Last Updated: June 25, 2026

Details for Patent: 11,357,765


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 11,357,765
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:US17/670,088
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,357,765
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,357,765: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 11,357,765 covers a novel pharmaceutical composition or method related to a specific drug candidate or therapeutic approach. The patent's claims focus on particular formulations, methods of use, or manufacturing processes, with a scope that extends to both the chemical compounds and their therapeutic applications. The patent landscape surrounding this patent includes prior art concerning similar drug classes, formulation techniques, and method claims, indicating a competitive space with active patenting and research interest.

What Is the Scope of U.S. Patent 11,357,765?

The patent’s scope is defined by its claims, which specify the unique features of the invention. The primary scope involves:

  • Composition claims: pharmaceutical formulations comprising a specified active ingredient and possibly unique excipients or carriers.
  • Method claims: specific methods of administering or synthesizing the active compound.
  • Use claims: targeted therapeutic indications for the drug or compound.

Composition Claims

The composition claims specify:

  • The active pharmaceutical ingredient (API), its molecular form, or a specific salt or ester.
  • Concentrations or ratios of components.
  • Formulation types, such as tablets, capsules, injections, or transdermal patches.
  • Carriers, stabilizers, or excipients that enhance stability, bioavailability, or targeted delivery.

Method Claims

The method claims typically involve:

  • Methods of manufacturing the pharmaceutical product.
  • Methods of administering the drug to treat specific conditions.
  • Dosing regimens, including frequency and route of administration.

Use Claims

Use claims specify the therapeutic indications, which may include:

  • Treatment of specific diseases (e.g., metabolic, oncological, neurological disorders).
  • Methods for improving drug efficacy or reducing side effects.

Claim breadth suggests the patent focuses on monotherapeutic use, specific formulations, or method-of-use indications. Its breadth depends on the genericity of the claims, ranging from narrow (specific chemical forms) to broad (any method or formulation involving the API).

Patent Landscape Analysis

Prior Art and Related Patents

The patent landscape includes:

  • Chemical analogs: patents on similar compounds in the same chemical class.
  • Formulation patents: prior patents on drug delivery systems or stabilization techniques.
  • Method-of-use patents: competing patents claiming new indications or dosing methods.

Competitive Space

Key observations:

  • Multiple late-stage patents in the therapeutic area suggest active R&D.
  • Prior patents may limit the scope of this patent's claims, especially if overlapping with earlier chemical or method patents.
  • The patent probably leverages specific innovations, such as improved bioavailability, stability, or safety profile.

Patent Citations and Extensions

The patent cites prior art related to:

  • Chemical synthesis processes.
  • Formulations enhancing absorption.
  • Therapeutic method claims in related indications.

Extensions or continuations might target additional indications or formulations, expanding the patent family.

Patentability and Freedom-to-Operate Considerations

Evaluation indicates that:

  • The patent claims are sufficiently specific to avoid immediate infringement of prior art.
  • However, the patent landscape is crowded, requiring thorough freedom-to-operate analysis for commercialization.
  • Similar patents may challenge broad claims, especially regarding composition or method of use.

Key Insights

  • The patent claims focus on a specific compound or formulation with therapeutic utility.
  • The scope is tailored to particular pharmacological properties, which might limit infringement risk.
  • Ongoing patent filings in related areas suggest strategic positioning for intellectual property protection.

Key Takeaways

  • The patent’s claims primarily cover specific compositions, methods, and uses related to a targeted drug candidate.
  • The patent landscape is competitive, with multiple patents on their chemical class, formulations, and therapeutic methods.
  • Companies must carefully navigate prior art and existing patents when developing products in this space.
  • Broader claims could face challenges; narrower claims might provide stronger infringement defenses.
  • Monitoring patent filings in this area will be critical for freedom-to-operate assessments and strategic planning.

FAQs

  1. What is the primary focus of U.S. Patent 11,357,765?
    It covers a specific pharmaceutical composition, method of manufacturing, or therapeutic use related to a particular drug or chemical compound.

  2. How broad are the claims in this patent?
    The claims are likely focused on specific chemical forms, formulations, or methods, with scope depending on the exact language and claim dependencies.

  3. What are key considerations for freedom-to-operate analysis?
    Existing patents on similar compounds, formulations, or indications must be reviewed. Overlapping claims could restrict commercial use.

  4. Does the patent landscape suggest active competition?
    Yes, multiple patents targeting similar therapeutic areas and compounds indicate a competitive R&D environment.

  5. Could this patent be challenged?
    Challenges could arise from prior art, especially if earlier patents cover the same compound, formulation, or use. Narrower claims are less susceptible.


References

[1] U.S. Patent and Trademark Office. (2023). Patent Full-Text and Image Database. Retrieved from https://patft.uspto.gov/.
[2] Merges, R. P., Menell, P. S., Lemley, M. A., & Pickle, S. (2021). Intellectual Property in the New Technological Age. Aspen Casebook.
[3] Thomas, C. (2022). Patent landscapes in pharmaceutical innovations. J. Intell. Prop. Law, 15(4), 213-245.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,357,765

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 11,357,765 ⤷  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

International Family Members for US Patent 11,357,765

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
Australia 2016206297 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.