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Last Updated: December 23, 2024

Details for Patent: 11,278,599


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Which drugs does patent 11,278,599 protect, and when does it expire?

Patent 11,278,599 protects OPFOLDA and is included in one NDA.

This patent has seventeen patent family members in six countries.

Summary for Patent: 11,278,599
Title:High concentration alpha-glucosidase compositions for the treatment of Pompe disease
Abstract:The present application provides for compositions comprising high concentrations of acid a-glucosidase in combination with an active site-specific chaperone for the acid α-glucosidase, and methods for treating Pompe disease in a subject in need thereof, that includes a method of administering to the subject such compositions. The present application also provides methods for increasing the in vitro and in vivo stability of an acid α-glucosidase enzyme formulation.
Inventor(s):Valenzano Kenneth, Crowley John, Khanna Richie, Flanagan John
Assignee:Amicus Therapeutics, Inc.
Application Number:US16580541
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Understanding the Scope and Claims of a US Patent: A Detailed Analysis of United States Patent 11,278,599

Introduction to Patents and Patent Claims

Patents are a crucial component of intellectual property protection, allowing inventors to secure exclusive rights to their inventions. The U.S. Patent and Trademark Office (USPTO) is responsible for granting these patents, and the process involves several key elements, including the scope and claims of the patent[2][4].

What are Patent Claims?

Patent claims are the heart of a patent application, defining the scope of protection for the invention. These claims must be clear, concise, and supported by the specification and drawings provided in the application. The claims determine what is considered to be within the bounds of the patent's protection and what is not[4][5].

Importance of Claim Scope

The scope of patent claims is critical for several reasons:

  • Validity and Enforcement: A patent with overly broad claims risks being invalidated due to failure to meet the written description requirement or falling under the abstract idea exception, as seen in cases like Yu v. Apple Inc. and Minerva Surgical, Inc. v. Hologic, Inc.[5].
  • Cost and Complexity: Broader claims are more difficult to get allowed and can increase the costs associated with patent prosecution. Narrower claims, on the other hand, are often associated with a higher probability of grant and a shorter examination process[3][5].

The Patent Application Process

To understand the scope and claims of a specific patent, it is essential to grasp the patent application process:

  • Filing Types: There are three main types of patent applications: utility, design, and plant patents. Utility patents are the most common and cover functional inventions[4].
  • Provisional and Non-Provisional Applications: Inventors can file a provisional application to establish an early filing date, followed by a non-provisional application within 12 months. The non-provisional application must comply with all statutory requirements[4].

Analyzing the Scope of United States Patent 11,278,599

To analyze the scope of a specific patent like United States Patent 11,278,599, one must delve into the patent's claims and specification.

Claims Analysis

  • Independent and Dependent Claims: The patent will include independent claims that stand alone and dependent claims that refer back to the independent claims. Independent claims are crucial as they define the broadest scope of the invention[4].
  • Claim Language: The language used in the claims must be precise and supported by the specification. Overly broad claims can lead to invalidation, while narrower claims may not fully capture the invention's scope[5].

Specification and Drawings

  • Support for Claims: The specification and drawings must provide sufficient support for the claims. This includes detailed descriptions of the invention, its components, and how it operates[4].
  • Embodiments: The specification will often include multiple embodiments of the invention, which help to anchor the claims and ensure they are not overly broad[5].

Patent Landscape and Trends

Understanding the broader patent landscape can provide context for the scope and claims of a specific patent:

  • Technology Areas: Patents can be classified into various technology areas, such as electrical engineering, mechanical engineering, and chemistry. This classification helps in analyzing trends and focus areas in patenting[1].
  • Global and Domestic Trends: The USPTO data shows that electrical and mechanical engineering patents dominate the landscape, with significant growth in areas like computer technology and digital communication[1].

Case Studies and Industry Insights

Industry experts and court decisions offer valuable insights into the importance of claim scope:

  • Court Decisions: Cases like Yu v. Apple Inc. and Minerva Surgical, Inc. v. Hologic, Inc. highlight the risks of overly broad claims and the importance of aligning claims with the specification[5].
  • Expert Advice: Patent practitioners emphasize the need for balanced claim scope, avoiding both overly broad and overly narrow claims to ensure the patent's validity and enforceability[5].

Key Takeaways

  • Precision in Claims: The language and scope of patent claims are critical for the validity and enforceability of the patent.
  • Support from Specification: Claims must be well-supported by the specification and drawings to avoid invalidation.
  • Balanced Scope: A balanced claim scope, neither too broad nor too narrow, is essential for effective patent protection.
  • Trends and Classification: Understanding the broader patent landscape and technology areas can help in strategizing patent applications.

FAQs

Q: What is the primary purpose of patent claims in a patent application? A: The primary purpose of patent claims is to define the scope of protection for the invention, determining what is included and excluded from the patent's coverage.

Q: Why is it important to avoid overly broad claims in a patent application? A: Overly broad claims can lead to invalidation due to failure to meet the written description requirement or falling under the abstract idea exception, and they are more difficult and costly to get allowed.

Q: How does the USPTO classify patents into different technology areas? A: The USPTO classifies patents using the World Intellectual Property Organization (WIPO) classification system, which includes 35 International Patent Classification (IPC) technical fields. These fields are aggregated into broader technology areas for trend analysis[1].

Q: What is the difference between a provisional and a non-provisional patent application? A: A provisional application allows for an early filing date with fewer formal requirements, while a non-provisional application must comply with all statutory requirements and is filed within 12 months of the provisional application[4].

Q: How do court decisions influence the drafting of patent claims? A: Court decisions, such as Yu v. Apple Inc. and Minerva Surgical, Inc. v. Hologic, Inc., provide guidance on avoiding overly broad claims and ensuring that claims are well-supported by the specification to avoid invalidation[5].

Sources

  1. Invention: U.S. and Comparative Global Trends - National Science Foundation.
  2. U.S. Patent and Trademark Office (USPTO) | USAGov - USA.gov.
  3. Patent Claims and Patent Scope - SSRN.
  4. Patents | The Maryland People's Law Library - People's Law Library.
  5. The Importance of Getting the Claim Scope Right in a US Patent Application - Rimon Law.

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Drugs Protected by US Patent 11,278,599

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 11,278,599

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2866683 ⤷  Subscribe
European Patent Office 2823043 ⤷  Subscribe
Japan 2015509542 ⤷  Subscribe
Japan 2018027945 ⤷  Subscribe
Japan 2020143071 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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