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Patent landscape, scope, and claims: |
Scope and Claims Analysis for US Patent 11,633,489 (Method to Treat or Prevent Fetal/Infant Iron Deficiency Using Iron Hydrogenated Oligoisomaltoside)
US Patent 11,633,489 claims a protected treatment/prevention method focused on maternal parenteral administration of an iron carbohydrate complex during pregnancy and/or breastfeeding to address fetal (and indirectly infant) iron deficiency, with claim narrowing to specific carbohydrate linkage patterns and specific molecular weight/half-life/dose/time and to brain/neurologic endpoints. The strongest protection is for parenteral use of iron hydrogenated oligoisomaltoside (including iron isomaltoside 1000) in defined dosing and pharmacokinetic ranges for brain metal/iron deficiency-related conditions and fetal brain development.
What is US Patent 11,633,489 and what does it claim?
Core claim concept
- Method for treatment or prevention of iron deficiency of a fetus by:
- Parenterally administering to the mother during pregnancy a pharmaceutical composition containing:
- An iron carbohydrate complex comprising iron hydrogenated oligoisomaltoside.
Claim structure
- Independent claim (Claim 1): fetal iron deficiency prevention/treatment via maternal parenteral dosing during pregnancy using the specified iron carbohydrate complex.
- Dependent claims (2–17): narrow to brain iron deficiency, brain metal deficiency disorders, PK half-life, dosing amounts, carbohydrate linkage composition, specific chemical complex form, molecular weight limits, infusion durations, timing within trimesters, repeat dosing windows, and fetal brain/neurodevelopment endpoints.
- Dependent claims (18–22): expand to infant treatment/prevention by maternal parenteral administration during breastfeeding to increase maternal milk iron, again using the iron hydrogenated oligoisomaltoside complex, including iron isomaltoside 1000 and defined infusion and elemental iron dose ranges.
Practical “infringement trigger”
- Any product or regimen that meets all of the following will fall into the patent’s direct claim scope:
- Iron carbohydrate complex that is specifically an iron hydrogenated oligoisomaltoside (explicitly including “iron hydrogenated oligoisomaltoside,” and dependent claims call out iron isomaltoside 1000).
- Parenteral administration to the mother.
- Timing: pregnancy (for fetal claims) and/or breastfeeding (for milk/infant claims).
- Method endpoint: treatment/prevention of fetal iron deficiency (and in narrower dependents, brain iron deficiency/brain metal deficiency or neurodevelopment outcomes).
- For narrower dependents: specified dose, PK half-life, molecular weight, infusion duration, and carbohydrate linkage/branch ratio.
How broad are the claims in US 11,633,489?
Breadth tiers
- Broadest (Claim 1 and Claim 18 framing)
- Any method that fits:
- fetal iron deficiency (pregnancy maternal parenteral),
- iron carbohydrate complex comprising iron hydrogenated oligoisomaltoside,
- and “effective amount” (not fixed dose).
- Medium breadth (branched linkage/molecular weight/infusion windows dependents)
- Claims 6–10 define compositional and physicochemical boundaries:
- carbohydrate linkage ratios,
- explicit complex identification,
- molecular weight ranges (carbohydrate MW and dextran-standard relative MW for the iron complex),
- infusion time windows.
- Narrowest (brain/PK/dose/trimester/disorder-specific dependents)
- Claims 2–5 and 11–17 and 19–22 specify:
- brain iron deficiency and disorders linked to brain metal deficiency,
- repeat dosing timing,
- half-life thresholds (10h+ through 22h+),
- elemental iron dose thresholds (300mg+ through 1000mg+),
- trimester timing,
- infusion time (including 3–30 min, 16–30 min, 5–25 min, 10–20 min; and fixed 20–30 min for infant-specific dependents),
- and specific neurodevelopmental endpoints.
Interpretive impact
- Even if a competitor uses the same drug substance (iron hydrogenated oligoisomaltoside), infringement risk shifts based on:
- whether they target fetal/infant iron deficiency using maternal parenteral administration during the relevant period,
- and whether they operationalize the method in the constrained dose/PK/infusion/composition band of the dependent claims.
What elements in the claims define chemical scope (iron hydrogenated oligoisomaltoside)?
Carbohydrate backbone and linkage constraints (Claim 6)
- Carbohydrate component:
- backbone of glucose units linked by α-1,6 glycosidic linkages
- optionally branches via α-1,3 linkages, but with tight limits:
- α-1,3 : α-1,6 less than 5:100 or less than 1:100, or
- carbohydrate component has no detectable α-1,3 branches.
This locks the claim away from non-matching isomaltoside polymers and toward a hydrogenated oligoisomaltoside with defined branching degree.
Explicit complex identity (Claim 7)
- The iron carbohydrate complex is:
- (1→6)-α-D-glucopyranan-(1→6)-D-glucitol iron(III) complex.
This is the narrowest chemical “nameable” target in the claim set and will matter for claim construction and freedom-to-operate when competitors source different iron-carbohydrate complexes.
Carbohydrate molecular weight (Claim 8)
- Carbohydrate component MW:
- 800–2000 Daltons or “about 1000 Daltons.”
Overall iron complex molecular weight (Claim 9)
- Apparent molecular weight relative to dextran standards:
- ≤ 400,000 Da (and narrower caps: ≤300,000; ≤200,000).
Operational effect
- If a competitor’s iron-hydrogenated oligoisomaltoside product has different polymer MW distribution or detectable branching above the stated thresholds, it may avoid dependent-claim compositional constraints, though Claim 1 may still capture any composition “comprising” the specified complex unless a narrowing construction limits “comprising” to matching structure.
What pharmacokinetic, dosing, and infusion parameters are protected?
Half-life thresholds (Claim 4)
- t1/2 thresholds for the iron carbohydrate complex:
- 10 hours or more
- 12h+
- 14h
- 16h
- 18h
- 20h
- 22h+
This is unusual because it ties method infringement to PK characteristics of the complex under relevant administration conditions.
Elemental iron dosing (Claim 5)
- Total elemental iron administered to the mother:
- 300 mg+,
- 400 mg+,
- 500 mg,
- 600 mg,
- 700 mg,
- 800 mg,
- 900 mg,
- 1000 mg or more.
Because Claim 1 uses “effective amount,” Claim 5 is the biggest narrowing lever for dose-defined regimens. Any regimen that is plainly in the labeled or trial range for high-dose iron isomaltoside 1000 is at risk.
Infusion time windows (Claim 10)
- Infusion into mother during:
- 3–30 minutes,
- 16–30 minutes,
- 5–25 minutes, or
- 10–20 minutes.
Infant breastfeeding regimen timing (Claims 20 and 22)
- Iron isomaltoside 1000
- IV infusion into mother for 20 to 30 minutes
- Elemental iron dose:
This is a targeted regimen that maps to specific dosing and administration practice.
When does the patent protect use during pregnancy and breastfeeding?
Pregnancy timing by trimester (Claim 11)
- Administration to mother during:
- first trimester,
- second trimester,
- or third trimester.
Repeat dosing (Claim 12)
- Further administration during pregnancy and/or breastfeeding period.
- Additional administration 1 month to 12 months after previous administration.
This captures multi-dose or re-dosing protocols across extended fetal/infant developmental windows.
What fetal brain and neurodevelopment outcomes are specifically claimed?
Brain iron deficiency and brain metal deficiency (Claims 2, 3, 13, 14, 15)
- Claim 2:
- iron deficiency is brain iron deficiency.
- Claim 3:
- treatment/prevention of disorder caused by brain metal deficiency.
- Claim 13:
- prevents/treats abnormal development of fetal brain structures including:
- fetal brain generally
- substantia nigra
- thalamus
- putamen
- ventral midbrain
- pallidum
- Claim 14:
- supports cognitive, motor, social-emotional, or neurophysiologic development of the fetus.
- Claim 15:
- disorder caused by brain iron deficiency resulting in copper or zinc imbalance.
These dependents are designed to create a “medical narrative” around metal homeostasis, not just hematologic correction.
Named neuropsychiatric and neurodegenerative disorders (Claim 16)
- Disorders caused by brain metal deficiency include:
- restless leg syndrome (RLS)
- ADHD
- ADD
- absence seizure
- bipolar disorder
- schizophrenia
- obsessive-compulsive disorder (OCD)
- autism
- borderline personality disorder (BPD)
- Alzheimer’s disease
- Parkinson’s disease
This is a broad laundry list. The legal scope will still require a nexus to the claimed “disorder caused by brain metal deficiency,” but the claim language is built to capture many downstream indications.
What is the infant claim scope and what does it require?
Infant method (Claim 18)
- Treat or prevent iron deficiency of an infant by:
- Parenterally administering to mother during breastfeeding
- effective amount of pharmaceutical composition with iron carbohydrate complex
- to increase iron concentration in maternal milk
- where complex comprises iron hydrogenated oligoisomaltoside.
Link to specific complex: iron isomaltoside 1000 (Claims 19, 21)
- Claim 19 and 21 specify:
- iron carbohydrate complex is iron isomaltoside 1000.
Regimen details (Claims 20, 22)
- IV infusion 20–30 minutes.
- Elemental iron dose 800 mg+ or 1000 mg.
What serum exposure parameter is claimed?
Serum total iron Cmax range (Claim 17)
- Cmax after administering composition is between:
This introduces a measurable exposure window that can become a fence if competitors deliberately target different PK profiles via infusion speed, formulation changes, or dosing.
How to read infringement risk by claim level (for competitors and formulators)
| Scenario |
Likely captured claims |
Main risk driver |
| Maternal IV iron hydrogenated oligoisomaltoside during pregnancy to prevent/treat fetal iron deficiency |
Claim 1 |
Product identity + maternal parenteral + pregnancy timing + endpoint “fetal iron deficiency” |
| Same as above, but targeting brain iron deficiency / metal deficiency |
Claims 2,3 |
Brain-specific endpoint framing |
| Same as above with defined polymer characteristics (α-1,6-rich, α-1,3 branch ratio <1:100 or <5:100; MW caps) |
Claim 6–9 |
Chemical/compositional matching |
| Same regimen but with different dosing schedule or lower elemental iron |
Claims 5 and dependents |
Elemental dose thresholds |
| Different infusion duration (outside the cited windows) |
Claim 10 (and infant dependents 20–30 min) |
Infusion time adherence |
| Maternal IV dosing during breastfeeding to increase milk iron |
Claim 18 |
Timing + milk iron mechanism |
| Maternal dosing with specified PK half-life / Cmax |
Claims 4 and 17 |
PK fence |
| Downstream advertising/labeling around neurodevelopment or specific neurologic/psychiatric disorders |
Claims 13–16 |
Medical use claims |
What patents likely surround US 11,633,489 (landscape map by subject matter)?
Because only the claims text was provided, a complete, accurate “patent landscape” with citation-verified US publication numbers, priority dates, assignees, and expiry dates cannot be produced from the supplied inputs alone.
What can be stated from the claim content is the technical and legal adjacent claim space that typically clusters around this type of patent:
Adjacent patent categories (expected in the same family or neighbors)
- Iron isomaltoside 1000 composition and manufacturing
- polymer composition, iron loading, MW distribution, and branching specs.
- Iron carbohydrate complex pharmacokinetics
- half-life and exposure characteristics across dosing/infusion protocols.
- Pregnancy iron deficiency treatment using IV iron
- methods for pregnant populations and fetal outcomes.
- Breastfeeding and milk iron enrichment
- maternal administration to modify milk iron concentrations.
- Brain iron deficiency/neurodevelopment endpoints
- method-of-use for pediatric neurologic outcomes tied to prenatal exposure.
- Neurometal imbalance disorders linked to brain iron
- disorders list-style method-of-use.
- Dosing regimens
- infusion timing windows and elemental dose thresholds.
Freedom-to-operate angles most likely to matter
- Are competitors using the same iron hydrogenated oligoisomaltoside ingredient or a different iron-carbohydrate complex (e.g., iron sucrose, ferric carboxymaltose, ferumoxytol, iron dextran)? If not, chemical scope is likely avoided.
- Are competitors using pregnancy/breastfeeding maternal parenteral administration specifically aimed at fetal/infant iron deficiency or milk iron? If not, method-of-use scope is avoided.
- Do competitors adopt different polymer branching and MW distributions (if they source different grades or manufacturing processes)? That is relevant primarily to dependent claims 6–9.
- Do competitors operate dosing and infusion to stay outside the elemental iron, PK, infusion time, and Cmax constraints? That impacts dependent claims 4,5,10,17, and infant regimen claims 20/22.
Claim-to-Formulation and product mapping: where infringement usually concentrates
Most direct mapping
- Iron hydrogenated oligoisomaltoside with stated structure and MW limits.
- Maternal IV infusion during pregnancy or breastfeeding.
- Dosing at 800–1000 mg elemental iron and infusion durations around 20–30 minutes are specifically targeted in the infant dependents, and multiple infusion ranges are covered in the fetal dependents.
Most contestable points in litigation
- Whether the competitor’s complex meets the claimed carbohydrate linkage and MW characteristics (Claim 6–9).
- Whether the competitor’s dosing regimen yields t1/2 and/or Cmax within the stated thresholds (Claims 4 and 17).
- Whether the asserted “disorder” is truly “caused by brain metal deficiency” in the way the patent claims it (Claims 3,15,16).
Key Takeaways
- US 11,633,489 protects a method-of-treatment/prevention where iron hydrogenated oligoisomaltoside is parenterally administered to the mother during pregnancy to treat/prevent fetal iron deficiency, and during breastfeeding to increase maternal milk iron for infant iron deficiency.
- The claims include both broad composition identity coverage (iron hydrogenated oligoisomaltoside in Claims 1 and 18) and tight dependent limits on:
- carbohydrate linkage/branching (α-1,6 backbone with α-1,3 branches limited),
- carbohydrate MW (800–2000 Da, about 1000 Da),
- iron complex apparent MW limits,
- infusion time windows,
- elemental iron dose thresholds up to 1000 mg+,
- PK half-life thresholds (10h+ to 22h+),
- and serum total iron Cmax range (99 to 681 μg/dL).
- Brain and neurodevelopment protection is built through dependent claims covering fetal brain structures and downstream neurodevelopment/neuropsychiatric/neurodegenerative disorders tied to brain iron/metal deficiency.
FAQs
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Does US 11,633,489 require fetal testing to infringe?
The claims are method claims tied to administering to the mother during pregnancy for fetal iron deficiency; dependent claims specify fetal brain/neurodevelopment endpoints, but direct practice of the claimed method language can be satisfied without waiting for clinical confirmation.
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How much does dosing matter for infringement of US 11,633,489?
Dose thresholds (300 mg+ up to 1000 mg+) are required for dependent claims 5 and the narrow infant regimen dependents (20 and 22). Claim 1 itself uses “effective amount,” making dose a key differentiator between claim coverage levels.
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Can a competitor avoid the patent by changing infusion duration?
Changing beyond the cited infusion ranges may avoid dependent claims 10 and the infant-specific 20–30 minute limitation, but Claim 1’s breadth depends on how courts construe the relationship between “infusion duration” limitations and the independent claim.
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Is the claim limited to iron isomaltoside 1000 or broader iron hydrogenated oligoisomaltoside?
Claim 1 and 18 cover iron hydrogenated oligoisomaltoside broadly, while Claims 19, 21, and 20, 22 explicitly name iron isomaltoside 1000.
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What is the main strongest “fence” for claim scope: chemical structure or clinical indication?
The strongest fencing typically comes from the iron carbohydrate complex identity and compositional constraints (Claims 6–9), with clinical indication acting as a major fence for the brain/brain-metal deficiency dependent claims (Claims 2,3,13–16).
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