United States Patent 10,806,697: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,806,697, titled "Vaginal inserted estradiol pharmaceutical compositions and methods," is a significant patent in the field of pharmaceuticals, particularly in women's health. This patent, assigned to TherapeuticsMD, Inc., covers innovative formulations and methods for delivering estradiol, a crucial hormone in various therapeutic applications.
Background
Estradiol is a naturally occurring estrogen hormone used in various pharmaceutical products, especially for treating menopausal symptoms and other estrogen-deficiency conditions. The patent in question addresses the need for effective and safe vaginal delivery systems for estradiol.
Patent Overview
Publication Number and Status
The patent number is US10,806,697B2, with the application number US14/521,002. It was granted on September 15, 2020, and is currently active[4].
Inventors and Assignees
The patent is assigned to TherapeuticsMD, Inc., and the inventors are listed in the patent documentation, although their names are not specified in the provided sources.
Prior Art and Related Patents
The patent builds upon prior art related to pharmaceutical formulations, particularly those involving estradiol. It references various prior art keywords such as "pharmaceutical formulation," "estradiol," and "vaginal inserted" compositions[4].
Scope of the Patent
Pharmaceutical Compositions
The patent describes pharmaceutical compositions that include solubilized estradiol. These compositions are designed for vaginal insertion and are formulated to enhance the bioavailability and stability of estradiol. The patent details various aspects of the formulation, including the use of specific excipients and the geometric mean of the estradiol concentration[4].
Methods of Administration
The patent also covers methods for administering these compositions. It outlines the procedures for preparing and using the vaginal inserts, ensuring effective delivery of estradiol to the target area. The methods are designed to optimize the therapeutic effects while minimizing side effects[4].
Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the pharmaceutical compositions, the methods of preparing them, and the methods of administration. For example, Claim 1 might describe a pharmaceutical composition comprising solubilized estradiol and specific excipients, while Claim 2 might describe a method for preparing such a composition[4].
Dependent Claims
Dependent claims further specify the independent claims by adding additional limitations or features. These claims help to narrow down the scope and provide more detailed descriptions of the invention. For instance, a dependent claim might specify the concentration range of estradiol or the type of excipients used[4].
Patent Landscape
Related Patents
TherapeuticsMD holds several patents related to estradiol formulations and delivery systems. For example, patents such as US10835487 and US10888516 also cover various aspects of vaginal estradiol compositions and methods, indicating a robust patent portfolio in this area[2].
Competitors and Market
The patent landscape in the field of women's health and hormone replacement therapy is competitive. Other companies also hold patents for similar products, making it essential for TherapeuticsMD to maintain a strong patent position to protect its intellectual property and market share.
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection provided by this patent, a Claim Coverage Matrix can be useful. This matrix categorizes the patents and claims by scope concepts, helping to identify which claims actively protect the intellectual property and where gaps or opportunities exist. This tool is particularly useful for companies like TherapeuticsMD, which have multiple patents covering various aspects of their products[3].
Claim Charts
Interactive claim charts generated by software like ClaimScape® can help technical experts review the patent coverage. These charts make it easy to determine whether a particular scope concept is applicable to a target product or method, highlighting areas where there may be gaps in current coverage and future design opportunities[3].
Legal and Regulatory Considerations
Patent Enforcement
The enforcement of this patent is crucial for TherapeuticsMD to protect its market position. Any potential infringers must be identified and addressed through legal means. The USPTO and other regulatory bodies play a significant role in ensuring that patents are enforced fairly and that intellectual property rights are respected.
Small Claims Patent Court
There have been discussions and studies on the feasibility of a small claims patent court, which could potentially streamline the process of resolving patent disputes, especially for smaller entities. However, this concept is still under consideration and has not been implemented as of the current date[5].
Key Takeaways
- Innovative Formulations: The patent covers innovative pharmaceutical compositions and methods for delivering estradiol via vaginal insertion.
- Scope and Claims: The patent includes detailed claims that define the scope of the invention, covering both the compositions and methods of administration.
- Patent Landscape: TherapeuticsMD holds a robust patent portfolio in this area, with several related patents protecting its intellectual property.
- Patent Analytics: Tools like Claim Coverage Matrix and claim charts are essential for understanding and managing the patent landscape effectively.
- Legal Considerations: The enforcement of this patent is critical, and ongoing discussions about a small claims patent court could impact future dispute resolution processes.
FAQs
What is the main focus of United States Patent 10,806,697?
The main focus of this patent is on pharmaceutical compositions and methods for delivering estradiol via vaginal insertion.
Who is the assignee of this patent?
The assignee of this patent is TherapeuticsMD, Inc.
What are the key components of the pharmaceutical compositions described in the patent?
The compositions include solubilized estradiol and specific excipients designed to enhance bioavailability and stability.
How does the patent landscape look for TherapeuticsMD in this area?
TherapeuticsMD holds several related patents, indicating a strong patent position in the field of vaginal estradiol formulations and delivery systems.
What tools can be used to analyze and manage the patent claims effectively?
Tools such as Claim Coverage Matrix and interactive claim charts generated by software like ClaimScape® can be used to analyze and manage the patent claims effectively.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- TherapeuticsMD - Product Patents: https://www.therapeuticsmd.com/patents.php
- SLWIP - Patent Analytics: https://www.slwip.com/services/patent-analytics/
- Google Patents - US10806697B2: https://patents.google.com/patent/US10806697B2/en
- ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
