# 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.

- **Patent:** US 8399514
- **Original title:** Treatment for multiple sclerosis
- **Owner:** Biogen Idec MA Inc
- **Granted:** 2013
- **Status:** Active
- **Times cited:** 52
- **Field:** biotech, pharmaceutical

## What it does

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.

## 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.

## 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.

## Real-world examples

1. Tecfidera (dimethyl fumarate)

## Why it matters

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.

## 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.

**Full plain-English explainer:** https://patentbrief.org/patent/us/8399514/gilenya-fingolimod

**Original patent:** https://patents.google.com/patent/US8399514

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_Source: PatentBrief — https://patentbrief.org. Patent facts are from public records; the plain-English explanation is PatentBrief's._