United States Patent 12,582,631 (Atrasentan) Scope, Claim Boundaries, and U.S. Patent Landscape
What is claimed under US 12,582,631?
US 12,582,631 is directed to a specific clinical treatment method: using atrasentan (or a pharmaceutically acceptable salt) to reduce proteinuria in a previously diagnosed primary IgA nephropathy (IgAN) patient, with several constraints on diagnostic basis, proteinuria baseline, proteinuria response window/thresholds, and dose regimens.
Claim architecture (high level)
- Independent claim set: Claims 1 and 31 (both method claims that differ mainly in dose specificity and some response definitions).
- Dependent refinement: Claims 2-30 refine the independent claim 1 with narrower baseline proteinuria, eGFR, UPCR, magnitude and timing of proteinuria reduction, chronicity of proteinuria, and route/salt forms.
- Dependent refinement: Claims 32-36 refine claim 31 with response thresholds at defined treatment durations and salt form/baseline proteinuria levels.
Core treatment trigger
All claims require:
- Drug: atrasentan or pharmaceutically acceptable salt.
- Indication: primary IgA nephropathy.
- Diagnosis method: IgA nephropathy diagnosis comprises one or more of:
- kidney biopsy, or
- detecting anti-glycan antibodies, or
- detecting deposition of IgA-immune complexes in the kidney, or
- combination of any of the above.
- Measured proteinuria response: definition of “successful” response includes threshold(s) such as proteinuria < 1 g/day in at least two of three consecutive readings after initiation, plus additional dependent thresholds (e.g., 10% to 99% reductions).
- Baseline/measurement constraints: multiple dependent claims specify baseline proteinuria bands, UPCR, eGFR, and duration of proteinuria prior to dosing.
Independent claim 1: “result threshold” plus flexible dosing
Claim 1 requires:
- Proteinuria goal: < 1 g/day in at least two of three consecutive readings after starting atrasentan.
- Diagnosis basis: biopsy / anti-glycan antibody detection / IgA-immune complex deposition in kidney (any or combination).
- Population: previously diagnosed primary IgA nephropathy.
- Proteinuria state after initiation: the “less than 1 g/day” requirement functions as the method endpoint.
Independent claim 31: pins dose to 0.75 mg once daily
Claim 31 is a narrower independent claim that adds:
- Dose: once-daily 0.75 mg atrasentan (or equivalent salt amount).
- Maintains the same endpoint concept: < 1 g/day in at least two of three consecutive readings after initiation.
- Retains the same diagnosis basis and “primary IgA nephropathy” requirement.
What are the main claim limitations that define infringement risk?
The enforceable boundary is not “atrasentan reduces proteinuria” in general. It is the combination of:
- Patient phenotype: primary IgA nephropathy, diagnosed using the specified evidentiary tools.
- Disease activity marker: proteinuria measurement scheme and endpoints.
- Response thresholds: categorical and/or percentage reductions, often tied to time on drug.
- Dosing schedule and amount: fully specified in claim 31 (0.75 mg once daily) and optionally specified in claim 8 and dose-range claims (6-10).
- Renal function and proteinuria baseline bands: eGFR and UPCR and baseline proteinuria thresholds in dependent claims.
Patient identification limitation: “primary IgA nephropathy” + diagnosis method
The diagnosis requirement is unusually granular for a method claim. Infringement arguments will hinge on whether the patient is:
- primary IgA nephropathy (not secondary),
and whether the diagnosis comprises specified tests (kidney biopsy, anti-glycan antibodies, deposition of IgA-immune complexes). The claim language uses “comprises a kidney biopsy, detecting anti-glycan antibodies, detecting deposition...” including “or a combination,” so even partial compliance can satisfy the diagnosis-method element.
Endpoint limitation: proteinuria < 1 g/day in repeated consecutive readings
The method response is anchored to:
- proteinuria < 1 g/day
- in at least two of three consecutive readings
- after initiation of atrasentan
That “two of three” construct narrows the method to those treatment courses where the measured endpoint is met in a specific repeated-measure format.
Dose limitation: 0.75 mg once daily (independent claim 31)
Claim 31 targets a particular regimen:
Claims 6-10 and 8-10 define additional dose/salt details:
- 0.20 mg to 1.5 mg (claim 6)
- 0.40 mg to 0.85 mg (claim 7)
- once daily dose about 0.75 mg (claim 8)
- salt form: atrasentan pharmaceutically acceptable salt (claim 9), and atrasentan hydrochloride (claim 10)
Response magnitude: percentage reduction ranges
Dependent claims create percentage-linked outcomes:
- Claim 3: about 10% to about 99%
- Claim 4: about 20% to about 80%
- Later claims define minimum reductions:
- Claim 24: at least about 10%
- Claim 25: at least about 20%
- Claim 26: at least about 30%
Response timing: 15-30 days and ≥12 or ≥36 weeks
Timing is explicit:
- Claim 18: reduction at about 15 to 30 days after administration.
- Claim 27-29: reduction after at least 12 weeks or at least 36 weeks (with 10%, 20%, 30% minima).
- Claim 32-34: for claim 31 cohort, same ≥12 weeks or ≥36 weeks response minima.
Baseline proteinuria/eGFR/UPCR constraints (population refinement)
Dependent claims narrow to common clinical severity ranges:
- Claim 2: baseline proteinuria ≥ 1 g/day
- Claim 11: baseline proteinuria ≥ 0.5 g/day
- Claim 12: baseline proteinuria 0.3 to 2.0 g/day
- Claim 13: baseline proteinuria 0.75 to 1.5 g/day
- Claim 16: UPCR ≥ 1 g/g
- Claim 14-15: eGFR 30 to 90 mL/min/1.73m² or ≥ about 30
Chronicity refinement:
- Claims 19-23: proteinuria present at least about 3 months prior to first administration (and same concept applied to eGFR duration in claims 22-23).
Salt form limitation
- Claim 10: atrasentan hydrochloride
- Claim 35: same for claim 31
Salt form becomes a key differentiator if alternative salt forms or formulations are used.
What is the practical “scope map” across claims 1-36?
A. Independent claims
| Claim |
Required drug |
Dose specificity |
Diagnosis limitation |
Proteinuria endpoint |
Key differentiator |
| 1 |
atrasentan or salt |
not fixed; “therapeutically effective amount” |
primary IgAN; diagnosis method includes biopsy/anti-glycan/immune-complex deposition |
proteinuria <1 g/day in ≥2 of 3 consecutive readings after start |
broader dosing; broad “therapeutically effective amount” |
| 31 |
atrasentan or salt |
0.75 mg once daily |
same diagnosis limitation |
same <1 g/day in ≥2 of 3 consecutive readings |
regimen is pinned, enabling stronger carve-in protection |
B. Major dependent claim groupings
- Dose range/schedule (claims 6-10, 8, 9-10)
- 0.20-1.5 mg (6)
- 0.40-0.85 mg (7)
- once daily about 0.75 mg (8)
- salt form including hydrochloride (10)
- Baseline proteinuria (claims 2, 11-13, 30, 36)
- ≥1 g/day (2, 30, 36)
- ≥0.5 g/day (11)
- 0.3-2.0 g/day (12)
- 0.75-1.5 g/day (13)
- 1 g/day or 1.5 g/day (30)
- similar for claim 31 (36)
- Renal function (claims 14-15, 22-23)
- eGFR 30-90 (14)
- eGFR ≥30 (15)
- duration concept: eGFR present at least about 3 months (22-23)
- Measurement definition of proteinuria (claims 5, 16)
- albuminuria (5)
- UPCR ≥1 g/g (16)
- Magnitude and timing (claims 3-4, 18, 24-29, 32-34)
- percent reduction ranges and minimums
- response timing: 15-30 days; and ≥12 weeks or ≥36 weeks
- Chronicity (claims 19-23)
- proteinuria present at least about 3 months before dosing (multiple dependent chains)
How strong is the claim focus on “method outcome” versus “composition”/“mechanism”?
This patent is a method-of-treatment patent, not a composition-of-matter claim. The claim scope is outcome-driven:
- It is not enough that a clinician administers atrasentan.
- Infringement requires that the patient satisfies:
- baseline disease marker constraints (in dependent claims),
- and reaches the defined endpoint based on repeated proteinuria measurements (independent claims 1 and 31),
- and diagnosis test requirements are met (biopsy/biomarker/immune complex deposition).
That structure increases the factual burden in any enforcement action: the method claim is tightly linked to clinical measurement protocols and diagnostic evidence.
What would be the most “claim-prone” patient cohorts?
Based solely on the claim language, the most directly targeted cohorts are:
- Primary IgA nephropathy patients with:
- proteinuria ≥0.5 g/day (claim 11) and often ≥1 g/day (claim 2/30/36),
- eGFR ≥30 (claims 14-15),
- UPCR ≥1 g/g (claim 16),
- proteinuria present for at least 3 months (claims 19-23),
- Treated with atrasentan, especially:
- 0.75 mg once daily (claim 31, also claim 8),
- and in some narrower circumstances:
- doses in 0.20 to 1.5 mg (claim 6) or 0.40 to 0.85 mg (claim 7).
The “two of three consecutive readings <1 g/day” endpoint implies:
- frequent proteinuria monitoring and follow-up after initiation in a way that produces three consecutive readings.
Where does the scope leave room around the edges? (operationally)
The claim structure leaves potential non-infringement pathways by design:
- Not primary IgAN or diagnosis not based on the specified evidentiary methods (in the claim’s “comprises” framework).
- No repeated-measure pattern that meets the “<1 g/day in at least two of three consecutive readings.”
- Different drug exposure such as not using atrasentan (obvious), or not using atrasentan within the claimed dosing structure if only claim 31 is asserted (0.75 mg once daily).
- Different proteinuria assessment definitions if the method proof is tied to albuminuria versus total proteinuria and to UPCR.
Whether these are legally effective defenses depends on claim construction and evidentiary use in a specific case, but they are clear scoping levers in the claim drafting.
What is the U.S. patent landscape around atrasentan for IgA nephropathy?
The prompt requests “scope and claims and patent landscape” for United States Drug Patent 12,582,631. However, no bibliographic identifiers beyond the claims text were provided, and no filing/publication numbers, assignee, priority, expiry, prosecution history, related family members, or cited references were supplied. Without those details, a complete, accurate, claim-by-claim and family-by-family landscape mapping across the U.S. requires external patent record retrieval that is not present in the input.
No actionable landscape conclusions can be produced from the claim text alone without risking inaccuracies about:
- related U.S. continuations/divisionals,
- overlapping scope with other atropentan/ETA-antagonist patents,
- whether the patent is part of a larger asserted portfolio,
- whether there are carve-outs, terminal disclaimers, or PTA-driven expiry timing,
- or whether other patents cite or are cited by this one.
Per the operating constraints, only information directly supported by the provided record can be analyzed.
Accordingly, the landscape section here is confined to intra-document scope implications rather than external U.S. family mapping.
Claim-by-claim infringement “checklist” (from the provided text only)
Below is a condensed checklist aligned to the key limitations that appear in claims 1 and 31, plus major dependent carve-ins.
Universal elements for claims 1 and 31
- Patient: previously diagnosed primary IgA nephropathy
- Diagnosis basis includes at least one of:
- kidney biopsy, or
- detecting anti-glycan antibodies, or
- detecting deposition of IgA-immune complexes in the kidney, or a combination
- Administer:
- atrasentan or pharmaceutically acceptable salt
- Endpoint:
- proteinuria <1 g/day in at least two of three consecutive readings after initiation
Claim-prone dependent refinements
- Baseline:
- proteinuria threshold(s) such as ≥0.5 g/day, ≥1 g/day, or ranges (0.3-2.0, 0.75-1.5) and UPCR ≥1 g/g
- Renal function:
- Chronicity:
- proteinuria and/or eGFR present for at least about 3 months
- Response:
- percent reduction:
- 10-99% (claim 3)
- 20-80% (claim 4)
- minimums ≥10%, ≥20%, ≥30% (claims 24-26, and parallels 32-34)
- timing:
- 15-30 days (claim 18)
- ≥12 weeks or ≥36 weeks (claims 27-29, 32-34)
- Dose:
- fixed regimen for claim 31: 0.75 mg once daily
- salt:
- atrasentan hydrochloride (claims 10 and 35)
- Proteinuria definition:
Key Takeaways
- US 12,582,631 is a tightly constrained method-of-treatment patent for primary IgA nephropathy using atrasentan, with diagnosis evidence requirements (biopsy/anti-glycan/immune complex deposition) and a repeated-measure endpoint (proteinuria <1 g/day in at least 2 of 3 consecutive readings after initiation).
- The strongest independent claim in operational dosing terms is claim 31, which is 0.75 mg once daily atrasentan (or equivalent salt) with the same <1 g/day in ≥2 of 3 endpoint.
- Dependent claims broaden enforcement leverage by adding baseline severity (proteinuria/UPCR/eGFR), treatment duration (15-30 days; ≥12/≥36 weeks), and magnitude of reduction (≥10%, ≥20%, ≥30%), plus salt form (hydrochloride).
- A reliable full U.S. patent landscape cannot be stated from the provided claims text alone because the required bibliographic and citation data to map related U.S. patents, families, and overlaps is not in the input.
FAQs
1) Is US 12,582,631 about atrasentan’s mechanism or about clinical outcomes?
It is a method-of-treatment defined by clinical outcomes, specifically proteinuria reduction with defined measurement thresholds and repeated-reading criteria.
2) What patient diagnosis elements are required?
The patient must have primary IgA nephropathy, and diagnosis must comprise at least one of: kidney biopsy, anti-glycan antibody detection, and kidney IgA-immune complex deposition detection.
3) What is the central proteinuria endpoint?
Proteinuria < 1 g/day in at least two of three consecutive readings after starting atrasentan.
4) Which claim pins the dose most explicitly?
Claim 31 requires 0.75 mg once daily atrasentan (or equivalent salt amount).
5) Which dependent claims add timing and magnitude to strengthen enforceability?
Claims include timing such as 15-30 days and ≥12/≥36 weeks, and magnitude minima like ≥10%, ≥20%, and ≥30% proteinuria reduction.
References
[1] Provided claim text for United States Drug Patent 12,582,631 (claims 1-36).
