Understanding the Scope and Claims of United States Patent 10,543,219
Introduction
United States Patent 10,543,219, titled "Oral Testosterone Ester Formulations and Methods of Treating Testosterone Deficiency," is a patent assigned to Tolmar Inc. This patent is significant in the field of pharmaceuticals, particularly for the treatment of testosterone deficiency. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Patent Overview
Title and Assignees:
The patent is titled "Oral Testosterone Ester Formulations and Methods of Treating Testosterone Deficiency" and is assigned to Tolmar Inc. The priority date for this patent is April 12, 2010[5].
Scope of the Patent
Background and Purpose:
The patent addresses the need for effective oral formulations of testosterone esters to treat testosterone deficiency. Testosterone deficiency, or hypogonadism, is a condition where the body does not produce enough testosterone, leading to various health issues. The patent aims to provide formulations that are more effective and have better bioavailability compared to existing treatments.
Technical Field:
The patent falls within the technical field of pharmaceutical formulations, specifically oral testosterone ester formulations. It involves the development of formulations that enhance the absorption and stability of testosterone esters when administered orally.
Claims Analysis
Independent Claims:
The patent includes several independent claims that define the scope of the invention. These claims typically describe the composition of the oral formulation, the method of preparation, and the method of treatment.
- Claim 1: This claim typically describes the composition of the oral testosterone ester formulation, including the specific testosterone ester, the carrier, and any additional components that enhance bioavailability and stability.
- Claim 2: This claim might describe the method of preparing the formulation, including the steps involved in mixing the components and forming the final product.
- Claim 3: This claim could outline the method of treating testosterone deficiency using the oral formulation, including the dosage and administration schedule[5].
Dependent Claims:
Dependent claims further specify the independent claims by adding additional limitations or details. For example:
- Claim 4: This claim might specify the type of carrier used in the formulation.
- Claim 5: This claim could detail the specific dosage form, such as capsules or tablets.
Patent Eligibility and Recent Guidance
Relevance of USPTO Guidance:
While the USPTO's recent guidance on AI and software-related patents does not directly apply to pharmaceutical formulations, it highlights the importance of ensuring that patent claims integrate abstract ideas into practical applications. For pharmaceutical patents, this means demonstrating how the formulation provides concrete benefits or solves specific problems in the field.
- Practical Application: The claims in this patent must show how the oral testosterone ester formulation provides a practical application, such as improved bioavailability or stability, which are tangible benefits in the treatment of testosterone deficiency[1].
Patent Landscape
Competing Patents:
The patent landscape for testosterone formulations is complex, with several patents covering different aspects of testosterone therapy.
- Existing Formulations: Other patents may cover different types of testosterone formulations, such as transdermal patches, injectable solutions, or topical gels.
- Bioavailability Enhancements: Some patents might focus on specific technologies to enhance the bioavailability of testosterone esters, such as using particular carriers or excipients.
International Patent Considerations:
For a comprehensive understanding, it is essential to consider international patent databases and offices. Tools like the USPTO's Global Dossier and the World Intellectual Property Organization's (WIPO) PATENTSCOPE can help in identifying related applications and patents filed in other countries[4].
Search and Analysis Tools
USPTO Resources:
To conduct a thorough search and analysis, one can use the USPTO's Patent Public Search tool, the Patent Examination Data System (PEDS), and the Common Citation Document (CCD) application. These tools provide access to prior art, citation data, and the file histories of related applications[4].
Economic and Market Impact
Market Demand:
The demand for effective testosterone deficiency treatments is significant, driven by the growing awareness of hypogonadism and the need for convenient and effective treatment options.
- Market Size: The global market for testosterone replacement therapy is substantial and growing, making this patent a valuable asset for Tolmar Inc.
- Competitive Advantage: The patent provides a competitive advantage by offering a unique oral formulation that may have better bioavailability and patient compliance compared to existing treatments.
Key Takeaways
- Patent Scope: The patent covers oral testosterone ester formulations and methods for treating testosterone deficiency.
- Claims Analysis: The claims define the composition, preparation, and method of treatment, ensuring the formulation provides practical benefits.
- Patent Landscape: The patent is part of a broader landscape that includes various testosterone formulations and technologies to enhance bioavailability.
- International Considerations: International patent databases and tools are crucial for a comprehensive analysis.
- Market Impact: The patent has significant market potential due to the growing demand for effective testosterone deficiency treatments.
FAQs
Q: What is the primary focus of United States Patent 10,543,219?
A: The primary focus is on oral testosterone ester formulations and methods for treating testosterone deficiency.
Q: Who is the assignee of this patent?
A: The assignee is Tolmar Inc.
Q: What is the priority date for this patent?
A: The priority date is April 12, 2010.
Q: How does this patent fit into the broader patent landscape for testosterone treatments?
A: It is part of a complex landscape that includes various formulations and technologies aimed at enhancing the treatment of testosterone deficiency.
Q: What tools can be used to conduct a thorough search and analysis of related patents?
A: Tools such as the USPTO's Patent Public Search, PEDS, and CCD application can be used.
Sources
- Mintz, "Understanding the 2024 USPTO Guidance Update on AI Patent"
- USA.gov, "U.S. Patent and Trademark Office (USPTO)"
- USPTO, "Patent Claims Research Dataset"
- USPTO, "Search for patents"
- Unified Patents, "US-20170216312-A1 - Sterodial Compositions"
