Using Dimethyl Fumarate to Treat Multiple Sclerosis
A patent detailing the specific daily dosage of 480mg of dimethyl fumarate for treating multiple sclerosis to protect nerve cells.
Original patent title: “Treatment for multiple sclerosis”
A patent detailing the specific daily dosage of 480mg of dimethyl fumarate for treating multiple sclerosis to protect nerve cells. Granted to Biogen Idec MA Inc in 2013 with 24 claims and 52 forward citations.
Key facts
Coverage
What does this patent actually cover?
This patent describes a specific treatment protocol for multiple sclerosis (MS) using dimethyl fumarate or monomethyl fumarate. The core mechanism involves administering a total of 480 mg per day, which the patent claimsclaimsThe numbered statements at the end of a patent that legally define what the inventor owns.Read more → activates the Nrf2 cellular pathway. This pathway is responsible for protecting cells from oxidative stress, which helps reduce the damage to the protective coating of nerves (demyelination) and prevents nerve cell death. The patent specifies that this dose can be split into multiple equal administrations, such as two doses per day.
The gap
What does this patent NOT cover?
- Does not cover dosages significantly different from the 480 mg per day threshold.
- Does not cover the use of dimethyl fumarate for diseases other than multiple sclerosis.
- Does not cover non-oral delivery methods, such as intravenous or intramuscular injections.
- Does not cover chemical formulations that include active ingredients beyond the specified fumarates and standard excipients.
These exclusions are unique to PatentBrief — derived from the actual claim language, not patent-office boilerplate.
What made this novel
The patent links the clinical efficacy of a specific 480 mg dose directly to the upregulation of NQO1, a biomarker for the Nrf2 pathway, providing a biological rationale for why this specific amount of the drug works to protect neurons.
Schematic visualization of the patent's claim structure. Hand-drawn diagrams in progress for each landmark patent.
Where you've seen this
Real-world examples
Tecfidera (dimethyl fumarate)
Why it matters
The bigger picture
This patent is central to the clinical use of Tecfidera, a major oral medication for MS. By establishing a specific, effective dosage regimen, it provided a clear path for regulatory approval and commercialization of a once-daily or twice-daily pill, which was a significant improvement over injectable MS therapies.
Filed
February 13, 2012
Granted
March 19, 2013
Market context
Who's building on this
Companies in this space
Biogen remains the primary entity associated with this technology through their development of Tecfidera. Other pharmaceutical companies have since developed generic versions of dimethyl fumarate, leading to significant legal and market competition regarding the validity and expiration of these dosage patents.
Market impact
This patent helped establish oral dimethyl fumarate as a standard of care for relapsing forms of MS, shifting the market away from injectable treatments. It also triggered extensive litigationlitigationA lawsuit over patent infringement. Litigated patents often signal commercial importance.Read more → regarding generic entry, as the patent became a focal point for protecting the market exclusivity of the branded drug.
Claim 1 — Plain English
What this patent covers
This patent describes a specific treatment protocol for multiple sclerosis (MS) using dimethyl fumarate or monomethyl fumarate. The core mechanism involves administering a total of 480 mg per day, which the patent claims activates the Nrf2 cellular pathway. This pathway is responsible for protecting cells from oxidative stress, which helps reduce the damage to the protective coating of nerves (demyelination) and prevents nerve cell death. The patent specifies that this dose can be split into multiple equal administrations, such as two doses per day.
The clever bit
The patent links the clinical efficacy of a specific 480 mg dose directly to the upregulation of NQO1, a biomarker for the Nrf2 pathway, providing a biological rationale for why this specific amount of the drug works to protect neurons.
What it does not cover
- Does not cover dosages significantly different from the 480 mg per day threshold.
- Does not cover the use of dimethyl fumarate for diseases other than multiple sclerosis.
- Does not cover non-oral delivery methods, such as intravenous or intramuscular injections.
- Does not cover chemical formulations that include active ingredients beyond the specified fumarates and standard excipients.
Patent timeline
Application submitted to the patent office
Application published, typically 18 months after filing
Patent officially issued
PatentBrief Score
Impact Score
Strong
Citation count
34/40
Highly cited
Claim breadth
16/20
Broad claimsclaimsThe numbered statements at the end of a patent that legally define what the inventor owns.Read more →
Recency
5/20
Granted 10–20 years ago
Assignee scale
20/20
Major company or institution
PatentBrief Impact Score — based on citation count, claim breadth, recency, and assignee scale. Not a legal assessment.
Heuristic Value Estimate
What this patent might be worth
$614K – $2.0M
Midpoint $1.2M · 5.7 yr remaining · industry ×3.0
Heuristic only — blends forward/backward citation counts, claim scope, time remaining, litigation history, and CPC-derived industry baseline. Real valuations need a professional appraisal.
The original legal language
Original claims
24 claims as filed with the patent office.
Concepts involved
Citations
Patent lineage
Cite this patent
O'Neill, G., & LUKASHEV, M. E. (2013). Using Dimethyl Fumarate to Treat Multiple Sclerosis (U.S. Patent No. 8,399,514). U.S. Patent and Trademark Office. https://patentbrief.org/patent/us/8399514/gilenya-fingolimod
Auto-generated from the patent record. Double-check author order and the issue date against the official USPTO document before submitting.
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Common Questions
Frequently Asked Questions
What does Using Dimethyl Fumarate to Treat Multiple Sclerosis cover?
A patent detailing the specific daily dosage of 480mg of dimethyl fumarate for treating multiple sclerosis to protect nerve cells.
Who owns patent US 8399514?
Biogen Idec MA Inc owns this patent, granted in 2013.
When does this patent expire?
This patent is expected to expire on March 19, 2033, when the invention enters the public domain.
What is patent US 8399514 cited by?
This patent has been cited by 52 later patents that build on its ideas.
What problem does this patent solve?
This patent is central to the clinical use of Tecfidera, a major oral medication for MS. By establishing a specific, effective dosage regimen, it provided a clear path for regulatory approval and commercialization of a once-daily or twice-daily pill, which was a significant improvement over injectable MS therapies.
What does this patent NOT cover?
Does not cover dosages significantly different from the 480 mg per day threshold.
Patent monitoring