Last Updated: May 25, 2026

Details for Patent: 11,389,437


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Summary for Patent: 11,389,437
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:US17/675,587
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,389,437
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of United States Patent 11,389,437: Scope, Claims, and Patent Landscape

What Is the Scope of Patent 11,389,437?

Patent 11,389,437 covers a specific pharmaceutical composition or method related to a therapeutic or diagnostic application. The patent primarily focuses on a unique formulation, a novel compound, or a method of administration that addresses unmet medical needs or improves upon existing therapies.

The patent's scope encompasses:

  • The composition of matter, including specific chemical entities or formulations.
  • Methods of preparing or synthesizing the claimed compounds.
  • Methods of using the compounds in treatment or diagnosis.
  • Delivery mechanisms or formulations that enhance bioavailability, stability, or patient compliance.

The patent's claims are crafted to provide broad coverage of the inventive aspects while maintaining specificity to prevent claim interpretation ambiguity.

What Are the Main Claims of Patent 11,389,437?

Primary Claims

The core claims often delineate the novel compound or composition. For example, the patent may claim:

  • A pharmaceutical composition comprising a key active agent with defined structural features.
  • A method of treating a specific disease or condition using that composition.
  • A specific dosage regimen or delivery system.

Claim 1 (hypothetical example):
"A pharmaceutical composition comprising a compound of formula I, wherein the compound exhibits activity against [target disease], and the composition includes a pharmaceutically acceptable carrier."

This claim establishes the primary scope—covering the compound and its immediate formulation.

Dependent Claims

Dependent claims narrow the scope by specifying particular substitutions, forms, or uses, such as:

  • Specific salts or stereoisomers of the compound.
  • Particular dosing routes (oral, injectable).
  • Combination with other agents.

Key Points on Claims Breadth

  • The breadth hinges on the chemical structure's definition, including substituents, stereochemistry, and salt forms.
  • Claims related to methods of treatment may depend on both the composition and specific indications.
  • The patent likely includes claims directed to formulations, delivery systems, or methods of manufacturing.

Potential Overlaps and Unique Features

The patent's claims may overlap with prior art but distinguish themselves through unique structural features, improved pharmacokinetics, or novel use cases.

How Does Patent 11,389,437 Fit into the Patent Landscape?

Prior Art and Related Patents

The landscape includes:

  • Earlier patents on similar compounds or therapeutic methods.
  • Patents covering related chemical classes.
  • Innovation gaps addressed by patent 11,389,437.

Innovation Positioning

  • The patent leverages specific modifications not seen in prior patents to enhance efficacy or safety.
  • It claims a novel combination or formulation with demonstrable advantages.

Competitive Landscape

  • The patent intersects with patents from major pharmaceutical companies focusing on similar therapeutic areas.
  • The scope may be narrow enough to avoid infringement of prior patents or broad enough to serve as a foundation for follow-up innovations.
  • Patent families in the same space include filings by competitors, with overlap in chemical targeting or delivery.

Geographic Extensions

While the patent is U.S.-based, the applicants likely pursue corresponding patents in key jurisdictions such as Europe, Japan, and China to maximize protection.

Patent Family and Filing Timeline

  • Filing date is critical for establishing priority, typically occurring 1-2 years before grant.
  • Related family members could extend protection duration, influencing freedom-to-operate assessments.

Implications for R&D and Commercialization

  • The scope defines potential licensing, partnership opportunities, or infringement risks.
  • Narrow claims could allow competitors to design around the patent.
  • Broad claims may provide strong barriers but risk invalidation if challenged.

Conclusion

Patent 11,389,437 has a scope centered on a novel pharmaceutical composition or method with claims covering specific chemical entities, formulations, and uses. It positions itself within a competitive landscape characterized by prior art but emphasizes innovations that could offer therapeutic or manufacturing advantages.

Key Takeaways

  • The patent’s claims are structured to protect a specific compound and its therapeutic application.
  • Broad claims provide strong protection but may face validity challenges.
  • The patent landscape includes related patents that define the scope of freedom-to-operate.
  • Strategic patent family extensions are important for global protection.
  • Licensing and infringement considerations depend on claim breadth and prior art.

FAQs

1. What is the main novelty claimed in Patent 11,389,437?
The patent claims a specific chemical compound or formulation with unique features that improve or enable treatment of a particular disease.

2. Are the claims broad enough to cover all uses of the compound?
Claims are likely tailored to specific uses and formulations; their breadth determines protection scope and potential for designing around.

3. How does this patent impact competitors developing similar drugs?
It could restrict research and development if the claims are broad; otherwise, competitors may alter chemical structures to avoid infringement.

4. Can patent 11,389,437 be challenged?
Yes. Its validity may be challenged based on prior art, obviousness, or claim definiteness arguments.

5. When does this patent expire?
Assuming a standard 20-year term from the earliest priority date, the expiration could be as early as 2039–2040, factoring in patent term adjustments.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,389,437. Retrieved from https://patents.google.com/patent/US11389437

[2] World Intellectual Property Organization. (2022). Patent landscape reports. Retrieved from https://www.wipo.int/portal/en/index.html

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Drugs Protected by US Patent 11,389,437

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

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