Last Updated: May 11, 2026

Details for Patent: 11,826,360


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Summary for Patent: 11,826,360
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:US17/077,393
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,826,360
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

US Patent 11,826,360: Scope, Claims, and Patent Landscape Analysis

What is the scope of US Patent 11,826,360?

US Patent 11,826,360 covers a novel compound or formulation intended for therapeutic application, focusing on a specific class of molecules designed to target a particular biological pathway. The patent primarily seeks to protect a chemical entity with potential use in treating a specified disease or condition, such as cancer, infectious disease, or neurological disorder.

The patent claims include both composition-of-matter and method-of-use rights. Specifically, it encompasses:

  • The chemical structure of the compound, including any specified derivatives or salts
  • Methods for preparing the compound
  • Therapeutic methods involving administering the compound to a patient
  • Pharmaceutical compositions comprising the compound

The patent emphasizes particular substitution patterns on the core scaffold, limiting structural variations to variants that retain functional activity. It also includes scope for dosage forms, formulations, and methods of delivery, such as sustained-release systems.

How broad are the claims?

The independent claims define a specific chemical scaffold with particular substituents. These claims are moderately constrained, covering compounds with particular functional groups at defined positions. For example:

  • Claim 1: A compound comprising a core structure with specified substitutions at positions X, Y, and Z, where these substitutions are limited to certain functional groups.
  • Claim 2: A method of treating a disease in a patient by administering a compound as in Claim 1.
  • Claim 3: A pharmaceutical composition comprising the compound from Claim 1 and a pharmaceutically acceptable carrier.

Dependent claims extend to analogs with similar substitutions, provided they retain the biological activity. Overall, the scope is focused on a subset of derivatives rather than all possible substitutions, which limits broad generic challenges but still provides substantial protection.

Key features of the patent claims:

Claim Type Scope Description
Independent Core structure with specified substitutions
Dependent Variants with additional structural modifications
Method of use Administering the compound for particular therapeutic indications
Composition Pharmaceutical formulations including the compound

Patent Landscape and Related Patents

The patent landscape indicates a sizable cluster of related patents filed by the same assignee and third parties targeting similar chemical scaffolds and therapeutic areas.

Patent Family and Priority

US Patent 11,826,360 is part of a patent family with priority claims dating back to an international application filed under PCT, indicating a strategic global patent filing.

Overlapping and Related Patents

  • Patents covering related scaffold variations with broader substitution patterns
  • Method claims targeting similar disease indications, with some overlap
  • Patents filed in key jurisdictions: Europe (EP), Japan (JP), China (CN), reflecting broad protection aims

Patent Citations

The patent cites several prior art references related to the chemical class and therapeutic applications, including:

  • Patent documents covering similar compounds used in cancer treatment
  • Scientific articles describing biological activity of related chemical entities

Patent Challengers and Litigation

No recent litigation explicitly targeting this patent has been publicly documented. However, competitors may challenge the patent based on prior art, especially if structural similarities are identified.

Technical and Legal Considerations

Novelty and Inventive Step

The patent claims the specific substitution pattern and synthesis method that differentiate it from prior art. Its novelty hinges on the particular chemical modifications and their associated biological activity.

The inventive step involves demonstrating that these specific modifications confer unexpected therapeutic advantages or improved pharmacokinetic properties.

Potential For Patent Term Extension

Given the patent filing date, the patent is likely to expire around 2040, considering the 20-year term from the earliest priority date and any terminal disclaimers or patent term adjustments.

Data and Disclosure

The patent includes experimental data supporting the claimed compound’s activity, including in vitro assays and preliminary in vivo results, which bolster its validity.

Implications for R&D and Commercialization

The claims provide a protected space for developing therapeutic products based on the scaffold, but the relatively specific substitutions limit scope. Companies aiming for broad coverage will need to consider additional patent filings.

The patent’s focus on method claims broadens exclusivity for treatment indications, which can be a strategic advantage.


Key Takeaways

  • US Patent 11,826,360 protects a specific chemical scaffold with particular substitutions, covering composition, synthesis, and use.
  • The claims are moderate in scope, focused on variants maintaining biological activity, limiting broad generic challenges.
  • The patent family extends internationally, with related patents covering similar compounds and indications.
  • Its validity depends on the novelty of the substitution patterns and supporting biological data.
  • The patent provides a strategic patent position for developing specific therapeutics within the covered chemical space.

FAQs

1. How does US Patent 11,826,360 compare to similar patents in the field?
It covers a specific subclass of compounds with defined substituents, offering moderate breadth compared to broader patents that may claim entire chemical classes. It is more focused, reducing the risk of invalidity but limiting scope.

2. Can competitors design around this patent?
Yes. They can alter the core structure or substituents beyond the claims' scope, provided these modifications do not infringe on the claims and do not fall under prior art.

3. What strategies can extend patent protection around this compound?
Filing additional patents on related chemical scaffolds, different therapeutic uses, or improved formulations can create a patent thicket to bolster protection.

4. How strong are the patent’s claims in defending against invalidity challenges?
They rely on demonstrated novelty and inventive step, supported by experimental data. Challenges based purely on prior art must show prior actions that anticipate or render the claims obvious.

5. Will this patent influence market entry for other companies?
Yes. It establishes a protected area that restricts manufacturing and marketing of similar compounds unless licenses are obtained or the patent expires.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 11,826,360. https://patents.google.com/patent/US11826360B2

  2. Patent literature and related filings.

  3. Scientific articles on chemical class and biological activity.

More… ↓

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Drugs Protected by US Patent 11,826,360

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 11,826,360 ⤷  Start Trial Y ⤷  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

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