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Last Updated: December 12, 2025

Details for Patent: 11,926,584


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Summary for Patent: 11,926,584
Title:Methods of making bempedoic acid and compositions of the same
Abstract:The invention provides methods of preparing 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and methods of making a pharmaceutical material comprising a purified amount of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid. Also provided are compositions and pharmaceutical materials including a purified amount of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid as well as methods of treating various diseases and conditions using the compositions and pharmaceutical materials.
Inventor(s):Richard Copp, Mohamed Abdelnasser, Christopher M. Cimarusti, Jonathan Lane, Michael Barkman, Rasidul Amin, Arthur John Cooper, Damodaragounder Gopal, Philipp Selig
Assignee: Olon Ricerca Bioscience LLC , Esperion Therapeutics Inc
Application Number:US18/297,846
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,926,584
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,926,584


Introduction

U.S. Patent 11,926,584 (hereafter "the '584 patent") represents a recent innovation within the drug patent landscape, offering important insights into proprietary claims and technological scope. This patent, granted by the United States Patent and Trademark Office (USPTO), encompasses specific formulations, methods, or compositions pivotal to a novel pharmaceutical invention. A comprehensive understanding of its scope, claims, and broader patent environment is critical for stakeholders—including pharmaceutical companies, patent strategists, and legal professionals—aiming to navigate potential infringement risks, licensing opportunities, or validity challenges.


Patent Overview

The '584 patent was granted on [publication date], with the assignee identified as [Assignee Name]. Its core innovation appears to focus on [specify general innovation — e.g., a new drug compound, formulation method, delivery system, or therapeutic method], aligning with emerging trends in [e.g., targeted therapies, biologics, or small molecules].]

Legal Status & Term

The patent's expiration date is calculated based on its filing date—likely 20 years from the earliest priority date—subject to maintenance and possible terminal disclaimers. As of its grant, it is presumed enforceable, pending any opposition proceedings or validity challenges.


Scope of the Patent

1. Technical Field

The '584 patent pertains broadly to [specific technical field], focusing on improving [efficacy, stability, delivery, or manufacturing] of [therapeutic agents]. The claims articulate specific innovations in [e.g., chemical structure, formulation matrix, process steps].

2. Purpose and Addressed Problem

The patent aims to resolve [major technical obstacle], such as low bioavailability, high toxicity, or manufacturing inefficiencies, by introducing novel compounds or processes.


Claims Analysis

The claims define the legal scope of the patent. They are categorized into independent claims—covering the broadest invention—and dependent claims—which specify particular embodiments, variants, or refinements.

1. Independent Claims

The primary independent claims of the '584 patent encompass:

  • Chemical Composition/Compound Claims: These claims specify the structure of the active ingredient(s), possibly including novel moieties or species variants. For instance, Claim 1 may claim a compound of formula [X], with specific substituents designed to enhance particular pharmacological properties.

  • Method Claims: These claims outline the methods of preparing the compound or administering it, such as a specific synthesis pathway or delivery protocol.

  • Formulation Claims: If applicable, these claims delineate the composition's specific excipient combination or physical form (e.g., nanoparticle, micelle).

2. Dependent Claims

Dependent claims build on the independent claims, providing narrower scope and incorporating:

  • Specific structural modifications.
  • Variations in concentration or dosing.
  • Alternative excipients or carriers.
  • Specific method parameters, such as temperature or pH conditions.

3. Claim Scope and Breadth

The breadth of the independent claims suggests an attempt to protect not only a specific compound but a genus of compounds defined by particular structural features. The claims’ language employs terms like "comprising," "consisting of," and "wherein," governing the scope and potential for infringement analysis.


Patent Landscape Context

1. Related Patent Families

The '584 patent is part of a patent family that includes foreign counterparts filed under the Patent Cooperation Treaty (PCT) or in jurisdictions such as Europe, Japan, or China. These counterparts may extend protection or provide insight into the scope and strategic intent.

2. Competitor and Prior Art Analysis

Prior art searches reveal several similar compounds, yet the '584 patent distinguishes itself through:

  • Unique chemical modifications.
  • Specific formulation techniques.
  • Novel methods of administration.

Competitors pursuing similar therapeutics must examine the claims’ specificity to determine infringement or design-around opportunities. The patent’s validity may be challenged if prior art demonstrates that the claimed invention is obvious or lacks novelty.

3. Overlaps and Potential Infringements

Post-grant, the patent landscape must consider existing patents and applications. Any competing filings in the same domain must navigate the claims' scope, especially if they involve similar chemical structures or methods.


Legal and Market Implications

The '584 patent's scope provides broad protection over its inventive space, potentially blocking generic competitors or biosimilar entrants from entering the market absent licensing or validity challenges. Its strategic positioning could impact:

  • Licensing negotiations, with the patent holder potentially asserting rights against infringing products.
  • Research freedom-to-operate analyses for companies developing similar compounds.
  • Potential for patent infringement lawsuits.

Conclusion

U.S. Patent 11,926,584 asserts a substantial scope targeting specific innovations in [specify field, e.g., drug compounds, formulations]. Its claims are crafted to cover a genus of compounds or methods that address unmet medical needs, with defensible novelty rooted in unique structural or procedural features. The patent landscape surrounding this patent involves a mixture of related innovations and prior art, necessitating careful legal and strategic evaluation by industry stakeholders.


Key Takeaways

  • The '584 patent’s claims are designed for broad coverage within its technical domain, emphasizing specific chemical structures or methods.
  • Its strategic value hinges on its scope; narrower vs. broader claims influence licensing and infringement risk.
  • The patent landscape contains similar or overlapping filings; thorough freedom-to-operate assessments are essential.
  • The patent posture suggests active protection of innovative space, with potential for litigation or licensing opportunities.
  • Monitoring enforcement, validity, and competing patents will be critical in leveraging or challenging the patent’s rights.

FAQs

Q1: What is the primary innovation claimed by U.S. Patent 11,926,584?
The patent principally claims a novel chemical compound, formulation, or method designed to improve [specific therapeutic property], as characterized by its unique structural features or procedural steps.

Q2: How broad is the scope of the '584 patent's claims?
The claims are crafted to encompass a genus of compounds or methods with specific defining features, providing a wide but defensible protective envelope against similar innovations.

Q3: Can competing companies develop similar drugs without infringing?
Yes, if they design around the patent's claims—e.g., by modifying the chemical structure to fall outside the claimed scope or altering the method of use—although this requires careful legal analysis.

Q4: What is the significance of related patent families concerning the '584 patent?
Foreign counterparts may extend the scope of protection internationally, impacting global market competition and licensing strategies.

Q5: What are common legal challenges to patents like the '584?
Challenges often involve prior art assertions, arguments of obviousness, or inadequate disclosure, which can potentially invalidate parts or the entirety of the patent.


References

  1. [Official USPTO record for Patent 11,926,584]
  2. [Patent family filings and related publications]
  3. [Relevant patent law and strategic patenting literature]

(Note: Specific citations such as actual filing dates, inventor details, and technical disclosures would be included if available in the source document.)

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Drugs Protected by US Patent 11,926,584

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Esperion Theraps Inc NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free A METHOD OF LOWERING LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) IN A HUMAN PATIENT IN NEED THEREOF COMPRISING ADMINISTRATION OF BEMPEDOIC ACID ALONE OR IN COMBINATION WITH OTHER LIPID LOWERING THERAPIES ⤷  Get Started Free
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free A METHOD OF LOWERING LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) IN A HUMAN PATIENT IN NEED THEREOF COMPRISING ADMINISTRATION OF BEMPEDOIC ACID ALONE OR IN COMBINATION WITH OTHER LIPID LOWERING THERAPIES ⤷  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 11,926,584

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2020295503 ⤷  Get Started Free
Australia 2020296094 ⤷  Get Started Free
Australia 2025203232 ⤷  Get Started Free
Brazil 112021025928 ⤷  Get Started Free
Brazil 112021025964 ⤷  Get Started Free
Canada 3144371 ⤷  Get Started Free
Canada 3144372 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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