits 19	inherits	adds nocturia	none additional
21–23	BPH therapy class in 19 family	inherits 19	class specified	inherits	none additional
24	Numeric efficacy including urgency reduction, volume voided, nocturia placebo-relative	75 mg/day	inherits	inherits	urgency reduction ≥30%; volume voided +; nocturia placebo-relative
25	Adds PVR range	inherits 19	inherits	inherits	PVR change 10 mL to −20 mL
26	Treat OAB with 75 mg/day + “no substantial PVR change”	75 mg/day	on BPH therapy	any OAB symptom list	PVR not substantially changed
27	Symptom list in 26	inherits 26	inherits	list	none additional
28	Quantifies PVR constraint	inherits 26	inherits	list	PVR change about 10 mL or less
29	PK anchor	inherits 10	inherits	inherits	steady state within 7 days

What is actually “in the invention,” claim-wise

The strongest definitional “invention hooks” for a licensing or litigation posture are:

Combination context: OAB treatment in male BPH patients receiving BPH pharmacological therapy.
Dose band: 60–90 mg/day, with extensive focus on 75 mg/day.
Quantitative endpoints: micturitions change, urgency episode reductions, nocturia placebo-relative shift, and voided volume improvement.
PVR guardrails: multiple claims explicitly constrain PVR change magnitude/range.

Is the patent limited to a specific dose (75 mg) or does it cover 60–90 mg/day too?

Short answer: It covers both, with a broad independent claim at 60–90 mg/day and multiple dependent claims that harden coverage around about 75 mg/day, which is where the strongest numeric endpoint limitations appear.

Dose coverage by claim family

Broad dose band (60–90 mg/day):
- Claim 1 (method treating ≥1 OAB symptom)
- Claim 17 (decreasing micturitions)
Narrower dose “about 75 mg/day”:
- Claim 9 (dependent off claim 1 family)
- Claim 19 (independent in 75 mg family)
- Claims 24–28 (numeric efficacy and PVR conditions mostly live in this family)

Practical infringement interpretation

For generic or licensee activity, the critical question is whether product labeling and actual use match:

oral daily administration
dose within 60–90 mg/day
and for the highest-risk sub-assertions, whether the clinical outcomes align with the quantified endpoints and PVR constraints.

What overactive bladder symptoms are covered by US 12,357,636?

Short answer: Covered symptoms include urge urinary incontinence, urgency, urinary frequency, nocturia, plus combinations, with some claims narrowing to specific symptom sets.

Symptom coverage detail

Claim 1: “at least one overactive bladder symptom”
Claim 2: selected from the full symptom list
Claim 3: narrow triad (urge urinary incontinence, urgency, urinary frequency)
Claim 19: explicitly requires the symptom triad (urge urinary incontinence + urgency + urinary frequency)
Claim 20: adds nocturia to that triad
Claims 26–28: treat at 75 mg/day with “no substantial change” in PVR while symptoms can be selected from the same list

Implication: The patent supports both “broad symptom bucket” and “tight symptom basket” theories. Tight baskets (urgency + incontinence + frequency) are structurally more restrictive and thus more litigation-significant.

What does the patent require about BPH concomitant therapy in men?

Short answer: It requires that the male subject is on pharmacological therapy for BPH, and it includes dependent claim options pegged to specific BPH drug classes: 5-alpha reductase inhibitors, alpha blockers, or combination therapy.

BPH therapy limitations

Claim 5, 12: 5-alpha reductase inhibitor
Claim 6, 13: alpha blocker
Claim 7, 14: combination
Claim 21–23: same class mapping in the 19-family

Infringement sensitivity

This structure means method-of-use infringement is more likely to be tied to:

the patient’s ongoing BPH regimen
rather than vibegron alone
creating a pathway for design-around arguments focused on whether the patient was “on pharmacological therapy for BPH” at the relevant time window.

When does the method claim require once-daily dosing and steady-state within 7 days?

Short answer: Once-daily dosing is explicitly required in dependent claims, and steady-state within 7 days is explicitly recited in another dependent claim.

Timing and dosing constraints

Claim 8: once per day (dependent from claim 1)
Claim 10: once per day (dependent from claim 9)
Claim 29: “steady state concentrations are achieved within 7 days”

Practical impact: For real-world use, these features narrow the set of “covered uses” to regimens consistent with once-daily oral vibegron and PK behavior consistent with the steady-state assertion.

How do the efficacy endpoints in claim 15 and claim 24 define what counts as “treating”?

Short answer: They define treating in part by numeric clinical outcome ranges, including micturition frequency change, urgency reductions, nocturia shifts relative to placebo, and (in claim 24) volume voided improvement.

Claim 15 endpoint set (75 mg family)

Change from baseline in average number of micturitions per 24 hours: about −1.4 to −2.5
Urgency episodes per day: at least 30% reduction from baseline
Nocturia episodes per night: change from baseline about −0.2 to about −0.4 greater than placebo

Claim 24 endpoint set (75 mg family)

At least 30% reduction from baseline in urgency episodes per day
At least 30% increase from baseline in average volume voided per micturition
Nocturia placebo-relative change: about −0.2 to −0.4 greater than placebo

Enforcement angle: These claims can be asserted without requiring full labeling language, but they are inherently tied to what outcomes occurred in the treated population and measurement protocol used.

What does the patent require about post-void residual (PVR) urine volume?

Short answer: It includes dependent claims that allow or demand particular PVR change magnitudes, including a “no substantial change” posture.

PVR constraints by claim

Claim 16: PVR change from about 10 mL to about −20 mL
Claim 25: same PVR range condition in the 19-family
Claim 26: subject does not experience a “substantial change” in PVR
Claim 28: “change from baseline in PVR” of about 10 mL or less

Design-around leverage: PVR-sensitive claims create litigation focus on:

whether PVR changed substantially for treated BPH patients
and whether observed PVR shifts fall inside the numeric bounds.

How could a generic or biosimilar competitor avoid infringement under US 12,357,636?

Short answer: The cleanest theoretical levers created by the claim set are patient-context and measurable-outcome levers: not treating BPH-medicated male patients with the specified vibegron oral dosing, and/or avoiding regimens that meet the numeric endpoint/PVR limitations. Once-daily dosing and PK steady-state timing also provide additional constraints for narrower dependent claims.

Most plausible noninfringing usage theories created by claim drafting

Patient context: carve out use in men not “on pharmacological therapy for BPH.”
Dose: use outside 60–90 mg/day or outside “about 75 mg/day” where dependent numeric endpoint claims are asserted.
Schedule: if a product is used on a schedule not matching “once per day,” the once-daily dependent claims are easier to differentiate.
Endpoints/PVR: avoid demonstrating (or avoid the actual observed patient outcomes) that match the specified endpoint and PVR bounds in claim 15/16/24/25/28.

What is the likely patent strength in litigation based on claim breadth vs. dependent numeric limitations?

Short answer: The estate mixes broad independent coverage (dose band; male; BPH-medicated; OAB symptoms) with dependent claims that narrow to quantified clinical results and PVR behavior. That mix can support a layered assertion strategy: start broad, then add dependent claims only where evidence fits.

Breadth profile

Broader: claim 1 and claim 17 are less endpoint constrained.
More evidence-heavy: claims 15, 16, 24, 25, 28 depend on quantitative endpoint and PVR measurement.

Litigation behavior: asserting both types is common. Numeric dependent claims also reduce arguments that “treating” is overly vague.

Key competitor risk: how do these claims map to typical OAB-in-BPH prescribing patterns?

Short answer: The patent targets a scenario that is common in OAB/BPH clinical practice: male patients receiving BPH therapy (5-ARI, alpha blocker, or both) who are then treated for OAB with an oral OAB agent at fixed daily dosing. If competitors market and prescribe vibegron similarly, risk rises for broad claims and even more for the symptom and outcome-specific dependent claims.

Where risk is highest

Vibegron 60–90 mg/day orally in men on BPH medication
75 mg/day once daily in BPH-medicated men with urgency/incontinence/frequency and observed reductions in urgency frequency and micturitions
populations where PVR is stable or within the cited numeric window

What does claim 29 imply about pharmacokinetics and dosing regimen evidence?

Short answer: It ties coverage to a PK behavior (steady state within 7 days), which is typically supported by clinical PK studies rather than day-to-day real-world endpoints.

Implication for evidentiary strategy

For infringement proof, claim 29 is likely to rely on dosing and PK study data consistent with the product’s formulation and dosing regimen.
For noninfringement, challengers would focus on whether the accused regimen achieves steady state materially outside the recited timing, or whether the claim is not met due to regimen differences.

Key Takeaways

U.S. Patent 12,357,636 protects method-of-use treatment of OAB symptoms with oral vibegron in male BPH patients already on BPH pharmacotherapy.
Coverage spans 60–90 mg/day and is heavily reinforced with about 75 mg/day dependent claims.
Claim scope includes OAB symptoms (urge urinary incontinence, urgency, urinary frequency, nocturia) with both broad and narrow symptom versions.
Dependent claims add substantial specificity via quantitative efficacy endpoints (micturitions, urgency episode reduction, nocturia placebo-relative change, volume voided improvement).
Additional dependent claims incorporate PVR behavior constraints, including numeric ranges and “no substantial change” language.
The estate’s enforceability is strongest when accused use matches (i) the male + BPH-medicated context, (ii) dose and once-daily regimen, and (iii) clinical outcome/PVR measurement windows.

FAQs

Does US 12,357,636 require the patient to be taking both BPH drugs and vibegron simultaneously?
The claims require the male subject is “on pharmacological therapy for BPH” while vibegron is administered; the text does not require a specific overlap duration but places the BPH regimen in the treatment context.
Can a clinician avoid infringement by prescribing vibegron to men with BPH who are not on pharmacological therapy?
Claims require BPH pharmacological therapy as a claim element; “not on pharmacological therapy” is a direct differentiation.
Are the endpoint-based dependent claims (eg, claim 15, claim 24) enforceable without evidence of placebo comparisons?
Those claims expressly define nocturia using placebo-relative change and numeric ranges, so infringement proof tracks those measurement constructs.
Does claim coverage depend on the measured post-void residual (PVR) change staying within specific ranges?
Only the PVR-dependent claims require PVR constraint satisfaction; the broader independent claims do not recite those numeric PVR thresholds.
Is steady-state timing (within 7 days) a required limitation across the patent?
No. Steady-state within 7 days appears in a dependent claim (claim 29), not the broad independent claim language.

References (APA)

U.S. Patent 12,357,636 (claims as provided in the prompt).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sumitomo Pharma Am	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY IN ADULT MALES ON PHARMACOLOGICAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA (BPH)	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	117674	⤷ Start Trial
Australia	2019393372	⤷ Start Trial
Brazil	112021010856	⤷ Start Trial
Canada	3115190	⤷ Start Trial
Chile	2021001397	⤷ Start Trial
China	113164486	⤷ Start Trial
Eurasian Patent Organization	202190678	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 12,357,636

Which drugs does patent 12,357,636 protect, and when does it expire?

Summary for Patent: 12,357,636