Analyzing the Scope and Claims of United States Patent 10,519,142
Introduction
Understanding the scope and claims of a patent is crucial for navigating the intellectual property landscape, especially in highly regulated and competitive fields such as pharmaceuticals. This article delves into the details of United States Patent 10,519,142, focusing on its claims, scope, and the broader patent landscape it inhabits.
Patent Overview
United States Patent 10,519,142 is associated with the human drug product FRUZAQLA™ (fruquintinib), a medication that has undergone extensive regulatory review. Here is a brief overview of the patent:
- Patent Number: 10,519,142
- Associated Product: FRUZAQLA™ (fruquintinib)
- Regulatory Approval: Approved by the FDA on November 8, 2023[4].
Claims of the Patent
The claims of a patent define the scope of the invention and are critical for determining what is protected under the patent.
Types of Claims
Patents typically include various types of claims, such as:
- Independent Claims: These claims stand alone and define the invention without reference to other claims.
- Dependent Claims: These claims refer back to and further limit the independent claims.
For U.S. Patent 10,519,142, the specific claims would need to be reviewed in detail from the patent document itself. However, it is common for pharmaceutical patents to include claims related to the composition of the drug, methods of use, and methods of manufacture.
Claim Analysis
To analyze the claims, one would typically:
- Identify the independent claims to understand the core invention.
- Review dependent claims to see how they narrow down the scope.
- Consider any claim limitations or exceptions.
For example, if the patent includes claims related to the specific formulation of fruquintinib, these would be key in understanding what aspects of the drug are protected.
Scope of the Patent
The scope of a patent is defined by its claims and is influenced by several factors:
Prior Art
The scope is limited by prior art, which includes all publicly available information before the patent's filing date. Tools like the USPTO's Patent Public Search and the Common Citation Document (CCD) can help identify relevant prior art[1].
Patent Family
The patent family, which includes all related applications filed at participating IP Offices, can provide insight into the broader scope of protection. The Global Dossier service offered by the USPTO is useful for this purpose[1].
Patent Landscape
Understanding the patent landscape involves looking at related patents and applications.
Related Patents
Other patents related to FRUZAQLA™, such as U.S. Patent Nos. 7,829,574 and 8,212,033, are part of the same patent family and may share similar claims or scope. These patents would need to be analyzed together to understand the overall protection[4].
Regulatory Environment
The regulatory environment, particularly the FDA approval process, plays a significant role in the patent landscape. The regulatory review period, as determined by the FDA, can impact the patent term extension, which is crucial for maintaining market exclusivity[4].
Patent Term Extension
Patent term extensions are often sought for pharmaceutical patents to compensate for the time spent in regulatory review. For U.S. Patent 10,519,142, the FDA has determined the regulatory review period, which forms the basis for the patent term extension application[4].
- Regulatory Review Period: The FDA determined a regulatory review period of 2,604 days for FRUZAQLA™, which includes both the testing and approval phases[4].
- Extension Application: The applicant has sought patent term extensions of 544 days, 793 days, or 1,414 days, subject to USPTO approval[4].
Tools and Resources for Analysis
Several tools and resources are available for analyzing patents:
USPTO Resources
- Patent Public Search: A powerful tool for searching prior art and understanding the patent landscape[1].
- Global Dossier: Provides access to file histories and related applications from participating IP Offices[1].
- Patent Claims Research Dataset: Offers detailed information on claims from U.S. patents and applications, which can be used to analyze claim scope and trends[3].
Regulatory Documents
- FDA Determinations: Documents from the FDA, such as the determination of the regulatory review period, are crucial for understanding the patent term extension process[4].
Industry Impact
Understanding the scope and claims of U.S. Patent 10,519,142 is vital for industry professionals, particularly those in the pharmaceutical sector.
Market Exclusivity
The patent term extension can significantly impact market exclusivity, allowing the patent holder to maintain exclusive rights for a longer period.
Competitive Landscape
Analyzing the patent landscape helps competitors understand the boundaries of what is protected and what areas may be open for innovation.
Key Takeaways
- Claims Analysis: Understanding the independent and dependent claims is crucial for determining the scope of protection.
- Prior Art and Patent Family: Reviewing prior art and the patent family helps in understanding the broader patent landscape.
- Regulatory Environment: The FDA's regulatory review period and patent term extension process are critical for maintaining market exclusivity.
- Tools and Resources: Utilizing USPTO resources and regulatory documents is essential for a comprehensive analysis.
FAQs
Q: What is the significance of the regulatory review period in patent term extension?
A: The regulatory review period, determined by the FDA, forms the basis for calculating the patent term extension, compensating for the time spent in regulatory review.
Q: How can I access the file histories of related patent applications?
A: The Global Dossier service provided by the USPTO allows users to access the file histories of related applications from participating IP Offices[1].
Q: What tools can I use to analyze the claims of a patent?
A: The USPTO's Patent Claims Research Dataset and the Patent Public Search tool are valuable resources for analyzing patent claims and understanding the patent landscape[1][3].
Q: Why is it important to review the patent family of a patent?
A: Reviewing the patent family helps in understanding the broader scope of protection and identifying related applications that may share similar claims or scope.
Q: How does the FDA's approval impact the patent term extension?
A: The FDA's approval date and the regulatory review period are critical in determining the eligibility and duration of the patent term extension[4].
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Regulations.gov - FDA Application for Patent Term Extension: https://downloads.regulations.gov/FDA-2024-E-0430-0001/attachment_1.pdf
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Federal Register - FDA Determination of Regulatory Review Period: https://www.govinfo.gov/content/pkg/FR-2024-09-25/html/2024-21930.htm
- Regulations.gov - FDA U.S. FOOD & DRUG: https://downloads.regulations.gov/FDA-2024-E-0428-0005/attachment_1.pdf
