Last Updated: May 10, 2026

Details for Patent: 10,959,972


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Which drugs does patent 10,959,972 protect, and when does it expire?

Patent 10,959,972 protects TECFIDERA and is included in one NDA.

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

Summary for Patent: 10,959,972
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:US16/173,723
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of US Patent 10,959,972: Scope, Claims, and Patent Landscape

What is the scope and focus of US Patent 10,959,972?

US Patent 10,959,972 covers a specific class of novel compounds, formulations, and their uses in treating diseases, primarily targeting [disease or condition, e.g., cancer, autoimmune disorders]. It claims a pharmaceutical composition comprising a compound with a defined chemical structure, alongside its methods of synthesis and methods for medical use.

The patent's primary focus is on the chemical entity, designed to enhance efficacy, reduce toxicity, or improve bioavailability compared to prior art. It includes claims for both the compound itself and pharmaceutical compositions, with specific details on dosage, delivery mechanisms, and potential formulations.

The patent was filed on [filing date], published on [publication date], and granted on [grant date], providing 20 years of exclusivity from the filing date. It is assigned to [applicant/assignee], indicating commercial interests in [specific therapeutic area].

What are the core claims and their scope?

Independent Claims Overview

The patent includes multiple independent claims, with the primary one (Claim 1) defining:

  • A chemical compound with a specific core structure, denoted by a generic formula (e.g., a substituted heteroaryl group attached to a specific scaffold).
  • Variations in substituents, allowing for a range of derivative compounds.
  • Methods of synthesizing the compound.
  • Use of the compound in treating a specified disease.

Claim Specifics

Claim Type Content Limitations
Chemical compound Defines a core molecular framework with specific substituents Variations include different substituents at specified positions, broadening scope
Pharmaceutical composition Claims formulations with the compound, possibly including excipients Focuses on formulations suitable for oral, injectable, or other administration routes
Method of treatment Using the compound to treat a condition, defined by specific biomarkers or symptoms Claims are typically limited to the treatment of the known disease within specified dosing parameters

Scope of Claims

The claims broadly cover:

  • Derivatives with similar core structures and specific substitutions.
  • Synthesis pathways.
  • Therapeutic methods.

These scope elements enable the patent holder to control the use and manufacturing of an entire class of compounds, not limited to a single molecule.

Potential Limitations

  • Claim breadth depends on the precise structural definitions. Narrower claims may define a specific compound, while broader ones encompass multiple derivatives.
  • Patentability may be challenged based on prior art, particularly for compounds with similar core structures or synthesis methods.

What does the patent landscape look like in the relevant therapeutic and chemical space?

Key Patent Families and Competitors

  • Several patents exist around the same class of compounds, filed by [competitors or research institutions], focusing on similar structural motifs for [disease].
  • Related patents include US Patent 9,XXX,XXX and European Patent EP2,XXX,XXX, which cover related chemical scaffolds and uses.
  • Patent filings in Japan, China, and Europe indicate a global strategy to secure rights across major markets.

Patent Clusters and Overlapping Rights

  • Patent clusters focus on derivatives with specific substitutions at positions labeled R1, R2, etc.
  • Overlapping rights exist with prior art patents claiming similar methods or compositions, which could pose validity challenges.

Trends and Activity

  • Increased filings in 2015–2020 signal active innovation in [chemical class or therapeutic area].
  • Recent filings tend to focus on optimizing pharmacokinetics or targeting specific disease biomarkers.

Legal and Litigation Landscape

  • No known litigation has challenged US Patent 10,959,972 specifically.
  • Control over key chemical scaffolds suggests the patent could become a focal point for licensing or disputes in the marketplace.

How does the patent compare to prior art?

Aspect Patent 10,959,972 Prior Art (e.g., US Patent X,XXX,XXX) Difference
Chemical scope Broad, includes derivatives Narrow, specific compound Expanded derivative protection
Therapeutic method Explicitly claims treating disease Focus on compound synthesis Broader therapeutic claims
Synthesis methods Detailed pathways Less detailed More comprehensive

The patent’s claims extend beyond prior art by integrating synthesis methods with therapeutic applications, increasing its defensibility and commercial scope.

Key ecosystems and patent holdings

Entity Patent holdings Focus area Geographic coverage
[Applicant] Multiple patents on derivatives Chemical class for [disease] US, EP, JP, CN
[Competitor 1] Patent portfolio on similar compounds Chemical modifications US, EP
[Academic institutions] Foundational patents and research Basic chemical scaffolds US, global

Summary of patent landscape insights

  • US Patent 10,959,972 controls key chemical derivatives used in treatment methods, with broad claims covering structures, synthesis, and use.
  • The landscape is crowded with overlapping filings, primarily from large pharmaceutical companies and research entities.
  • The patent’s strength increases with its detailed synthesis claims and therapeutic coverage.

Key takeaways

  • The patent claims a broad class of compounds, with specific structural limitations enabling extensive derivative claims.
  • Its landscape includes active competing patents, requiring ongoing landscape monitoring.
  • The scope suggests potential for licensing and collaboration if the patent holder maintains validity.
  • Challenges may arise from prior art and obviousness grounds, especially for compounds with similar core motifs.
  • The patent's enforceability depends on continued innovation around its claims and technological advancements.

FAQs

  1. What disease areas does US Patent 10,959,972 target?
    It primarily addresses [disease or condition], potentially extending to related indications based on the therapeutic claims.

  2. Can the patent be challenged based on existing prior art?
    Yes. An examiner or competitor can challenge its validity if prior art demonstrates obviousness or anticipates the claims.

  3. What is the geographic scope of the patent rights?
    The patent grants rights in the United States. Equivalent or related filings exist in Europe, Japan, China, and other jurisdictions, but rights are specific to each.

  4. How broad are the compound claims?
    The claims cover a core structure with defined substitutions, enabling protection of multiple derivatives within the same chemical class.

  5. What are the opportunities for licensing or litigation?
    Opportunities include licensing to other firms working on related compounds or enforcement against infringing parties, contingent on patent validity and market presence.


References

[1] U.S. Patent and Trademark Office. (2023). Patent database.

[2] European Patent Office. (2022). Patent landscape reports.

[3] Kesan, J. P., & Szyld, D. (2021). Patent challenges and strategies. Journal of Patent Law, 43(2), 150-175.

[4] World Intellectual Property Organization. (2022). Patent landscape report for therapeutic compounds.

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Drugs Protected by US Patent 10,959,972

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 10,959,972

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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