Details for Patent: 9,744,144

Which drugs does patent 9,744,144 protect, and when does it expire?

Patent 9,744,144 protects LODOCO and is included in one NDA.

This patent has forty patent family members in twenty-four countries.

Summary for Patent: 9,744,144

Title:	Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent
Abstract:	Methods of treating and/or preventing a cardiovascular event in a patient, the method comprising orally administering a colchicine to a patient who is receiving concurrent treatment with at least one antiplatelet agent, thereby treating and/or preventing the cardiovascular event in the patient are provided.
Inventor(s):	Mark Nidorf
Assignee:	Murray and Poole Enterprises Ltd
Application Number:	US14/603,049
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Dosage form;

Scope and Claims Assessment for US Patent 9,744,144 (Colchicine + Antiplatelet Once-Daily to Reduce Cardiovascular Events)
US 9,744,144 claims a once-per-day method using a colchicine composition (0.5 mg or 0.6 mg embodiments) administered to patients receiving concurrent antiplatelet therapy, with target cardiovascular endpoints limited to acute coronary syndrome (ACS), out-of-hospital cardiac arrest, or noncardioembolic ischemic stroke. The claim set also covers broad antiplatelet classes (and specific named agents), broad administration routes/formats, and limited combination expansion via a second agent (including colchicine-compatible statins). The estate’s enforceable core is tight on (1) the colchicine + antiplatelet concurrency, (2) specific cardiovascular event types, and (3) dosing frequency (once daily) with dose-strength embodiments (0.5 mg/0.6 mg).

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US Patent 9,744,144: What does the patent claim and what is the practical claim scope?

Short answer: The independent claim is a method claim that requires all of: colchicine (or salt), concurrent antiplatelet treatment, once-per-day administration, and an endpoint category (ACS, out-of-hospital cardiac arrest, or noncardioembolic ischemic stroke).

Independent claim 1 scope (core elements)

Claim 1 is an actionable method-of-treatment and/or risk-reduction claim with these limiting features:

1. Therapeutic agent: “a composition comprising an effective amount of (i) colchicine, (ii) a salt of (i), or any combination of (i)-(ii).”
2. Clinical setting: patient is receiving concurrent treatment with at least one antiplatelet agent.
3. Indication endpoints (strictly enumerated):
   • acute coronary syndrome (ACS)
   • out-of-hospital cardiac arrest
   • noncardioembolic ischemic stroke
4. Dosing cadence: composition administered once per day.
5. Claim purpose: “thereby treating and/or reducing the risk of the cardiovascular event.”

Dependent claim architecture (what narrows vs expands)

Dependent claims mostly narrow by adding patient subgroup, dose, antiplatelet list, and/or specific administration details:

• Claims 2-3: patient has coronary disease, limited further to clinically stable coronary disease.
• Claims 4, 7-8: antiplatelet specification. Claim 4 anchors aspirin specifically. Claim 7 lists antiplatelet classes; Claim 8 lists representative drugs within those classes.
• Claims 5-6: dosing embodiments at ~0.6 mg and ~0.5 mg colchicine.
• Claim 9: pharmaceutically acceptable carrier (typical format support; method claims often treat this as non-limiting unless it drives dosage form).
• Claim 10-12: add a second agent; Claim 11 narrows to “colchicine-compatible statin,” with representative statins in Claim 12.
• Claims 13-14: broad route and dosage form/vehicle language.
• Claims 15-18: second independent-style claim (claim 15) with explicit ~0.6 mg colchicine and the same endpoint and antiplatelet concurrency concept.

Claim 15 vs claim 1 (what changes)

Claim 15 is narrower than claim 1 because it requires:

• colchicine composition with about 0.6 mg colchicine (or salt/combination), plus
• concurrent antiplatelet therapy,
• same endpoint categories,
• same once-per-day framing is not repeated in the snippet but claim 15 mirrors the same risk/endpoint framing.

In enforcement, claim 15 is the “dose-anchor” that may be more directly mapped to trial regimens and commercial strengths.

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How do the claims limit the method: what counts as “concurrent antiplatelet agent” and “once per day”?

Short answer: The concurrency requirement is categorical (“receiving concurrent treatment”), and the dosing frequency is categorical (“once per day”), both of which are usually straightforward for fact patterns based on prescribing and administration records.

Concurrency requirement practical meaning

Claim 1 requires that, at the time the colchicine composition is administered, the patient is “receiving concurrent treatment with at least one antiplatelet agent.” The claim text does not specify duration, loading, or agent selection within concurrency. That creates two key enforcement consequences:

• Broad entry risk: any combination product or co-prescribed regimen that includes colchicine administered once daily while the patient is on aspirin or another antiplatelet within the claim’s list could read on the claim if the patient meets the endpoint definition.
• Design-around via antiplatelet substitution is possible only if the regimen omits all “antiplatelet agents” or uses an agent outside the claim’s implicit definition. The claim’s dependent list is extensive, but it does not define “antiplatelet agent” as a closed set in claim 1.

Once-per-day dosing requirement

The once-per-day limitation is a strong method constraint. If a competitor uses twice-daily colchicine or non-daily schedules, it may avoid the specific cadence limitation, depending on whether “once per day” is interpreted strictly or as covering equivalent total daily dosing regimens.

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What cardiovascular events are covered: ACS, out-of-hospital cardiac arrest, or noncardioembolic ischemic stroke?

Short answer: These three endpoints are the only cardiovascular event types enumerated in the claims you provided, so they define the claim’s clinical scope.

Covered endpoints (strict enumeration)

• Acute Coronary Syndrome (ACS)
• Out-of-hospital Cardiac Arrest
• Noncardioembolic Ischemic Stroke

What is not explicitly covered

Your claim set does not list other high-frequency cardiovascular outcomes such as:

• myocardial infarction (as a standalone label)
• stable angina
• venous thromboembolism
• cardioembolic stroke
• transient ischemic attack
• coronary revascularization endpoints
  In litigation, competitors often exploit such omissions by repositioning efficacy claims and patient selection. However, because claim 1 is a method “treating and/or reducing the risk of” the specified events, factual mapping to those endpoints becomes central.

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What antiplatelet drugs and classes are within scope under US 9,744,144?

Short answer: Claim 1 requires at least one antiplatelet agent, while claims 4 and 7-8 add explicit examples and drug-name coverage.

Claim 4: aspirin

• Antiplatelet agent is aspirin.

This creates clear coverage for standard secondary prevention cohorts.

Claim 7: antiplatelet classes

Claim 7 covers, at minimum, the following classes as “antiplatelet agent” examples:

• irreversible cyclooxygenase inhibitor
• ADP receptor inhibitor
• phosphodiesterase inhibitor
• PAR-1 antagonist
• glycoprotein IIB/IIIA inhibitor
• adenosine reuptake inhibitor
• thromboxane inhibitor
• thromboxane receptor antagonist

Claim 8: named representatives

Claim 8 provides explicit representative agents:

• Irreversible COX inhibitor: aspirin and/or triflusal
• ADP receptor inhibitor: clopidogrel, prasugrel, ticagrelor, ticlopidine (and combinations)
• PDE inhibitor: cilostazol
• PAR-1 antagonist: vorapaxar
• GPIIb/IIIa inhibitor: abciximab, eptifibatide, tirofiban
• Adenosine reuptake inhibitor: dipyridamole
• Thromboxane inhibitor: terutroban

Scope implication: Even if a challenger argues “antiplatelet agent” should be limited, the dependent claims supply a large set of named drugs. That tends to limit room for narrow interpretation without contradicting dependent-claim examples.

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What colchicine dose embodiments are claimed: 0.5 mg vs 0.6 mg?

Short answer: The patent includes method embodiments reciting about 0.5 mg and about 0.6 mg, plus an independent-style claim requiring about 0.6 mg.

Dose-limited dependent claims

• Claim 5: colchicine included at about 0.6 mg
• Claim 6: colchicine included at about 0.5 mg

Dose-anchored claim 15

• Claim 15 requires a composition comprising about 0.6 mg colchicine.

Enforcement consequence

Dose-specific claims are often the easiest to map against commercial tablets (strengths and dosing regimens). If a generic or competitor launches a formulation at a different strength or uses a different effective daily dose, they may avoid specific dose-dependent claims while still risking read-on to the broader “effective amount” language in claim 1.

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What formulation/administration scope exists: oral tablets to intracranial and topical routes?

Short answer: The method claim includes extremely broad route and dosage-form language, covering oral and a wide range of non-oral administrations.

Routes in claim 13

Claim 13 lists:

• oral
• topical
• parenteral
• ophthalmically
• intraventricularly
• intracranially
• intraperitoneally
• buccally
• rectally
• vaginally
• intranasally
• by aerosol administration and/or inhalation spray

Dosage forms in claim 14

Claim 14 lists:

• tablet
• capsule
• liquid dose
• gel
• powder

Scope implication: From a claim construction perspective, this reduces design-around leverage based on route or dosage form. A competitor would need to change the concurrency, event endpoints, dosing frequency, or antiplatelet pairing rather than the delivery system.

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How does the patent handle combination therapy: second agent and colchicine-compatible statins?

Short answer: The patent supports combination therapy through a second-agent dependent pathway, with explicit coverage for “colchicine-compatible statin” agents.

Claim 10: second agent co-administration

Claim 10 adds a second agent for treating and/or reducing risk of the same cardiovascular event categories.

Claim 11-12: statins as second agent

• Claim 11: second agent is a colchicine-compatible statin
• Claim 12: statin examples: atorvastatin, fluvastatin, lovastatin, pitavastatin, rosuvastatin, simvastatin, pravastatin, salts, or combinations.

Design-around implication: If a competitor’s regimen uses statins that are argued not “colchicine-compatible” in a clinical-pharmacology sense, they still face mapping risk because the dependent language is broad (“compatible” is not tightly defined in your excerpt). A generic labeling change may not avoid literal read if the regimen in practice includes statin therapy.

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What makes this estate vulnerable or strong: how to assess validity and enforceability risk from claim structure

Short answer: The claim set is strong on factual mapping levers (dosing frequency, concurrency, event types). It is vulnerable where competitors can decouple at least one limiting feature.

Enforceability strengths (mapping clarity)

• Endpoint categories are enumerated: litigation can focus on whether the treated/risk-reduced event is one of the three categories.
• Concurrency is categorical: antiplatelet use is generally documented in secondary prevention.
• Once-daily is categorical: dosing schedule is often traceable through labels and patient adherence.

Potential weak points for a challenger (conceptual)

• Method claim breadth depends on the definition of “antiplatelet agent.” Dependent claims provide examples, but claim 1 uses broader language. Still, if a challenger can persuade the fact finder that a particular regimen is not “antiplatelet” or does not meet “concurrent treatment,” that can avoid literal infringement.
• Route/dosage breadth is expansive, which can support infringement but can also increase prior-art search breadth for validity if the core concept is already known for colchicine plus standard antiplatelet therapy in cardiovascular indications.

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What generic entry risks exist for colchicine once-daily regimens paired with antiplatelets?

Short answer: The biggest risk is not the formulation itself but the prescribing and treatment pattern: once-daily colchicine concurrently with antiplatelet therapy in cohorts where the target outcomes align with ACS, out-of-hospital cardiac arrest, or noncardioembolic ischemic stroke.

Scenario mapping to claim elements

A generic manufacturer’s exposure rises when:

• its product is prescribed once per day,
• patients are on aspirin and/or other antiplatelets covered by claim examples,
• promotional or clinical use targets the enumerated cardiovascular endpoints.

Scenario mapping where risk reduces

Risk decreases when:

• the dosing cadence is not once daily,
• the regimen does not involve antiplatelet concurrency,
• the clinical objective is outside the enumerated endpoint categories, even if secondary benefits overlap.

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What patent-landscape work typically follows from a method claim like this (scope/claims to landscape)?

Short answer: The landscape is usually built around (1) other colchicine patents tied to cardiovascular risk reduction, (2) colchicine dosage forms and strengths, and (3) related method-of-treatment claims that differ by endpoint, dosing cadence, or combination partner.

Given only the claim text you provided for US 9,744,144, this section is limited to actionable landscape dimensions implied by the claim elements:

Landscape vectors likely to matter

• Different dosing frequencies (BID vs once daily)
• Different dose strengths (0.5 mg vs 0.6 mg vs other totals)
• Endpoint variations (MI, revascularization, cardioembolic stroke)
• Antiplatelet concurrency variants (single agent vs dual antiplatelet therapy; excluding certain agents)
• Combination therapy boundaries (statins only vs other background therapies)

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Key Takeaways

• US 9,744,144 is a method claim anchored to colchicine (or salt) given once daily to patients on concurrent antiplatelet therapy with endpoints restricted to ACS, out-of-hospital cardiac arrest, or noncardioembolic ischemic stroke.
• The most “literal mapping” claims are the dose embodiments: about 0.6 mg (including claim 15) and about 0.5 mg.
• Antiplatelet scope is broad in claim 1 and reinforced by extensive dependent examples in claims 4 and 7-8, including aspirin, P2Y12 inhibitors, PAR-1 antagonist, and GPIIb/IIIa inhibitors.
• Route and dosage form are expansive, making delivery-system design-arounds less effective than adjusting the concurrency, dose, dosing cadence, or endpoint framing.

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FAQs

1) Does US 9,744,144 cover colchicine without an antiplatelet drug?
Claim 1 requires the patient to be receiving at least one antiplatelet agent concurrently.

2) Is the antiplatelet limited to aspirin in the independent claim?
No. Claim 1 requires at least one antiplatelet agent; aspirin is specifically covered in dependent claim 4 and other agents are covered in dependent claims 7-8.

3) Can a competitor avoid the patent by changing the dosage form (e.g., capsule vs tablet)?
The claims broadly cover tablet, capsule, liquid dose, gel, and powder, and include many routes, so changing dosage form alone is unlikely to avoid literal scope.

4) Are only once-daily regimens covered?
Yes for claim 1’s independent limitation: composition administered once per day.

5) Does the patent require a specific statin to be used?
Not in the independent claim. Statins appear only in the dependent combination path (claims 10-12) as “colchicine-compatible” statins with listed representative agents.

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References

No sources were provided or cited for US 9,744,144 beyond the claim text included in the prompt.

Drugs Protected by US Patent 9,744,144

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Agepha Pharma Fz	LODOCO	colchicine	TABLET;ORAL	215727-001	Jun 16, 2023		RX	Yes	Yes						METHOD OF TREATING AND/OR REDUCING THE RISK OF A CARDIOVASCULAR EVENT

International Family Members for US Patent 9,744,144

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013337605
Australia	2018203715
Australia	2019232879