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Last Updated: May 24, 2025

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 twelve 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): Viglietta; Vissia (Boston, MA)
Assignee: Biogen MA Inc. (Cambridge, MA)
Application Number:16/729,710
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 10,994,003: A Comprehensive Guide

Understanding the Patent System

Before diving into the specifics of United States Patent 10,994,003, it is crucial to have a basic understanding of the patent system in the United States. The U.S. Patent and Trademark Office (USPTO) is the agency responsible for granting U.S. patents and registering trademarks[2].

Patent Search and Analysis

To analyze the scope and claims of a patent, one must first locate and review the patent document. The USPTO provides several tools for searching patents, including the Patent Public Search tool, which replaced older search tools like PubEast and PubWest. This tool offers enhanced access to prior art and improves the overall patent searching process[4].

Locating Patent 10,994,003

To find the specific patent, you can use the Patent Public Search tool on the USPTO website. Enter the patent number, "10,994,003," into the search bar to access the patent document.

Reading and Interpreting the Patent Document

Patent Title and Abstract

The title and abstract provide a brief overview of the invention. Understanding these sections helps in grasping the general scope of the patent.

Claims

The claims section is the most critical part of a patent document as it defines the scope of the invention. Claims are typically divided into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims[1].

Description and Drawings

The detailed description and drawings provide a comprehensive explanation of the invention. This section often includes examples, embodiments, and explanations of how the invention works.

Analyzing the Scope of Patent 10,994,003

Claim Charts and Scope Concepts

To analyze the scope of the patent, you can use claim charts, such as those generated by ClaimScape® software. These charts help in reviewing the patent coverage with engineers, scientists, and management. They categorize the scope concepts of the patent claims into high, medium, or low value, indicating their current and potential future importance to the company[3].

Identifying Gaps and Opportunities

Claim charts also highlight areas where there are gaps in the current claim coverage, indicating potential future design opportunities. This is crucial for determining whether the patent adequately protects the intellectual property and where additional patent filings might be necessary.

Patent Landscape Analysis

Global Dossier

Using the Global Dossier service, you can view the file histories of related applications from participating IP Offices. This helps in understanding the patent family for a specific application, including all related applications filed at participating IP Offices, along with the dossier, classification, and citation data[4].

Common Citation Document (CCD)

The CCD application consolidates prior art cited by all participating offices for the family members of a patent application. This allows for a single-point access to up-to-date citation data, facilitating a more integrated view of the global patent landscape[4].

Legal and Practical Considerations

Patent Eligibility

Ensuring that the patent meets the eligibility criteria under U.S. patent law is essential. This involves proving that the invention is novel, non-obvious, and useful. The USPTO's guidance on proving patent eligibility under step two of the Alice test is critical in this analysis[1].

Potential for Litigation

Understanding the potential for litigation is important. For instance, the concept of a small claims patent court, as studied by the Administrative Conference of the United States (ACUS), could impact how patent disputes are resolved in the future. This study considered the feasibility and structure of such a court, which could affect how patent holders and challengers approach disputes[5].

Industry Expert Insights

Industry experts often provide valuable insights into the practical implications of patent claims and scope. For example, Andrei Iancu, former Undersecretary of Commerce for IP and Director of the USPTO, has emphasized the importance of clear and definite claims in patent applications to avoid ambiguity and potential litigation[5].

Illustrative Statistics

  • Patent Filings: The number of patent filings can indicate the competitive landscape. For instance, in recent years, there has been a significant increase in patent filings in certain technology sectors, reflecting the growing importance of intellectual property in these areas.
  • Litigation Rates: Statistics on patent litigation rates can also provide insights into the enforceability and value of patents. According to some studies, patents with clearer and more definite claims are less likely to be involved in litigation.

Key Takeaways

  • Comprehensive Search: Conduct a thorough search using tools like the Patent Public Search and Global Dossier to understand the patent landscape.
  • Claim Analysis: Use claim charts to analyze the scope and value of the patent claims.
  • Legal Compliance: Ensure the patent meets all eligibility criteria under U.S. patent law.
  • Industry Insights: Consider insights from industry experts to understand practical implications.
  • Litigation Preparedness: Be aware of potential litigation scenarios and the evolving legal landscape.

FAQs

Q: How do I locate a specific patent document on the USPTO website?

A: You can use the Patent Public Search tool on the USPTO website and enter the patent number to access the document.

Q: What is the importance of claim charts in patent analysis?

A: Claim charts help in reviewing patent coverage, identifying gaps, and determining the value and future potential of the patent claims.

Q: How does the Global Dossier service aid in patent landscape analysis?

A: The Global Dossier service provides access to file histories of related applications from participating IP Offices, helping to understand the patent family and related applications.

Q: What are the key criteria for patent eligibility under U.S. law?

A: The invention must be novel, non-obvious, and useful to meet the eligibility criteria.

Q: Why is the concept of a small claims patent court important?

A: It could simplify and reduce the cost of resolving patent disputes, making it more accessible for smaller entities to enforce their intellectual property rights.

Sources

  1. BitLaw: Patent Law in the United States - BitLaw
  2. USAGov: U.S. Patent and Trademark Office (USPTO) | USAGov
  3. SLWIP: Patent Analytics | Intellectual Property Law
  4. USPTO: Search for patents - USPTO
  5. ACUS: U.S. Patent Small Claims Court

More… ↓

⤷  Try for Free


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 10,994,003 ⤷  Try for Free METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE ⤷  Try for Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 AB RX Yes Yes 10,994,003 ⤷  Try for Free METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE ⤷  Try for Free
>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 ⤷  Try for Free
Australia 2018229422 ⤷  Try for Free
Australia 2020213345 ⤷  Try for Free
Australia 2022221548 ⤷  Try for Free
Canada 2942690 ⤷  Try for Free
European Patent Office 3116536 ⤷  Try for Free
European Patent Office 3650042 ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.