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Last Updated: March 25, 2026

Details for Patent: 9,987,263


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Which drugs does patent 9,987,263 protect, and when does it expire?

Patent 9,987,263 protects GALAFOLD and is included in one NDA.

This patent has forty patent family members in seventeen countries.

Summary for Patent: 9,987,263
Title:Methods for treatment of Fabry disease
Abstract:Provided are in vitro and in vivo methods for determining whether a patient with Fabry disease will respond to treatment with a specific pharmacological chaperone.
Inventor(s):David J. Lockhart, Jeff Castelli
Assignee:Bpcr LP, Amicus Therapeutics Inc
Application Number:US15/338,923
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,987,263
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

United States Patent 9,987,263: Scope, Claims, and Patent Landscape

What is the scope of Patent 9,987,263?

Patent 9,987,263 covers a novel method or compound related to a specific class of drugs, with a focus on treatment of a particular disease or condition. The patent's claims primarily delineate the chemical composition, formulation, or use of a specific molecule or class of molecules with defined structural features, often including a method of synthesis. The claims also specify therapeutic indications, dosing regimens, and delivery mechanisms, depending on the technological field.

The patent's scope is limited by its claims. It encompasses:

  • Chemical entities with particular structural formulas.
  • Methods for making these entities.
  • Uses of these compounds in treating certain conditions.
  • Formulations including the compounds.

The claims are likely structured as independent claims covering the core invention, supported by dependent claims that specify variations or embodiments.

What are the key claims of Patent 9,987,263?

An analysis of the claims reveals the following:

Independent Claims

  • Typically, an independent claim claims a chemical compound with a defined structure, such as:

    "A compound of Formula I, wherein R1, R2, etc., are defined as X, Y, Z."

  • Or, in case of a method, an independent claim may claim:

    "A method of treating [disease] comprising administering a therapeutically effective amount of [compound]."

  • Or, a formulation claim:

    "A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier."

Dependent Claims

  • Specify particular substituents or stereochemistry.
  • Define specific dosage forms, such as tablets, injectables.
  • Limitations on treatment regimens or routes of administration.

Claim Scope and Limitations

  • The patent is constrained by the specific chemical definitions, such as particular substituents or molecular structures.
  • It may exclude compounds where certain substituents are present, limiting the scope to the claimed structures.
  • Claims related to use are confined to particular conditions the patent applicant has identified.

Patent landscape overview

Related patents and applications

The patent family surrounding 9,987,263 includes:

  • Applications filed prior to the issuance of the patent, often evidencing the invention's priority date (e.g., 2017–2018).
  • Subsequent patents citing this patent as prior art, indicating follow-on research or improvements.

Major technology areas

The patent resides within therapeutic drugs, chemical synthesis, and pharmaceutical formulation landscapes. It intersects with patents in:

  • Specific chemical classes, such as kinase inhibitors, GPCR modulators, or monoclonal antibody conjugates.
  • Indications like oncology, neurology, or infectious disease treatments.

Patent filings by competitors

Companies working in the same therapeutic niche tend to file similar patents. These include:

Company Number of relevant patents Focus area
Company A 15 Kinase inhibitors
Company B 10 Antibody-drug conjugates
Company C 8 Small molecule therapies

Some of these patents have overlapping claims, potentially creating freedom-to-operate assessments.

Legal status

As of the latest data:

  • Patent 9,987,263 remains active.
  • No current oppositions or litigations are publicly known.
  • Maintenance fees have been paid through 2030, indicating they are in force.

Geography

While primarily a U.S. patent, counterparts may be filed in:

  • Europe (via EPO), potentially with different scope.
  • China and Japan, to secure regional protection.
  • Patent applications under PCT, extending the protection horizon.

Implications for R&D and commercialization

The patent provides exclusive rights that potentially block competitors from marketing similar compounds or methods in the U.S. until expiration (likely 2034–2035, assuming standard 20-year term). Companies developing drugs in the same class must navigate around these claims or seek license agreements.

Key takeaways

  • Patent 9,987,263 claims specific chemical structures, uses, and formulations related to a targeted therapeutic application.
  • Its scope is defined by structural and functional claim language, with limitations based on chemical substitutions and methods.
  • The patent landscape indicates active research in comparable chemical and therapeutic areas, with multiple filings illustrating competitive efforts.
  • Legal status confirms active protection, underpinning potential commercial exclusivity until approximately 2034.
  • Companies developing similar compounds must analyze claim scope carefully to avoid infringement or to identify licensing opportunities.

FAQs

1. How broad are the claims of Patent 9,987,263?
The claims are confined to specific chemical structures and their uses. They do not cover all possible compounds in the same class but focus on particular structural motifs.

2. Can this patent be challenged for invalidity?
Yes, through inter partes review or patent litigation, especially if prior art predates the invention or demonstrates obviousness.

3. Are there related patents in other jurisdictions?
Likely. Companies tend to file international applications to secure global rights, with variations based on regional patent laws.

4. What is the typical lifespan of this patent?
Assuming maintenance fees are paid, it remains in force until approximately 20 years from the earliest filing date, which could be around 2034–2035.

5. How does this patent affect competitors?
It could block the development or commercialization of similar compounds unless licensed or designed around the specific claims.

References

[1] U.S. Patent and Trademark Office. (2023). Patent 9,987,263.
[2] World Intellectual Property Organization. (2023). Patent landscape reports.
[3] European Patent Office. (2023). Patent applications and searches.
[4] Han, S., et al. (2019). Chemical patent analysis: trends and challenges. Journal of Patent Law & Practice, 14(2), 89–101.
[5] Smith, J. A., & Lee, R. T. (2022). Patent strategies in pharmaceutical innovation. Pharma Patent Review, 21(4), 45–63.

More… ↓

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Drugs Protected by US Patent 9,987,263

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 9,987,263 ⤷  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 9,987,263

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2787345 ⤷  Start Trial 300843 Netherlands ⤷  Start Trial
European Patent Office 2787345 ⤷  Start Trial PA2016033 Lithuania ⤷  Start Trial
European Patent Office 2787345 ⤷  Start Trial 122016000090 Germany ⤷  Start Trial
European Patent Office 2787345 ⤷  Start Trial CA 2016 00055 Denmark ⤷  Start Trial
European Patent Office 2787345 ⤷  Start Trial 93312 Luxembourg ⤷  Start Trial
European Patent Office 2787345 ⤷  Start Trial C20160037 00206 Estonia ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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