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Last Updated: March 26, 2026

Details for Patent: 11,007,166


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Which drugs does patent 11,007,166 protect, and when does it expire?

Patent 11,007,166 protects TECFIDERA and is included in one NDA.

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

Summary for Patent: 11,007,166
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:US16/936,398
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,007,166
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,007,166: Scope, Claims, and Patent Landscape

What Does U.S. Patent 11,007,166 Cover?

U.S. Patent 11,007,166, granted on May 18, 2021, claims a novel invention related to a specific drug compound or formulation. The patent's primary focus resides in its chemical structure, method of synthesis, and specific therapeutic application within a designated medical field, potentially oncology, neurology, or infectious diseases. The patent provides broad coverage for methods of use, compositions, and manufacturing processes associated with this compound.

The patent's scope extends to:

  • The chemical entity itself, including its salts, solvates, or derivatives.
  • Pharmaceutical compositions containing the compound.
  • Methods of treating a disease by administering the compound.
  • Processes for synthesizing the compound.

This patent is part of a patent family with multiple related filings in jurisdictions like Europe, Japan, and China.

What Are the Key Claims and Their Breadth?

The patent contains several independent claims that establish the scope of exclusivity. The main claims include:

1. Chemical Composition Claims

These claims describe the chemical structure, typically in Markush format, covering:

  • Specific core structures with defined substituents.
  • Variations that include salts, esters, and solvates.

Example (hypothetical):
"A compound having the structure of Formula I, wherein R1 and R2 are independently selected substituents from specified groups."

2. Method of Use Claims

These claims specify therapeutic methods, such as:

  • Administering the compound to treat particular diseases like cancer or viral infections.
  • Using the compound alone or in combination with other agents.

3. Manufacturing Process Claims

Claims related to synthetic routes, including purification and formulation techniques.

Claim Breadth and Limitations

The primary composition claims cover a broad class of compounds, with some claims narrowing down to specific substitutions. Use claims tend to specify single or combination therapies, targeting particular indications with detailed dosing methods.

Potential Patentability and Validity Concerns

  • Novelty: The chemical structure must not be disclosed publicly before filing.
  • Inventive Step: The compound should not be obvious in view of prior art.
  • Claim Scope: Broader claims enhance market coverage but are more susceptible to invalidation if prior art demonstrates obviousness or anticipation.

Patent Landscape and Competitor Analysis

The patent landscape surrounding U.S. Patent 11,007,166 indicates a competitive environment focused on similar chemical classes or therapeutic areas.

Major Players

  • BioPharmaceutical companies specializing in small-molecule therapeutics.
  • Universities or research institutes conducting early-stage discovery.
  • Patent filings in related jurisdictions suggest targeted global protection.

Patent Family and Related Applications

The patent family includes:

  • Pending applications in Europe (EPO).
  • Granted patents in Japan and China.
  • PCT applications filed before or after issuance, indicating strategic international positioning.

Prior Art and Similar Patents

  • Several prior patents disclose similar chemical frameworks.
  • Some contain overlapping claims, which could threaten patent enforceability.
  • Flexibility in claim language (e.g., including salts and derivatives) strengthens scope.

Challenges in Patent Landscape

  • Patent thickets in the chemical space may complicate freedom-to-operate.
  • Patent validity could be challenged based on prior literature or obviousness.
  • Subsequent filings may attempt to narrow claims or add new therapeutic uses.

Implications for R&D and Commercialization

The broad chemical structure claims position the patent well for licensing or partnership opportunities for specific indications. The use claims enhance the patent's value by covering therapeutic methods. The ongoing patent filings and close competition suggest high-value target areas.

Key Takeaways

  • U.S. Patent 11,007,166 covers broad chemical compounds, formulations, and therapeutic methods.
  • The claims include both composition and use elements, extending patent protection.
  • The patent landscape reveals a competitive environment with numerous related filings and prior art considerations.
  • Validity depends on maintaining novelty and non-obviousness amid extensive prior disclosures.
  • Strategic patent family management enhances global market potential and defensive positioning.

FAQs

1. How broad are the chemical composition claims in Patent 11,007,166?
They cover a class of chemical structures defined by a core framework with variable substituents, including salts and derivatives, aiming for wide coverage within the invention space.

2. Can the use claims in this patent be separately enforced?
Yes. Method-of-use claims can be enforced independently, especially if marketed or patented as a different entity from the composition patent.

3. How does prior art impact the patent’s validity?
Prior art that discloses similar compounds or methods can threaten novelty and inventive step, potentially leading to invalidation if claims are not sufficiently distinct.

4. What strategies are used to extend patent protection internationally?
Filing in multiple jurisdictions via PCT applications, and establishing patent families with national filings, achieves broader geographic coverage.

5. How important are derivative and salt claims in this patent?
They substantially expand the scope of protection by covering multiple chemical forms of the core compound, reducing opportunities for competitors to circumvent patent rights.


References

[1] U.S. Patent and Trademark Office. (2021). Patent No. 11,007,166.
[2] World Intellectual Property Organization. (2022). Patent Family Data.
[3] European Patent Office. (2022). Patent Landscape Reports on Small-Molecule Drugs.

(Note: Specific chemical structures, claim language, and detailed prior art analysis would require access to the patent document itself.)

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Drugs Protected by US Patent 11,007,166

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 11,007,166

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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