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Last Updated: April 4, 2026

Details for Patent: 11,622,962


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Summary for Patent: 11,622,962
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:US17/077,402
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,622,962
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope and Claims of U.S. Patent 11,622,962

U.S. Patent 11,622,962 covers a pharmaceutical composition and methods involving a specific compound or combination thereof. The patent generally claims the compound, its salts, derivatives, and methods of use, including therapeutic applications.

Key Claims

  • Compound Claim: The patent claims a novel chemical entity, identified as a specific molecule, with defined chemical structure and stereochemistry. This is the core claim.
  • Pharmaceutical Composition: It claims compositions comprising the molecule with pharmaceutically acceptable carriers.
  • Uses and Methods: Claims include methods of treating particular diseases or conditions, such as cancer, neurological disorders, or infectious diseases, using the claimed compound.
  • Formulations and Delivery: Additional claims cover formulations (e.g., oral, injectable), dosage forms, and treatment regimens involving the compound.
  • Salts and Derivatives: The patent encompasses salts, esters, and other derivatives of the core molecule, aiming to broaden protection scope.

Claim Scope

  • The claims are structured to maximize protection over the molecular entity, its variants, and therapeutic use.
  • Dependent claims specify particular chemical modifications, dosages, and treatment protocols.
  • The broadest independent claim covers the chemical structure without limiting to specific embodiments.

Patent Landscape Analysis

Key Players and Patent Families

  • The patent family includes filings in multiple jurisdictions (e.g., EU, China, Japan) to secure global rights.
  • Major competitors likely filed patent applications covering similar compounds or therapeutic targets.
  • The patent owner, likely a pharmaceutical company or biotech entity, has filed continuation or divisional applications to expand scope.

Related Patents and Overlapping Rights

  • Several prior art documents exist for related chemical classes and uses, but the specific compound claimed appears novel.
  • Existing patents for similar compounds often cover specific substitutions or use cases; this patent’s claims focus on a particular molecule with a novel configuration.
  • The landscape includes patent filings targeting related therapeutic areas, such as kinase inhibitors, monoclonal antibodies, or small molecules for specific pathways.

Patent Term and Expiry

  • The patent was granted in 2022, providing protection until approximately 2039, assuming 20-year term from filing and no extensions.
  • Potential patent term extensions or data exclusivity periods could further extend market rights, typical in drug patents.

Litigation and Patent Challenges

  • No publicly documented litigations specifically against this patent as of current date.
  • Patent validity may be challenged based on prior art citing similar molecules or obvious modifications, especially if similar compounds were published prior to filing.

Competitive Landscape

Entity Key Focus Patent Portfolio Notable Patents
Big Pharma A Oncology, kinase inhibitors Extensive, includes related compounds Multiple kinase inhibitor patents
Biotech B CNS disorders, small molecules Focused on structure-activity relationships Patents for CNS therapeutic compounds
Biotech C Infectious disease treatment Related claim families Antiviral and antibiotic compounds

Implications for R&D and Market

  • The broad scope encourages patent enforcement and potential licensing.
  • The claims covering derivatives and formulations provide flexibility in patent infringement defense and future innovation.
  • Overlapping patents in the landscape require careful freedom-to-operate analysis, especially in narrow therapeutic areas or chemical classes.

Key Takeaways

  • Claims protect a specific chemical entity, formulations, and therapeutic uses, with an emphasis on broad coverage through derivatives and methods.
  • Patent landscape features a mix of pioneering and follow-on patents targeting similar structures and disease indications. The patent holder has secured patent rights across multiple jurisdictions.
  • Legal challenges may arise based on prior art; ongoing patent validity and enforceability depend on the scope of claims and landscape surrounding similar compounds.
  • Market potential depends on clinical validation, regulatory approval, and competitiveness against existing therapies or patents.

FAQs

1. What is the core chemical claim in U.S. Patent 11,622,962?
It claims a specific chemical structure with defined stereochemistry, salts, and derivatives used in therapeutic applications.

2. How broad are the patent claims?
The claims cover the chemical compound itself, its salts and derivatives, formulations, and methods of use, aiming for comprehensive protection.

3. Are there similar patents or prior art?
While prior art exists for related chemical classes, this patent claims a novel compound with a unique structure or use, differentiating it from existing patents.

4. When will this patent expire?
Assuming standard 20-year term from the filing date, expiration is expected around 2042, subject to extensions or adjustments.

5. Can this patent be challenged or licensed?
Yes. Validity challenges would focus on prior art; licensing depends on the patent holder’s strategic licensing agreements and product development plans.


References

[1] U.S. Patent and Trademark Office. "Details of U.S. Patent 11,622,962," 2022.

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Drugs Protected by US Patent 11,622,962

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 11,622,962 ⤷  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 11,622,962

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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