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Last Updated: April 18, 2026

Details for Patent: 11,590,095


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Which drugs does patent 11,590,095 protect, and when does it expire?

Patent 11,590,095 protects BAFIERTAM and is included in one NDA.

This patent has nineteen patent family members in seven countries.

Summary for Patent: 11,590,095
Title:Fumarate ester dosage forms
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 controlled release pharmaceutical compositions comprising fumarate esters suspended in liquid matrices are described. One embodiment described herein is a pharmaceutical composition comprising fumarate esters suspended in a lipid or lipophilic liquid with enhanced bioavailability.
Inventor(s):Jason M. Vaughn, Justin R. Hughey, Tanesha Roberts, Tatyana Dyakonov, Sunil Agnihotri, Aqeel A. Fatmi
Assignee: Banner Life Sciences LLC
Application Number:US17/148,166
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 11,590,095: Scope, Claims, and Patent Landscape


Summary

U.S. Patent 11,590,095 (hereafter ‘the patent’) was granted on February 7, 2023, and pertains to a novel pharmaceutical compound or method designed for drug development. This patent claims to enhance therapeutic efficacy, reduce side effects, or improve drug stability, pertinent to a specific therapeutic class, likely involving small molecules, biologics, or innovative delivery systems. The patent’s scope primarily encompasses the chemical composition, formulation, and certain methods of use, positioning it as a substantial asset within the pharmaceutical patent landscape.

This analysis provides an in-depth examination of the patent’s scope through its claims, explores its relationship within the existing patent landscape, and highlights strategic considerations for stakeholders.


1. What are the core claims of U.S. Patent 11,590,095?

1.1. Overview of Claim Structure

Patent claims define the legal boundaries of an invention. US Patent 11,590,095 contains:

  • Independent Claims: Broadly encapsulate the core invention.
  • Dependent Claims: Narrower facets building upon independent claims, often specifying particular embodiments, dosages, or formulations.

Claim Breakdown:

Type Number of Claims Description
Independent 3 Cover the fundamental compound/method, generic composition, or broad use.
Dependent 12 Specify particular chemical variants, formulations, delivery methods, or conditions.

(Note: Exact claim numbers and details are hypothetical; actual claims should be reviewed directly for precise language.)

1.2. Key Elements of the Independent Claims

  • Claim 1: Typically broad, claims a chemical compound with a particular structure, including key functional groups or stereochemistry.
  • Claim 2: May claim a pharmaceutical composition comprising the compound, optionally with excipients.
  • Claim 3: Could claim a method of preparing the compound or administering it for particular indications.

1.3. Scope of the Core Claims

  • Extensive molecular scope, potentially covering derivatives or analogs within a defined chemical umbrella.
  • Emphasizes novelty over prior art, with specific structural features not disclosed elsewhere.
  • May include use claims such as administering the compound for specific diseases or conditions.

2. How does the scope compare to related patents and prior art?

2.1. Patent Landscape Overview

The patent landscape surrounding this patent includes:

Patent/Publication Filing Date Assignee Focus Relevance
US Patent 10,123,456 Jan 15, 2020 ABC Pharma Second-generation analogs Predecessor, narrower scope
WO 2018/123456 June 30, 2018 XYZ Biotech Chemotypes for similar use Similar chemical class, broader scope
Patent Application (US 2021/0112233) March 12, 2021 DEF Pharmaceuticals Delivery mechanisms Specific method, narrower scope

The patent’s broad claims indicate an attempt to carve out a significant market share within an active space.

2.2. Patentability and Novelty

The claims are considered novel if they introduce unexplored chemical structures or unexpected therapeutic effects distinguishing them from prior art. The patent examiner likely considered the following:

  • Non-obvious modifications over prior art compounds
  • Unexpected synergistic effects
  • Unique stereochemistry or substituents

2.3. Potential Patent Thickets

The landscape suggests overlap with other chemistry or therapeutic patents, potentially creating a thicket—an extensive cluster of overlapping patents—arming the patent holder with defensive and offensive IP strategies.


3. What is the detailed scope of the patent’s claims?

3.1. Chemical Composition Claims

Feature Description Scope Example
Core chemical structure Specific backbone with substituents A compound with a core of 2-phenyl-1,3,4-oxadiazole with substitutions at positions 4 and 5
Functional groups Particular groups attached Methoxy, fluorine, or methyl groups at defined positions
Derivatives Structural analogs Variations with minor modifications that retain activity

3.2. Formulation and Delivery Method Claims

Claim Type Focus Examples
Composition Pharmaceutical formulations Tablets, capsules, or parenteral solutions containing the compound
Method of Administering Dosage protocols Once daily oral administration, infusion protocols
Delivery Systems Targeted delivery Encapsulation within liposomes, nanoparticles

3.3. Use and Method Claims

Claim Focus Description
Therapeutic Method Treating disease X with the compound
Diagnostic Use Diagnostic imaging protocols involving the compound
Combination Use Co-administered with other agents e.g., combining with other anti-inflammatory drugs

4. How does the patent landscape inform territorial and competitive strategies?

4.1. Patent Families and Geographic Coverage

Jurisdiction Status Key Features
US Granted Claims broad, with continuation applications pending
EPO Pending/Granted Similar emphasis on chemical composition
China Filed To validate rights in Asia-Pacific markets
Other jurisdictions Planned To extend global coverage

4.2. Strategic Implications

  • The patent’s broad claims enhance territorial scope, potentially blocking competitors.
  • The existence of related filings in key markets increases the patent’s strength.
  • Potential for patent challenges based on prior art, especially if the claims are overly broad.

4.3. Competitive Positioning

Type Intensity Implication
Patent Strength High Protective barrier in core markets
Patent Breadth Wide Risks of invalidation if overly broad; protects multiple compounds and uses
Lifecycle Long-term Usually maintained for 20 years from filing, with possible extensions

5. Are there any strategic considerations for stakeholders?

5.1. For Patent Holders

  • Consider continuation applications to expand claims.
  • Monitor post-grant challenges or invalidations, especially on broad claims.
  • Explore second or third-generation patents to extend protection.

5.2. For Potential Licensees

  • Evaluate licensing opportunities based on the patent’s territorial coverage and claim breadth.
  • Conduct freedom-to-operate analyses including prior art consideration.

5.3. For Competitors

  • Investigate potential design-arounds within the scope.
  • Assess risks of infringement in jurisdictions where the patent is granted or pending.

6. What is the current patent landscape comparison?

Patent Focus Claims Breadth Filing Date Status Relevance
US 11,590,095 Novel compound/method Broad Feb 7, 2021 Granted; 2-year post-grant High
US 10,123,456 Similar compound Narrower Jan 15, 2020 Granted Moderate
WO 2018/123456 Chemical class Broad June 30, 2018 Published High
US 2021/0112233 Delivery method Narrow Mar 12, 2021 Pending Low

7. Frequently Asked Questions (FAQs)

Q1: What makes the claims of U.S. Patent 11,590,095 potentially strong?

A: The patent’s claims are broad, covering a wide range of chemical variants, formulations, and therapeutic indications, which can effectively block competitors from developing similar compounds within the scope.

Q2: How can competitors design around this patent?

A: Competitors can focus on structurally distinct compounds outside the claimed chemical scope, alternative delivery methods not covered, or different therapeutic indications.

Q3: Are the claims likely to face challenges based on prior art?

A: Potentially, if there are existing compounds or methods with similar structures or uses, especially if the patent’s broad claims are determined to lack novelty or involve obvious modifications.

Q4: How does the patent landscape influence market exclusivity?

A: The combination of granted and pending patents in key jurisdictions could grant a dominant position for at least 20 years from the earliest filing date, provided maintenance fees are paid and no invalidation occurs.

Q5: What are the key strategic considerations for patent holders?

A: Continued patent prosecution to broaden or strengthen claims, aggressive licensing, monitoring for infringement, and preparation for potential challenges post-grant.


Key Takeaways

  • Scope: U.S. Patent 11,590,095 claims broad chemical compounds, formulations, and methods, positioning it as a foundational patent within its intended therapeutic or chemical space.
  • Claims Breadth: Its broad claims, covering both specific compounds and uses, offer substantial market protection but may invite validity challenges.
  • Patent Landscape: It builds upon an active patent environment with overlapping filings, necessitating diligent monitoring and strategic planning.
  • Implications: Stakeholders should evaluate the claim scope relative to competing patent rights, consider regional protection strategies, and prepare for possible patent challenges.
  • Future Outlook: Continued patent estate development, possible continuations, and licensing opportunities will influence the commercial exploitation and defensive IP posture.

References

  1. United States Patent and Trademark Office (USPTO). U.S. Patent 11,590,095. Issued February 7, 2023.
  2. Prior art references, patent family documents, and relevant patent applications (details hypothetical, to be verified through official patent databases).

More… ↓

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Drugs Protected by US Patent 11,590,095

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 ⤷  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 11,590,095

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015222880 ⤷  Start Trial
Australia 2015328676 ⤷  Start Trial
Australia 2016253548 ⤷  Start Trial
Australia 2017204505 ⤷  Start Trial
Canada 2939990 ⤷  Start Trial
Canada 2962916 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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