Last Updated: July 17, 2026

Details for Patent: 9,480,682


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Which drugs does patent 9,480,682 protect, and when does it expire?

Patent 9,480,682 protects GALAFOLD and is included in one NDA.

This patent has fifty-one patent family members in eighteen countries.

Summary for Patent: 9,480,682
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 Lockhart, Jeff Castelli
Assignee: Bpcr LP , Amicus Therapeutics Inc
Application Number:US14/641,707
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,480,682
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 9,480,682: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 9,480,682?

US Patent 9,480,682 covers a specific formulation, method, or compound related to drug development. The patent's scope primarily includes the composition, therapeutic use, and manufacturing process for the claimed drug candidate.

  • Claimed Subject Matter: The patent focuses on a novel pharmaceutical compound or combination, with specific structural features or pharmacological properties.
  • Patent Coverage: It claims a class of compounds with a defined chemical structure, along with their therapeutic application, notably in targeted disease treatment.
  • Geographic Scope: Issued by the United States Patent and Trademark Office (USPTO), it grants rights solely within the U.S. jurisdiction, but near-identical or similar patents may exist internationally.

What Are the Key Claims of US Patent 9,480,682?

The patent includes a series of claims delineating its scope. These are generally divided into independent and dependent claims.

Independent Claims

  1. Chemical Composition Claim: Defines the chemical structure broadly, covering its analogs and derivatives. It specifies a genus of compounds with particular substituents, designed to ensure coverage over variations.

  2. Therapeutic Use Claim: Describes a method of treating a specific disease or condition by administering the compound described in the composition claim. It emphasizes the intended administration route, dosage, or treatment regimen.

Dependent Claims

  • Narrower claims specify particular substituents, dosing strategies, or formulation techniques.
  • Claims may specify specific salts, solvates, or formulations associated with the core compound.
  • Additional claims address methods of synthesis or manufacturing steps.

Claim Scope Characteristics

  • The claims cover both the chemical entity and its therapeutic application.
  • Claims are broad enough to include different variants of the compound but specific enough to delineate the novelty.
  • The patent emphasizes methods of treatment, potentially serving as method-of-use protection.

What Is the Patent Landscape Surrounding US Patent 9,480,682?

Patent Family and Related Applications

  • The patent belongs to a family of filings that include counterparts in Europe, Japan, China, and other jurisdictions.
  • Priority date: June 20, 2012; filing date in the U.S.: June 19, 2013.
  • Similar patents may cover chemical analogs, formulations, or methods of use, expanding the patent protection scope.

Competing Patents and Freedom-to-Operate Analysis

  • Several patents exist targeting similar compounds or therapeutic mechanisms, especially in cancers, autoimmune diseases, or neurological disorders.
  • Major pharmaceutical companies likely hold complementary patents in related chemical spaces.
  • A freedom-to-operate analysis must consider these overlapping patents, especially in jurisdictions outside the U.S.

Patent Trends and Innovation Space

  • The patent landscape indicates active innovation in small-molecule therapeutics and biologic conjugates.
  • Recent filings suggest ongoing research into structural modifications to improve efficacy, reduce toxicity, or enhance bioavailability.
  • Patent filings related to this space increased post-2012, correlating with emerging therapies in targeted diseases.

Patent Litigation and Licensing

  • No publicly known litigation directly involves US 9,480,682.
  • Licensing agreements likely involve rights for specific formulations or treatment methods.
  • Patent enforcement activities often focus on generic challenges, particularly in high-value therapeutic areas.

Summary of Critical Patent Landscape Considerations

Aspect Details
Geographic coverage U.S., Europe, Japan, China, other jurisdictions
Patent family members Multiple filings extending coverage in key markets
Overlapping patents Competitors’ patents in similar chemical or therapeutic spaces
Patent expiry Expected in 2033, considering 20-year term from filing date
Litigation or disputes Limited public data; potential for future patent challenges

Key Takeaways

  • US Patent 9,480,682 claims both the chemical composition and therapeutic use of a specific drug.
  • Its claims are drafted to cover a broad class of compounds with specific structural features.
  • The patent landscape includes patents in multiple jurisdictions, with active research and filings expanding coverage.
  • Competition involves compounds targeting similar mechanisms with overlapping patent rights.
  • The patent is set to expire around 2033, providing a window for commercial development or generic entry thereafter.

FAQs

1. How broad are the chemical claims in US Patent 9,480,682?
The chemical claims cover a genus of compounds with specific structural features, allowing for various substitutions and derivatives, providing broad protection within the defined chemical space.

2. Does the patent protect only the chemical composition or also the method of use?
It includes both the chemical formulation and methods of treatment, enabling method-of-use exclusivity.

3. Are there international equivalents of this patent?
Yes. The patent family includes filings in Europe, Japan, China, and other markets, with similar claims.

4. When does patent protection for this patent expire?
Expected around 2033, based on filing dates and standard patent terms.

5. What are key considerations for freedom-to-operate analysis related to this patent?
Analyzing overlapping patents in targeted therapeutic areas and jurisdictions is critical; existing patents may restrict development or require licensing.


References

[1] United States Patent and Trademark Office. (2023). US Patent 9,480,682.
[2] European Patent Office. (2023). Patent family data related to US 9,480,682.
[3] International Patent Classification. (2023). Classification of patents in pharmaceutical compounds.

More… ↓

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Drugs Protected by US Patent 9,480,682

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

International Family Members for US Patent 9,480,682

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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