Analyzing the Scope and Claims of United States Patent 8,815,258
Introduction
United States Patent 8,815,258, titled "Compositions, methods and systems for respiratory delivery of two or more active agents," is a patent that outlines innovative approaches to pulmonary and nasal delivery of medicinal agents. This analysis will delve into the patent's scope, claims, and the broader patent landscape to provide a comprehensive understanding.
Patent Overview
The patent, assigned the number US8815258B2, was granted on August 26, 2014. It describes compositions, methods, and systems designed for the delivery of two or more active agents via a metered dose inhaler (MDI). This technology is particularly relevant in the field of respiratory medicine, addressing the need for efficient and precise delivery of therapeutic agents directly to the lungs or nasal passages[4].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are crucial as they delineate what is considered novel and non-obvious, thereby establishing the patent's boundaries.
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Claim 1: This claim describes a composition for pulmonary or nasal delivery, comprising a suspension of two or more active agents in a propellant. The claim specifies the types of active agents and the characteristics of the suspension[4].
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Claim 10: This claim outlines a method for delivering two or more active agents to the lungs or nasal passages using an MDI. It details the steps involved in preparing and administering the composition[4].
Dependent Claims
Dependent claims further refine the independent claims by adding additional limitations or specifications. These claims help to narrow down the scope and provide more detailed descriptions of the invention.
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Claim 2: This claim depends on Claim 1 and specifies the types of propellants that can be used in the composition[4].
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Claim 11: This claim depends on Claim 10 and details the specific concentrations of the active agents in the composition[4].
Patent Scope
The scope of a patent is a critical aspect that determines its breadth and the extent of protection it offers. Here are some key metrics and considerations:
Independent Claim Length and Count
Research suggests that the length and count of independent claims can be indicative of the patent's scope. Generally, narrower claims with fewer independent claims are associated with a higher probability of grant and a shorter examination process[3].
- US8815258B2 has multiple independent claims, but they are relatively specific, indicating a balanced scope that is neither overly broad nor too narrow.
Classification and Categories
The patent is classified under various categories within the International Patent Classification (IPC) system:
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A61K31/46: This classification pertains to medicinal preparations containing organic active ingredients, specifically those related to 8-azabicyclo [3.2.1] octane derivatives[4].
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A61M15/00: This classification is related to inhalators, including those with dosage or measuring devices[4].
These classifications help in understanding the patent's position within the broader medical and pharmaceutical landscape.
Prior Art and Novelty
Prior art refers to the existing body of knowledge and inventions in the field at the time of the patent application. The novelty of US8815258B2 lies in its unique combination of active agents and the method of delivery.
- Prior Art Keywords: The patent document lists keywords such as "suspension," "active agent," and "particles," which indicate the areas where the invention improves upon existing technologies[4].
Legal Status and Expiration
The legal status of the patent is active, but it is set to expire based on the patent term, which is typically 20 years from the filing date of the application.
- Expiration Date: The patent will expire on the 20th anniversary of its filing date, which was August 12, 2011[4].
Broader Patent Landscape
Global Patent Databases
The patent landscape for respiratory delivery systems is extensive and global. Databases such as the USPTO's Patent Public Search, the European Patent Office's worldwide database, and the WIPO's PATENTSCOPE database provide access to a vast array of patent documents from over 100 patent-granting authorities. These resources are essential for conducting thorough patent searches and analyzing the competitive landscape[1].
Cooperative Patent Classification (CPC)
The Cooperative Patent Classification (CPC) system is used to classify patents based on their technological content. This system helps in identifying relevant patents and understanding the classification schemes that apply to US8815258B2[1].
Practical Implications and Applications
The technology described in US8815258B2 has significant practical implications for the treatment of respiratory diseases. Here are a few examples:
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Efficient Delivery: The use of metered dose inhalers ensures precise and efficient delivery of therapeutic agents directly to the lungs or nasal passages, enhancing the efficacy of treatments[4].
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Combination Therapies: The ability to deliver two or more active agents in a single inhaler simplifies treatment regimens and can improve patient compliance[4].
Industry Expert Insights
Industry experts often highlight the importance of well-defined patent claims and the impact on innovation and litigation.
"Patent scope is one of the important aspects in the debates over ‘patent quality.’ The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or ‘overly broad’ patents), decreased clarity, and questionable validity."[3]
Statistics and Trends
- Patent Filings: The number of patent filings in the respiratory delivery sector has been increasing, reflecting the growing interest in innovative delivery systems.
- Litigation Costs: Patents with narrower claims tend to have lower litigation costs, which can be a significant factor in the pharmaceutical industry[3].
Key Takeaways
- Patent Scope: The scope of US8815258B2 is defined by its independent and dependent claims, which specify the composition, method, and system for respiratory delivery.
- Classification: The patent is classified under various IPC categories related to medicinal preparations and inhalators.
- Novelty: The patent's novelty lies in its unique combination of active agents and delivery method.
- Legal Status: The patent is active but set to expire based on the patent term.
- Practical Implications: The technology has significant implications for the treatment of respiratory diseases, offering efficient and precise delivery of therapeutic agents.
FAQs
Q: What is the main subject of United States Patent 8,815,258?
A: The main subject is compositions, methods, and systems for the respiratory delivery of two or more active agents via a metered dose inhaler.
Q: How are the claims in US8815258B2 structured?
A: The patent includes independent claims that define the scope of the invention, with dependent claims that further refine these independent claims.
Q: What is the significance of the Cooperative Patent Classification (CPC) system?
A: The CPC system helps in classifying patents based on their technological content, making it easier to identify relevant patents and understand the classification schemes.
Q: What are the practical implications of this patent?
A: The technology described enhances the efficiency and precision of delivering therapeutic agents directly to the lungs or nasal passages, simplifying treatment regimens and improving patient compliance.
Q: How does the patent's scope impact its validity and litigation?
A: A well-defined scope with narrower claims can reduce litigation costs and improve the patent's validity by avoiding overly broad claims that might be challenged.
Sources
- Clemson University Libraries - Research and Course Guides: Patent Searching, Advanced.
- USA.gov - U.S. Patent and Trademark Office (USPTO).
- SSRN - Patent Claims and Patent Scope.
- Google Patents - US8815258B2 - Compositions, methods and systems for respiratory delivery of two or more active agents.
- Administrative Conference of the United States - U.S. Patent Small Claims Court.
