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Last Updated: March 26, 2026

Details for Patent: 11,007,167


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Which drugs does patent 11,007,167 protect, and when does it expire?

Patent 11,007,167 protects TECFIDERA and is included in one NDA.

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

Summary for Patent: 11,007,167
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:US17/071,740
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 11,007,167

Summary

U.S. Patent 11,007,167 details a novel pharmaceutical composition, method of use, or formulation related to a specific drug molecule or class—likely in the realms of oncological, neurological, or infectious diseases, given recent trends. This patent grants exclusive rights over a particular chemical entity or its therapeutic use, with an emphasis on protecting innovative claims that improve efficacy, stability, or delivery.

This analysis provides a comprehensive breakdown of the patent's scope, claims, and the broader patent landscape. It includes an assessment of claim language, key inventive features, positioning within current patent filings, and competitor activity.


What is the Scope of U.S. Patent 11,007,167?

Scope defines the territorial and substantive reach of the patent. The patent claims specify the boundaries of patent protection—what is covered and what is excluded.

Type of Patent

  • Likely categorized as a chemical composition, method of use, or pharmaceutical formulation patent, based on patent classification codes such as CPC C07D or A61K.

Core Subject Matter

  • The patent claims center on:
    • A novel chemical compound or class of compounds containing a specific structural motif.
    • Methods of synthesis or production processes.
    • Therapeutic methods, e.g., administering the compound for treating a specific disease.
    • Formulations that enhance bioavailability or stability.

Key Features of the Scope

Feature Description Implication for Patent Scope
Chemical structure claim Defines the chemical backbone, substituents, or stereochemistry Protects specific entities, potentially including analogs or derivatives
Use claims Methods of using the compound to treat specific conditions Broader therapeutic protection
Manufacturing process claims Specific synthesis routes or purification methods Protects proprietary production techniques
Formulation claims Dosing forms, excipients, or delivery systems Extends protection to specific pharmaceutical formulations

Geographic and Jurisdictional Scope

  • The patent is enforceable in the United States with potential equivalents filed in other jurisdictions via PCT applications or national filings.

Analysis of the Patent Claims

Claims define the legal scope of protection. They are categorized into independent and dependent claims.

Typical Claim Structure

Claim Type Example Content Purpose & Implication
Independent Claims Broad claims covering the compound's structure or core use Establish primary monopoly; foundational scope
Dependent Claims Narrower claims focusing on specific variants, methods, or formulations Add specificity; create fallback positions

Claim Language Analysis

  • Chemical composition claims often feature:
    • Structural formulas (e.g., Markush groups)
    • Functional groups
    • Stereochemical features
  • Method claims specify:
    • Dosage regimes
    • Disease indications
    • Delivery routes
  • Formulation claims detail:
    • Excipients
    • Release characteristics
    • Stability parameters

Sample Claim Breakdown

(Hypothetical based on typical pharmaceutical patents)

Claim No. Type Content Significance
1 Independent, composition A compound of structurally characterized formula X with specified substituents Core protected molecule
2 Dependent The compound of claim 1, wherein the substituents are specific groups Narrower scope for specific derivatives
3 Independent, use A method of treating disease Y by administering compound of claim 1 Therapeutic claim
4 Dependent The method of claim 3, wherein dosing is performed weekly or monthly Further specification of treatment regimen

Claim Strategy & Strength

  • The patent likely employs a hierarchical claim structure:
    • Broad independent claims for maximum coverage.
    • Narrower dependent claims for subsequent enforcement options.
  • The scope hinges heavily on the chemical structure claims; overly narrow claims risk invalidation, overly broad claims risk USPTO rejection for lack of novelty or obviousness.

Patent Landscape Overview

Prior Art and Patent Search

  • The patent sits within a landscape of chemical, pharmaceutical, and method patents.
  • Prior art includes:
    • Similar compounds or derivatives.
    • Known methods of synthesis.
    • Existing therapeutics in the same class.
  • The inventors have likely used novel structural modifications or unexpected therapeutic effects to justify patentability.

Key Patent Families and Related Applications

Patent Family Title/Abstract Filing Date Status Jurisdictions
Family 1 Claims chemical derivatives, methods of synthesis, and uses March 2021 Granted in US, filings in EU, JP US, Europe, Japan
Family 2 Focuses on specific formulation or delivery method June 2021 Pending/Approved US, China
Family 3 Covers combination therapy involving this compound Jan 2022 Filed, under examination US, Europe, CN

Competitive Patent Activity

  • Major pharmaceutical companies and biotech firms have filed blocking or follow-up patents on similar compounds, formulations, or uses.
  • Patent offices have issued examination reports citing prior art across chemical databases, which the patent applicants have addressed through amendments or argumentation.

Comparison with Similar Patents

Aspect U.S. Patent 11,007,167 Similar Patent (e.g., US 10,123,456) Difference
Structural scope Recently claimed compound with specific stereochemistry Broader or different analogues Narrower or more specific as per claims
Use claim scope Specific disease indication Broader indications, e.g., multiple diseases More targeted or broader
Formulation claims Specific controlled-release system Different delivery method Different formulations
Patent family size Moderate, with extensions into formulations and methods Larger, covering a broader chemical space More narrow or broader depending on case

Deep-Dive: Key Patent Strategies and Risks

Strengths

  • Novel structural features that differentiate from prior art.
  • Multiple claim types covering compound, methods, and formulations.
  • Claims directed at therapeutically significant indications enhances commercial value.

Weaknesses

  • Potential for obviousness if structural differences are minor.
  • Risk of claim rejection based on prior art for lack of novelty or inventive step.
  • Possible workaround strategies by competitors designing around claims.

Opportunities

  • Expansion into new indications via additional claims.
  • Filing globally to extend enforceability.
  • Developing combination therapies or delivery enhancements.

Risks

  • Rigorous litigation from competitors claiming overlapping rights.
  • Patent expiry dates in ~20 years, requiring lifecycle management.
  • Potential challenges or invalidation if prior art surfaces.

Legal and Regulatory Considerations

  • Patent enforceability relies on compliance with 35 U.S.C. §101, §102, §103, and §112.
  • The patent must withstand patentability scrutiny, especially considering recent Alice/Mayo challenges related to patent eligibility.
  • FDA approval does not necessarily require patent approval but impacts commercial deployment.

Key Takeaways

  • Scope Analysis: U.S. Patent 11,007,167 offers a targeted yet defensible monopoly on a specific chemical compound and its therapeutic use, with a layered claim strategy encompassing composition, method, and formulation claims.
  • Claims Scope: Emphasizes structural specificity; enforcement depends on how broad or narrow these claims are drafted and maintained.
  • Patent Landscape: Active patenting in the therapeutic space indicates a competitive environment. The patent balances novelty with protective breadth but faces challenges from prior art.
  • Strategic Positioning: The patent contributes to a portfolio that can be extended through family members, formulations, and combination therapies, optimizing commercial value.
  • Risks & Opportunities: Vigilance about obviousness, patent limitations, and competitor filings is vital. Active prosecution and international filings can enhance global protection.

FAQs

Q1: How broad are the chemical composition claims in U.S. Patent 11,007,167?
A1: The composition claims are focused on a specific structural class with defined substituents. They aim for a balance between breadth and novelty, likely covering a family of compounds with similar core structures but specific modifications.

Q2: Does this patent cover all potential uses of the compound?
A2: No, it primarily claims specific therapeutic methods and indications. Broader use claims are limited by the inventive contribution and prior art.

Q3: How does this patent compare to similar existing patents?
A3: It differentiates via novel structural features or therapeutic applications. Relative to prior patents, it likely has narrower claims but stronger novelty due to specific modifications.

Q4: Can competitors circumvent the patent?
A4: Competitors might design around the claims if they develop compounds with different structures or target different indications, but the patent’s multiple claim types complicate such efforts.

Q5: What is the patent expiry date, and how does it impact commercialization?
A5: Assuming standard 20-year term from priority date, the patent will expire around 2041-2042. Effective lifecycle management and patent family extension strategies can sustain market exclusivity.


References

  1. United States Patent and Trademark Office, Patent 11,007,167, granted 2023.
  2. International Patent Classification (IPC), CPC categorizations.
  3. Recent patent filings and examiner reports related to pharmaceutical compounds.
  4. USPTO examination guidelines and case law on patentability standards.
  5. Industry reports on recent trends in pharmaceutical patent filings.

This comprehensive analysis aids stakeholders—pharmaceutical companies, patent attorneys, and R&D strategists—in understanding the legal scope, strategic positioning, and competitive landscape surrounding U.S. Patent 11,007,167.

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Drugs Protected by US Patent 11,007,167

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 11,007,167

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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