Detailed Analysis of the Scope and Claims of United States Patent 8,466,136
Introduction
United States Patent 8,466,136, titled "Testosterone gel and method of use," is a significant patent in the field of pharmaceuticals, particularly in the treatment of testosterone deficiency. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication and Filing Details
The patent was published on June 18, 2013, with the application number US13/180,316. It is assigned to the United States and falls under the jurisdiction of the USPTO[4].
Invention Description
The patent describes an improved transdermal hydroalcoholic testosterone gel formulation. This formulation is designed to provide a stable and effective delivery of testosterone through the skin, addressing issues such as skin irritation and inconsistent dosing associated with earlier formulations[4].
Scope of the Invention
Key Components
The invention includes several key components:
- Formulation: The patent details a hydroalcoholic gel formulation containing testosterone, along with various excipients such as carbomer, methanol, and glycerine. These ingredients help in stabilizing the testosterone and enhancing its transdermal absorption[4].
- Method of Use: The method involves applying the gel to the skin, typically on the shoulders, upper arms, or abdomen, to deliver a consistent dose of testosterone over a specified period.
Advantages
The formulation and method of use outlined in the patent offer several advantages, including:
- Improved Stability: The hydroalcoholic base helps in maintaining the stability of testosterone, ensuring consistent delivery.
- Enhanced Absorption: The use of specific excipients improves the transdermal absorption of testosterone, reducing the risk of skin irritation.
- Convenient Application: The gel formulation is easy to apply and can be administered at home, making it a convenient treatment option for patients with testosterone deficiency[4].
Claims
Independent and Dependent Claims
The patent includes both independent and dependent claims:
- Independent Claims: These claims define the broad scope of the invention, including the composition of the testosterone gel and the method of its application.
- Dependent Claims: These claims further specify the details of the invention, such as the concentration of testosterone, the types of excipients used, and the method of application[4].
Claim Examples
- Claim 1: A transdermal hydroalcoholic testosterone gel formulation comprising testosterone, a carbomer, and a solvent system.
- Claim 2: The formulation of claim 1, wherein the solvent system includes methanol and glycerine.
- Claim 3: A method of treating testosterone deficiency, comprising applying the formulation of claim 1 to the skin of a patient[4].
Patent Landscape Analysis
Competitors and Related Patents
To understand the broader patent landscape, it is essential to identify competitors and related patents:
- Competitor Analysis: Companies like AbbVie, which markets AndroGel, a similar testosterone gel product, are key players in this space. Analyzing their patent portfolios can reveal strategic insights into the technology area[3][5].
- Related Patents: Searching databases such as the USPTO's Patent Public Search, European Patent Office's esp@cenet, and WIPO's PATENTSCOPE can help identify other patents related to testosterone formulations and transdermal delivery systems[1].
Patent Saturation
A full patent landscape analysis can help in understanding the saturation level in the technology area:
- High Saturation Areas: Identifying areas with high patent saturation can indicate mature technologies where innovation might be more challenging. This can guide business and R&D decisions to pivot towards newer inventive spaces[3].
Strategic Insights
- Abandoned Technologies: Analyzing abandoned technologies, as shown in Figure 3A and 3B from patent landscape analysis, can provide insights into areas where companies have shifted their focus. This can help in identifying emerging trends and opportunities[3].
- Niche Technologies: Identifying companies that are focusing a significant portion of their resources on niche technologies, such as the company at position eight in the Top Patent Owners chart, can highlight potential areas for innovation and collaboration[3].
Global Patent Family
International Filings
The patent family for US 8,466,136 includes filings in other jurisdictions, which can be accessed through the Global Dossier service provided by the USPTO. This service allows users to see the patent family for a specific application, including all related applications filed at participating IP Offices[1].
Litigation and Legal Status
Litigation History
The patent has been involved in litigation, as seen in the case involving AndroGel, where counterclaims were addressed. Understanding the litigation history can provide insights into the patent's enforceability and potential challenges[2].
Legal Status
The legal status of the patent is active, but it is important to note that legal status can change over time due to various factors such as expiration, revocation, or settlement of litigation[4].
Key Takeaways
- Improved Formulation: The patent describes an improved hydroalcoholic testosterone gel formulation with enhanced stability and absorption.
- Comprehensive Claims: The patent includes detailed independent and dependent claims that define the scope of the invention.
- Competitive Landscape: Analyzing the patent landscape reveals competitors, related patents, and areas of high patent saturation.
- Global Filings: The patent has international filings that can be accessed through the Global Dossier service.
- Litigation History: Understanding the litigation history is crucial for assessing the patent's enforceability.
FAQs
What is the main invention described in US Patent 8,466,136?
The main invention is an improved transdermal hydroalcoholic testosterone gel formulation and its method of use.
What are the key components of the testosterone gel formulation?
The key components include testosterone, carbomer, and a solvent system such as methanol and glycerine.
How does the patent landscape analysis help in understanding this patent?
Patent landscape analysis helps in identifying competitors, related patents, and areas of high patent saturation, guiding business and R&D decisions.
What is the significance of the Global Dossier service in relation to this patent?
The Global Dossier service allows users to see the patent family for a specific application, including all related applications filed at participating IP Offices.
Has this patent been involved in any litigation?
Yes, the patent has been involved in litigation, such as the case involving AndroGel.
Sources
- USPTO - Search for patents - USPTO
- Law360 - U.S. Patent Number 8,466,136 : Articles :: Law360
- AcclaimIP - Patent Landscape Analysis - Uncovering Strategic Insights
- Google Patents - US8466136B2 - Testosterone gel and method of use
- Law Insider - AndroGel 1.62% Patent Definition | Law Insider
