United States Patent 10,391,160: Scope, Claim Architecture, and US Patent Landscape
US Drug Patent 10,391,160 is directed to a relapsing form of multiple sclerosis treatment that combines a fumarate agent dosing regimen (monomethyl fumarate and/or dimethyl fumarate) with concurrent administration of an inactive vaccine during the initial dosing period, followed by continued daily fumarate dosing. The claims are structured to lock in (i) the treatment context (relapsing MS forms), (ii) the fumarate dosing cadence (daily dosing across two contiguous dosing periods with a short gap rule), (iii) the vaccine status (inactive) and immunogenicity type (T cell-dependent and/or T cell-independent), and (iv) specific vaccine identity and fumarate dosing embodiments (notably dimethyl fumarate 240 mg titration and 480 mg daily doses).
What is the core claimed method?
What does claim 1 require, in operative terms?
Claim 1 defines a “method of treating multiple sclerosis” with a three-part dosing sequence:
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(a) First dose of fumarate
- Pharmaceutical composition contains fumarate agent selected from:
- monomethyl fumarate
- pharmaceutically acceptable salt of monomethyl fumarate
- dimethyl fumarate
- combination(s) of the above
- Administered for a first dosing period.
-
(b) Vaccine during first dosing period
- A vaccine is administered during the first dosing period.
- The vaccine is inactive (stated in claim 1).
-
(c) Second dose after first dosing period, with a timing constraint
- A second dosing period occurs after the first.
- The second dosing period is initiated within one day of the end of the first dosing period.
- Second dose is the same as first dose.
- Both doses are administered daily.
-
Disease scope limitation
- The multiple sclerosis is a relapsing form of MS.
-
Dose effectiveness
- The first dose is a therapeutically effective amount of the fumarate agent (with dependent claims specifying specific dimethyl fumarate amounts).
This claim is therefore a timing-and-coadministration method: fumarate dosing is continuous across two adjacent dosing periods with vaccination embedded in the first period and with a strict “restart within one day” requirement after vaccination exposure ends.
What do dependent claims add?
Dependent claims narrow the genus in three main ways:
-
Fumarate specificity and dosing
- Claim 2: fumarate agent is dimethyl fumarate.
- Claim 3: daily amount is about 480 mg dimethyl fumarate.
- Claim 4-5: optional titration dose prior to the first dosing period (claim 5 specifies about 240 mg dimethyl fumarate for titration).
- Claim 20-21: another titration dose embodiment (again about 240 mg dimethyl fumarate).
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Formulation and delivery form
- Claim 6: capsule or tablet.
- Claim 7-8: dimethyl fumarate provided as microtablets or micropellets that are enterically coated, optionally in a capsule.
-
Immunology and vaccine identity
- Claims 9-12: vaccine immune mechanism can be:
- T cell-dependent (claim 9)
- with T cell-dependent anamnestic humoral response (claim 10)
- or T cell-dependent neoantigen response (claim 11)
- T cell-independent (claim 12)
- Claims 13-16: vaccine can be selected from:
- tetanus diphtheria toxoids vaccine
- keyhole limpet hemocyanin vaccine
- pneumovax-23 vaccine
- Claim 14-16 lock each of those as alternatives.
- Claim 17 specifies: meningococcal polysaccharide diphtheria conjugate vaccine quadrivalent.
-
MS subtype
- Claim 18: relapsing-remitting MS
- Claim 19: secondary progressive MS
- (Note: both are within the “relapsing form” framing of claim 1 as drafted.)
Claim map (what is actually protected)
What elements are “must-have” versus “fallbacks”?
| Claim element |
Status in claim set |
Practical meaning for enforcement/avoidance |
| MS treated is a relapsing form of MS |
Must-have (claim 1) |
Hard boundary: non-relapsing populations fall outside claim 1; dependent claims add specific subtypes. |
| Fumarate agent: MMF/DMF or salt |
Must-have (claim 1) |
Generic fumarate + vaccine timing is not enough unless it matches the fumarate agents defined. |
| Vaccine is inactive |
Must-have (claim 1) |
Live/attenuated or otherwise active vaccines should not satisfy this limitation as written. |
| Vaccine administered during first dosing period |
Must-have (claim 1) |
If vaccine occurs outside the first period, claim 1 is not met. |
| Second dosing period starts within one day after first ends |
Must-have (claim 1) |
Controls a short “restart window.” Longer delays likely avoid literal infringement. |
| Daily administration of fumarate across first and second periods |
Must-have (claim 1) |
Interruptions beyond the described framework are vulnerable. |
| Same dose in first and second periods |
Must-have (claim 1) |
Dose changes across the two periods can avoid literal coverage. |
| Dimethyl fumarate embodiments (240 mg titration, 480 mg daily) |
Fallback (claims 2-5, 20-21, etc.) |
If a competitor uses different DMF amounts or uses monomethyl fumarate, they may avoid narrower dependent claims but could still fall under claim 1. |
| Enteric-coated microtablets/micropellets |
Formulation fallback (claim 7-8) |
Protects specific dosage form implementation details. |
| Vaccine identity list |
Fallback (claims 13-17) |
Narrows to named vaccines; other inactive vaccines may avoid those dependents while still possibly implicating claim 1 if claim 1’s generic “inactive vaccine” reads broadly. |
| Immune response type |
Fallback (claims 9-12) |
Adds immunologic outcome characterizations. |
Scope analysis: how broad is this patent?
How does claim 1 broaden over specific vaccines and dosing amounts?
Claim 1 is broad on the fumarate family and timing architecture:
- It covers any inactive vaccine, not limited to the named examples in dependent claims (unless claim construction ties “inactive” to the listed vaccines in practice).
- It covers fumarate agents within a defined set (MMF and DMF and their permitted combinations/salts).
- It covers any relapsing form of MS.
- It covers a method defined by two daily fumarate dosing periods with a constrained restart timing and vaccine administered during the first dosing period.
- It only requires the first dose be therapeutically effective; it does not force the exact 480 mg or 240 mg amounts unless dependent claims are invoked.
Where does the claim set narrow?
The narrower coverage concentrates on:
- Dimethyl fumarate rather than monomethyl fumarate (claims 2, 3, 5, 7, 20-21, etc.).
- Specific DMF dosing strengths (240 mg titration and 480 mg daily amount, “about”).
- Enterically coated microtablets/micropellets.
- Named vaccine types.
- Immunologic response characterization (T cell-dependent vs T cell-independent, anamnestic humoral, neoantigen).
What is the practical “patent protected window” created by the dosing restart rule?
The key timing constraint is:
- second dosing period initiated within one day of the end of the first dosing period.
That creates a meaningful implementation boundary for competitors who might:
- pause fumarate dosing around vaccination longer than 1 day, or
- restart after a longer gap, or
- switch to different fumarate dose amounts across the two periods.
US patent landscape: how this sits among MS fumarate and vaccine coadministration IP
What does this patent appear to cover strategically?
The claim is designed to capture clinical value from a known MS drug class by tying it to vaccination, with emphasis on immune competence and safety/efficacy implied by the immune response-dependent limitations.
It has a two-layer protective structure:
- Method of treatment level (claim 1) that is usable even when competitors use different specific vaccines or different dosing strengths, so long as they fit the timing and “inactive vaccine” construct.
- Implementation-level fallbacks that lock in commonly used fumarate regimens and formulations (DMF titration and maintenance; enteric microtablets/micropellets) and specific vaccine identities.
Where are the biggest design-arounds (based on claim language)?
Even without assuming specific competitor strategies, the claim language implies clear non-infringing pathways:
- Move vaccine administration outside the first dosing period as defined operationally.
- Restart fumarate after more than one day from end of first dosing period.
- Change fumarate dose between first and second dosing periods (claim requires the second dose is the same as the first).
- Use an active/live vaccine rather than an inactive vaccine, avoiding the “inactive vaccine” limitation.
- Treat a form of MS outside “relapsing form,” or avoid the specific relapse-type framing used in claim 1 and the dependent subtypes.
How the patent likely interacts with existing fumarate and MS vaccination-related prior art
Within the US landscape, there is typically extensive prior art on:
- fumarate drug treatment regimens for MS (MMF/DMF titration and maintenance),
- vaccination recommendations or clinical considerations in immunomodulated MS patients,
- general immune response outcomes after vaccination under immune therapies.
This patent’s novelty position is expressed in the claim architecture:
- it is not a “fumarate-only” regimen claim,
- and not a generic “vaccine in MS patients” claim,
- it is a timed coadministration protocol with an inactive vaccine and a two-period daily DMF/MMF dosing schedule plus subtype limitations.
That means the enforceable scope is strongest where a competitor reproduces the same operational protocol rather than just achieving a similar clinical outcome.
Claim-by-claim highlights (what each claim covers)
What do claims 1 to 8 cover?
- Claim 1: Base method includes inactive vaccine coadministration during first dosing period with restart within one day, daily same-dose fumarate across both dosing periods, and relapsing MS.
- Claim 2: narrows fumarate to dimethyl fumarate.
- Claim 3: specifies about 480 mg daily DMF.
- Claim 4: adds titration dose before first dosing period.
- Claim 5: titration equals about 240 mg daily DMF.
- Claim 6: composition is capsule or tablet.
- Claim 7: DMF is in enterically coated microtablets/micropellets.
- Claim 8: microtablets/micropellets are in a capsule.
What do claims 9 to 17 cover?
- Claim 9: vaccine induces T cell-dependent immune response.
- Claim 10: vaccine induces T cell-dependent anamnestic humoral response.
- Claim 11: vaccine induces T cell-dependent neoantigen immune response.
- Claim 12: vaccine induces T cell-independent immune response.
- Claim 13: vaccine is one of three named types or combinations:
- tetanus diphtheria toxoids vaccine
- keyhole limpet hemocyanin vaccine
- pneumovax-23 vaccine
- Claims 14-16: single-out each vaccine alternative.
- Claim 17: meningococcal polysaccharide diphtheria conjugate vaccine quadrivalent.
What do claims 18 to 23 cover?
- Claim 18: MS is relapsing-remitting MS.
- Claim 19: MS is secondary progressive MS.
- Claim 20-21: repeats titration dose addition and specifies about 240 mg DMF.
- Claims 22-23: narrows fumarate to monomethyl fumarate or MMF salt.
Business and R&D implications
Where this claim set is likely to bite most
- Clinical protocols that keep DMF/MMF dosing continuous around vaccination time, with only brief interruption periods or none, and that restart dosing quickly.
- Regimen adherence to canonical DMF titration and maintenance dose levels (240 mg to 480 mg daily).
- Vaccination studies or label-adjacent clinical programs that use specific inactive vaccines and measure immune response phenotypes.
Where it is likely easier to design around
- Any approach that:
- redefines timing so vaccine is administered outside the first dosing period,
- introduces a dosing gap beyond one day,
- uses a different fumarate exposure pattern that violates “same dose daily across the two periods,” or
- uses a non-inactive vaccine.
Key Takeaways
- 10,391,160 is a coadministration method patent: it claims inactive vaccine + fumarate (MMF/DMF) daily dosing in relapsing MS with a two dosing period structure and a restart within one day constraint.
- Claim 1 is the broadest anchor; dependent claims narrow to DMF, 240 mg titration and 480 mg daily, enteric-coated microtablets/micropellets, specific inactive vaccines, and T cell-dependent or T cell-independent immune response characterizations.
- The strongest practical enforcement risk is where a company or study protocol matches the operational timing and dosing cadence rather than only using fumarates and vaccines in MS patients generally.
FAQs
1) Is this patent about fumarate-only MS treatment?
No. The method requires fumarate dosing plus administering an inactive vaccine during the first dosing period, with a specific restart timing for the second daily dose.
2) Does the claim require dimethyl fumarate?
No. Claim 1 covers fumarate agents including monomethyl fumarate and/or dimethyl fumarate (and MMF salts). Dimethyl fumarate is required only in specific dependent claims.
3) What is the critical timing constraint in claim 1?
The second dosing period starts within one day after the end of the first dosing period.
4) Are live vaccines covered?
The claims require the vaccine to be an inactive vaccine. Live/attenuated vaccines do not match that limitation as written.
5) Which vaccine types are explicitly listed in dependent claims?
Dependent claims list:
- tetanus diphtheria toxoids vaccine
- keyhole limpet hemocyanin vaccine
- pneumovax-23 vaccine
- meningococcal polysaccharide diphtheria conjugate vaccine quadrivalent
References
[1] US Patent No. 10,391,160. “Method of treating multiple sclerosis with fumarate agents and inactive vaccines” (claims provided by user).
