United States Patent 12,564,590: Scope, Claim Architecture, and Landscape Implications
What is US 12,564,590 actually claiming?
US 12,564,590 claims method-of-use protection for oral administration of a menin inhibitor of “Formula (II)” at specific daily dose ranges, in combination with a “strong CYP3A4 inhibitor”. The independent concept is narrow on dose and broad on indication.
At the claim level, the patent is built to capture a dosing strategy where the menin inhibitor’s exposure is controlled by co-administration with CYP3A4 inhibition, including multiple exemplified CYP3A4 inhibitors, with special emphasis on azole antifungals and pharmacokinetic boosters.
Core claim scope (independent claim 1)
What does claim 1 cover?
Claim 1 is the principal breadth anchor:
- Treatment target: “a leukemia in a human in need thereof”
- Administration route: oral
- Menin inhibitor dosing: about 280–350 mg/day
- Drug identity: “a menin inhibitor of Formula (II)”
- Co-therapy: a strong CYP3A4 inhibitor
This is a combination regimen claim with a fixed dose band and an exposure-modulating partner (CYP3A4 inhibitor).
What is the practical meaning of “about 280–350 mg/day”?
It creates infringement leverage across a continuous dosing band rather than a single fixed dose, while the dependent claims add “about 300–340 mg/day” and specific dose points (310/320/330 mg/day), including a repeated “320 mg/day” theme later.
Claim architecture: how breadth is expanded and how it is segmented
How do dependent claims expand the CYP3A4 inhibitor universe?
Claim 2 enumerates a non-exhaustive set (as framed by “selected from the group consisting of”) of strong CYP3A4 inhibitors. The list is extensive and includes:
- Boceprevir
- Nefazodone
- Clarithromycin
- Nelfinavir
- Conivaptan
- Posaconazole
- Grapefruit juice
- Ritonavir
- Indinavir
- Saquinavir
- Itraconazole
- Telaprevir
- Ketoconazole
- Telithromycin
- Lopinavir
- Voriconazole
- Cobicistat
- Mibefradil
Then claim 3 narrows by function: the strong CYP3A4 inhibitor is an azole antifungal.
Claim 17 narrows to a smaller azole subgroup:
- Cobicistat, posaconazole, itraconazole, voriconazole
(cobicistat is not an azole, so this dependent claim is best read as a subset selection strategy within the broader “strong CYP3A4 inhibitor” definition.)
How do dependent claims expand the menin inhibitor dose precision?
From claim 6 onward, the patent locks onto a dose granularity ladder:
- Claim 6: about 300–340 mg/day
- Claim 7: about 310 mg/day
- Claim 8: about 320 mg/day
- Claim 9: about 330 mg/day
These make it harder for a competitor to “design around” by switching dose to a neighboring value while still co-administering with a strong CYP3A4 inhibitor.
How do dependent claims lock timing and unit-dose configuration?
Claims 4–5 and later claims 23–24, 30–31, etc. control formulation and administration logistics:
- Claim 4: menin inhibitor and CYP3A4 inhibitor are in separate unit doses
- Claim 5: administered concurrently, sequentially, simultaneously, essentially simultaneously, or within a treatment protocol
This matters because many real-world regimens use separate tablets or schedules; the claim text is drafted to cover operational variability.
How do dependent claims manage dosing frequency?
- Claim 10: daily 280–350 mg/day divided into multiple doses twice daily
- Claim 11: 320 mg/day divided into multiple doses twice daily
This adds a second design pressure point: a competitor switching from BID to QD (or to a different split schedule) may reduce risk against those specific dependent claims, while claim 1 may still capture any oral regimen meeting the daily dose band.
Indication scope: breadth is very wide at claim 12
What leukemia categories are covered?
Claim 12 is a large list that expands the “leukemia” term across broad oncology labels, including:
- MLL / MLL-related / MLL-positive / MLL-r
- Acute, chronic, indolent leukemia
- ALL, AML, CLL, CML
- Therapy-related leukemia, MDS, MPD, MPN
- Multiple myeloma, plasma cell neoplasm
- Cutaneous T-cell lymphoma, Sezary syndrome, mycosis fungoides
- Waldenstrom’s macroglobulinemia
- and other leukemic/lymphoid entities
This list is not a minimal “MLL-only” claim; it is engineered to capture a broad leukemia/hematologic oncology universe under the umbrella language.
How do later claims focus subsets?
Claims 13–16 narrow claim 1’s leukemia definition via examples:
- Claim 13: acute leukemia
- Claim 14: AML or ALL
- Claim 15: MLL-r leukemia
- Claim 16: NPM1-mutated leukemia
Then independent claim 19 targets:
- NPM1-mutated leukemia OR MLL-r leukemia
- at about 320 mg/day, menin inhibitor twice daily, plus strong CYP3A4 inhibitor
And claims 26 targets:
- ALL or AML
- about 320 mg/day menin inhibitor twice daily conceptually implied in dependent claim 31, plus strong CYP3A4 inhibitor.
The “320 mg/day + BID + strong CYP3A4 inhibitor” strategy is the center of gravity
Where does 320 mg/day appear as an anchor?
- Claim 8: about 320 mg/day
- Claim 19: explicitly about 320 mg/day, twice daily, for NPM1-mutated or MLL-r leukemia
- Claim 26: method for ALL or AML with about 320 mg/day
- Claim 31: 320 mg/day divided into multiple doses twice daily
- Claim 6/10/11: additional dosing band and BID language
The result is a claim set that repeatedly converges on a single dosing point (320 mg/day), suggesting that the patent is designed around a preferred exposure target likely intended to be reached only when the menin inhibitor is paired with a strong CYP3A4 inhibitor.
Scope table: what is claimed vs what is operationally constrained
Key claim elements mapped to boundaries
| Element |
Claim 1 (base) |
Claim 19 / 26 (focused) |
Design pressure created |
| Target disease |
“leukemia” |
NPM1-mutated or MLL-r (19) ; ALL/AML (26) |
Captures multiple AML/ALL subsets; broad disease lexicon via claim 12 |
| Menin inhibitor dose |
about 280-350 mg/day |
about 320 mg/day |
Competitor dose changes can reduce dependent-claim fit but not necessarily claim 1 |
| Route |
oral |
oral |
IV/or other route would avoid literal match |
| Co-therapy |
strong CYP3A4 inhibitor |
strong CYP3A4 inhibitor |
Avoiding “strong CYP3A4 inhibitors” category reduces risk |
| Frequency |
not limited in claim 1 |
twice daily in 19; twice daily via 31 for 26 |
BID switching can reduce dependent claim exposure |
| Timing/config |
concurrent/sequential/simultaneous in claim 5 |
simultaneously in claim 24; protocol in 30 |
Separate schedules still captured |
| CYP3A4 inhibitors |
broad list + azole concept |
narrowed lists (17,21,32) |
Using a non-listed CYP3A4 inhibitor or a non-“strong” one changes risk profile |
Claim construction risk areas for competitors
1) “Strong CYP3A4 inhibitor” is doing most of the legal work
The claim is combination-based and will typically be interpreted through:
- express inclusion via lists of examples (claims 2, 17, 20, 21, 27, 32)
- functional class limitation (“azole antifungal” in claims 3, 22, 28)
Even if a competitor chooses a CYP3A4 inhibitor not in the list, it can still fall within “strong CYP3A4 inhibitor” unless the competitor can argue the inhibitor is not strong.
2) Dose bands and “about” language reduce escape routes
The menin inhibitor dose is constrained tightly:
- 280–350 mg/day (claim 1)
- and a more specific ladder around 300–340 and exact points (310/320/330)
The repeated focus on 320 mg/day means that switching from 320 to 300 or 340 may avoid some dependent claims, but claim 1 can still read if the regimen lands within 280–350.
3) Administration logistics are drafted to be execution-proof
By covering separate unit doses and different timing constructs (“concurrently, sequentially, simultaneously, essentially simultaneously, or within a treatment protocol”), the claim language is built to match common combination regimen workflows.
Patent landscape implications (what US 12,564,590 is likely trying to fence)
Why the CYP3A4 inhibitor pairing matters
This patent is designed around a standard pharmacokinetic approach: boosting systemic exposure of a substrate drug by co-administering a strong CYP3A4 inhibitor. The claim does not specify exposure metrics (AUC, Cmax), but it does specify the class and the dosing.
That pairing strategy tends to create a landscape pattern:
- Core compound patent(s) for the menin inhibitor (not shown in your prompt)
- Combination / dosing regimen patent(s) for specific dose bands and specific pharmacokinetic co-medicines (this patent)
- Potential downstream patents that change:
- inhibitor choice (different CYP enzymes)
- dosing schedules (QD vs BID)
- patient subsets (MLL-r, NPM1)
- formulation (salt/solvate/hydrate) around the “Formula (II)” compound
Where this patent likely sits in a family
Given the claim style:
- “Formula (II)” menin inhibitor language is consistent with chemical series filings.
- Multiple independent methods (claims 1, 19, 26) suggest a family that targets different patient subsets while keeping the pharmacokinetic pairing constant.
Without bibliographic metadata for the patent family in the prompt, the landscape conclusion is operational rather than genealogical: US 12,564,590 is a dosing-and-combination fence around a menin inhibitor plus strong CYP3A4 inhibition for leukemia subtypes, especially AML/ALL and MLL-related or NPM1-mutated disease.
Practical freedom-to-operate (FTO) mapping: what could avoid literal claims
Ways a regimen can potentially reduce literal exposure
Based strictly on the claim text provided:
- Use an oral route but set the menin inhibitor dose outside 280–350 mg/day and specifically outside “about 300–340 mg/day” and “about 320 mg/day” if the product is designed to avoid those dependent claims.
- Use a CYP3A4 inhibitor that is not a “strong CYP3A4 inhibitor.”
- Avoid the azole antifungal classification if the azole subgroup is central to your risk.
- Change from BID split dosing if you want to reduce dependent claim overlap tied to BID (claims 10, 11, 19, 31).
- Avoid the simultaneous/concurrent/protocol timing constructs if the regimen uses timing concepts that cannot be characterized as covered. The current language is broad, so this is typically a weak lever.
Ways a regimen will almost certainly remain within scope
- Oral menin inhibitor dosing in 280–350 mg/day
- Paired with one of the enumerated CYP3A4 inhibitors, or a well-accepted strong CYP3A4 inhibitor
- Treatment of leukemia that fits the expansive leukemia/hematologic list in claim 12
- Regimens using BID split doses around 320 mg/day
Key takeaways
- US 12,564,590 is a combination regimen patent for an oral menin inhibitor (Formula II) dosed at about 280–350 mg/day with a strong CYP3A4 inhibitor.
- The claim set repeatedly centers on about 320 mg/day and often ties it to twice daily dosing and leukemia subsets including MLL-r and NPM1-mutated leukemia, plus ALL/AML.
- The CYP3A4 inhibitor universe is broad and includes a long list of drugs and azole antifungals, plus “strong CYP3A4 inhibitor” functional framing.
- Operationally, the claim language is built to capture real-world administration patterns: separate unit doses and flexible timing (“concurrently/sequentially/simultaneously within a protocol”).
- For landscape planning, this patent functions as a pharmacokinetic pairing fence: risk concentrates on regimens that replicate the menin inhibitor dose band plus strong CYP3A4 inhibition, especially using azole antifungals or enumerated inhibitors.
FAQs
1) Does US 12,564,590 protect the menin inhibitor molecule itself?
No. Based on the claim text provided, it protects methods of treating leukemia using an oral regimen with a menin inhibitor of Formula (II) plus a strong CYP3A4 inhibitor.
2) What is the key dosing boundary that defines claim 1?
Claim 1 covers oral administration of the menin inhibitor of Formula (II) at about 280–350 mg/day.
3) Which leukemia subsets get explicit independent claim targeting?
- Claim 19 targets NPM1-mutated leukemia or MLL-r leukemia at about 320 mg/day with strong CYP3A4 inhibition.
- Claim 26 targets ALL or AML with about 320 mg/day and strong CYP3A4 inhibition.
4) Are specific CYP3A4 inhibitors required to fall within the patent?
The claims include enumerated examples (claims 2, 17, 20, 21, 27, 32) and also rely on the functional class “strong CYP3A4 inhibitor” plus an “azole antifungal” subgroup in multiple claims.
5) Is twice-daily dosing part of the scope?
Yes, in multiple places: claim 10 covers BID for the 280–350 mg/day band; claim 11 ties BID to 320 mg/day; claim 19 and dependent claim 31 tie BID to 320 mg/day.
References
[1] United States Patent Application/Patent US 12,564,590. Claims as provided in prompt.
