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Last Updated: December 22, 2024

Details for Patent: 11,278,536


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Summary for Patent: 11,278,536
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:17/400,623
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of a U.S. Patent: A Detailed Guide Using USPTO Resources

Introduction

When analyzing the scope and claims of a U.S. patent, such as United States Patent 11,278,536, it is crucial to utilize the various resources and tools provided by the United States Patent and Trademark Office (USPTO). This article will guide you through the process, highlighting key steps, tools, and considerations.

Understanding Patent Claims

Patent claims are the heart of a patent, defining the scope of the invention and what is protected by the patent. The USPTO's Patent Claims Research Dataset is a valuable resource for understanding claims in depth. This dataset contains detailed information on claims from U.S. patents granted between 1976 and 2014 and U.S. patent applications published between 2001 and 2014[3].

Locating the Patent

To begin, you need to locate the specific patent. The USPTO's Patent Public Search tool is an excellent resource for this. This tool replaced older search tools like PubEast and PubWest and offers enhanced access to prior art and modern interfaces for searching patents[1].

Using Patent Public Search

  • Access the Patent Public Search tool on the USPTO website.
  • Enter the patent number, in this case, 11,278,536, into the search bar.
  • Review the patent details, including the abstract, description, and claims.

Analyzing Patent Claims

Claim Structure

Patent claims are typically divided into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to an independent claim and further limit the invention.

Claim Scope

The scope of the claims is critical in determining what is protected by the patent. The USPTO's guidance on patent subject matter eligibility can help in evaluating whether the claims are valid and within the bounds of patentable subject matter[5].

Utilizing Additional Resources

Global Dossier

The Global Dossier service provides access to the file histories of related applications from participating IP Offices. This can help in understanding the global patent family and any office actions related to the patent[1].

Common Citation Document (CCD)

The CCD application consolidates prior art citations from participating IP Offices, allowing you to see the citations relevant to the patent family on a single page. This is particularly useful for understanding the prior art landscape[1].

Patent and Trademark Resource Centers (PTRCs)

Local PTRCs offer training in patent search techniques and maintain local search resources. These centers can be invaluable for getting hands-on assistance and guidance[1].

Evaluating Prior Art

Prior art is any publicly available information that existed before the filing date of the patent application. The USPTO's Patent Public Search and other international databases like the European Patent Office's esp@cenet and the World Intellectual Property Organization's PATENTSCOPE can be used to search for prior art[1].

International Patent Databases

Searching international patent databases is essential to ensure that the invention is novel and non-obvious globally. Resources like the Japan Patent Office, Korean Intellectual Property Rights Information Service, and China National Intellectual Property Administration provide access to machine translations of patents in various languages[1].

Understanding Patent Litigation

Patent litigation can provide insights into the validity and enforceability of patent claims. The Government Accountability Office (GAO) report on patent infringement litigation highlights key factors that contribute to patent lawsuits, such as changes in patent law and the involvement of non-practicing entities (NPEs)[4].

Statistical Analysis

The USPTO's economic research datasets, including the Patent Claims Research Dataset, offer statistical insights into patent claims and their trends. These datasets can help in understanding the broader patent landscape and how specific patents fit within it[3].

Practical Steps for Analysis

Step-by-Step Search Strategy

  • Use the Multi-Step strategy outlined by the USPTO for conducting a preliminary patent search.
  • Start with a broad search using keywords and classifications.
  • Narrow down the search using more specific terms and filters.

Reviewing Office Actions

The Global Dossier and the Patent Examination Data System (PEDS) can provide access to office actions and examination data, which are crucial for understanding how the patent was examined and any issues that arose during the process[1].

Consulting Experts

Engage with experts from Patent and Trademark Resource Centers or consult with legal practitioners who have experience in patent law. The consultative group members involved in the ACUS study on small claims patent courts can serve as examples of the kind of expertise that can be valuable[2].

Key Takeaways

  • Locate the Patent: Use the USPTO's Patent Public Search tool to find and review the patent details.
  • Analyze Claims: Understand the structure and scope of the claims, and evaluate their validity using USPTO guidance.
  • Utilize Additional Resources: Leverage tools like Global Dossier, CCD, and international patent databases.
  • Evaluate Prior Art: Search for prior art to ensure the invention is novel and non-obvious.
  • Consider Litigation: Review patent litigation trends and the impact of changes in patent law.
  • Statistical Insights: Use USPTO datasets to understand broader patent trends.

FAQs

Q: How do I locate a specific U.S. patent?

A: Use the USPTO's Patent Public Search tool and enter the patent number into the search bar.

Q: What is the importance of prior art in patent analysis?

A: Prior art helps determine if the invention is novel and non-obvious, which are critical for patent validity.

Q: How can I access international patent databases?

A: Use resources like the European Patent Office's esp@cenet, Japan Patent Office, and World Intellectual Property Organization's PATENTSCOPE.

Q: What is the role of the Global Dossier in patent analysis?

A: The Global Dossier provides access to the file histories of related applications from participating IP Offices, helping in understanding the global patent family.

Q: How can statistical datasets help in patent analysis?

A: Statistical datasets like the Patent Claims Research Dataset offer insights into patent claims trends and help in understanding the broader patent landscape.

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
  3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. GAO - Assessing Factors That Affect Patent Infringement Litigation: https://www.gao.gov/products/gao-13-465
  5. Federal Register - Guidance Update on Patent Subject Matter Eligibility: https://unblock.federalregister.gov/

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Drugs Protected by US Patent 11,278,536

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 ⤷  Subscribe ⤷  Subscribe THE TREATMENT OF FABRY PATIENTS ⤷  Subscribe
>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 11,278,536

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 111971 ⤷  Subscribe
Australia 2009214648 ⤷  Subscribe
Australia 2010239779 ⤷  Subscribe
Australia 2014221321 ⤷  Subscribe
Australia 2016206297 ⤷  Subscribe
Australia 2017268649 ⤷  Subscribe
Australia 2018220047 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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