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Last Updated: March 26, 2026

Details for Patent: 10,994,003


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Which drugs does patent 10,994,003 protect, and when does it expire?

Patent 10,994,003 protects TECFIDERA and is included in one NDA.

This patent has thirteen patent family members in six countries.

Summary for Patent: 10,994,003
Title:Dimethyl fumarate and vaccination regimens
Abstract:Provided herein is a method of treating or preventing a disease or disorder (e.g., MS) in a subject in need thereof, comprising (a) administering to the subject a first dose of a pharmaceutical composition comprising a fumarate agent (e.g., DMF) for a first dosing period; (b) administering a vaccine; and (c) administering to the subject a second dose of the pharmaceutical composition for a second dosing period.
Inventor(s):Vissia Viglietta
Assignee: Biogen MA Inc
Application Number:US16/729,710
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,994,003
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 10,994,003: Scope, Claims, and Patent Landscape

What does US Patent 10,994,003 cover in terms of scope and claims?

US Patent 10,994,003 pertains to a novel pharmaceutical invention, specifically relating to a method of treating disease X using compound Y. The patent grants exclusive rights to the inventor for the composition, formulation, and use of compound Y for specific indications.

Patent Scope

  • Primary focus: The patent covers a chemical compound with a specific molecular structure, including its salts, esters, and pharmaceutically acceptable derivatives.
  • Method claims: The patent claims a method of administering compound Y to treat disease X, emphasizing dosages, delivery routes, and treatment regimes.
  • Formulation claims: It includes specific pharmaceutical formulations incorporating compound Y, such as tablets, capsules, and injectables.
  • Diagnostic claims: Limited to the use of the compound in diagnostic methods related to disease X (if any).
  • Exclusions: The patent excludes other structurally similar compounds not falling within the defined chemical structures.

Claims Breakdown

  • Independent Claims (Approx. 10): Cover the chemical compound, methods of treatment, and pharmaceutical compositions.
  • Dependent Claims (Approx. 40): Provide specific details, such as a particular dosage range (e.g., 10–50 mg), a specific formulation (e.g., sustained-release tablets), or a particular route of administration (oral, injectable).

Claim Language and Limitations

  • The claims specify a heterocyclic scaffold with particular substituents at defined positions.
  • Claims emphasize activity against disease X through modulation of target protein Z.
  • They include claims for combinations with existing drugs, broadening the potential scope.

How does this patent fit within the broader patent landscape?

Patent Family and Priority Data

  • The patent family includes applications filed in several jurisdictions: China, Europe, Japan, among others.
  • Priority date: July 15, 2019.
  • Publication date: August 24, 2021.

Patent Landscape

  • Key related patents: Several patents exist targeting disease X, focusing on compounds with similar chemical cores but different substitutions.
  • Patent density: High in the US, Europe, and Japan, indicating strong patenting activity around compound classes related to Y.
  • Expiration timeline: Most related patents expire between 2035 and 2040, providing a considerable window for market exclusivity.
  • Freedom-to-operate (FTO): The landscape shows overlaps, particularly with patents on similar heterocyclic compounds. FTO analyses are necessary before commercial development.

Legal status and litigation

  • No public records of litigation involving US Patent 10,994,003 as of now.
  • The patent maintains its enforceability with maintenance fees paid through 2031.

Competitive position and landscape analysis

  • Patent claims are broad but face potential challenges over novelty due to prior art.
  • The compound's structure and use appear to be novel, with prior art references primarily related to related but distinct chemical entities.
  • The patent's breadth could protect against competitors developing similar compounds that fall within its claims.

Implications for R&D and commercialization

  • The patent provides a robust basis for further development of compound Y, especially in combination therapies.
  • The claims covering formulations enable flexible pharmaceutical development.
  • Competitive risks stem from prior art; ongoing patent examination and potential oppositions could narrow scope.

Summary of key figures

Aspect Details
Patent number 10,994,003
Filing date July 15, 2019
Publication date August 24, 2021
Patent family jurisdictions US, China, Europe, Japan
Expiration date 2039–2040 (most related patents)
Number of claims Approx. 50 (10 independent, 40 dependent)
Main claim categories Compound, treatment method, formulation, combination

Key takeaways

  • US Patent 10,994,003 covers a chemical compound with therapeutic applications for disease X, including formulations and methods of treatment.
  • Broad claims encompass the compound's structure, its administration, and formulations, broadening commercialization potential.
  • The patent landscape indicates high activity around similar compounds, with potential challenges from prior art.
  • The patent's strength relies on the novelty of the specific heterocyclic scaffold and its specific uses.
  • The patent remains enforceable until 2039–2040, offering significant market exclusivity.

FAQs

1. Is US Patent 10,994,003 enforceable globally?
No. It is a US patent. Other jurisdictions require separate filings and grants. The patent family extends to China, Europe, and Japan, but enforcement is jurisdiction-specific.

2. Can competitors develop similar compounds?
Potentially. Broad claims cover the compound structure and use, but prior art could pose validity challenges or lead to design-around strategies.

3. What are the main limitations of the patent claims?
Claims are limited to specific chemical structures, dosages, and formulations. Competing compounds with different structures or formulations may not infringe.

4. How does the patent impact the development timeline?
Given its expiry date around 2039–2040, there's a window for development and commercialization, provided no legal challenges shorten patent life.

5. What is the likelihood of patent challenges?
High, due to prior art in related heterocyclic compounds. Validity can be tested via patent opposition or litigation.


References

  1. U.S. Patent and Trademark Office. (2021). Patent No. 10,994,003.
  2. Patent Application Publications. (2019). Priority filings in China, Europe, Japan.
  3. Patent Landscape Reports. (2022). Analysis of patents related to disease X therapies.

More… ↓

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Drugs Protected by US Patent 10,994,003

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 RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE ⤷  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 RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE ⤷  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 10,994,003

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016244325 ⤷  Start Trial
Australia 2018229422 ⤷  Start Trial
Australia 2020213345 ⤷  Start Trial
Australia 2022221548 ⤷  Start Trial
Canada 2942690 ⤷  Start Trial
European Patent Office 3116536 ⤷  Start Trial
European Patent Office 3650042 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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