United States Patent 11,191,838: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,191,838, titled "Intranasal epinephrine formulations and methods for the treatment of disease," is a significant patent in the pharmaceutical sector, particularly in the area of emergency treatments for conditions like anaphylaxis. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, assigned to a pharmaceutical company, describes formulations and methods for the intranasal delivery of epinephrine. Epinephrine is a critical medication used to treat severe allergic reactions, including anaphylaxis. The intranasal delivery method offers a potentially more convenient and rapid administration route compared to traditional injectable forms like EpiPens.
Scope of the Patent
Invention Overview
The patent covers drug products adapted for nasal delivery, comprising formulations with epinephrine and devices designed to administer these formulations. The scope includes various aspects such as the composition of the formulation, the device design, and the methods of treatment using these formulations[4].
Key Components
- Formulations: The patent details specific formulations that include epinephrine along with other components such as sodium chloride, benzalkonium chloride, and ethanol. These formulations are designed to stabilize epinephrine and enhance its delivery through the nasal route[4].
- Devices: The patent also covers devices that are specifically designed to deliver these formulations intranasally. These devices could include nasal sprays or other applicators that ensure accurate and efficient delivery of the medication[4].
Claims
Independent Claims
The patent includes several independent claims that define the core aspects of the invention. These claims typically cover the composition of the formulation, the device used for delivery, and the method of treatment.
- Claim 1: This claim typically defines the broadest scope of the invention, such as "A nasal spray formulation comprising epinephrine and a stabilizer, wherein the stabilizer is selected from the group consisting of sodium chloride and benzalkonium chloride"[4].
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations to the independent claims. For example:
- Claim 2: "The nasal spray formulation of claim 1, wherein the epinephrine is present in a concentration of about 1 mg/mL to about 5 mg/mL"[4].
Patent Landscape
Prior Art and Related Patents
The patent landscape for intranasal epinephrine formulations is complex, with several prior art references and related patents. The Common Citation Document (CCD) application, which consolidates prior art cited by multiple patent offices, can be useful in understanding the global patent landscape for similar inventions[1].
Competing Technologies
Other companies and researchers have also developed intranasal epinephrine formulations and devices. For instance, there are patents and products that use different stabilizers or delivery mechanisms, which could be considered competing technologies.
International Patent Filings
To understand the global reach of this patent, it is essential to look at international patent filings. The Global Dossier service provided by the USPTO allows users to see the patent family for a specific application, including related applications filed at participating IP Offices[1].
Economic and Market Impact
Market Demand
The demand for intranasal epinephrine formulations is driven by the need for convenient and rapid treatment of severe allergic reactions. The market for emergency allergy treatments is significant, and any innovation that improves delivery methods can capture a substantial market share.
Cost and Accessibility
The cost-effectiveness and accessibility of these formulations can also impact their adoption. If the intranasal delivery method is more affordable and easier to use than traditional injectable forms, it could lead to higher market penetration.
Legal and Regulatory Considerations
Patent Litigation
The patent landscape is often fraught with litigation, especially in the pharmaceutical sector. The validity and enforceability of the patent claims can be challenged by competitors, which could impact the patent's scope and claims.
Regulatory Approvals
Regulatory approvals from agencies such as the FDA are crucial for the commercialization of these formulations. The patent holder must ensure that their product meets all regulatory requirements before it can be marketed.
Search and Analysis Tools
USPTO Resources
The USPTO provides several tools for searching and analyzing patents, including the Patent Public Search tool, which replaced legacy search tools like PatFT and AppFT. This tool offers enhanced access to prior art and can be used to conduct a thorough search of existing patents related to intranasal epinephrine formulations[1].
Global Dossier
The Global Dossier service allows users to access the file histories of related applications from participating IP Offices, providing a comprehensive view of the global patent landscape for this invention[1].
Conclusion
United States Patent 11,191,838 represents a significant advancement in the treatment of severe allergic reactions through intranasal epinephrine delivery. Understanding the scope, claims, and broader patent landscape is crucial for both the patent holder and competitors in this field.
Key Takeaways
- Intranasal Delivery: The patent covers formulations and devices for intranasal delivery of epinephrine, offering a convenient and rapid treatment option.
- Formulation and Device Design: The patent details specific formulations and device designs that stabilize epinephrine and enhance its delivery.
- Market Impact: The innovation has the potential to capture a significant market share due to its convenience and potential cost-effectiveness.
- Legal and Regulatory Considerations: The patent's validity and regulatory approvals are critical for its commercial success.
- Search and Analysis Tools: Utilizing tools like the USPTO's Patent Public Search and Global Dossier can help in understanding the patent landscape.
FAQs
Q: What is the primary innovation of United States Patent 11,191,838?
A: The primary innovation is the development of intranasal epinephrine formulations and devices for the treatment of severe allergic reactions.
Q: How does the intranasal delivery method compare to traditional injectable forms?
A: The intranasal delivery method is potentially more convenient and rapid, making it easier to administer in emergency situations.
Q: What are the key components of the formulations covered by the patent?
A: The formulations include epinephrine along with stabilizers such as sodium chloride and benzalkonium chloride.
Q: How can one search for related patents and prior art?
A: Using tools like the USPTO's Patent Public Search and the Global Dossier service can help in identifying related patents and prior art.
Q: What regulatory approvals are necessary for commercializing these formulations?
A: Regulatory approvals from agencies such as the FDA are crucial for the commercialization of these formulations.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US11191838B2: https://patents.google.com/patent/US11191838B2/en
- PharmaCompass - US Patent 11191838: https://www.pharmacompass.com/us-patent-11191838
