You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 23, 2024

Details for Patent: 10,961,522


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 10,961,522 protect, and when does it expire?

Patent 10,961,522 protects OPFOLDA and is included in one NDA.

This patent has sixty-four patent family members in thirty-nine countries.

Summary for Patent: 10,961,522
Title:Highly potent acid alpha-glucosidase with enhanced carbohydrates
Abstract:Recombinant human alpha glucosidase (rhGAA) composition derived from CHO cells that contains a more optimized glycan composition consisting of a higher amount of rhGAA containing N-glycans carrying mannose-6-phosphate (M6P) or bis-M6P than conventional rhGAAs, along with low amount of non-phosphorylated high mannose glycans, and low amount of terminal galactose on complex oligosaccharides. Compositions containing the rhGAA, and methods of use are described.
Inventor(s):Gotschall Russell, Do Hung V.
Assignee:Amicus Therapeutics, Inc.
Application Number:US16252505
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 10,961,522: A Comprehensive Guide

Introduction

United States Patent 10,961,522, titled "Highly potent acid alpha-glucosidase with enhanced carbohydrates," is a significant patent in the field of biotechnology, particularly in the treatment of Pompe disease. This article will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Understanding the Patent

Overview of the Invention

The patent describes a highly potent acid alpha-glucosidase enzyme with enhanced carbohydrate structures. This enzyme is crucial for treating Pompe disease, a genetic disorder caused by the deficiency of the acid alpha-glucosidase enzyme. The invention focuses on modifying the enzyme to improve its stability, efficacy, and delivery to the affected cells[4].

Key Components of the Patent

  • Enzyme Modification: The patent details the modifications made to the acid alpha-glucosidase enzyme, including the addition of specific carbohydrates to enhance its potency and stability.
  • Therapeutic Application: The primary application of this enzyme is in the treatment of Pompe disease, with the goal of improving the quality of life for patients.
  • Manufacturing Process: The patent also outlines the methods for producing this modified enzyme, which is critical for large-scale therapeutic use.

Patent Scope and Claims

Claim Structure

The patent includes a series of claims that define the scope of the invention. These claims are categorized into independent and dependent claims. Independent claims stand alone and define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations to the independent claims[3].

Independent Claims

  • The independent claims typically describe the core aspects of the modified enzyme, such as its structure, the specific carbohydrates added, and the methods of production.
  • For example, an independent claim might state: "A highly potent acid alpha-glucosidase enzyme comprising a polypeptide sequence with specific carbohydrate modifications."

Dependent Claims

  • Dependent claims build upon the independent claims by adding specific details or limitations.
  • An example of a dependent claim could be: "The enzyme of claim 1, wherein the carbohydrate modifications include at least one N-glycan and one O-glycan."

Measuring Patent Scope

Metrics for Patent Scope

Research has shown that patent scope can be measured using metrics such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims. For instance, narrower claims at publication are often associated with a higher probability of grant and a shorter examination process[3].

Application to US 10,961,522

  • Claim Length: Analyzing the length of the independent claims in US 10,961,522 can help determine the complexity and breadth of the invention.
  • Claim Count: The number of independent and dependent claims can indicate the comprehensiveness of the patent protection.

Prior Art and Citation Data

Common Citation Document (CCD)

The Common Citation Document (CCD) application consolidates prior art cited by multiple patent offices, providing a single point of access to citation data. This tool is useful for understanding the prior art landscape relevant to US 10,961,522 and identifying potential overlaps or conflicts with other patents[1].

Global Dossier

The Global Dossier service allows users to view the file histories of related applications from participating IP Offices, including the IP5 Offices. This can help in understanding the global patent family and any office actions related to the patent[1].

Patent Landscape

Related Patents and Applications

To understand the broader patent landscape, it is essential to identify related patents and applications. This can be done using tools like the Patent Public Search and the Global Dossier. For instance, searching for patents related to Pompe disease treatment or enzyme modifications can reveal other inventions in the same field[1].

Competitors and Collaborators

Identifying competitors and potential collaborators in the field can provide strategic insights. Companies or research institutions working on similar enzyme modifications or Pompe disease treatments could be key players in the patent landscape.

Legal and Regulatory Considerations

Patent Office Actions

Office actions and any legal challenges to the patent can significantly impact its scope and validity. The Global Dossier and CCD tools can help track these actions and understand their implications[1].

Small Claims Patent Court

There have been discussions and studies on the feasibility of a small claims patent court, which could affect how patent disputes, including those related to US 10,961,522, are handled. Such a court could provide a more streamlined and cost-effective way to resolve patent infringement cases[5].

Practical Implications

Licensing and Collaboration

The scope and claims of US 10,961,522 will influence licensing agreements and potential collaborations. Companies interested in using the modified enzyme will need to navigate the patent claims carefully to avoid infringement.

Litigation Risks

Understanding the patent scope is crucial for mitigating litigation risks. Any overlap with existing patents or broad claims could lead to legal challenges, affecting the commercialization of the invention.

Public Access and Search Tools

USPTO Resources

The USPTO provides several resources for searching and analyzing patents, including the Patent Public Search tool, the Global Dossier, and the Public Search Facility. These resources are invaluable for conducting thorough searches and understanding the patent landscape[1].

Patent and Trademark Resource Centers (PTRCs)

Local PTRCs offer training and resources for patent searching, which can be beneficial for those looking to delve deeper into the patent details and related applications[1].

Conclusion

Understanding the scope and claims of United States Patent 10,961,522 is essential for anyone involved in the development, licensing, or commercialization of the modified acid alpha-glucosidase enzyme. By analyzing the patent claims, prior art, and the broader patent landscape, stakeholders can navigate the complex world of intellectual property more effectively.

Key Takeaways

  • Patent Claims: The patent includes independent and dependent claims that define the scope of the invention.
  • Metrics for Scope: Independent claim length and count can measure the breadth and clarity of the patent.
  • Prior Art: Tools like CCD and Global Dossier help in understanding prior art and related applications.
  • Legal Considerations: Office actions and potential small claims patent courts can impact the patent's validity and enforcement.
  • Practical Implications: Licensing, collaboration, and litigation risks are influenced by the patent scope.

FAQs

Q: What is the main focus of United States Patent 10,961,522?

A: The main focus is on a highly potent acid alpha-glucosidase enzyme with enhanced carbohydrate structures for treating Pompe disease.

Q: How can one measure the scope of a patent like US 10,961,522?

A: Metrics such as independent claim length and independent claim count can be used to measure the scope and clarity of the patent.

Q: What tools are available for searching and analyzing patents related to US 10,961,522?

A: Tools like the Patent Public Search, Global Dossier, and CCD are available for searching and analyzing patents.

Q: Why is understanding prior art important for US 10,961,522?

A: Understanding prior art helps in identifying potential overlaps or conflicts with other patents and ensures the novelty of the invention.

Q: How might a small claims patent court affect the enforcement of US 10,961,522?

A: A small claims patent court could provide a more streamlined and cost-effective way to resolve patent infringement cases related to US 10,961,522.

Sources

  1. USPTO: Search for patents - USPTO.
  2. USA.gov: U.S. Patent and Trademark Office (USPTO) | USAGov.
  3. SSRN: Patent Claims and Patent Scope.
  4. Google Patents: Highly potent acid alpha-glucosidase with enhanced carbohydrates.
  5. ACUS: U.S. Patent Small Claims Court.

More… ↓

⤷  Subscribe


Drugs Protected by US Patent 10,961,522

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 OPFOLDA miglustat CAPSULE;ORAL 215211-001 Sep 28, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe THE TREATMENT OF POMPE 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 10,961,522

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3201320 ⤷  Subscribe 301267 Netherlands ⤷  Subscribe
European Patent Office 3201320 ⤷  Subscribe LUC00336 Luxembourg ⤷  Subscribe
European Patent Office 3201320 ⤷  Subscribe CA 2024 00012 Denmark ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.