US Patent 11,364,260 Landscape: Scope and Claims for Iron Carbohydrate Complex Methods in Heart Failure and Cardiomyopathy
US Patent 11,364,260 claims specific method-of-treatment regimens using an intravenous iron carbohydrate complex, with dosage unit elemental iron thresholds (≥0.6 g; also ≥1.0 g), infusion rate and concentration windows, and tight compositional parameters for a named polynuclear iron(III)-hydroxide–glucopyranosyl complex. The estate also contains claim structure that captures broader “iron carbohydrate complex” selections (carboxymaltose, mannitol, polymaltose, gluconate, sorbitol) while layering immunogenicity and anti-dextran cross-reactivity limitations. The practical effect is a dual-layer protection strategy: (1) a composition-anchored technical claim set and (2) a disease-anchored, immunogenicity-limited method claim set for congestive heart failure/cardiomyopathy contexts and related iron deficiency/dysfunctional iron metabolism phenotypes.
What is the claimed invention in US Patent 11,364,260?
Core claim theme: treating iron deficiency or dysfunctional iron metabolism in humans with cardiac indications (congestive heart failure and cardiomyopathy) via administration of an iron carbohydrate complex in a single dosage unit containing at least ~0.6 grams elemental iron, including specific embodiments tied to infusion parameters and to a particular polynuclear iron(III)-hydroxide–glucopyranosyl complex.
How do the claims define the therapeutic target?
The independent method claim (claim 1) targets:
- “iron deficiency or dysfunctional iron metabolism associated with congestive heart failure.”
Dependent claim 22 narrows “iron deficiency” to iron deficiency anemia.
Independent method claim (claim 23) is the cardiomyopathy analog:
- “iron deficiency or dysfunctional iron metabolism associated with cardiomyopathy.”
Dependent claim 33 narrows “iron deficiency” to iron deficiency anemia.
Independent “disease characterized by iron deficiency or dysfunctional iron metabolism resulting in reduced bioavailability of dietary iron” appears in claims 34 and 37, and it is then explicitly anchored to:
- cardiomyopathy (claim 34)
- congestive heart failure (claim 37)
How do the claims define the drug substance?
Claim 1 (and the congestive heart failure route) is directed to:
- “an iron carbohydrate complex in a single dosage unit of at least about 0.6 grams of elemental iron.”
Claim 8 then hard-codes a specific complex:
- polynuclear iron(III)-hydroxide 4(R)-(poly-(1→4)-O-α-D-glucopyranosyl)-oxy-2(R),3(R),5(R),6-tetrahydroxy-hexanoate with additional numeric constraints (molecular weight, % iron, % carbohydrate, core size, particle size).
Claim 34/37 are broader and define the complex “selected from the group consisting of”:
- iron carboxymaltose complex
- iron mannitol complex
- iron polymaltose complex
- iron gluconate complex
- iron sorbitol complex
Those broader claims also impose:
- “substantially non-immunogenic carbohydrate component”
- “substantially no cross reactivity with anti-dextran antibodies”
They further exclude a specific unrelated condition:
- “wherein the disease, disorder or condition is not Restless Leg Syndrome” (claims 35 and 38)
What dosing concepts are protected?
The claims repeatedly anchor protection to single-dose-unit elemental iron thresholds and parenteral administration:
- At least about 0.6 g elemental iron (claims 1, 23, 34, 37)
- At least 0.7 g elemental iron (claim 7)
- At least 1.0 g elemental iron (claims 19, 29, 36, 39)
Administration modality is also claimed:
- infusion (claim 4) and intravenous (claims 20, 31)
- parenteral (claims 21, 32)
- infusion timing ≤ 15 minutes (claims 17–18 in one chain)
The technical infusion parameters are protected:
- rate about 100 mg elemental iron per minute (claim 3)
- concentration about 2 mg to 4 mg elemental iron per ml (claim 5)
- rate about 12.5 to 25 ml/min (claim 6)
What biological response metrics are claimed?
The claims require or define response endpoints only in dependent claims:
- increase in hemoglobin versus baseline (claim 2)
- increase in transferrin saturation (TSAT) versus baseline (claim 18)
How broad are the claims: method, composition-defined, or immunogenicity-limited?
The estate is layered and not uniformly broad. It includes a narrow, composition-characterized embodiment (polynuclear iron(III)-hydroxide–glucopyranosyl complex) and broader method claims that use a genus definition (“selected from the group consisting of…”), then narrow via immunogenicity and dextran cross-reactivity.
A. Composition-and-structure-limited claims (narrower)
The most structurally constrained chain is claim 8 plus its descendants:
- specific polynuclear iron(III)-hydroxide–glucopyranosyl complex
- molecular weight 100,000–350,000 daltons (claim 9)
- elemental iron 24%–32% (claim 10)
- carbohydrate 25%–50% (claim 11)
- pH 5.0–7.0 (claim 12)
- physiological osmolarity (claim 13)
- mean iron core size ≥1 nm and ≤9 nm (claim 14)
- mean diameter particle size ≤35 nm (claim 15)
- and a specific embodiment: about 150,000 daltons, 28% iron, 37% carbohydrate (claim 16)
These are not generic “iron carbohydrate complexes.” They target a specific physicochemical envelope plus formulation conditions.
B. Modality and regimen-limited claims (intermediate breadth)
- infusion-based administration
- infusion time ≤ 15 minutes
- infusion rate and concentration windows
- single-dose elemental iron thresholds
These can capture multiple iron carbohydrate products if the regimen parameters and elemental iron amounts match.
C. Genus + immunogenicity constraints (strategic breadth with a quality gate)
Claims 34 and 37 claim a genus of iron carbohydrate complexes (listed) but then enforce:
- “substantially non-immunogenic carbohydrate component”
- “substantially no cross reactivity with anti-dextran antibodies”
That combination is designed to:
- allow defendants to argue that their carbohydrate moiety immunogenicity/cross-reactivity profile does not meet the “substantially” language; and
- prevent treating the broader genus as unconstrained.
Disease scope exclusions
Claims 35 and 38 exclude Restless Leg Syndrome, which narrows potential off-label claim arguments tied to that indication.
Claim chart style: what each claim adds beyond claim 1 (congestive heart failure)
Base method claim
- Claim 1: Treat iron deficiency/dysfunctional iron metabolism associated with congestive heart failure using an iron carbohydrate complex in a single dosage unit containing ≥0.6 g elemental iron.
Dependent claim increments
- Claim 2: Hemoglobin increases vs pre-treatment.
- Claim 3: Administration rate about 100 mg elemental iron/min.
- Claim 4: Infusion.
- Claim 5: Concentration 2–4 mg elemental iron/ml.
- Claim 6: Rate 12.5–25 ml/min.
- Claim 7: Single dosage unit contains ≥0.7 g elemental iron.
- Claim 8: Iron carbohydrate complex is the named polynuclear iron(III)-hydroxide–glucopyranosyl complex.
- Claim 9: Molecular weight 100,000–350,000 Da.
- Claim 10: Iron content 24%–32%.
- Claim 11: Carbohydrate 25%–50%.
- Claim 12: pH 5.0–7.0.
- Claim 13: Physiological osmolarity.
- Claim 14: Iron core size 1–9 nm.
- Claim 15: Particle diameter ≤35 nm.
- Claim 16: Specific embodiment (150k Da; 28% iron; 37% carbohydrate).
- Claim 17: Administered in ≤15 minutes.
- Claim 18: TSAT increases vs baseline.
- Claim 19: Single dosage unit contains ≥1.0 g elemental iron.
- Claim 20: Administered intravenously.
- Claim 21: Administered parenterally.
- Claim 22: Iron deficiency is iron deficiency anemia.
Practical read
The congestive heart failure claim set is both:
- regimen-protective (elemental iron dose per unit, infusion speed, concentration, duration), and
- material-protective (explicit complex identity and physicochemical constraints).
How do the cardiomyopathy claims compare (claims 23–33)?
Cardiomyopathy claims track congestive heart failure claims with parallel structure.
Base method
- Claim 23: Treat iron deficiency/dysfunctional iron metabolism associated with cardiomyopathy using iron carbohydrate complex single dose unit containing ≥0.6 g elemental iron.
Dependent additions
- Claim 24–28: Lock in the same named polynuclear iron(III)-hydroxide–glucopyranosyl complex with the same numeric constraints (molecular weight, iron %, carbohydrate %, and specific embodiment).
- Claim 29: Single dosage unit ≥1.0 g elemental iron.
- Claim 30: pH 5.0–7.0.
- Claim 31: Intravenous.
- Claim 32: Parenteral.
- Claim 33: Iron deficiency is iron deficiency anemia.
Practical read
Cardiomyopathy is protected by a mirror claim strategy. Any challenge or design-around that addresses “congestive heart failure” dosing/device/regimen features will likely propagate to cardiomyopathy unless the accused regimen differs between those indications.
What is the broad “selected from group” protection and what is excluded? (claims 34–39)
Claims 34 and 37 shift from the named complex to a group selection of iron carbohydrate complexes, then use immunologic gating and indication exclusions.
Claims 34 (cardiomyopathy) and 37 (congestive heart failure)
Each includes:
- disease characterized by iron deficiency/dysfunctional iron metabolism with reduced bioavailability of dietary iron
- administration to a human in need thereof
- single dosage unit ≥0.6 g elemental iron
- complex is selected from:
- iron carboxymaltose
- iron mannitol
- iron polymaltose
- iron gluconate
- iron sorbitol
- carbohydrate component is “substantially non-immunogenic”
- carbohydrate has “substantially no cross reactivity with anti-dextran antibodies”
- indication: cardiomyopathy (claim 34) or congestive heart failure (claim 37)
Exclusions
- Claim 35: not Restless Leg Syndrome (cardiomyopathy chain)
- Claim 38: not Restless Leg Syndrome (congestive heart failure chain)
Dose floor
- Claim 36: single dosage unit ≥1.0 g elemental iron (for cardiomyopathy chain)
- Claim 39: single dosage unit ≥1.0 g elemental iron (for congestive heart failure chain)
Practical read
This portion is designed to capture product classes beyond the specific named complex, but it is constrained by immunogenicity and anti-dextran cross-reactivity limitations, which will be litigable facts if asserted.
What US patent claims are likely “at risk” given the structure?
Based on the claim text provided, risk concentrates in three scenarios:
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IV iron carbohydrate treatments in congestive heart failure/cardiomyopathy where dosing uses large single infusion units (≥0.6 g elemental iron, and potentially ≥1.0 g) and where infusion time and rate fall within the claimed windows (≤15 minutes; ~100 mg/min; 2–4 mg/ml; 12.5–25 ml/min).
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Use of a named polynuclear iron(III)-hydroxide–glucopyranosyl complex with matching:
- molecular weight and composition percentages
- iron core and particle size constraints
- formulation parameters (pH 5.0–7.0; physiological osmolarity)
-
Brand-to-generic or brand-to-brand substitution that uses one of the listed “iron carbohydrate complex” classes but with an immunogenicity profile argued to meet:
- “substantially non-immunogenic carbohydrate component”
- “substantially no cross reactivity with anti-dextran antibodies”
What does the claim strategy imply for defendant design-arounds?
From an infringement-avoidance perspective, the claim set provides multiple levers:
- Lower single-unit elemental iron dose below the thresholds (particularly <0.6 g and/or <1.0 g), if clinically acceptable.
- Alter infusion regimen outside the explicit rate/concentration windows (claim 3/5/6) and/or move treatment duration above 15 minutes (claim 17).
- Use an iron carbohydrate complex not in the listed group for claims 34/37, or one with carbohydrate immunogenicity/cross-reactivity evidence that does not satisfy the “substantially” limitations.
- Avoid the named polynuclear iron(III)-hydroxide–glucopyranosyl complex and its physicochemical envelope (claims 8–16), including pH and osmolarity if those are linked to the formulation and administration.
How should this patent be positioned against the broader iron carbohydrate patent ecosystem?
11,364,260 is method-of-use and regimen-centric with an explicit tied composition embodiment. It is not drafted as a platform claim to all iron carbohydrate compositions; it is drafted to constrain:
- target patient phenotype tied to congestive heart failure/cardiomyopathy and dysfunctional iron metabolism,
- IV delivery mechanics and elemental iron dosing per unit,
- and, in key dependent claims, a specific iron-carbohydrate physicochemical construct with detailed parameters.
This drafting pattern typically coexists with:
- composition patents covering manufacturing and physicochemical specifications,
- additional method-of-use patents covering alternative dosing strategies or response endpoints,
- and new formulation patents that tweak pH/osmolarity, particle size, or infusion rates.
For infringement and licensing, the most actionable question is not “does the product contain an iron carbohydrate complex,” but:
- whether the specific dose per single unit and infusion mechanics match the claim windows; and
- whether, if the product is the named polynuclear complex, its measured core size, particle diameter, iron %, carbohydrate %, and molecular weight align with the claimed ranges.
Key Takeaways
- US Patent 11,364,260 protects IV iron carbohydrate complex regimens for iron deficiency/dysfunctional iron metabolism tied to congestive heart failure and cardiomyopathy.
- The strongest literal hooks are single-dose-unit elemental iron thresholds (≥0.6 g; also ≥0.7 g; also ≥1.0 g) paired with infusion-specific limitations (≤15 minutes; ~100 mg/min; 2–4 mg/ml; 12.5–25 ml/min).
- The claim set contains a highly specific composition-defined embodiment for a polynuclear iron(III)-hydroxide–glucopyranosyl complex with detailed physicochemical and formulation constraints (molecular weight, iron%, carbohydrate%, core size, particle size, pH, osmolarity).
- Broader coverage in claims 34 and 37 is constrained by immunogenicity and anti-dextran cross-reactivity limitations and by excluding Restless Leg Syndrome.
- Design-arounds are most plausible by changing single-unit elemental dose, moving infusion rate/concentration/duration outside the windows, using an unlisted complex type for the genus claims, or using evidence that defeats the substantially non-immunogenic / no cross-reactivity limitations.
FAQs
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What infusion dosing elements are explicitly claimed in US Patent 11,364,260?
The claims explicitly cover infusion rate (~100 mg elemental iron/min), concentration (2–4 mg elemental iron/ml), infusion volume rate (12.5–25 ml/min), and duration (about 15 minutes or less).
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Does US Patent 11,364,260 require hemoglobin or TSAT outcomes?
No. Hemoglobin increase (claim 2) and TSAT increase (claim 18) are in dependent claims, not the independent core method claim.
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Is the polynuclear iron(III)-hydroxide–glucopyranosyl complex required to practice the patent?
No for independent claims 1 and 23 (which use “iron carbohydrate complex” generally), but yes for dependent claims 8 and related descendants.
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What immunogenicity gates appear in the broad “selected from the group” claims?
The claims require a “substantially non-immunogenic carbohydrate component” and “substantially no cross reactivity with anti-dextran antibodies.”
-
Which non-target indication is expressly excluded?
Restless Leg Syndrome is excluded in claims 35 and 38.
References
- United States Patent 11,364,260. Claims as provided in the prompt text.
