United States Patent 10,220,158: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,220,158, titled "Devices and methods for delivering opioid antagonists including formulations for naloxone," is a significant patent in the field of medicament delivery systems. This patent, owned by Kaleo Inc., is part of a broader portfolio of patents related to the Evzio autoinjector, a device designed for the emergency treatment of opioid overdose.
Patent Overview
Patent Title and Number
- Title: Devices and methods for delivering opioid antagonists including formulations for naloxone
- Patent Number: US 10,220,158
Publication and Expiry Dates
- Publication Date: March 5, 2019
- Expiry Date: March 2035[2][5].
Claims and Scope
Independent and Dependent Claims
The patent includes a combination of independent and dependent claims that define the scope of the invention. Independent claims typically outline the broadest aspects of the invention, while dependent claims narrow down the scope by adding specific details.
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Independent Claims: These claims describe the core components and functionalities of the device, such as the medicament delivery system, the housing, the movable member, the valve, and the actuator. For example, Claim 1 might describe a device comprising a housing, a movable member, and a valve coupled to the movable member, configured to deliver a medicament into a body[4].
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Dependent Claims: These claims build upon the independent claims by adding specific features or limitations. For instance, a dependent claim might specify the material of the housing (e.g., stainless steel, aluminum, polycarbonate) or the configuration of the actuation guard to prevent accidental activation[4].
Claim Language and Scope Metrics
The scope of the patent claims can be measured using metrics such as independent claim length (ICL) and independent claim count (ICC). These metrics help in understanding the breadth and clarity of the claims. Narrower claims with fewer words and fewer independent claims are generally associated with a higher probability of grant and a shorter examination process[3].
Patent Landscape
Related Patents and Family Members
The patent US 10,220,158 is part of a larger family of patents related to the Evzio autoinjector. This family includes multiple patents filed between 2016 and 2023, all focusing on various aspects of medicament delivery systems, such as devices, systems, and methods for delivering opioid antagonists like naloxone[2].
Legal Activities and Maintenance
The patent's life and scope can be influenced by various legal activities, including maintenance fee payments, term extensions, and amendments to claims. For example, recent activities include the payment of maintenance fees in 2024, which ensures the patent remains active until its expiry date[2].
Technical Details
Device Components and Functionality
The patent describes a medicament delivery device that includes a housing, a movable member, a valve, and an actuator. The movable member is configured to be disposed within the housing and has a first end portion defining a gas chamber and a second end portion coupled to a needle for delivering the medicament. The valve and actuator work together to control the flow of gas and the delivery of the medicament[4].
Safety Features
The device includes safety features such as an actuation guard to prevent accidental activation. The housing is constructed from durable materials to protect the compressed gas container, medicament, and the user[4].
Market and Clinical Significance
Emergency Treatment of Opioid Overdose
The Evzio autoinjector, covered by this patent, is designed for the emergency treatment of opioid overdose. It provides a critical tool in the fight against the opioid epidemic by delivering naloxone, an opioid antagonist, quickly and effectively.
Competitive Landscape
The patent landscape in this area is highly competitive, with multiple companies developing similar devices. The expiry of these patents, including US 10,220,158, will open up opportunities for generic versions of these devices, potentially increasing accessibility and reducing costs.
Challenges and Critiques
Patent Quality and Scope
There have been debates over patent quality, particularly regarding the breadth and clarity of claims. Some critics argue that overly broad claims can impede innovation by increasing licensing and litigation costs. The metrics of independent claim length and count can help in evaluating the quality and scope of these patents[3].
Future Implications
Generic Entry and Market Impact
The expiry of the patent in March 2035 will allow for the entry of generic versions of the Evzio autoinjector. This could significantly impact the market by increasing competition, reducing prices, and improving accessibility to this life-saving device.
Innovation and R&D
The expiry of this patent will also encourage further innovation in the field of medicament delivery systems. Companies may focus on developing new technologies or improving existing ones, leading to better and more efficient devices.
Key Takeaways
- Patent Scope and Claims: The patent includes detailed claims defining the device's components and functionalities.
- Technical Details: The device features a housing, movable member, valve, and actuator, with safety features like an actuation guard.
- Market Significance: The Evzio autoinjector is crucial for emergency opioid overdose treatment.
- Future Implications: The patent's expiry will open up opportunities for generic versions and encourage further innovation.
FAQs
What is the main purpose of the Evzio autoinjector covered by US 10,220,158?
The main purpose of the Evzio autoinjector is to deliver naloxone, an opioid antagonist, for the emergency treatment of opioid overdose.
When does the patent US 10,220,158 expire?
The patent US 10,220,158 expires in March 2035.
What are the key components of the device described in the patent?
The key components include a housing, a movable member, a valve, and an actuator, along with safety features such as an actuation guard.
How does the patent landscape affect the market for medicament delivery devices?
The patent landscape influences the market by controlling the entry of generic versions and encouraging innovation. The expiry of patents like US 10,220,158 will increase competition and reduce costs.
What metrics are used to measure the scope of patent claims?
Metrics such as independent claim length (ICL) and independent claim count (ICC) are used to measure the scope and clarity of patent claims.
Cited Sources:
- US9149579B2 - Devices, systems and methods for medicament delivery - Google Patents
- Evzio (autoinjector) patent expiration - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- US9149579B2 - Devices, systems and methods for medicament delivery - Google Patents
- Pharmaceutical drugs covered by patent 10,220,158 - Drug Patent Watch
