Scope and Claim Construction for US Patent 9,511,043: Immediate-Release Fumarate Esters in Single-Phase Lipid/Lipophilic Matrices for Multiple Sclerosis and Psoriasis

US Patent 9,511,043 is centered on orally administered, immediate-release (IR) pharmaceutical compositions for multiple sclerosis (MS) and psoriasis, using fumarate esters (notably dimethyl fumarate (DMF) and monomethyl fumarate (MMF)) formulated in a single-phase lipid or lipophilic liquid matrix at defined weight ratios. The claims drive enforceable scope through (i) a composition architecture (single phase lipid/liquid matrix), (ii) quantitative formulation ratios, (iii) capsule format options (soft capsule vs enteric soft capsule for delayed release), and (iv) clinical tolerability and dosing-rate constructs (GI/flushing event rate below a threshold).

What is the protected invention in US 9,511,043 and how broad are the claims?

Core invention in one sentence: Treating or reducing MS or psoriasis symptoms by oral dosing with an IR fumarate-ester composition where the fumarate ester(s) are suspended in a single-phase lipid/liophilic liquid matrix in a specified fumarate ester:matrix weight ratio.

Claim 1 is the primary independent method claim

Claim 1 requires all of the following:

Use/indication: “treating or reducing symptoms of multiple sclerosis or psoriasis.”
Route: oral administration.
Timing/release label: “immediate release pharmaceutical composition.”
Drug substance: “one or more fumarate esters.”
Dosage form architecture: fumarate esters are suspended in a single phase liquid matrix.
Matrix definition: matrix is a lipid liquid or lipophilic liquid vehicle.
Quantitative relationship: fumarate ester to matrix about 1:1 to about 1:9 by weight.

Practical claim breadth: Claim 1 is broad on:

fumarate esters (generic “one or more” in Claim 1),
lipid vehicle (any lipid liquid/lipophilic liquid vehicle),
tolerability endpoints are not required in Claim 1 (those appear in dependent claims),
capsule form is not required in Claim 1.

Claim 1 is narrow on:

single-phase matrix,
suspension state (not a dissolved system),
specific weight ratio (1:1 to 1:9).

Claims 2–13 refine Claim 1 with formulation, vehicle exemplars, tolerability, and packaging

Key dependent claim clusters:

Dose and fumarate identity

Claim 2: composition has ~60 mg to ~240 mg fumarate ester.
Claims 3–5: fumarate ester includes DMF and/or MMF.
Claims 4–5: specify DMF or MMF.

Vehicle embodiment

Claim 6: vehicle comprises a vegetable oil, fatty acid, fatty acid ester, or combinations.
Claim 7: vehicle consists of soybean oil.
Claim 8: vehicle mixture includes mono- and di-glycerides, PVP, and polyoxyl 40 hydrogenated castor oil.
Claim 9: matrix further comprises lactic acid.

Tolerability

Claim 10: subject experiences one or more GI/flush events (flushing, abdominal pain, diarrhea, nausea) at a rate < ~20%.

Capsule format / release

Claim 11: encapsulated in a soft capsule or enteric soft capsule.
Claim 12: if enteric soft capsule, it provides delayed release of fumarate ester.

Dosing regimen

Claim 13: “two dosage forms … simultaneously administered to the subject twice per day.”

How do Claims 14–22 differ from Claims 1–13? What is the tighter invention they cover?

Claim 14 is another independent method claim with a different quant structure:

It requires an oral IR composition containing:
- about 10% to about 50% of fumarate esters comprising DMF and/or MMF, and
- about 50% to about 90% of a single-phase lipid liquid/lipophilic liquid vehicle.

So Claim 14 is essentially a percentage composition version of Claim 1’s weight ratio limitation, but also adds:

explicit quantitative % range for fumarate esters,
explicit restriction to DMF/MMF in the fumarate ester fraction.

Claims 15–17: dose and vehicle embodiments

Claim 15: total fumarate ester ~60–240 mg.
Claim 16: vehicle mixture includes mono- and di-glycerides, PVP, polyoxyl 40 hydrogenated castor oil, and lactic acid.
Claim 17: vehicle consists of soybean oil.

Claims 18–20: fumarate identity and tolerability

Claims 18–19: fumarate ester includes DMF or MMF.
Claim 20: tolerability threshold <20% for flushing/GI events.

Claims 21–22: capsule and simultaneous dosing

Claim 21: encapsulated in soft or enteric soft capsule.
Claim 22: two dosage forms simultaneously administered twice daily.

Scope note: Claim 14 is narrower than Claim 1 because it hard-codes the fumarate ester identity fraction to DMF/MMF and specifies percentage composition for fumarate vs vehicle. It is broader than some dependent examples because it still allows a wide set of single-phase lipid vehicles in the percentage architecture (except where dependent claims constrain to soybean oil or specific multi-component excipient packages).

What do Claims 23–29 add beyond Claims 14–22 (capsule “dosage form” structure and dosing-unit splitting)?

Claim 23 is the third independent claim and it is structurally tied to a capsule encapsulating an IR composition defined by the percentage composition.

It requires:

oral administration of a dose,
where the dose is a soft capsule encapsulating an immediate release composition containing:
- ~10%–~50% DMF/MMF (or combination),
- ~50%–~90% single-phase liquid vehicle comprising lipid liquid/lipophilic liquid.

Claims 24–29: more specific vehicle, dose-range by unit, and delayed release option

Claim 24: vehicle mixture includes mono- and di-glycerides + PVP + polyoxyl 40 hydrogenated castor oil.
Claim 25: dosage form contains ~60 mg to ~120 mg fumarate ester.
Claim 26: two dosage forms simultaneously administered twice per day.
Claim 27: one dosage form contains ~120 mg to ~220 mg fumarate ester.
Claim 28: one dosage form administered twice per day (splitting scenario).
Claim 29: soft capsule is an enteric soft capsule providing delayed release of fumarate ester.

Scope note: Claims 23–29 convert the earlier method composition concept into a unit-dose/capsule-defined framework, tightening enforceability around “what the product looks like” rather than only “what the formulation comprises.”

How should “single-phase liquid matrix” and “suspended” be construed for enforceable claim coverage?

The claim language requires a single-phase matrix and that fumarate esters are suspended within it.

Single-phase requirement

To fall within the claims, the matrix must behave as a single liquid phase rather than a multi-phase emulsion system. Enforcement typically turns on:

whether the formulation forms distinct dispersed phases detectable by standard analytical methods,
whether the matrix is characterized as one continuous phase during relevant conditions (e.g., formulation and administration conditions).

Suspension requirement

“Suspended” excludes systems where fumarate esters are fully dissolved at formulation-relevant concentrations. It also creates a potential technical boundary:

If a competitor reformulates to dissolve DMF/MMF fully in the lipid vehicle (a “solution” instead of “suspension”), they may attempt to avoid literal coverage even if the composition otherwise matches ratios.

Business implication: The patent’s commercial protection is most robust against competitors who maintain a dispersion/suspension approach in a lipid/liophilic single-phase vehicle rather than switching to solution or multi-phase emulsion architectures.

What formulations are explicitly protected: DMF, MMF, soybean oil, and specific excipient blends?

Fumarate ester identity

The patent’s dependent claims explicitly cover:

DMF (Claims 3–4, 14, 18, 23, 27–29 via dependent layering),
MMF (Claims 3, 5, 14, 19, 23 similarly),
DMF+MMF combination (Claims 3, 14, 23).

Claim 1 is broader because it is not restricted to DMF/MMF, but most competitors in this space will focus on DMF/MMF.

Vehicle examples and “vehicle consists of” anchors

High-enforceability anchor terms:

Claim 7: “vehicle consists of soybean oil.”
Claim 17: “single phase lipid liquid or lipophilic liquid vehicle consists of soybean oil.”

These “consists of” formulations narrow claim scope to the specified vehicle alone for those dependent claims.

Multi-component vehicle embodiments

The claims name specific excipient packages:

mono- and di-glycerides + PVP + polyoxyl 40 hydrogenated castor oil (Claim 8; also Claim 24),
mono- and di-glycerides + PVP + polyoxyl 40 hydrogenated castor oil + lactic acid (Claim 16).

Business implication: If a generic or competitor uses the same package in a single-phase system and keeps fumarate ester fractions/ratios within the claimed ranges, it will likely face claim-strength pressure. If they substitute excipients but keep the single-phase lipid architecture, coverage depends on whether dependent claims are the limiting step or only Claim 1/14 are invoked.

What is the claim coverage for capsule format and release timing (immediate vs delayed)?

The patent text includes both:

immediate release pharmaceutical composition requirements (Claims 1, 14, 23), and
dependent coverage for enteric soft capsules providing delayed release (Claims 12 and 29).

This creates a dual-track argument structure:

The base invention is IR-composition oriented.
Dependent claims add product-level formats where an enteric capsule delays release of fumarate ester.

Commercial implication: A competitor moving to a different release strategy (true delayed-release microstructures, different capsule coatings, or altered release mechanisms) can try to exit the claimed “immediate release composition” limitation for Claims 1/14/23. However, because dependent claims explicitly cover enteric soft capsules with delayed release of fumarate ester, the enforcement posture may be stronger if the competitor’s dosage form matches the capsule/release linkage described.

What patents might surround US 9,511,043 (likely landscape themes and how they interact)?

Without external citation data for 9,511,043’s full bibliographic record, the landscape can only be structured by known adjacent claim themes typical for fumarate ester oral formulations:

1) Formulation method patents

US 9,511,043’s claim set is method-of-treatment tied to formulation characteristics. Adjacent patents in the same family or nearby families usually include:

formulation process steps for preparing suspensions in lipid vehicles,
specific excipient roles to maintain single-phase character,
stability and particle size control approaches.

2) Dosage-unit and titration-scheme patents

Claims 13, 22, 26–28 are dosing regimen constructs:

simultaneous administration of two dosage forms,
twice-daily schedule,
unit dose ranges (Claims 25 and 27).

Adjacent claims in the broader estate often cover:

titration strategies to reduce flushing/GI risk,
unit dose splitting and schedule implementation.

3) Enteric capsule coating / delayed-release assembly patents

Because dependent claims reference enteric soft capsules, related patents frequently cover:

coating compositions and process,
dissolution delay conditions,
compatibility of fumarate esters with enteric polymers and capsule materials.

4) Tolerability/clinical outcome patents

Claim 10 is tied to a tolerability endpoint (<20% for flushing/GI events). In a landscape sense, such patents typically overlap with:

patient management,
formulation excipient combinations intended to reduce GI toxicity,
dosing timing adjustments.

Business implication: Enforcement often concentrates on formulation characterization and product architecture. Dosing constructs and tolerability endpoints are typically used to strengthen both infringement and validity narratives, especially if clinical data is included in the patent specification.

Where could enforcement be strongest versus weakest within these claims?

Strongest claim elements

Single-phase liquid matrix + suspension together: this is a technical product-structure requirement.
Quantitative boundaries:
- Claim 1: 1:1 to 1:9 weight ratio
- Claim 14/23: 10%–50% fumarate esters and 50%–90% single-phase vehicle
“Consists of” vehicle:
- soybean oil exclusivity in dependent claims (Claims 7 and 17)
Capsule format:
- soft capsule/enteric soft capsule (Claims 11–12, 21, 29)
Tolerability endpoint:
- GI/flush event rate <20% (Claim 10, 20)

Weakest or easiest-to-design-around elements

Broad therapeutic intent: “treating or reducing symptoms” can be broad, but it is often not the main design-around point. The enforceability fight typically shifts to formulation/product architecture.
Vehicle definition in Claim 1: “lipid liquid or lipophilic liquid vehicle” can be wide. If a competitor uses a different liquid vehicle yet still maintains single-phase behavior and suspension plus ratio constraints, they may still fall into Claim 1. If they change to non-single-phase systems or change the physical state from suspension to dissolved solution, they can attempt to avoid.

Claim-by-claim “coverage map” of constraints (what must be true)

Claim	Indication/Route	Release concept	Fumarate scope	Composition architecture	Quant constraint	Vehicle constraint	Capsule constraint	Tolerability endpoint
1	MS/psoriasis, oral	IR	one or more fumarate esters	suspended in single-phase lipid/lipophilic liquid matrix	fumarate ester:matrix 1:1 to 1:9	lipid/liophilic vehicle (generic)	none required	none required
2	same	same	same	same	fumarate ester ~60–240 mg	none	none	none
3–5	same	same	DMF/MMF or one	same	same	none	none	none
6–9	same	same	same	same	same	vegetable oil/fatty acid/fatty acid ester; soybean oil; or specific blend with lactic acid	none	none
10	same	same	same	same	same	same	none	flushing/GI events rate <20%
11–12	same	same	same	same	same	same	soft capsule or enteric soft capsule; enteric provides delayed release	none required
13	same	same	same	same	same	same	two dosage forms simultaneously, twice daily	none required
14	same	IR	DMF/MMF or combo	single-phase lipid/lipophilic liquid vehicle; fumarate esters fraction	fumarate ester 10%–50% and vehicle 50%–90%	single-phase lipid vehicle	none required	none required
15–17	same	same	same	same	same	soybean oil or specific blend	none	none
18–20	same	same	DMF or MMF	same	same	same	none	event rate <20%
21–22	same	same	same	same	same	same	soft or enteric soft	none required
23	same	IR	DMF/MMF or combo	soft capsule encapsulating IR composition	fumarate 10%–50% and vehicle 50%–90%	vehicle lipid/liophilic	soft capsule (enteric optional via 29)	none required
24–28	same	same	same	same	same	multi-component blends and unit dose ranges	dosing schedule via 26–28	none
29	same	IR composition; enteric capsule provides delayed release	same	same	same	same	enteric soft capsule	none required

What generic entry risks exist for a DSM-like “fumarates in lipid vehicle” product?

High risk of infringement if a generic/competitor:

keeps single-phase lipid architecture,
uses a suspension rather than a dissolved solution,
stays within:
- fumarate ester:vehicle 1:1 to 1:9 (Claim 1),
- or fumarate ester 10%–50% and vehicle 50%–90% (Claims 14/23),
uses DMF/MMF (at least to satisfy Claim 14/23 dependency paths),
matches capsule formats (Claims 11–12, 21, 29),
preserves clinical tolerability characteristics enough to meet <20% threshold (Claim 10/20).

Design-around pressure points typically include:

converting the system from suspension to solution (if feasible),
moving to a multi-phase emulsion/dispersion system instead of single-phase,
shifting formulation ratios outside the numerical boundaries,
changing from soft capsule IR to a materially different dosage form/release architecture (though enteric soft capsule is not a clean escape given dependent claims).

Key Takeaways

US 9,511,043 protects oral immediate-release fumarate-ester compositions for MS and psoriasis where fumarate esters are suspended in a single-phase lipid/lipophilic vehicle with defined ratio/percentage boundaries.
The independent claim set is three-pronged:
- Claim 1: weight ratio 1:1 to 1:9 with “one or more fumarate esters” (broad therapeutic/formulation architecture).
- Claim 14: DMF/MMF fraction 10%–50% with 50%–90% single-phase vehicle (composition percentage version).
- Claim 23: capsule-defined unit dose concept with DMF/MMF fraction 10%–50% and vehicle 50%–90% (product form tightened).
Dependent claims lock in enforceable embodiments: soybean oil, specific excipient blends (mono/di-glycerides, PVP, polyoxyl 40 hydrogenated castor oil, lactic acid), GI/flushing rate <20%, and soft vs enteric soft capsules with delayed release.
The most meaningful infringement determinants are technical: single-phase characterization, suspension vs solution, and staying inside formulation ratio/percentage ranges.

FAQs

1) What formulation changes could avoid US 9,511,043 if a product uses DMF?
Avoiding literal coverage hinges on moving outside the claimed single-phase suspension architecture and/or the specified fumarate ester:matrix ratio (Claim 1) or fumarate ester percentage ranges (Claims 14/23). Switching to a non-single-phase system or a dissolved solution approach is a primary design-around route.

2) Does US 9,511,043 cover both immediate-release and enteric soft capsules?
The independent composition is labeled immediate release, while dependent claims explicitly cover enteric soft capsules that provide delayed release of fumarate ester.

3) How do the dosing-unit claims (60–120 mg and 120–220 mg ranges) affect enforcement?
Claims 25 and 27 narrow enforceability to specific unit-dose content in a capsule. If an accused product uses different mg-per-unit amounts, it can reduce coverage under those dependent paths, while still potentially implicating broader independent claims.

4) Are tolerability claims (GI/flushing event rate <20%) required for every infringement theory?
No. The <20% threshold appears in dependent claims (not the independent Claim 1/14/23 statements). It becomes relevant when those dependent claims are asserted.

5) If a competitor uses soybean oil, does that increase risk?
Yes, for dependent claims that specify vehicle “consists of soybean oil” (Claims 7 and 17). A soybean oil-only vehicle can increase literal infringement exposure if other constraints are met.

References

United States Patent No. 9,511,043 (claims as provided).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Banner Life Sciences	BAFIERTAM	monomethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210296-001	Apr 28, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				METHOD OF TREATING MULTIPLE SCLEROSIS	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015222880	⤷ Start Trial
Australia	2015328676	⤷ Start Trial
Australia	2016253548	⤷ Start Trial
Australia	2017204505	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,511,043

Which drugs does patent 9,511,043 protect, and when does it expire?

Summary for Patent: 9,511,043