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Patent landscape, scope, and claims: |
United States Patent 11,285,145 (Relacorilant + Reduced-Dose Paclitaxel): Scope, Claim Parsing, and US Patent Landscape
Executive summary: US Drug Patent 11,285,145 claims a combination treatment method for cancer using relacorilant (effective dose) plus reduced-dose paclitaxel (20% to 35% reduction from a specified “single agent” paclitaxel dose) administered so that paclitaxel exposure and relacorilant exposure overlap. The claims are heavily constrained by dose ranges, reduction percentages, timing windows, optional nab-paclitaxel form, oral/intermittent relacorilant dosing, and specific oncology tumor types. The enforceable scope is strongest where all constraints are met, especially the 20–35% reduction and relacorilant dosing schedule relative to paclitaxel dosing. The patent landscape analysis below maps the likely adjacent claim clusters around (i) relacorilant monotherapy dosing, (ii) paclitaxel dose-reduction strategies in combination regimens, (iii) scheduling/overlap windows, (iv) nab-paclitaxel-specific embodiments, and (v) tumor-indication subsets that narrow infringement.
Note: A complete “patent landscape” across the US requires bibliographic and prosecution data (title/assignee/filing dates/priority, related family members, and the Orange Book or FDA linkage). No such data is provided here beyond the claims text. Without that, the only defensible landscape is the claim-scope map and infringement design space derived from the claim language itself.
What does US patent 11,285,145 claim for cancer treatment with relacorilant and paclitaxel?
Core claim theme (Claims 1 and 17): A method of treating cancer with:
- Paclitaxel given initially as a “single agent dose” in a constrained range,
- then relacorilant given at an effective dose, and
- then paclitaxel is administered as an effective reduced dose for co-administration with relacorilant,
- with both agents timed so that effective levels occur at the same time,
- and the reduced paclitaxel dose is quantitatively tied to the “single agent dose.”
Claim 1: anchored to a 20%–35% paclitaxel reduction from a defined single-agent dose
- Paclitaxel “single agent dose” range: about 100 mg/m² to 125 mg/m²
- Paclitaxel reduced dose reduction: reduced by about 20% to about 35%
- Relacorilant effective dose: not fixed in claim 1, but constrained in dependent claims
- Timing/overlap: “Wherein a) and b) are performed at times effective to provide… effective level… at the same time”
- Constraint framing: “administered without other anticancer pharmaceutical agents” (meaning the single-agent dose is not part of a multi-drug baseline in the claim)
Claim 17: alternative broad framing of reduced dose without the explicit 20%–35% tie
- Single agent paclitaxel dose: about 100 mg/m² to 125 mg/m² (same anchor)
- Reduced paclitaxel range with relacorilant: about 60 mg/m² to about 95 mg/m²
- Timing/overlap: same simultaneous effective level requirement
- Allows broader “reduced dose” embodiments than claim 1, but still tethered to the single-agent reference concept
How do the dependent claims narrow infringement risk in US 11,285,145?
Claim 11,285,145 uses a layered structure: each dependent claim adds dose specificity or operational constraints. For enforcement, the practical question becomes whether an accused regimen matches the extra constraints in any asserted dependent claim.
Dose reduction specificity (Claims 2 and 3)
- Claim 2: reduction amount selected from 20%, 25%, 30%, 35%
- Claim 3: reduced dose values selected from 72, 75, 80, 83, 88, 94, 96 mg/m²
- In litigation, this is a high-value narrowing device: it converts “about” ranges into a finite set of numeric selections.
Drug form constraint: nab-paclitaxel (Claims 4, 14, 18, 30)
- Claim 4: paclitaxel is nab-paclitaxel
- Claim 14: in a specific 28-day schedule: paclitaxel as nab-paclitaxel, reduced dose selected from 65, 72, 75, 80, 83 mg/m² on days 1, 8, 15
- Claim 18 and 30: additional nab-paclitaxel schedule specificity
This matters because “paclitaxel” in claim 1/17 is broader, but the narrowing embodiments create stronger match scenarios for nab formulations.
Relacorilant dose range and selection (Claims 5–6, 20–21)
- Relacorilant effective dose: 75 mg/day to 200 mg/day
- Selection set in dependent claims: 75, 100, 125, 150, 175, 200 mg/day
These “selected from” lists are typically easier to map to product labels, trial dosing schedules, and dosing modifications.
Indication narrowing (Claims 7–9, 22–24)
- Claim 7 / 22: solid tumors
- Claim 8 / 23: ovarian, pancreatic, prostate, esophageal, melanoma
- Claim 9 / 24: specifically ovarian or pancreatic
This creates a jurisdictional and clinical targeting layer. A regimen used in an unlisted tumor type can be outside the dependent claims, but still potentially inside independent claim 1/17 if they are not limited to those enumerated cancers (they are not explicitly limited in claim 1/17 as provided other than “cancer” and the dependent claims impose the enumerations).
Route and schedule of relacorilant (Claims 10–16, 25–28, 29)
- Route: relacorilant administered orally (Claims 10 and 25)
- Pattern options:
- every day (Claims 11 and 26)
- intermittently (Claims 12 and 27)
- Intermittent timing tied to paclitaxel:
- relacorilant administered day before, day of, day after reduced-dose paclitaxel (Claims 13 and 28)
- 28-day cycle synchronization (Claims 14–16, 15 and 17 line dependencies, 29–30):
- nab-paclitaxel on days 1, 8, 15
- relacorilant on day before, day of, day after those days
- relacorilant dose selection includes numeric sets (Claims 16 and 29)
What is the practical claim “unit” of infringement: dose overlap, numeric reduction, or schedule?
Three distinct infringement “gates” appear in the claims:
Gate 1: Numeric definition of paclitaxel reduction relative to a reference “single-agent dose”
- Claim 1: reduction must be 20% to 35% (and dependent claim 2 can lock exact selections)
- Claim 17: reduced paclitaxel must lie in 60–95 mg/m²
- Because claim 1 ties reduction to the single-agent paclitaxel dose (100–125 mg/m²), infringement analysis turns on how an accused regimen defines and implements the “single agent dose” concept operationally. Claim language suggests a reference frame, not necessarily that the patient ever receives only paclitaxel alone, but the claim still uses “single agent dose… administered without other anticancer pharmaceutical agents,” which is a potential factual hook.
Gate 2: Co-administration timing with “effective levels… at the same time”
All independent and many dependent claims include the overlap element:
- “performed at times effective to provide… relacorilant and… paclitaxel at the same time.”
This creates a scheduling sensitivity: if relacorilant is dosed so that systemic exposure overlaps differently than claimed, design-around may target the pharmacokinetic overlap.
Gate 3: Optional narrowing embodiments (nab-paclitaxel; specific 28-day schedules; oral/intermittent dosing)
These are typically the easiest to prove in litigation if the accused regimen is a close match to the trial-like schedule:
- nab-paclitaxel on days 1/8/15
- relacorilant taken daily vs intermittent windowing around paclitaxel dosing
Where is claim scope strongest under US 11,285,145? (Best “fit” scenarios for accused regimens)
The strongest match zones are regimens that replicate the claim architecture:
Scenario A: Reduced-dose paclitaxel by ~20–35% from ~100–125 mg/m² plus relacorilant
- If a regimen starts from a baseline intended paclitaxel dose in the 100–125 mg/m² range, and then reduces paclitaxel by 20–35% when relacorilant is present, it fits Claim 1.
- If the reduced paclitaxel dose is within 60–95 mg/m², it fits Claim 17.
Scenario B: Nab-paclitaxel + 28-day schedule + relacorilant intermittent day-before/day-of/day-after
- Claim 14 and Claim 30 include tight mechanical dosing days (1, 8, 15) and relacorilant windowing around those days.
Scenario C: Ovarian or pancreatic cancer use
- Claims 9 and 24 narrow to ovarian/pancreatic in dependent claims. Even if independent claim 1/17 is broader, plaintiffs often assert dependent claims to reduce interpretation risk.
Where can competitors design around US 11,285,145 based on the claim language?
Design-around typically targets one of the gates above:
1) Break the paclitaxel reduction percentage requirement (Claim 1)
- Claim 1 requires ~20% to ~35% reduction.
- Competitors can move outside the range (e.g., reduction less than ~20% or greater than ~35%) to avoid Claim 1, while still potentially risking Claim 17 depending on the reduced-dose numeric range (60–95 mg/m²).
2) Move reduced dose outside the “about 60–95 mg/m²” frame (Claim 17)
- If reduced paclitaxel is outside 60–95 mg/m² while relacorilant is co-administered, Claim 17 can be avoided.
- Claim 3 adds specific selected values that should be avoided when operating near those values.
3) Change the co-administration overlap timing
The overlap requirement is present across independent claims. A regimen that gives relacorilant such that “effective levels” do not overlap with paclitaxel effective levels can attempt to avoid the timing element. This is a factual and technical showing but is claim-relevant.
4) Avoid the narrowed embodiments
- Use a non-oral route for relacorilant (dependent claims 10 and 25).
- Use a dosing cadence that is not “every day” or not “intermittently” in a way that matches the specified day-before/day-of/day-after window (claims 12–13, 27–28).
- Use paclitaxel formulations not falling under “nab-paclitaxel” (dependent claims 4, 14, 18, 30).
Which claim elements are most likely to be litigated in US 11,285,145?
The “single agent dose” construct
Claim 1 and 17 use a “single agent dose of paclitaxel” range and then define a reduced dose as a reduction from that construct. If accused regimens never implement a single-agent baseline in the manner described, defendants may argue that the reference construct is improperly imported. Conversely, plaintiffs can argue it is a reference point for dose arithmetic rather than a requirement of actual clinical sequence.
“About” interpretation
Many numeric elements use “about.” Courts weigh specification and prosecution history to interpret “about.” Dependent claims with “selected from” lists reduce uncertainty, which is why those claims matter strategically.
Overlap timing
“Effective levels… at the same time” is both pharmacokinetic and dosage-form dependent. Disputes typically focus on plasma exposure and dosing schedules.
What formulations are protected by US 11,285,145 (paclitaxel vs nab-paclitaxel)?
Paclitaxel (broad)
- Claim 1 and 17 generically recite paclitaxel, allowing both standard solvent-based paclitaxel and other paclitaxel forms unless narrowed elsewhere.
nab-paclitaxel (narrow embodiments)
- Claim 4, 14, 18, and 30 explicitly require nab-paclitaxel and in some cases tie it to a specific cycle structure and day schedule.
Key implication: If a competitor uses nab-paclitaxel-like dosing days and reduction levels, they face higher risk due to literal match of multiple dependent claims. If they use a different formulation, they may avoid the nab-specific dependent claims but remain exposed to the broader independent method claims.
How does US 11,285,145 compare with other typical cancer combination method patents?
Compared with common combination patents that broadly claim “administering drug A and drug B,” 11,285,145 is more restrictive in three ways:
- Dose arithmetic: explicit percent reduction or numeric ranges
- Overlap timing: “effective level… at the same time”
- Operational schedule: intermittent dosing relative to paclitaxel and a mechanical 28-day nab-paclitaxel schedule in dependent claims
This structure tends to produce clearer infringement mapping when the accused regimen mirrors a clinical protocol. It also increases design-around degrees of freedom.
What Orange Book status or FDA exclusivity does US 11,285,145 relate to?
No FDA regulatory linkage (NDA/BLA number, listed patents, or Orange Book entries) is provided in the prompt, so no accurate status can be determined from the available information.
What generic entry risks exist for paclitaxel in combination with relacorilant under US 11,285,145?
Paclitaxel generics are not prevented by combination method patents in the abstract; the practical enforcement is directed at the method steps that involve:
- administering relacorilant and
- administering paclitaxel at the claimed reduced dose and timing.
So the relevant “generic entry risk” is:
- If a generic paclitaxel manufacturer supplies drug product to a clinic, that alone is not typically the method act, but it can increase exposure for method infringement by providers if the regimen is prescribed and administered within the claim scope.
The risk therefore concentrates on:
- clinical adoption of the exact reduction + overlap + schedule pattern, and
- whether relacorilant itself is branded/controlled (because relacorilant is central to the method claim).
Key takeaways
- Independent claims (1 and 17) are method claims requiring co-administration of relacorilant with reduced-dose paclitaxel and simultaneous “effective level” overlap.
- Claim 1 is the tighter numeric anchor: 20% to 35% reduction from an assumed ~100–125 mg/m² single-agent paclitaxel dose.
- Claim 17 expands the reduced-dose envelope to ~60–95 mg/m², still within a reduced-dose construct tied to the single-agent reference range.
- High-value dependent claim constraints include:
- reduction selections (20/25/30/35%) and reduced-dose numeric selections (e.g., 72/75/80/83/88/94/96 mg/m²),
- nab-paclitaxel embodiments and specific 28-day dosing days (1, 8, 15),
- relacorilant dosing values (75–200 mg/day) and route/schedule (oral; daily vs intermittent; day-before/day-of/day-after).
- Design-around most credibly targets: the percent/numeric reduction boundaries, the timing overlap element, and the schedule/formulation constraints in dependent claims.
FAQs
1) Does US 11,285,145 require patients to have received paclitaxel as a single agent before relacorilant?
The claim text uses a “single agent dose” reference construct, but infringement turns on how “single agent dose… administered without other anticancer pharmaceutical agents” is interpreted in the claim context and evidence of regimen implementation.
2) Are ovarian and pancreatic cancers the only indications protected?
Not in the independent claim language as provided, but dependent claims expressly list ovarian, pancreatic, prostate, esophageal, and melanoma, with a further narrowing to ovarian/pancreatic.
3) If a regimen uses relacorilant with reduced-dose paclitaxel outside 60–95 mg/m², is it outside the patent?
That avoids Claim 17, but Claim 1 could still be asserted if the reduction percent still falls within 20–35% and other elements match.
4) Can a competitor avoid nab-paclitaxel dependent claims by using non-nab paclitaxel?
Yes for nab-specific dependent claims that explicitly require nab-paclitaxel. Independent claims still cover paclitaxel generally as provided.
5) Which claim element is most sensitive to dosing schedule disputes?
The “effective level at the same time” overlap requirement is central and typically drives technical/pharmacokinetic fights.
References (APA)
- US Patent 11,285,145, “method of treating cancer comprising administering relacorilant and reduced-dose paclitaxel” (claims as provided in prompt).
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