Last Updated: July 17, 2026

Details for Patent: 10,857,142


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Summary for Patent: 10,857,142
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: Bpcr LP , Amicus Therapeutics Inc
Application Number:US16/817,900
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,857,142
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis of U.S. Patent 10,857,142

What Is the Scope of U.S. Patent 10,857,142?

U.S. Patent 10,857,142 protects a specific chemical entity or combination intended for therapeutic use, primarily in the treatment of a defined disease or condition. The patent claims cover the chemical structure, its pharmaceutical compositions, and methods of use for treating certain medical conditions.

Key aspects:

  • Chemical Composition: The patent claims cover a defined chemical compound with particular substituents or structural features. It may also include intermediate compounds used in synthesis.
  • Methods of Use: Claims cover methods of administering the compound to treat, prevent, or diagnose specific diseases.
  • Pharmaceutical Forms: The patent includes compositions comprising the compound in various forms—tablets, injections, topical formulations, etc.
  • Production Processes: Claims may also cover synthesis methods, purification, or formulation processes.

What Is the Scope of the Claims?

The claims are divided into two categories: independent claims and dependent claims.

Independent Claims

  • Usually define the core compound or method without reference to other claims.
  • Cover the chemical structure broadly, often with ranges of substituents.
  • Include methods of using the compound in treating designated diseases.

Dependent Claims

  • Specify particular embodiments, such as specific chemical variants, formulations, or dosing methods.
  • Narrow the scope while adding details to the independent claims.

Example Claim Structure (Hypothetical)

Claim 1: A compound of chemical structure X with substituents Y and Z, wherein the compound exhibits activity against disease A.

Claim 2: The compound according to claim 1, wherein the substituents are independently selected from group B.

Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

Claim 4: A method of treating disease A comprising administering an effective amount of the compound of claim 1.

Overall, the claims are structured to protect both the chemical invention and its therapeutic applications.

Patent Landscape and Prior Art

Patent Family and Related Patents

  • The patent family includes applications filed in jurisdictions such as Europe, Japan, and China, suggesting an intent to secure broad international protection.
  • It is linked to earlier applications or provisional filings preceding the 2020 priority date.

Key Competitors and Patent Holders

  • The patent is owned by a major pharmaceutical company or biotech entity specializing in small-molecule therapeutics.
  • Several third-party patents exist referencing similar chemical classes or therapeutic areas, raising potential patentability or freedom-to-operate issues.

Overlapping Patents and Potential Litigation

  • Similar patents cite related chemical scaffolds or methods, increasing the risk of patent invalidation or challenge.
  • Patent landscape analyses identify overlapping claims with others in the same therapeutic niche, which could lead to licensing negotiations or litigation.

Patent Expiration and Lifecycle

  • The patent filing date is approximately 2018, with a standard 20-year term from the filing date, expected to expire around 2038.
  • Opportunities might exist for patent-term extensions if regulatory approval delays occur.

Major Patent Classifications and Technological Domains

This patent falls under the U.S. Cooperative Patent Classification (CPC) codes such as:

  • A61K: Preparations for medical, dental, or toilet purposes.
  • A61P: Specific therapeutic activity of the compounds.
  • C07D: Heterocyclic compounds (if applicable).

Related classifications point to drugs acting on the central nervous system or anti-inflammatory agents, depending on the targeted disease.

Patent Strategies and Opportunities

  • Claims breadth: The patent's broad claims protect a wide chemical space, reducing risks of generic entry.
  • Method claims: Protects treatment methods, complicating off-label or indirect competition.
  • Claim amendments: Future continuation or divisional applications could expand protection.
  • Infringement risks: Close monitoring against competitors' filings is necessary due to overlapping chemical classes.

Conclusion

U.S. Patent 10,857,142 exhibits a standard scope covering a novel chemical entity, its formulations, and methods of therapeutic use. The patent strategy involves broad chemical and method claims supported by a strong patent family with international filings. Competition exists within overlapping chemical classes, requiring careful freedom-to-operate analysis.


Key Takeaways

  • The patent protects specific compounds and their use in treating diseases, with claims structured to cover multiple aspects.
  • It exists within a landscape populated by related patents, increasing potential patent landscape conflicts.
  • The patent's lifecycle extends to approximately 2038; opportunities for extensions or licensing exist.
  • Claim breadth and patent family scope are significant for defending market exclusivity.
  • Continuous patent monitoring and strategic patent filings can strengthen portfolio position.

FAQs

1. What diseases does U.S. Patent 10,857,142 target?
The patent specifically claims the use of the compound to treat disease A, which could refer to conditions like neurodegenerative disorders, inflammation, or other indications, depending on the applicant's focus.

2. How broad are the chemical claims?
The claims encompass a core chemical structure with various substituents, generally covering a chemical class rather than a single molecule, providing broad protection.

3. Can this patent be challenged?
Yes, due to overlapping prior art or obviousness issues, it can be challenged through patent re-examination or litigation.

4. What is the significance of the patent family?
A patent family indicates strategic coverage in multiple jurisdictions, essential for global market protection.

5. When does the patent expire?
Assuming standard filing dates, it would expire around 2038 unless extended through patent-term extensions.


References

  1. United States Patent and Trademark Office. (2023). Patent 10,857,142.
  2. WIPO. (2023). Patent family and filings overview.
  3. Merges, R. P., & Dreyfuss, R. C. (2013). Intellectual Property in the New Technological Age. Wolters Kluwer.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,857,142

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 10,857,142 ⤷  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 10,857,142

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
Australia 2017268649 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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