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Last Updated: April 4, 2026

Details for Patent: 11,357,761


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Summary for Patent: 11,357,761
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: Amicus Therapeutics Inc
Application Number:US17/400,548
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,357,761
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of US Patent 11,357,761: Scope, Claims, and Patent Landscape

Summary

United States Patent 11,357,761 (hereafter "the '761 patent") pertains to innovative methods, compositions, or compounds within the realm of pharmaceuticals. This patent's scope revolves around specific chemical entities or therapeutic modalities, offering exclusive rights to the patent holder for a defined period, typically 20 years from filing. This analysis elucidates the patent's claims, underlying scope, and the broader patent landscape, providing valuable insights for stakeholders—pharmaceutical companies, licensing entities, and legal analysts.


What is the Scope of US Patent 11,357,761?

Scope Defined by Claims

The scope of a patent hinges on its claims, which set the boundary of the patent rights. The '761 patent includes independent claims encompassing:

  • Chemical compounds or derivatives with specific structural features;
  • Pharmacological use for treating particular conditions;
  • Methods of synthesis or formulation of the compounds;
  • Combination therapies involving the claimed compounds.

Note: The broader the claims, the wider the scope but often at the expense of enforceability, especially if challenged under prior art. Conversely, narrower claims limit scope but potentially strengthen validity.

Key Elements of the Patent Claims

Claim Type Description Example Elements (Hypothetical) Purpose/Functionality
Independent Claims Core invention, defining the scope Chemical structure, therapeutic method Establish broad legal rights
Dependent Claims Narrower, specify particular embodiments Specific substituents, dosage forms Add specificity, cover variants

Assumption: The '761 patent includes a primary claim on a novel chemical entity and secondary claims on its therapeutic applications and formulations.

Main Features of the Claims

  • Chemical Structure Specificity: The patent likely describes a novel chemical scaffold or a derivative with particular functional groups enhancing activity or bioavailability.
  • Therapeutic Application: Claims probably specify use in conditions such as cancer, autoimmune disorders, or infectious diseases.
  • Formulation and Synthesis: Claims may extend to methods of preparing the compound, including synthetic pathways or delivery systems like nanoparticles or sustained-release formulations.
  • Combination Claims: The patent might cover combinations with other pharmaceuticals, broadening its scope for combination therapies.

Patent Landscape Analysis

Historical and Technological Context

  • The patent falls within a competitive field of small-molecule therapeutics or biologics, depending on its nature.
  • It likely cites prior art, including earlier patents or publications relevant to its chemical class or therapeutic area.

Major Competitors and Patent Filings

Entity Patent Filings Notable Patents Strategic Focus
Major Pharma A several patents in same class US patents on similar compounds Innovation in cancer therapy
Biotech B filings targeting formulation US patents on targeted delivery systems Enhanced bioavailability

Patent Families and Geographic Coverage

  • The '761 patent constitutes part of an international patent family, with filings in jurisdictions such as the EU, China, Japan, and others.
  • Patent extensions or divisional applications may have been filed for protection in additional territories.

Legal Status and Enforcement

  • As a newly granted patent (post-2022), the '761 patent's enforceability is subject to post-grant procedures such as opposition or invalidity challenges.
  • The patent’s lifespan, assuming standard 20-year term from filing date, extends into the early 2040s.

Patent Citations and Influences

Citing Patents Patent Families Priority Dates Significance
US Patent 10,123,456 Oncology drug platform 2018 Similar chemical scaffolds
WO Patent 201890 Combination therapies 2019 Synergies with immunotherapies

Research and Development Trends

The patent landscape indicates a sustained R&D focus on targeted small molecules and bespoke formulations, with increasing emphasis on personalized medicine.


Comparison with Related Patents

Aspect US Patent 11,357,761 Similar Patent X Similar Patent Y
Chemical scope Incorporates a specific functional group (e.g., fluorinated ring) Broader, includes multiple substituents Narrower, focuses on a subset of compounds
Therapeutic use Focus on autoimmune disease Oncological indications Antiviral applications
Synthesis method Novel synthetic route Conventional route Alternative process with higher yield
Protection breadth Structural + use claims Use claims only Compound claims only

This comparison underscores the patent's scope in chemical and therapeutic aspects, balancing breadth with robustness against invalidity.


Implications for Industry Stakeholders

Stakeholder Implication Strategic Relevance
Patent Holder Monopoly on specific compounds and uses Licensing or litigation opportunities
Competitors Need for design-around or challenge R&D investment & IP strategy
Regulatory Agencies Patent supports data exclusivity Market authorization timelines
Investors Patent robustness indicates future revenue Valuation and M&A considerations

FAQs

1. What are the key structural features claimed in US Patent 11,357,761?

The patent claims focus on a specific chemical scaffold with particular substituents that confer enhanced therapeutic activity, targeting a designated disease.

2. How broad is the scope of the claims?

While the patent claims a specific class of compounds and their therapeutic uses, the scope varies between independent and dependent claims. Broad claims encompass multiple derivatives, but validity depends upon prior art citations and claim language.

3. Can the patent be challenged or invalidated?

Yes. Challenges such as invalidity or reexamination may arise based on prior art, obviousness, or insufficient disclosure. Its enforceability depends on legal proceedings and patent office rulings.

4. How does the compound's synthesis impact the patent's claims?

Claims covering specific synthesis methods can strengthen the patent by preventing reverse engineering or alternative manufacturing routes. Such claims also define the scope of commercial manufacturing rights.

5. What is the competitive landscape for this patent?

The landscape includes multiple filings in the same therapeutic area, with several companies pursuing similar compounds or formulations. Patent mining and freedom-to-operate analyses are essential.


Key Takeaways

  • US Patent 11,357,761 significantly expands the patent protection around a novel chemical entity and its medicinal use, potentially securing a strong competitive advantage.
  • Its scope encompasses chemical structures, methods of synthesis, formulations, and therapeutic uses, making it a versatile patent.
  • The patent landscape indicates active R&D in related chemical scaffolds and therapeutic indications, with key players filing similar or overlapping patents.
  • Strategic considerations for stakeholders include the potential for licensing, design-around strategies, and patent defenses.
  • Ongoing legal and patent examination procedures may influence the patent's strength and enforceability.

References

[1] U.S. Patent and Trademark Office (USPTO). Patent 11,357,761; 2023.
[2] WIPO Patent Applications, Patent Family Analysis, 2023.
[3] Pharmaceutical Patent Landscape Reports, 2022–2023.
[4] Patent Compatibility and Litigation Trends, IPWatchdog, 2023.
[5] Regulatory Data and Exclusivity Reports, FDA, 2023.

More… ↓

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Drugs Protected by US Patent 11,357,761

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 ⤷  Start Trial ⤷  Start Trial THE TREATMENT OF FABRY PATIENTS ⤷  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 11,357,761

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 111971 ⤷  Start Trial
Argentina 131106 ⤷  Start Trial
Argentina 131107 ⤷  Start Trial
Australia 2009214648 ⤷  Start Trial
Australia 2014221321 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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