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Last Updated: July 17, 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 Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 11,234,972

Introduction

Understanding the scope and claims of a patent is crucial for both the patent holder and potential infringers. This analysis will delve into the specifics of United States Patent 11,234,972, exploring its claims, the patent landscape, and relevant legal and technical aspects.

Patent Overview

United States Patent 11,234,972 is part of a series of patents listed in legal documents related to pharmaceutical and biotechnological innovations. To analyze this patent, we need to consider the broader context in which it was granted.

Claims Analysis

Claim Structure

Patent claims are the heart of any patent, defining the scope of the invention. The claims of U.S. Patent 11,234,972 would typically include independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims[3].

Claim Scope

The scope of the claims is critical in determining the patent's breadth and validity. Metrics such as independent claim length and independent claim count can provide insights into the patent's scope. Narrower claims are often associated with a higher probability of grant and a shorter examination process, while broader claims may face more scrutiny and potential challenges[3].

Patent Landscape

Related Patents

U.S. Patent 11,234,972 is mentioned alongside other patents in the context of pharmaceutical litigation, specifically involving Amicus and Aurobindo. These patents are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluation (“Orange Book”), indicating their relevance to drug formulations and therapeutic uses[2].

Litigation Context

The patent is part of ongoing litigation, where Amicus asserts infringement claims against Aurobindo. This context highlights the importance of the patent in protecting intellectual property related to specific drug formulations and their uses. The litigation also underscores the need for precise claim language to avoid ambiguity and potential invalidation[2].

Inventorship and Conception

Determining Inventorship

Inventorship is a critical aspect of patent law, focusing on the conception of the idea rather than its reduction to practice. For U.S. Patent 11,234,972, the inventors would be those who conceived the subject matter of at least one claim. This involves identifying individuals who formed a definite and permanent idea of the complete and operative invention[4].

Conception vs. Reduction to Practice

It is important to distinguish between the conception of an idea and its reduction to practice. Only those who conceived the idea, not those who merely reduced it to practice using ordinary skill, are considered inventors. This distinction is crucial in ensuring that the correct individuals are credited with the invention[4].

Legal Considerations

Patent Eligibility

The patent eligibility of U.S. Patent 11,234,972 would be evaluated under the Alice test, which determines whether the claims are directed to patent-ineligible subject matter. The focus is on whether the claimed advance is over the prior art and whether the claims include elements sufficient to transform them into a patent-eligible application[5].

Validity and Enforcement

The validity and enforceability of the patent depend on several factors, including the accuracy of inventorship, the clarity and breadth of the claims, and the absence of deceptive intent. Errors in inventorship or fraudulent actions during the patent application process can render the patent unenforceable[4].

Technical Aspects

Multimodal Analysis

While U.S. Patent 11,234,972 is not a design patent, the concept of multimodal analysis can be relevant in understanding the technical aspects of pharmaceutical patents. Datasets like IMPACT, which include detailed captions for design patent figures, highlight the importance of comprehensive descriptions in patent applications. This approach ensures that the invention is clearly defined and distinguishable from prior art[1].

Key Takeaways

  • Claims Analysis: Understanding the structure and scope of the claims is essential for determining the patent's validity and breadth.
  • Patent Landscape: The patent is part of a larger landscape involving pharmaceutical litigation and is listed in the FDA’s Orange Book.
  • Inventorship: Accurate determination of inventorship is crucial, focusing on the conception of the idea rather than its reduction to practice.
  • Legal Considerations: The patent must pass the Alice test for eligibility and must be free from errors in inventorship and deceptive intent.
  • Technical Aspects: Comprehensive descriptions and clear definitions are vital in distinguishing the invention from prior art.

FAQs

  1. What is the significance of claim structure in a patent?

    • The claim structure, including independent and dependent claims, defines the scope of the invention and is crucial for determining the patent's validity and breadth.
  2. How is inventorship determined in U.S. patent law?

    • Inventorship is determined by identifying individuals who conceived the subject matter of at least one claim, focusing on the formation of a definite and permanent idea of the complete and operative invention.
  3. What is the Alice test in patent law?

    • The Alice test is a two-step process used to determine whether a patent claim is directed to patent-ineligible subject matter, focusing on whether the claimed advance is over the prior art.
  4. Why is accurate inventorship important?

    • Accurate inventorship is essential to ensure the patent's validity and enforceability. Errors or deceptive intent can render the patent unenforceable.
  5. How does the FDA’s Orange Book relate to pharmaceutical patents?

    • The FDA’s Orange Book lists approved drug products with therapeutic equivalence evaluations, including patents related to these drugs. This listing is crucial for pharmaceutical companies to ensure their products do not infringe on existing patents.

Sources

  1. IMPACT: A Large-scale Integrated Multimodal Patent Analysis and Creation Dataset for Design Patents - OpenReview
  2. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Insight.RPXCorp
  3. Patent Claims and Patent Scope - SSRN
  4. Determining Inventorship for US Patent Applications - Oregon State University
  5. CONTOUR IP HOLDING LLC v. GOPRO, INC. - CAFC.USCourts.gov

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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 ⤷  Try for Free ⤷  Try for Free THE TREATMENT OF FABRY PATIENTS ⤷  Try for 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

International Family Members for US Patent 11,234,972

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
China 109069494 ⤷  Try for Free
China 114159436 ⤷  Try for Free
European Patent Office 3432882 ⤷  Try for Free
Japan 2019510030 ⤷  Try for Free
Japan 2022130589 ⤷  Try for Free
Japan 2024122992 ⤷  Try for Free
Japan 7098529 ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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