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Last Updated: May 16, 2025

Details for Patent: 11,278,538


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Summary for Patent: 11,278,538
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 .alpha.-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): Castelli; Jeff (New Hope, PA), Benjamin; Elfrida (Millstone Township, NJ)
Assignee: Amicus Therapeutics, Inc. (Philadelphia, PA)
Application Number:17/400,922
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of a U.S. Patent: A Detailed Analysis of US Patent 11,278,538

Introduction

When analyzing a U.S. patent, it is crucial to understand the scope and claims of the patent, as these elements define the intellectual property rights granted to the patent holder. This article will delve into the specifics of U.S. Patent 11,278,538, using general principles and tools available for patent analysis.

What is a U.S. Patent?

A U.S. patent is a grant of exclusive rights to an inventor for a new and useful process, machine, manufacture, or composition of matter, or any improvement thereof. The U.S. Patent and Trademark Office (USPTO) is responsible for issuing these patents after a thorough examination process[4].

The Patent Application and Examination Process

To receive a U.S. patent, an applicant must file a patent application with the USPTO. The application includes a detailed description of the invention, drawings, and claims that define the scope of the invention. The USPTO examines the application to ensure that the invention is novel, non-obvious, and useful. The examination process can be complex, involving multiple rounds of review and potential continuation procedures[1].

Understanding Patent Claims

Patent claims are the most critical part of a patent application as they define the scope of protection granted by the patent. Claims must be clear, concise, and supported by the description and drawings in the patent application. There are different types of claims, including independent claims and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit an independent claim[3].

Analyzing the Scope of US Patent 11,278,538

To analyze the scope of US Patent 11,278,538, one must carefully review the claims section of the patent.

Independent Claims

Independent claims are the broadest claims in a patent and define the core of the invention. For example, if US Patent 11,278,538 has an independent claim that describes a "method for processing data," this claim sets the foundation for what the patent protects.

Dependent Claims

Dependent claims narrow down the independent claims by adding additional limitations. These claims are often more specific and can help in distinguishing the invention from prior art.

Claim Construction

Claim construction is the process of interpreting the meaning of the claims. This is crucial in determining the scope of the patent and can be a point of contention in patent litigation. The USPTO and courts use various tools and principles to construct claims, ensuring they are consistent with the description and drawings provided in the patent application[5].

Tools for Patent Analysis

Several tools and resources are available to help analyze the scope and claims of a U.S. patent.

Patent Public Search

The USPTO's Patent Public Search tool allows users to search and view patent documents, including the claims section. This tool provides enhanced access to prior art and can help in understanding the context of the patent claims[4].

Global Dossier

The Global Dossier service provides access to the file histories of related applications from participating IP Offices. This can be useful in understanding the global patent landscape and how the claims of US Patent 11,278,538 might be viewed in other jurisdictions[4].

Patent Examination Data System (PEDS)

The PEDS system allows users to search, view, and download bibliographic data for all publicly available patent applications. This can provide insights into the examination history and any office actions related to the patent claims[4].

Statistical Insights into Patent Allowance Rates

Understanding the broader patent landscape can provide context for the analysis of a specific patent. For instance, the allowance rate for U.S. patent applications has decreased over time, particularly in fields like "Drugs and Medical Instruments" and "Computers and Communications"[1].

The Role of Continuation Procedures

Continuation procedures, such as Requests for Continued Examination (RCEs), can significantly impact the prosecution history of a patent application. These procedures allow applicants to continue the examination process, potentially leading to the issuance of a patent that might not have been granted otherwise[1].

Expert Insights and Legal Considerations

Experts in the field, such as those involved in the study on small claims patent courts, emphasize the importance of understanding the legal and policy considerations surrounding patent claims. For example, the Administrative Conference of the United States (ACUS) study highlights the need for a balanced approach to patent litigation, which includes considering the scope and validity of patent claims[2].

Key Takeaways

  • Patent Claims Define Scope: The claims section of a patent is crucial in defining the scope of protection.
  • Tools for Analysis: Utilize tools like Patent Public Search, Global Dossier, and PEDS to analyze patent claims.
  • Continuation Procedures: These can impact the prosecution history and eventual allowance of a patent.
  • Legal Considerations: Understanding legal and policy considerations is vital in patent analysis and litigation.
  • Broader Patent Landscape: Statistical insights into patent allowance rates and trends can provide context.

FAQs

Q: What is the significance of independent claims in a patent?

Independent claims are the broadest claims in a patent and define the core of the invention, setting the foundation for what the patent protects.

Q: How do continuation procedures affect the patent examination process?

Continuation procedures, such as RCEs, allow applicants to continue the examination process, potentially leading to the issuance of a patent that might not have been granted otherwise.

Q: What tools can be used to analyze the scope of a U.S. patent?

Tools such as the USPTO's Patent Public Search, Global Dossier, and the Patent Examination Data System (PEDS) can be used to analyze the scope of a U.S. patent.

Q: Why is claim construction important in patent analysis?

Claim construction is important because it helps in interpreting the meaning of the claims, which is crucial in determining the scope of the patent and can be a point of contention in patent litigation.

Q: How has the allowance rate for U.S. patent applications changed over time?

The allowance rate for U.S. patent applications has decreased substantially over time, particularly in fields like "Drugs and Medical Instruments" and "Computers and Communications"[1].

Sources

  1. Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203-236.
  2. Administrative Conference of the United States. (2022). U.S. Patent Small Claims Court.
  3. USPTO. (2017). Patent Claims Research Dataset.
  4. USPTO. (2018). Search for patents.
  5. U.S. Code. (1994). 35 USC 282: Presumption of validity; defenses.

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Drugs Protected by US Patent 11,278,538

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 11,278,538

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 111971 ⤷  Try for Free
Australia 2009214648 ⤷  Try for Free
Australia 2014221321 ⤷  Try for Free
Australia 2016206297 ⤷  Try for Free
Australia 2017268649 ⤷  Try for Free
Australia 2018220047 ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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