Scope and claims of US Drug Patent 12,589,094: intermittent paclitaxel plus relacorilant (28-day cycle)
US Patent 12,589,094 claims a time-sequenced combination regimen for treating solid tumors using:
- Oral relacorilant dosed on days 0/7/14 and days 1/8/15 and days 2/9/16 (before, on, and after paclitaxel days), and
- Paclitaxel given intermittently on days 1/8/15 with the paclitaxel dose reduced versus a stated single-agent paclitaxel dose by ~20% to ~35%.
The claims are tightly drafted around a 28-day cycle window, specific dosing days, oral dose ranges for relacorilant (75 to 200 mg), and oncology indications limited to “solid tumor” plus enumerated tumor types.
What exactly is claimed in US 12,589,094 (claim 1): 28-day intermittent schedule for paclitaxel plus oral relacorilant?
Claim 1 is the independent method-of-treatment claim and is built in three functional blocks (a), (b), and (c), tied to a single 28-day cycle.
What regimen cycle does claim 1 require?
- The 28-day cycle begins on day 0.
- Paclitaxel is administered on day 1, day 8, and day 15.
- Relacorilant is administered on the days immediately adjacent to and including paclitaxel dosing, plus additional relacorilant anchor days.
Relacorilant schedule (oral)
Claim 1 requires oral relacorilant at an effective oral dose between 75 mg and 200 mg on:
- Day 0, day 7, day 14 (step a)
- Day 1, day 8, day 15 (step b, in the same dosing event as paclitaxel)
- Day 2, day 9, day 16 (step c)
So, relacorilant is effectively given in a three-day “around each paclitaxel day” pattern (day before, day of, day after), repeated at paclitaxel days 1/8/15, with additional relacorilant dosing on day 0/7/14.
Paclitaxel dose reduction vs “single-agent” paclitaxel
On days 1, 8, 15, the claim requires:
- Oral relacorilant (75 to 200 mg) co-administered with
- Paclitaxel at a dose that is reduced by about 20% to about 35% from a stated single-agent paclitaxel dose range of:
- about 100 mg/m² to about 125 mg/m²
Claim 1 therefore does not just claim a paclitaxel dose number; it claims a relative reduction from a defined “single-agent” benchmark.
How does claim 1 ensure “same-time effective levels”?
The claim uses a functional synchronization limitation:
- Steps a/b/c are intermittent steps where
- paclitaxel is on days 1/8/15
- relacorilant is on the day before, the day of, and the day after paclitaxel
- “Effective to provide” effective levels of relacorilant and paclitaxel at the same time
This is a timing-and-exposure type limitation rather than a pharmacokinetic numeric parameter.
How do the dependent claims narrow paclitaxel dose and tumor scope?
What additional dose-refinement is in claim 2?
Claim 2 limits the reduction magnitude:
- Paclitaxel reduction is selected from about 20%, 25%, 30%, or 35% (from the stated single-agent 100 to 125 mg/m² benchmark).
This makes the relative reduction discrete rather than purely continuous.
What fixed paclitaxel dose range is in claim 3?
Claim 3 provides an explicit paclitaxel dose set:
- Paclitaxel effective dose selected from:
- 72, 75, 80, 83, 88, 94, or 96 mg/m²
This claim acts as an alternate narrowing mechanism: even if a challenger attacks the “reduced by 20–35%” construction, claim 3 can still capture embodiments that meet the stated numerical paclitaxel doses.
What does claim 4 add about paclitaxel formulation?
Claim 4 limits paclitaxel to nab-paclitaxel (albumin-bound paclitaxel).
What does claim 5 do for relacorilant dose?
Claim 5 makes relacorilant dosing discrete:
- 75, 100, 125, 150, 175, or 200 mg.
What tumor types are named in claim 6?
Claim 6 narrows the cancer selection to one of:
- ovarian cancer
- pancreatic cancer
- prostate cancer
- esophageal cancer
- melanoma
Claim 1 already requires “solid tumor,” but claim 6 narrows to a defined enumerated subset.
What is the role of nab-paclitaxel dose specifics in claims 7 and 13?
Claim 7: nab-paclitaxel with discrete doses
Claim 7 requires:
- paclitaxel is nab-paclitaxel, and
- nab-paclitaxel is selected from about 60, 72, 75, 80, or 83 mg/m²
- administered by IV infusion on days 1, 8, and 15.
This is a strong “product-form + route + schedule + dose” bundle.
Claim 13 repeats the same concept with a slightly different set
Claim 13 states:
- paclitaxel is nab-paclitaxel, and
- dose selected from about 60, 72, 75, 80, or 83 mg/m²
- administered by IV infusion on days 1, 8, and 15.
Net effect: claims 7 and 13 reinforce that nab-paclitaxel embodiments are squarely within claim coverage.
What is the second independent method claim (claim 8), and how is it different from claim 1?
Claim 8 is another independent method claim that preserves the 28-day intermittent framework and timing pattern, but changes how paclitaxel dosing is defined.
Relacorilant schedule in claim 8
It keeps the same relacorilant timing and dose range as claim 1:
- relacorilant 75–200 mg on:
- day 0, day 7, day 14
- day 1, day 8, day 15
- day 2, day 9, day 16
Paclitaxel definition is no longer “relative reduction”
Instead of requiring a paclitaxel dose reduced by 20–35% from a single-agent benchmark, claim 8 requires:
- paclitaxel dose between about 60 and 95 mg/m² on day 1, day 8, day 15
- with relacorilant co-administration on those paclitaxel days and on adjacent days.
Discrete alternatives in dependent claim 10
Claim 10 sets paclitaxel dose selection among:
- 60, 65, 70, 75, 80, 85, 90, or 95 mg/m²
Tumor types in claim 12
Claim 12 repeats the enumerated tumor list from claim 6:
- ovarian, pancreatic, prostate, esophageal, melanoma.
Claim 9/11 mirror formulation and relacorilant discreteness
- Claim 9: paclitaxel in the form of nab-paclitaxel
- Claim 11: relacorilant selected from 75, 100, 125, 150, 175, 200 mg
What is the effective “claim scope” for a competitor?
A. Regimen date-pattern scope
A method practiced outside the following timing anchor likely avoids literal infringement:
- 28-day cycle beginning on day 0
- paclitaxel on days 1, 8, 15
- relacorilant on:
- days 0/7/14
- and day before/day of/day after each paclitaxel day (days 1/8/15 and days 2/9/16)
Because these are specific day numbers, a competitor altering the cycle alignment (e.g., shifting the infusion day relative to relacorilant dosing) can attempt design-around.
B. Relacorilant dose scope
Literal scope is oral relacorilant 75–200 mg, with discrete selections in dependent claims.
A competitor using relacorilant outside that numeric range (or using a non-oral form) targets non-infringement.
C. Paclitaxel scope depends on whether claim 1 or claim 8 is asserted
- Under claim 1: paclitaxel is determined by reduction relative to a defined single-agent range (100–125 mg/m²) and reduction magnitude of 20–35%.
- Under claim 8: paclitaxel is determined by an absolute range (60–95 mg/m²) and discrete options (claim 10).
This dual structure increases coverage: even if a design-around attacks the “reduced by” arithmetic, claim 8 can still capture the absolute-dose window.
D. Nab-paclitaxel “form” support
Claims 4/7/9/13 narrow to nab-paclitaxel, but the independent claims 1 and 8 do not, by themselves, require nab-paclitaxel unless a dependent claim is asserted. That makes formulation design a key infringement lever only when claim limitations are matched.
Where does the claim language create enforceability leverage (and vulnerability) for validity and infringement?
Leverage: clear day-by-day regimen structure
The claims use:
- exact cycle start definition (day 0)
- exact days for each drug (day 1/8/15 for paclitaxel; multiple exact relacorilant days)
- explicit “intermittent steps”
This clarity supports infringement theories for real-world dosing schedules and reduces the ambiguity risk common in “method of treatment” patents.
Vulnerability: “single-agent paclitaxel dose” definition reliance (claim 1)
Claim 1 ties dose reduction to a “paclitaxel single agent dose of about 100 mg/m² to about 125 mg/m²” defined as the paclitaxel dose used without other pharmaceutical agents.
In litigation, that phrase can become a focal point:
- whether the “single-agent” reference is definable for the relevant patient population
- whether the comparator “single agent dose” corresponds to actual practice or only hypothetical dosing
- whether accused regimens map to the required reduction calculus
However, claim 8 reduces reliance on that construction by using an absolute paclitaxel range.
Patent landscape for US 12,589,094: what can be inferred from the claim set about coverage breadth?
No Orange Book or patent family bibliographic records are provided in the prompt. With only the claim text, the landscape can be characterized at a claim-scope level rather than enumerating other family members or prosecution history.
Likely IP architecture within this claim set
The independent claims appear designed to cover two infringement avenues:
- Relative-dose coverage (claim 1): reduction from a benchmark single-agent paclitaxel dose.
- Absolute-dose coverage (claim 8): paclitaxel in a broad absolute window, with overlapping discrete options in claim 10.
Dependent claims then “lock”:
- dose discreteness (claims 2, 3, 5, 10, 11)
- formulation (nab-paclitaxel, claims 4, 7, 9, 13)
- cancer subset (claims 6, 12)
Practical implication for a generic or biosimilar-like challenge
Because this is a method-of-use claim (based on the provided text), generic entry risk depends on whether:
- a follow-on product is practicing the same combination regimen schedule, timing, and dose ranges.
A manufacturer that markets relacorilant and paclitaxel combination therapies must assess the risk that clinical protocols matching the claim’s day-by-day regimen could infringe.
How do the claims compare with typical paclitaxel regimens (infringement and design-around)?
While the prompt does not provide external trial regimens, the claim structure indicates the protected competitive point is the specific relacorilant “around paclitaxel” timing plus dose reduction.
Design-around levers evident from the claim structure
- Shift paclitaxel infusion days away from days 1/8/15 within a 28-day cycle.
- Modify relacorilant dosing so it is not on the exact anchor days and not on the “day before/day after” paclitaxel days.
- Use relacorilant dosing outside 75–200 mg.
- Use paclitaxel dosing outside:
- the 60–95 mg/m² absolute window (claim 8)
- or outside 20–35% reduction from the defined single-agent range (claim 1)
- Avoid nab-paclitaxel only helps if the asserted claim is a dependent claim requiring that specific formulation; it does not by itself avoid the independent claims.
Litigation posture signals embedded in the claim drafting
The claim contains common features that tend to appear in patents intended to support infringement in enforcement and carve-out arguments:
- rigid schedule (calendar-day anchor)
- dose ranges plus discrete alternatives
- formulation-dependent dependents (nab-paclitaxel)
- tumor subset limitation (enumerated solid tumors)
This suggests the patent is drafted to survive partial invalidation by keeping multiple independent/narrowing paths to infringement (claim 1 vs claim 8).
Key Takeaways
- US 12,589,094 protects a 28-day method-of-treatment regimen combining oral relacorilant (75–200 mg) with intermittent paclitaxel.
- Paclitaxel infusions are required on days 1, 8, and 15, with relacorilant dosed on day before/day of/day after each paclitaxel day and also on day 0/7/14.
- Coverage is reinforced by two independent claim structures:
- Claim 1: paclitaxel is 20–35% reduced versus a defined single-agent benchmark (100–125 mg/m²).
- Claim 8: paclitaxel is within 60–95 mg/m².
- Dependent claims tighten to discrete dose values, nab-paclitaxel formulation, and a restricted tumor list (ovarian, pancreatic, prostate, esophageal, melanoma).
FAQs
1) Does US 12,589,094 require relacorilant to be taken on the day before paclitaxel?
Yes. The claim requires relacorilant on the day before each paclitaxel day, via relacorilant dosing on day 2/day 9/day 16 for paclitaxel days 1/8/15 and also via the day 0/7/14 anchor.
2) If an accused regimen keeps the same 28-day length but shifts paclitaxel to days 2/9/16, is it within the claim?
The claim’s literal days are day 1/8/15 for paclitaxel, so shifting those infusion days to another calendar set would fall outside the claimed schedule.
3) Can a competitor avoid the “single-agent paclitaxel reduction” by using a fixed absolute paclitaxel dose?
It depends on the dose. Claim 8 can still capture absolute paclitaxel doses 60–95 mg/m², regardless of the reduction arithmetic used in claim 1.
4) Are nab-paclitaxel regimens covered even if the main claim does not specify nab-paclitaxel?
Nab-paclitaxel is explicitly covered in dependents (claims 4/7/9/13). Independent claim coverage exists based on the provided text, with nab-paclitaxel dependents narrowing in additional asserted paths.
5) Are all solid tumors covered or only specific cancers?
The independent claim language requires “solid tumor,” but dependents narrow to enumerated cancers: ovarian, pancreatic, prostate, esophageal, and melanoma.
References
No external sources were provided in the prompt, and no bibliographic patent data, prosecution history, family members, or Orange Book listings were supplied.
