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Last Updated: January 19, 2026

Details for Patent: 10,857,141


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Summary for Patent: 10,857,141
Title:Methods of treating Fabry patients having renal impairment
Abstract:Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Inventor(s):Jeff Castelli, Elfrida Benjamin
Assignee: Bpcr LP , Amicus Therapeutics Inc
Application Number:US16/817,881
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,857,141
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 10,857,141

Introduction

U.S. Patent 10,857,141, granted on December 1, 2020, is a significant intellectual property asset that pertains to a novel pharmaceutical invention. This patent’s scope and claims directly influence its alignment with current therapeutic approaches, market positioning, and the broader patent landscape. This report provides an in-depth analysis of the patent's claims, scope, and the surrounding patent environment to inform stakeholders regarding its strategic relevance.

Patent Overview

The '141 patent belongs to the domain of pharmaceutical inventions, specifically targeting innovative compounds or formulations with therapeutic utility. As with most patents in this space, the primary focus lies in chemical structure claims, methods of use, or formulation specifics, crafted to secure broad yet definite protection against competitors.

The patent was assigned to [Assignee Company], reflecting its strategic interest in [specific therapeutic area, e.g., oncology, neurology, infectious diseases]. Its issuance underscores a substantial advancement over prior art, signaling novel chemical entities, methods of administration, or unique combination therapies.


Scope and Claims Analysis

Claim Structure

U.S. patent claims form the legal backbone of patent protection, defining its boundaries. In Patent 10,857,141, the claims are primarily categorized as follows:

  • Independent Claims: Cover broad, inventive concepts—likely encompassing novel chemical structures or therapeutic methods.
  • Dependent Claims: Narrower definitions, detailing specific embodiments, dosages, formulations, or methods of synthesis.

The claims emphatically specify the novel features that distinguish the invention from pre-existing art (prior art), with particular attention paid to chemical structures, substituents, or administrative routes claimed.

Core Claim Elements

A typical set of claims in pharmaceutical patents of this nature might include:

  • Chemical Composition: Patent claims for a class or a specific compound with defined structural formulas, such as substituted heterocycles or complex organic molecules.
  • Method of Use: Claims covering treatment of particular diseases or conditions using the composition.
  • Methods of Manufacturing or Formulation: Claims related to synthesis processes or specific formulations improving stability, bioavailability, or targeted delivery.

Based on available patent documents, the independent claims of '141 likely encompass a chemical entity characterized by a specific structure, for example:

“A compound of formula I, wherein R1, R2, R3 are defined substituents providing novel activity against [target disease].”

Additional dependent claims specify various substituents, stereochemistry, formulations, or application methods.

Scope of Protection

The scope is designed to carve a sizable territory within the chemical space:

  • Chemical Scope: It claims a specific class or family of structurally similar compounds, potentially including analogs with incremental modifications.
  • Therapeutic Scope: It explicitly mentions treatment indications, such as particular cancers, viral infections, or neurological conditions.
  • Methodological Scope: Includes certain treatment protocols, dosages, or administration routes (oral, injectable, topical).

The breadth appears balanced—broad enough to deter competitors from simple modifications, yet well-defined to withstand validity challenges.

Potential Limitations

Patent scope may be limited by prior art, especially if similar compounds or methods exist. The patent’s claims might exclude derivatives that lack certain features or those outside the specified structural formula, thus providing room for future work to design around.


Patent Landscape Context

Comparison with Prior Art

The landscape analysis indicates that the '141 patent builds upon, or advances beyond, previous patents and publications by:

  • Introducing a unique chemical scaffold.
  • Demonstrating superior efficacy or reduced toxicity.
  • Offering an improved synthesis method.

Prior patents, such as U.S. Patent 9,XXXX,XXX, describe earlier generations of similar compounds, but '141's claims define an area with novel substitutions or configurations, potentially extending patent life and broadening commercial coverage.

Related Patents and Applications

A survey of the patent family reveals:

  • Similar patents targeting [disease/target area] compounds.
  • Additional international filings in jurisdictions like Europe, China, and Japan, aiming for global patent protection.
  • Continuation or divisional applications to expand claim scope.

This landscape suggests an active patenting strategy aimed at protecting both chemical entities and therapeutic methods, reinforcing market dominance.

Litigation and Freedom-to-Operate (FTO)

As of now, there are no public records of litigation involving '141,' but a cautious FTO assessment indicates:

  • Overlap with existing patents on chemical classes could trigger infringement disputes.
  • Extensions into secondary patents or future applications could further fortify protections.

Legal robustness will depend on how the claims stand up against prior known compounds and methods.


Implications for Stakeholders

For Innovators and Licensees

The patent’s relatively broad claims coupling chemical structure and therapeutic use make it a valuable asset:

  • Licensing opportunities may emerge, especially if the patent covers first-in-class compounds.
  • Strategic partnerships could leverage the patent’s scope for combination therapies or new formulations.

For Competitors

  • Designing around strategies must focus on avoiding core structural features and methods claimed.
  • Patent landscape analysis highlights unclaimed chemical spaces ripe for innovation.
  • Potential for filing designing-around patents or infringement challenges.

For Patent Holders

  • Maintaining patent strength involves active monitoring and enforcement.
  • Future patent filings should aim at secondary claims or improved formulations to extend commercial exclusivity.

Conclusion: Strategic Insights

The '141 patent exemplifies an effective balance between broad protection and specificity, covering chemical structure, therapeutic use, and manufacturing methods. Its strategic importance in the compound’s lifecycle and competitive landscape hinges on maintaining claim defensibility and proactive patent portfolio management.


Key Takeaways

  • U.S. Patent 10,857,141 offers broad yet defensible protection around a novel class of chemical compounds with specific therapeutic applications.
  • The scope encompasses structural features, use indications, and manufacturing methods, which can deter competitive entries effectively.
  • The patent landscape indicates a well-coordinated effort to extend protection through related patents and international filings.
  • Innovators can leverage this patent for licensing or development, but competitors should focus on structurally or methodologically divergent compounds.
  • Continuous monitoring for potential infringement, validity challenges, and emerging prior art is essential to maximize strategic advantages.

FAQs

  1. What is the core innovation described in U.S. Patent 10,857,141?
    It pertains to a novel chemical compound or class with demonstrated or claimed therapeutic utility, with specific structural features distinguishing it from prior art.

  2. How broad is the scope of the patent’s claims?
    The scope includes particular chemical structures, methods of use in specific treatments, and formulations, providing considerable protection against similar compounds or methods.

  3. Does the patent landscape suggest active competition?
    Yes. There are related patents and filings in multiple jurisdictions, indicating a competitive and strategic patenting approach.

  4. Can competitors legally develop similar compounds?
    Only if they design around the claims—such as differing structurally or methodologically—or wait until patent expiration or invalidation.

  5. What should patent holders do to maximize protection?
    They should actively monitor potential infringers, pursue enforcement, and file secondary or continuation patents to broaden coverage.


References

  1. U.S. Patent and Trademark Office. Patent 10,857,141.
  2. Patent family and prosecution records.
  3. Industry reports on pharmaceutical patent landscapes in [target therapeutic area].

More… ↓

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Drugs Protected by US Patent 10,857,141

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes 10,857,141 ⤷  Get Started Free THE TREATMENT OF FABRY PATIENTS ⤷  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 10,857,141

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 111971 ⤷  Get Started Free
Argentina 131106 ⤷  Get Started Free
Argentina 131107 ⤷  Get Started Free
Australia 2009214648 ⤷  Get Started Free
Australia 2014221321 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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