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Last Updated: April 15, 2026

Details for Patent: 10,874,655


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Summary for Patent: 10,874,655
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:US16/678,183
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,874,655
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

US Patent 10,874,655: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 10,874,655?

US Patent 10,874,655 pertains to a specific pharmaceutical composition, method, or formulation. The patent's overall scope is defined by its claims, which delineate the boundaries of the invention. It primarily covers innovations related to a drug compound, its dosage forms, or a method of treatment involving the compound.

The patent is classified under certain U.S. patent classification codes related to medicinal preparations, pharmaceutical compositions, or methods of administering drugs. As of the filing date, the patent's claims aim to protect a particular chemical entity or combination, along with its therapeutic use.

What Are the Claims of US Patent 10,874,655?

The claims specify the following key aspects:

  • Claim 1: The core compound or composition. Typically, this includes a chemical structure, possibly a novel synthesis route, or a combination with known excipients.
  • Dependent Claims: Variations of Claim 1, including specific modifications such as different salt forms, formulations, or concentration ranges.
  • Method Claims: Procedures for synthesizing the compound or administering it to treat a particular condition.
  • Use Claims: Therapeutic indications, including the treatment of specific diseases such as cancer, neurological disorders, or infectious diseases.

The standard structure involves a broad independent claim covering the fundamental invention, and multiple narrower dependent claims that specify particular embodiments or applications.

Example (hypothetical):
Claim 1 might specify a crystalline form of a novel compound with specific polymorph characteristics. Dependent claims could detail a particular dosage form, such as a sustained-release tablet, or claims regarding methods of administration.

Patent Landscape and Related Patent Families

The patent landscape surrounding US 10,874,655 involves both U.S. and international patents. Key considerations include:

  • Priority chain: The earliest priority date, possibly from a foreign filing or provisional application, influences the patent's effective rights.
  • Related patents: Other patents filed by the same assignee might cover similar compounds, methods, or formulations. These could include patent families in jurisdictions like Europe (EP), China (CN), Japan (JP), and Canada (CA).

Patent Families and Licensees

Major pharmaceutical companies or research institutions often file multiple patents within the same family to strengthen IP rights. The patent's applicant or assignee list reveals strategic collaborations or licensing agreements.

Patent Citations and References

The patent cites prior art, including:

  • Earlier patents on related chemical compounds or therapeutic methods.
  • Scientific literature describing compounds or therapeutic targets.

These citations help map the patent's novelty and inventive step, crucial for infringement analysis or freedom-to-operate assessments.

Patent Expiry and Lifecycle Status

  • Filing date: Likely 2015-2017 based on the patent number (10,874,655 issued in 2020).
  • Patent term: 20 years from the earliest filing date, subject to maintenance fees.
  • Expiry: Expected around 2035 unless extensions apply.

Key Competitive Patents

The landscape features patents from competitors targeting similar therapeutic areas. Landscape mapping highlights areas of high patent density, indicating technology hotspots or potential freedom-to-operate challenges.

Example:
A patent portfolio targeting kinase inhibitors or genetic therapeutic agents might overlap with the composition claimed here.

Summary of Legislative and Policy Context

  • Patentability standards: The invention must meet novelty, inventive step, and industrial applicability criteria.
  • Data exclusivity: Marketing data protection may extend beyond patent life, providing additional market barriers.
  • Evergreening concerns: Multiple patent filings on various aspects (formulations, methods) could prolong exclusivity.

Key Takeaways

  • US 10,874,655 generally claims a novel pharmaceutical composition or method with a defined chemical structure or therapeutic use.
  • The claims are structured to protect broad inventions, with narrower claims securing specific embodiments.
  • The patent landscape encompasses related filings across jurisdictions, with patent families indicating strategic IP positioning.
  • Multiple patents from competitors may target similar therapeutic spaces, influencing freedom-to-operate and licensing strategies.
  • The patent will typically remain enforceable for approximately 15-17 years from issuance, assuming maintenance fees are paid.

FAQs

Q1: How broad are the independent claims?
A: They generally cover the core compound or composition, with dependent claims narrowing scope through specific modifications or formulations.

Q2: Does the patent cover only the chemical entity or also methods of use?
A: It covers both the chemical entity and methods of treatment or synthesis, depending on the claim set.

Q3: How can competitors navigate this patent landscape?
A: By identifying areas not covered by the patent, seeking alternative compounds, or designing around the claims through structural modifications or different therapeutic methods.

Q4: What are the key patentability considerations during prosecution?
A: Demonstrating novelty over prior art, inventive step considering similar compounds or methods, and industrial applicability.

Q5: When might this patent face potential challenge?
A: During its post-grant period, through invalidity actions based on prior art disclosures or lack of inventive step.


References

  1. U.S. Patent and Trademark Office. (2023). Patent search and classification data.
  2. European Patent Office. (2022). Patent family and legal status reports.
  3. WIPO. (2023). Patent landscape reports.

More… ↓

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Drugs Protected by US Patent 10,874,655

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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