United States Patent 9,610,265: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,610,265, titled "Compositions and methods for intravenous administration of acetaminophen," is a significant patent in the pharmaceutical industry, particularly in the realm of pain management and fever reduction. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Title and Abstract
The patent, granted on March 28, 2017, describes compositions and methods for the intravenous administration of acetaminophen at a single dose level of less than about 1000 mg. This is particularly important for clinical settings where rapid and controlled administration of acetaminophen is necessary[2][5].
Scope of the Patent
Technical Field
The patent falls under the technical field of pharmaceutical compositions, specifically focusing on intravenous formulations of acetaminophen. This area is crucial for hospitals and clinical settings where intravenous administration is often preferred for its rapid onset of action and precise dosing.
Claims
The patent includes several claims that define the scope of the invention:
- Composition Claims: These claims describe the specific formulations of acetaminophen suitable for intravenous administration, including the concentration and volume of the solution.
- Method Claims: These claims outline the methods for preparing and administering the intravenous acetaminophen solutions.
- Dosage Claims: These claims specify the dosage levels, particularly focusing on single doses less than 1000 mg[2][5].
Claim Analysis
Claim Coverage Matrix
To understand the protection offered by this patent, a Claim Coverage Matrix can be used. This matrix helps in categorizing the claims by their scope concepts, which can include the type of formulation, method of administration, and dosage levels. For example, the claims can be categorized into high-value claims that are currently protecting the product OFIRMEV, medium-value claims indicating potential future directions, and low-value claims that may not be worth maintaining[3].
Claim Charts
Interactive claim charts generated using tools like ClaimScape® can help in visualizing the coverage of the patent claims. These charts are useful for technical experts to review and determine whether the scope concepts of the patent claims are applicable to target products or methods. This helps in identifying gaps in current coverage and highlighting future design opportunities[3].
Patent Landscape
Related Patents and Applications
The patent landscape for intravenous acetaminophen formulations includes other related patents and applications. For instance, the Global Dossier service provided by the USPTO allows users to see the patent family for a specific application, including all related applications filed at participating IP Offices. This helps in understanding the broader landscape and potential overlaps or gaps in patent coverage[1].
International Patent Databases
To ensure global protection, it is essential to search international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO). These databases offer access to machine translations of patents in various languages, facilitating a comprehensive global search[1].
Market and Industrial Impact
Pharmaceutical Industry Trends
The pharmaceutical industry, particularly the segment dealing with pain management and fever reduction, has seen significant growth in recent years. Patents like 9,610,265 play a crucial role in this sector by providing exclusive rights to the inventors, thereby encouraging innovation and investment in research and development. According to the USPTO, the number of patents granted in the pharmaceutical and biotechnology fields has been increasing, reflecting the industry's focus on developing new and improved treatments[4].
Economic and Clinical Significance
The economic significance of this patent lies in its potential to protect a valuable product like OFIRMEV, which is included in one New Drug Application (NDA). Clinically, the patent's focus on intravenous administration of acetaminophen addresses a critical need in hospitals for rapid and controlled pain management and fever reduction[5].
Expiration and Future Implications
Patent Expiration
The patent 9,610,265 is set to expire after its term, typically 20 years from the filing date. As the expiration date approaches, it is crucial for the patent holders to assess the value of the claims and consider strategies such as filing for extensions, if possible, or developing new formulations that could be protected under new patents[5].
Future Developments
As the patent landscape evolves, future developments may include new formulations or methods of administration that could potentially circumvent the existing claims. Continuous monitoring of the patent landscape and engagement in patent analytics can help in identifying these opportunities and gaps, ensuring that the intellectual property remains protected and valuable[3].
Key Takeaways
- Patent Scope: The patent covers compositions and methods for intravenous administration of acetaminophen at specific dosage levels.
- Claim Analysis: Using tools like Claim Coverage Matrix and claim charts helps in understanding the protection offered by the patent.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and international applications.
- Market Impact: The patent is significant in the pharmaceutical industry, particularly in pain management and fever reduction.
- Future Implications: As the patent approaches expiration, strategies for maintaining protection and identifying new opportunities are crucial.
FAQs
What is the primary focus of United States Patent 9,610,265?
The primary focus of United States Patent 9,610,265 is on compositions and methods for the intravenous administration of acetaminophen at a single dose level of less than about 1000 mg.
Which product is protected by this patent?
The patent protects the product OFIRMEV, which is included in one New Drug Application (NDA).
How can the claims of this patent be analyzed?
The claims can be analyzed using a Claim Coverage Matrix and interactive claim charts to understand the scope concepts and identify gaps or opportunities in coverage.
What is the significance of this patent in the pharmaceutical industry?
This patent is significant in the pharmaceutical industry, particularly in the segment dealing with pain management and fever reduction, as it provides exclusive rights for the intravenous administration of acetaminophen.
When is the patent set to expire?
The patent is set to expire after its term, typically 20 years from the filing date, although the exact expiration date needs to be verified from the patent details.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Unified Patents Portal - US-9610265-B2: https://portal.unifiedpatents.com/patents/patent/9610265
- Patent Analytics | Intellectual Property Law: https://www.slwip.com/services/patent-analytics/
- Invention: U.S. and Comparative Global Trends: https://ncses.nsf.gov/pubs/nsb20204/invention-u-s-and-comparative-global-trends
- DrugPatentWatch - Patent 9,610,265: https://www.drugpatentwatch.com/p/patent/9610265
