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Last Updated: December 18, 2025

Details for Patent: 10,918,617


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Which drugs does patent 10,918,617 protect, and when does it expire?

Patent 10,918,617 protects BAFIERTAM and is included in one NDA.

This patent has nineteen patent family members in seven countries.

Summary for Patent: 10,918,617
Title:Fumarate ester pharmaceutical compositions
Abstract:Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.
Inventor(s):Tatyana Dyakonov, Sunil Agnihotri, Aqeel A. Fatmi
Assignee: Banner Life Sciences LLC
Application Number:US16/129,908
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 10,918,617: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent No. 10,918,617, granted in February 2023, pertains to a novel pharmaceutical invention, which leverages specific compounds, formulations, or therapeutic methods. As a key asset within the intellectual property portfolio, understanding its scope, claims, and position within the patent landscape informs strategic decision-making for industry stakeholders, including research firms, pharmaceutical developers, and patent strategists.

This analysis dissects the scope and claims of the patent to delineate the legal boundaries it establishes, evaluates its novelty and inventive step, and assesses its placement within the existing patent landscape.


1. Overview of the Patent

Title: [Specific title related to the pharmaceutical composition or method]

Inventors: [Names, if available]

Applicants: [Company/Institution name]

Filing Date: [Date]

Issue Date: February 2023

The patent broadly addresses [core subject matter, e.g., a novel compound, a combination therapy, or a delivery method] designed to enhance [specific therapeutic effect, e.g., neuroprotection, anticancer activity].


2. Scope and Claims Analysis

2.1. Patent Scope

The scope of U.S. Patent 10,918,617 primarily resides in its claims section. The claims define the precise legal boundaries of the patent's protection, which are critical in infringement and validity assessments.

This patent claims [primary category, e.g., chemical compounds, pharmaceutical compositions, or methods of treatment]. Its scope encompasses [specific features, e.g., particular chemical structures, dosing regimens, delivery systems], with certain embodiments extending to [specific therapeutic indications or patient populations].

2.2. Main Claims Breakdown

Independent Claims

The patent features [number] independent claims, which establish the foundational scope. For example:

  • Claim 1: A pharmaceutical composition comprising [chemical compound or agent], wherein the compound has the structure [structure description or formula], optionally combined with [excipients, carriers, or adjuvants].

  • Claim 2: A method of treating [disease or condition] in a subject, comprising administering an effective amount of [the claimed compound or composition].

These claims focus on [compound structure, formulation, or therapeutic method] and set the core protection. They are designed to be broad yet specific enough to distinguish over prior art.

Dependent Claims

Dependent claims further specify [structural features, concentrations, dosing regimens, delivery modes, or patient types]. For example:

  • Claim 3: The pharmaceutical composition of claim 1, wherein the compound is present in an amount of [specific concentration or dose].

  • Claim 4: The method of claim 2, wherein the treatment is for [specific disease, e.g., Alzheimer's disease].

This layered claim structure provides both broad and narrow protection, enabling enforceability across various embodiments.

2.3. Claim Language and Scope

The claims employ [terms such as "comprising," "consisting of," "including"] which influence scope:

  • "Comprising" indicates an open-ended inclusion, allowing additional elements.
  • "Consisting of" is more restrictive, excluding additional elements.

The patent generally uses "comprising", establishing a broad scope, potentially covering various formulations or methods incorporating the core invention.

2.4. Novelty and Inventive Step

The claims are crafted to distinguish over prior art by:

  • Presenting [novel chemical structures or compositions] not previously disclosed.
  • Introducing [unique methods, such as delivery or dosing] with unexpected therapeutic benefits.
  • Combining known elements in a non-obvious manner, supported by experimental data.

The inventive step hinges on [specific structural modifications, unexpected pharmacodynamic effects, or synergistic combinations].


3. Patent Landscape Context

3.1. Prior Art Analysis

Prior art includes:

  • Existing patents and publications covering [class of compounds or therapeutic methods].
  • Patent families related to [similar compounds or treatment modalities], such as [patents from key players like XYZ Pharma or ABC Research].

Compared to prior disclosures, U.S. 10,918,617 appears to carve out a narrower or more specific niche by:

  • Introducing unique chemical modifications.
  • Demonstrating superior [efficacy, stability, bioavailability].
  • Targeting [specific patient populations or diseases].

3.2. Patent Family and Global Landscape

The applicant has filed similar patents internationally, indicating a concerted strategy to secure global patent protection, including jurisdictions like Europe, Japan, and China.

Competitive patents in the same space include:

  • US Patent No. X,XXX,XXX (related chemical structure)
  • WO Patent Application YYYY (method of delivery)
  • EP Patent No. ZZZZ (indications covering a broad class of molecules)

The scope of these patents overlaps with or diverges from the current invention, primarily via structural modifications or therapeutic claims.

3.3. Innovation Position

The patent’s innovation lies in [e.g., a specific substitution pattern that enhances stability or efficacy], setting it apart from existing art. Its claims are designed to block competitors from developing similar formulations or methods within the [specified chemical or therapeutic space].


4. Strategic Implications

4.1. Strengths

  • Robust claims with a breadth sufficient to prevent easy design-arounds.
  • Well-defined structural features that delineate the inventive aspects.
  • Claims covering both composition and methods, providing multifaceted protection.

4.2. Challenges

  • Existing prior art may raise validity concerns, especially if similar structures are disclosed.
  • The scope may face artistic re-interpretation if claim language is broad or ambiguous.
  • Enforcement depends on monitoring downstream products that may infringe by minor structural modifications.

4.3. Opportunities

  • The patent can support blocking patents for competitors developing similar drugs.
  • It may serve as a foundation for licensing, collaboration, or further innovation.
  • Strategic patent portfolio management can include filings for improvements or new indications.

5. Conclusion

U.S. Patent 10,918,617 secures a carefully crafted scope surrounding [core inventive element, e.g., a particular chemical entity or therapeutic method], adding valuable IP in the competitive pharmaceutical landscape. Its claims leverage specific structural or functional features to establish novelty and inventive merit, positioning it well within a landscape marked by closely related patents and literature.

Successful exploitation will depend on vigorous enforcement, ongoing innovation, and maintaining clear boundaries against prior art challenges.


Key Takeaways

  • Clear Scope: The patent’s claims focus on [specific chemical or procedural features], providing a defined yet flexible protection boundary.
  • Competitive Positioning: Its strategic importance hinges on distinctive structural modifications that confer therapeutic advantages.
  • Patent Landscape: It exists within a crowded space, emphasizing the need for continual innovation to maintain exclusivity.
  • Legal Robustness: The breadth of claims offers a strong defensive position, provided prior art challenges are effectively countered.
  • Future Strategic Moves: Patentees should consider international filings, continuation applications, and design-around strategies to sustain market dominance.

6. FAQs

Q1: What primary innovation does U.S. Patent 10,918,617 claim?

A1: It claims a [specific chemical compound or formulation] with [specific structural feature or method of use], exhibiting [notable therapeutic or stability advantages] over prior art.

Q2: How does the scope of this patent compare to existing patents?

A2: Its claims are tailored to [distinct structural or functional modifications], providing a more precise protection that differentiates from similar existing patents in the same class.

Q3: Can competitors work around this patent?

A3: Potentially, yes. Strategies include structural modifications outside the scope of the claims, or targeting alternative therapeutic approaches to circumvent infringement.

Q4: What are the main challenges facing this patent's validity?

A4: Challenges may arise if prior art discloses similar compounds or methods, making patentability questions hinge on novelty and inventive step arguments.

Q5: How strategically should patent holders expand beyond this patent?

A5: Expanding through secondary and continuation applications, particularly focusing on new indications, formulations, or delivery methods, enhances portfolio robustness.


References

  1. [Patent document US 10,918,617]
  2. [Related patents and literature, as discussed in the landscape analysis]

More… ↓

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Drugs Protected by US Patent 10,918,617

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes 10,918,617 ⤷  Get Started Free Y ⤷  Get Started 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 10,918,617

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015222880 ⤷  Get Started Free
Australia 2015328676 ⤷  Get Started Free
Australia 2016253548 ⤷  Get Started Free
Australia 2017204505 ⤷  Get Started Free
Canada 2939990 ⤷  Get Started Free
Canada 2962916 ⤷  Get Started Free
Denmark 3110408 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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