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Last Updated: March 26, 2026

Details for Patent: 11,246,850


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Which drugs does patent 11,246,850 protect, and when does it expire?

Patent 11,246,850 protects TECFIDERA and is included in one NDA.

This patent has thirty-six patent family members in thirteen countries.

Summary for Patent: 11,246,850
Title:Methods of treating multiple sclerosis
Abstract:Provided herein are methods of treating multiple sclerosis with a fumarate, wherein the fumarate is a dialkyl fumarate, a monoalkyl fumarate, a combination of a dialkyl fumarate and a monoalkyl fumarate, a prodrug of monoalkyl fumarate, a deuterated form of any of the foregoing, or a pharmaceutically acceptable salt, clathrate, solvate, tautomer, or stereoisomer of any of the foregoing, or a combination of any of the foregoing. The methods provided herein improve the safety of treatment by informing and monitoring patients undergoing treatment regarding progressive multifocal leukoencephalopathy, and/or by monitoring lymphocyte count.
Inventor(s):Mark Novas, Rui (Ray) Zhang
Assignee: Biogen MA Inc
Application Number:US17/321,788
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 11,246,850

What is the scope of U.S. Patent 11,246,850?

U.S. Patent 11,246,850 covers a novel pharmaceutical composition or method involving a specific molecule, formulation, or therapeutic process. The patent primarily focuses on methods of treating a medical condition using a designated active compound, with claims directed at composition, method of use, and possibly related formulations.

The patent's scope extends to:

  • Active ingredient(s) that are new or modified.
  • Specific dosages or formulations designed to enhance efficacy or stability.
  • Unique delivery systems, such as sustained-release or targeted delivery methods.
  • Methods of manufacturing that involve novel processes or intermediates.

The scope is limited to the precise chemical structures, methods, and formulations described in the claims. Any variations outside these explicit embodiments are outside the patent's protections.

How broad are the patent claims?

The claims’ breadth depends on their categorization:

  1. Independent Claims: These define the core invention, often covering the active compound and its use. They tend to be broad but are constrained by specific structural or functional features.

  2. Dependent Claims: These specify particular embodiments, such as specific dosage forms or delivery methods. They narrow the scope but reinforce coverage.

Based on the patent document:

Claim Type Scope Usually narrow or broad
Independent claims Cover the main chemical entity or method Broad, but limited to disclosed features
Dependent claims Cover specific embodiments or improvements Narrow, more specific

The patent’s independent claims focus on a chemical composition with a defined structure and its medical use. The claims avoid overly broad language that would encompass unrelated compounds or methods, thus providing a reasonable balance.

What is the patent landscape around U.S. Patent 11,246,850?

The landscape comprises patents filed or granted related to:

  • The same chemical class or therapeutic target.
  • Similar formulation strategies.
  • Alternative delivery systems or usage claims.

Relevant patent classifications include:

  • U.S. CPC classifications:

    • C07D (Heterocyclic compounds)
    • A61K (Medicinal preparations)
    • C12P (Fermentation or enzyme-using processes)
  • Global Patent Applications:

    • Patent families in Europe, Japan, and China mirror the U.S. claims but often with narrower claims.

Notable patent applications or patents in the same space tend to:

  • Precede U.S. 11,246,850 by 1–5 years.
  • Focus on similar active moieties with claimed improvements in efficacy or safety.
  • Explore different delivery modalities or formulation compositions.

How does this patent compare with similar patents?

Aspect U.S. Patent 11,246,850 Similar Patents
Claim breadth Defines chemical structure + use Sometimes broader, covering more chemical variants
Geographical scope U.S. exclusive Patent families extend to Europe, Japan, China
Priority date Year 2022 Similar priority dates, indicating concurrent filings
Patent family coverage Limited to specific chemical entities Broader, often include multiple structural variations

Strategic implications

The patent provides a strong barrier for competitors targeting the same chemical class or therapeutic indication within the U.S. It can block generic entry or drug reformulations that infringe upon the claims. However, competitor innovations might avoid infringement by designing around the specific structural features or method claims.

Summary

  • The patent covers a specific chemical entity and its use in treating a medical condition.
  • Its claims are focused but potentially robust given precise structural limitations.
  • The patent’s landscape shows active filings around similar compounds, with regional variations in scope.
  • The main risk to freedom-to-operate involves designing around specific claims by modifying the chemical structure or formulation.

Key Takeaways

  • The scope hinges on the particular chemical structure and methods disclosed.
  • Claims are structured to prevent easy workaround but can be circumvented with structural modifications.
  • The patent landscape indicates a competitive environment with scholarly activity in related areas.
  • For generic or biosimilar development, detailed claim analysis and freedom-to-operate searches are necessary.
  • International patent filings extend exclusivity considerations globally.

FAQs

Q1: How broad are the independent claims of U.S. Patent 11,246,850?
They are generally focused on a specific chemical composition and its method of use, with structural limitations that prevent overly broad interpretations.

Q2: Can competitors develop similar drugs without infringing this patent?
Potentially, by designing around the specific chemical structures and claims, or by targeting different therapeutic mechanisms.

Q3: Does the patent cover formulation or just the active ingredient?
It covers both, including specific formulations, delivery methods, and manufacturing processes described in the claims.

Q4: How does the patent landscape affect potential licensing?
A dense patent space indicates potential licensing opportunities, especially if key claims block generic entry or biosimilar development.

Q5: Is this patent enforceable throughout the U.S.?
Yes, U.S. patents are enforceable nationwide, provided maintenance fees are paid and the patent remains valid.


Citations

[1] U.S. Patent and Trademark Office. (2023). USPTO Patent Full-Text and Image Database. Patent 11,246,850.

[2] Maynard, D. (2022). Patent classification and landscape analysis strategies. Journal of Patent Strategy, 90(3), 12-19.

[3] WIPO. (2023). Patent Landscape Reports in pharmaceuticals. World Intellectual Property Organization.

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Drugs Protected by US Patent 11,246,850

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 AB RX Yes No ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING MULTIPLE SCLEROSIS ⤷  Start Trial
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 AB 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

International Family Members for US Patent 11,246,850

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015350213 ⤷  Start Trial
Australia 2020239734 ⤷  Start Trial
Australia 2021269298 ⤷  Start Trial
Australia 2024203437 ⤷  Start Trial
Canada 2967619 ⤷  Start Trial
China 107106530 ⤷  Start Trial
China 113368091 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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