United States Patent 9,050,348: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,050,348, titled "Dermal delivery device," was granted to Agile Therapeutics in June 2015. This patent is significant for its innovative design in transdermal drug delivery systems. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Details
- Publication Number: US9050348B2
- Authority: United States
- Prior Art Date: The patent application was filed on June 28, 2011[4].
Invention Description
The patent describes a transdermal drug delivery device designed to deliver active ingredients through the skin over an extended period. The device causes cumulative moderate irritation and significant irritation, which is a deliberate design feature to enhance drug delivery[4].
Scope of the Patent
Key Components
The scope of the patent encompasses several critical components of the transdermal delivery device:
- Peripheral Adhesive System: This is a key feature of the device, ensuring that the patch adheres to the skin effectively[5].
- Active Ingredients: The device is designed to deliver various active ingredients, including those for hormonal therapies like levonorgestrel[5].
- Polymer Layers: The device includes multiple layers made from various polymers such as polyisobutene, polyacrylate, and polysiloxane. These layers are crucial for the controlled release of the active ingredients[4].
Effects on Skin
The patent highlights the effects of the device on the skin, including cumulative moderate irritation and significant irritation. These effects are intended to enhance the permeability of the skin and improve drug delivery[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention:
- Claim 1: Describes the overall structure of the transdermal drug delivery device, including the peripheral adhesive system and the active ingredient layer[4].
- Claim 2: Specifies the materials used in the device, such as pressure-sensitive adhesives and matrix materials[4].
Dependent Claims
Dependent claims further detail the specifics of the device, including the types of polymers used, the configuration of the layers, and the method of application.
Metrics for Measuring Patent Scope
Independent Claim Length and Count
Research suggests that the scope of a patent can be measured using metrics such as independent claim length and independent claim count. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Application to US9050348B2
For US9050348B2, the independent claims are detailed but not overly broad, indicating a well-defined scope that likely contributed to its successful grant. The patent's focus on specific materials and design elements suggests a clear and narrow scope, aligning with best practices in patent drafting.
Patent Landscape
Global Context
The patent landscape for transdermal drug delivery devices is global and highly competitive. Other countries and organizations, such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO), provide searchable databases that can help in assessing the global patent landscape[1].
Related Patents
Agile Therapeutics has also been granted other patents related to transdermal patch designs, such as those covering progestin-only transdermal patches. These patents collectively strengthen Agile Therapeutics' position in the market for hormonal therapies delivered via transdermal patches[5].
Search and Analysis Tools
USPTO Resources
The United States Patent and Trademark Office (USPTO) provides several tools for searching and analyzing patents, including the Patent Public Search tool, Global Dossier, and the Patent and Trademark Resource Centers (PTRCs). These resources can be used to find related patents, analyze prior art, and understand the broader patent landscape[1].
International Databases
Databases such as esp@cenet from the EPO, PATENTSCOPE from WIPO, and others from various international intellectual property offices are essential for a comprehensive search of global patent filings related to transdermal drug delivery devices[1].
Impact on Innovation
Licensing and Litigation
The clarity and specificity of the claims in US9050348B2 can influence licensing and litigation outcomes. Narrow and well-defined claims reduce the likelihood of disputes and make it easier for other innovators to understand what is protected and what is not, thus promoting innovation[3].
Market Position
The issuance of this patent enhances Agile Therapeutics' market position by providing exclusive rights to the innovative design of the transdermal delivery device. This can be a significant competitive advantage, especially in the highly competitive pharmaceutical industry.
Key Takeaways
- Specific Claims: The patent includes detailed and specific claims that define the scope of the invention clearly.
- Global Landscape: The patent is part of a broader global landscape of transdermal drug delivery devices, with similar patents filed in other jurisdictions.
- Innovation Impact: The clarity of the claims can reduce licensing and litigation costs, promoting innovation in the field.
- Market Advantage: The patent provides Agile Therapeutics with a competitive advantage in the market for transdermal drug delivery systems.
FAQs
What is the main invention described in US Patent 9,050,348?
The main invention is a transdermal drug delivery device designed to deliver active ingredients through the skin over an extended period.
What are the key components of the transdermal delivery device?
The key components include a peripheral adhesive system, active ingredient layers, and various polymer layers such as polyisobutene and polyacrylate.
How does the device affect the skin?
The device causes cumulative moderate irritation and significant irritation to enhance drug delivery.
What metrics can be used to measure the scope of a patent?
Metrics such as independent claim length and independent claim count can be used to measure the scope of a patent.
Where can one find related patents and prior art for transdermal drug delivery devices?
Related patents and prior art can be found using resources such as the USPTO's Patent Public Search tool, Global Dossier, and international databases like esp@cenet and PATENTSCOPE.
Sources
- USPTO - Search for patents - USPTO
- Agile Therapeutics - Agile Therapeutics Reports Second Quarter Financial Results
- SSRN - Patent Claims and Patent Scope
- Google Patents - Dermal delivery device - US9050348B2
- Biospace - Agile Therapeutics, Inc. Announces Issuance Of Patent For Progestin Patch Designs
