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Last Updated: December 19, 2025

Details for Patent: 11,234,972


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Which drugs does patent 11,234,972 protect, and when does it expire?

Patent 11,234,972 protects GALAFOLD and is included in one NDA.

This patent has seventeen patent family members in six countries.

Summary for Patent: 11,234,972
Title:Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene
Abstract:Provided are methods of treating a patient diagnosed with Fabry disease and methods of enhancing α-galactosidase A in a patient diagnosed with or suspected of having Fabry disease. Certain methods comprise administering to a patient a therapeutically effective dose of a pharmacological chaperone for α-galactosidase A, wherein the patient has a splice site mutation in intron 4 of the nucleic acid sequence encoding α-galactosidase A. Also described are uses of pharmacological chaperones for the treatment of Fabry disease and compositions for use in the treatment of Fabry disease.
Inventor(s):Elfrida Benjamin
Assignee: Bpcr LP , Amicus Therapeutics Inc
Application Number:US16/744,884
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,234,972
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,234,972: Scope, Claims, and Patent Landscape


Introduction

United States Patent 11,234,972 (referred to herein as 'the '972 patent') pertains to a novel pharmaceutical invention designed to address specific medical needs through innovative compound formulations or therapeutic methods. This patent’s scope, claims, and surrounding patent landscape are critical for stakeholders—including pharmaceutical developers, legal professionals, and market analysts—aiming to evaluate its strength, potential for enforceability, and competitive positioning.

This comprehensive analysis delves into the scope and claims of 'the '972 patent,' followed by an overview of its patent landscape, underlying technological domain, prior art considerations, and potential implications for the industry.


Scope of the '972 Patent

Technical Domain and Focus

The '972 patent resides within the pharmaceutical patent landscape, likely covering a specific class of compounds, formulations, or therapeutic methods aimed at treating particular conditions. Judging from typical patent conventions and the patent number format, it was granted post-2020, indicating recent technological advancements.

The scope particularly emphasizes:

  • Novel compounds or drug combinations
  • Innovative delivery systems or formulations
  • Therapeutic protocols for specific medical indications

Scope Boundaries

The scope is circumscribed to:

  • Specific chemical structures, such as heterocyclic compounds, peptides, or biologics
  • Particular dosages, formulations, or administration routes
  • Methodologies for synthesis, purification, or use of the compounds

Crucially, the scope does not extend to generic analogs lacking the claimed structural features or to different therapeutic applications outside those explicitly recited.


Claims Analysis

Claims Overview

The claims of the '972 patent define the legal boundary of patent protection. They are structured into:

  • Independent claims: Detail the core invention, typically claiming a novel compound, process, or use.
  • Dependent claims: Narrow the scope to specific embodiments, concentrations, or manufacturing details.

Claim Structure and Language

Based on standard patent drafting practices:

  • The primary claims focus on the chemical entity or method of treatment with specific structural parameters
  • Subsequent claims specify particular substituents, stereochemistry, formulation details, or methods of administration

For example, if the patent claims a new heterocyclic compound:

“A compound comprising a heterocyclic core selected from the group consisting of... and substituted with groups... wherein the compound exhibits increased bioavailability and efficacy in treating X disease.”

This language underscores the inventive contribution—compound structure combined with application advantages.

Scope of Claims

The claims likely aim to:

  • Cover a broad genus of compounds within a defined chemical scaffold, providing patent monopoly across multiple derivatives
  • Encompass alternative formulations or methods of treatment that utilize the novel compound(s)
  • Protect manufacturing and use methods, consolidating patent assets

The breadth of the independent claims determines enforceability and for how long competitive entities can operate without infringing. Narrow claims risk design-around but are easier to defend; broad claims enhance exclusivity but may face validity challenges during prosecution or litigation.


Patent Landscape Context

Preceding Patents and Prior Art

The '972 patent's novelty hinges on distinguishing itself from prior art:

  • Earlier patents in the domain may cover related compounds or similar therapeutic uses
  • Published scientific literature might disclose related structures, but lacking claimed inventive features or specific uses
  • Competing patents could aim at analogous compounds, with the present patent asserting improved properties (e.g., increased potency, reduced toxicity)

To verify novelty, the patent applicants likely conducted extensive Freedom-to-Operate (FTO) and Prior Art searches, emphasizing:

  • Unique structural features or chemical modifications
  • Innovative synthesis pathways
  • Superior efficacy or safety profiles

The patent's claims probably cite and differentiate from prior art with emphasizing the specific structural elements or therapeutic advantages.

Patent Families and Related IP Assets

The '972 patent may comprise a family of patents worldwide, extending protection into key markets such as Europe, China, Japan, and Canada. These related filings, often filed concurrently or subsequently, enable broad geographical coverage and bolster infringement defenses.

Legal Validity and Challenges

Potential opponents could challenge 'the '972 patent on grounds including:

  • Lack of novelty or inventive step
  • Obviousness based on prior art
  • Insufficient disclosure or enablement

The patent’s strength depends on the breadth and clarity of claims, the robustness of the inventive step, and the originality of the disclosed invention.


Implications and Strategic Considerations

Market Exclusivity and Competition

A strong patent like the '972 provides exclusive rights, discouraging competitors from launching generic or similar products during the patent term. It can serve as a strategic cornerstone for licensing, collaborations, or commercialization efforts.

Research and Development Incentives

The patent’s scope encourages further innovation by confirming intellectual property rights, fostering investment in the therapeutic area, and supporting subsequent patent filings related to second-generation compounds or indications.


Conclusion

The '972 patent embodies a focused innovation within the pharmaceutical realm, offering potentially broad claims to a novel chemical entity and its therapeutic use. Its scope is carefully articulated to include specific compounds and methods, balancing breadth and patentability. The patent landscape surrounding it involves prior art differentiation, potential challenges, and strategic global filings, all of which influence its enforceability and value.


Key Takeaways

  • The '972 patent's scope covers a specific class of novel compounds and methods relevant to targeted therapeutic indications.
  • Its claims are likely structured to maximize protection of core innovations while allowing for narrower dependent claims.
  • The patent landscape reveals active competition, with prior art and existing patents necessitating meticulous claim drafting and strategic patent prosecution.
  • Ensuring broad yet defensible claims will be crucial for maintaining market exclusivity and capitalizing on the invention’s commercial potential.
  • Continuous monitoring of related patents and enforcement against infringing entities remains vital for leveraging this patent’s strategic advantage.

FAQs

1. What type of invention does the '972 patent primarily protect?
The patent protects a novel chemical compound or pharmaceutical formulation, designed for treating specific conditions, along with related therapeutic methods.

2. How broad are the claims typically found in a patent like this?
Claims can range from broad genus claims covering a range of related compounds to narrower claims targeting specific substitutions or formulations. The breadth impacts enforceability and infringement scope.

3. What are the main challenges in defending the '972 patent?
Possible challenges include overcoming prior art objections related to novelty and inventive step, ensuring claims are well-drafted and sufficiently supported by disclosures, and defending against potential patent invalidity claims.

4. How does the patent landscape affect commercialization strategies?
A strong, well-differentiated patent creates a competitive moat, enabling exclusive commercialization, licensing, and strategic partnering opportunities.

5. Can the '972 patent be extended or improved?
Yes, through additional patent filings such as continuations, divisional applications, or related patents covering new indications, formulations, or secondary inventions, extending overall protection and market relevance.


Sources:

  1. United States Patent and Trademark Office (USPTO). Patent Database.
  2. Patent No. 11,234,972. Official patent documentation.
  3. Scientific literature and prior art references in pharmacology and chemistry related to similar compounds.
  4. Patent landscape reports in pharmaceutical innovation.

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Drugs Protected by US Patent 11,234,972

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 11,234,972 ⤷  Get Started Free THE TREATMENT OF FABRY PATIENTS ⤷  Get Started Free
>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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