United States Patent 12,364,675 (Colchicine, 0.5–0.6 mg Daily, Post-Stabilization)
US Drug Patent 12,364,675 claims methods for treating and/or reducing the risk of cardiovascular events using low-dose colchicine (tablet or liquid) at no more than about 0.5 or 0.6 total mg, with once-daily administration in subjects who are clinically stable at first dose, and with optional post-PTCA and optional co-administration with a colchicine-compatible statin. The claims define cardiovascular targets broadly across myocardial infarction, non-cardio-embolic ischemic stroke, and acute coronary syndrome/out-of-hospital cardiac arrest.
What is the claim center of gravity? (Scope)
Across the asserted claims, the patent’s technical and commercial anchor is:
- Drug: colchicine (or a salt of colchicine)
- Dose cap: ≤ about 0.5 or 0.6 total mg per dose
- Dose frequency: once per day
- Initial clinical status: subject is clinically stable when administered the first dose
- Timing qualifier: in multiple claims, the subject has been clinically stable for at least 6 months prior to first dose
- Treatment duration: 24 to 44 months in multiple claims
- Patient pathway qualifiers: optional prior PTCA; history or presence of stable coronary artery disease
- Event targets: myocardial infarction, non-cardio-embolic ischemic stroke, acute coronary syndrome, out-of-hospital cardiac arrest, and noncardioembolic ischemic stroke
- Combination scope: optional co-administration of a second agent, specifically a colchicine-compatible statin, with a closed list of statins
This structure creates a scope that is simultaneously:
- dose-specific (tight mg ceiling and defined daily regimen),
- indication-specific (cardiovascular event types),
- condition-specific (stable CAD and/or post-PTCA and/or 6-month clinical stability),
- combination-variable (allowed with specified “compatible” statins).
What exactly do the claims cover? (Independent claim themes)
Independent claim 1 (method without PTCA element)
Claim 1 is a method for treating/reducing risk of a cardiovascular event by:
- Administering first dose of tablet or liquid composition containing ≤ about 0.5 or 0.6 total mg colchicine or salt, or combination.
- Administering additional doses once per day.
- Where the subject is clinically stable when administered the first dose.
It is then expanded by dependent claims 2–11.
Dependent claim expansions in the 1xx chain:
- PTCA pathway: Claim 2
- 6-month stability: Claim 3
- Stable coronary artery disease: Claim 4
- Event types: Claims 5–7
- Combination: Claims 8–10
- Co-administer with a “second agent” for treatment/risk reduction.
- If that second agent is a colchicine-compatible statin, it is limited to:
- atorvastatin, fluvastatin, lovastatin, pitavastatin, rosuvastatin, simvastatin, pravastatin,
- and salts of any of these,
- including combinations.
- Duration: Claim 11 (24–44 months)
Independent claim 12 (method with PTCA element)
Claim 12 requires:
- Applying PTCA treatment to the subject (step (a))
- Then the same colchicine dosing scheme (steps (b) and (c)):
- first dose tablet or liquid with ≤ about 0.5 or 0.6 mg total colchicine/salt
- then once daily additional doses
- with the subject clinically stable at first dose
Dependent claims 13–21 mirror claim 1’s dependent structure:
- 6-month stability: Claim 13
- Stable coronary artery disease: Claim 14
- Event types: Claims 15–17
- Combination with colchicine-compatible statin: Claims 18–20
- Duration: Claim 21 (24–44 months)
Independent claim 22 (once-daily plus duration and stability timing)
Claim 22 narrows scope further by adding explicit regimen boundaries:
- Composition in tablet or liquid form with ≤ about 0.5 or 0.6 mg
- Administered only once per day and no more than once per day
- Treatment duration: 24 to 44 months
- Subject is clinically stable for at least six months prior to first dose
Dependent claims 23–30 then add:
- PTCA: Claim 23
- Stable CAD history: Claim 24
- Event types: Claims 25–27
- Combination with colchicine-compatible statin: Claims 28–30 (statin list is the same as above)
What are the claim boundaries that create enforceable “slices”?
1) Dose cap slice (0.5 vs 0.6 mg)
The claims repeatedly use:
- “no more than about 0.5 or 0.6 total mg” colchicine or salts
This is an enforceable dosage ceiling. Scope does not extend (as written) to higher per-day colchicine amounts.
2) Regimen slice (once per day only)
- Independent 1: “following thereafter administering additional doses … once per day”
- Independent 22 explicitly adds “only once per day and no more than once per day”
This blocks multi-daily dosing strategies even if dose stays under 0.5–0.6 mg.
3) Stability slice (clinical stability at first dose; optional 6-month duration)
- Claim 1/12: clinical stability at time of first dose
- Claim 3/13/22: clinical stability for at least six months prior to first dose
This creates a “timing/eligibility” fence. A regimen applied to unstable patients at initiation falls outside these dependent and independent formulations.
4) Procedure slice (PTCA)
- Claims 2 and 23 include a prior PTCA requirement
- Claim 12 includes PTCA in the independent definition
This supports a differentiated enforcement strategy: PTCA-treated patients are harder targets for competitors to design around if they follow post-PTCA stabilization workflows.
5) Combination slice (colchicine-compatible statins only)
Claims 8/18/28 allow “co-administering” a second agent, but dependent claims lock the statin universe to a defined list:
- atorvastatin, fluvastatin, lovastatin, pitavastatin, rosuvastatin, simvastatin, pravastatin
- plus salts and combinations
This is a clear constraint: non-statin agents or non-listed statins are outside these dependent combinations (as claimed).
How broad is the cardiovascular event coverage?
The claims cover multiple event categories, with overlapping phrasing:
| Claim family |
Cardiovascular event types explicitly included |
| Claims 1–7 and 12–17 (event-dependent) |
Myocardial infarction (5, 15, 25) ; Non-cardio-embolic ischemic stroke (6, 16, 26) ; Acute coronary syndrome, out-of-hospital cardiac arrest, or noncardioembolic ischemic stroke (7, 17, 27) |
Practical implication for scope: the patent targets both coronary and ischemic stroke outcomes, plus a composite acute risk set.
What is the landscape shape created by these claims?
Given claim structure, the patent supports three main competitive “landscape lanes”:
Lane A: Low-dose colchicine once daily with clinical stability at initiation
- If a competitor sells a colchicine regimen below the cap (≤ 0.5/0.6 mg), administered once daily, and targets the claimed event types, it sits near the heart of Claim 1/12 scope.
- The “clinically stable when administered the first dose” qualifier can still matter operationally in labeling, protocol language, and trial inclusion criteria.
Lane B: Post-PTCA stabilized initiation
- Claim 12 and dependent claims 2/23 impose an additional procedural predicate.
- This can be a meaningful differentiator for competitor designs that target broader populations without a PTCA predicate.
Lane C: Combination strategy with colchicine-compatible statins
- Claims 8/18/28 allow combination; dependent claims 9/19/29 constrain the statin set to specific agents and salts.
- Competitors aiming to combine colchicine with cardiovascular background therapy must map their statin selection against the enumerated list to avoid stepping outside these combination-dependent claims.
Claim-by-claim scope map (what each claim adds)
Claims 1–11
- Core regimen: ≤0.5/0.6 mg colchicine/salt, once daily, clinically stable at first dose, treating/reducing risk of cardiovascular events.
- Adds prior PTCA.
- Adds ≥6 months clinical stability before first dose.
- Adds stable coronary artery disease (has/history).
- Sets event: myocardial infarction.
- Sets event: non-cardio-embolic ischemic stroke.
- Sets event: acute coronary syndrome / out-of-hospital cardiac arrest / noncardioembolic ischemic stroke.
- Adds co-administration of a second agent.
- Constrains second agent: must be colchicine-compatible statin.
- Constrains statin: atorvastatin, fluvastatin, lovastatin, pitavastatin, rosuvastatin, simvastatin, pravastatin, plus salts and combinations.
- Adds duration: 24–44 months once-daily dosing.
Claims 12–21
- Independent: includes PTCA plus core colchicine dosing/regimen/stability framework.
- Adds ≥6 months clinical stability.
- Adds stable coronary artery disease.
- Event: myocardial infarction.
- Event: non-cardio-embolic ischemic stroke.
- Event: acute coronary syndrome / out-of-hospital cardiac arrest / noncardioembolic ischemic stroke.
- Adds co-administration of a second agent.
- Constrains second agent: colchicine-compatible statin.
- Constrains statin list and salts.
- Adds duration: 24–44 months.
Claims 22–30
- Independent: colchicine composition dose cap plus strict regimen:
- once per day only
- no more than once per day
- 24–44 months
- clinically stable for ≥6 months prior to first dose
- Adds prior PTCA.
- Adds stable coronary artery disease.
- Event: myocardial infarction.
- Event: non-cardio-embolic ischemic stroke.
- Event: acute coronary syndrome / out-of-hospital cardiac arrest / noncardioembolic ischemic stroke.
- Adds co-administering a second agent.
- Constrains second agent: colchicine-compatible statin.
- Constrains statin list and salts (same universe as earlier).
Patent landscape implications (based strictly on the claim text provided)
Because this is a method patent with specific dosing and eligibility predicates, the landscape pressure concentrates on:
-
Colchicine dosing strategies
- Any protocol aiming to reduce cardiovascular events using colchicine must keep within the claimed dose ceiling (≤0.5/0.6 mg) and once-daily regimen to stay outside the claim core.
-
Patient selection and initiation timing
- The patent’s “clinically stable” language gives it practical control through enrollment criteria, label language, and prescriber protocols. The “≥6 months stable” qualifier in multiple claims adds a second gate.
-
Post-PTCA pathways
- PTCA is explicitly claimed as a qualifying step in multiple claims. Competitors pursuing post-angioplasty secondary prevention protocols may fall into Claim 12/2/23 territory.
-
Combination therapy with statins
- If colchicine is paired with a statin outside the enumerated list, the dependent combination claims are easier to distinguish. If paired with an enumerated statin, combination-dependent claim coverage is structurally harder to avoid.
What would be “in” vs “out” on the key design variables? (Actionable claim navigation)
More likely “in”
- Colchicine or colchicine salts at ≤ about 0.5/0.6 mg total per day
- Once-daily dosing
- Initiation only when subject is clinically stable (and in narrower formulations, stable for ≥6 months)
- Targeting MI, non-cardioembolic ischemic stroke, or ACS/out-of-hospital cardiac arrest
- Protocols including post-PTCA and/or stable CAD
- Combination with one of the listed statins (including their salts)
More likely “out” (relative to this claim set)
- Higher daily colchicine exposure above the claimed cap
- Multiple daily dosing schedules
- Initiation during clinical instability at first dose (for Claim 1/12) or without the ≥6 months stable predicate (for Claim 3/13/22)
- Event targets outside the claimed cardiovascular event set
- Co-administration with statins outside the enumerated list (for dependent combination claims)
Key Takeaways
- Core scope is a once-daily low-dose colchicine regimen: ≤ about 0.5 or 0.6 mg total colchicine (or salt) in tablet/liquid form, administered when the subject is clinically stable.
- Independent coverage is available both without PTCA (Claim 1) and with PTCA as a required step (Claim 12); the narrowest independent regimen also requires ≥6 months clinical stability and 24 to 44 months duration (Claim 22).
- The patent covers cardiovascular outcomes including myocardial infarction, non-cardio-embolic ischemic stroke, and a composite set of acute coronary syndrome and out-of-hospital cardiac arrest plus noncardioembolic ischemic stroke.
- Combination scope is controllable through “colchicine-compatible statin” dependent claims, with a closed list of statins: atorvastatin, fluvastatin, lovastatin, pitavastatin, rosuvastatin, simvastatin, pravastatin and salts.
FAQs
1) Does the patent claim colchicine tablets and liquids?
Yes. The claims specify the composition is in tablet form or liquid form.
2) What daily colchicine amount triggers the key limitation?
The claims cap colchicine at no more than about 0.5 or 0.6 total mg per first dose and the subsequent once-daily dosing regime.
3) Is PTCA required for all claims?
No. Claim 12 includes PTCA as a required step; Claim 1 does not. Other claims add PTCA as dependent limitations.
4) What statins are covered for the colchicine-compatible combination claims?
The dependent claims list atorvastatin, fluvastatin, lovastatin, pitavastatin, rosuvastatin, simvastatin, pravastatin, including salts and combinations.
5) What is the narrowest regimen requirement on timing and duration?
Claim 22 requires: clinically stable for at least six months before the first dose, with dosing once per day for 24 to 44 months.
References
[No external sources were used; analysis is based solely on the claim text provided in the prompt.]
