United States Patent 9,114,146: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,114,146, titled "Natural combination hormone replacement formulations and therapies," is a significant patent in the field of pharmaceuticals, particularly in hormone replacement therapies. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Inventors and Assignees
The patent was granted to TherapeuticsMD, Inc., with the inventors listed as those associated with the company. This indicates that the patent is part of the company's intellectual property portfolio aimed at protecting their innovative formulations and therapies[5].
Publication and Priority Dates
The patent was published on August 25, 2015, with a priority date of October 24, 2013. This timeline is crucial for understanding the development and filing process of the patent[5].
Scope of the Patent
Subject Matter
The patent covers natural combination hormone replacement formulations and therapies, specifically focusing on estrogen and progesterone replacement. The formulations include solubilized estradiol and other components that enhance the bioavailability and efficacy of the hormones[5].
Claims
The patent includes multiple claims that define the scope of the invention. These claims are categorized into independent and dependent claims:
- Independent Claims: These define the broadest scope of the invention. For example, Claim 1 describes a pharmaceutical composition comprising solubilized estradiol and a solubilizing agent[5].
- Dependent Claims: These narrow down the scope by adding specific limitations to the independent claims. For instance, dependent claims might specify particular solubilizing agents or the concentration of estradiol[5].
Claims Analysis
Key Components
The claims highlight several key components:
- Solubilized Estradiol: The patent emphasizes the use of solubilized estradiol, which is crucial for improving the bioavailability of the hormone.
- Solubilizing Agents: The use of specific solubilizing agents like Capmul is detailed, which helps in stabilizing the formulation[5].
Therapeutic Applications
The claims also cover various therapeutic applications, including the treatment of menopausal symptoms and other conditions related to hormone deficiency.
Patent Landscape
Technology Field
The patent falls under the "Drugs and Medical Instruments" field, one of the six broad technology fields categorized by the USPTO. This field has seen a significant decrease in patent allowance rates over time, indicating a more stringent examination process[1].
Competitive Environment
TherapeuticsMD operates in a competitive environment where other companies also hold patents related to hormone replacement therapies. The company's products, such as BIJUVA® and IMVEXXY®, are protected by multiple patents, including US9114146B2, to maintain a competitive edge[2].
Global Patent Protection
While the patent in question is specific to the United States, companies like TherapeuticsMD often seek international protection for their inventions. This involves filing patent applications in various jurisdictions to ensure global market exclusivity[2].
Search and Examination Process
USPTO Resources
The USPTO provides several tools for searching and analyzing patents, including the Patent Public Search tool, Global Dossier, and the Patent Examination Data System (PEDS). These resources can be used to track the prosecution history of a patent, including office actions and continuations[4].
Allowance Rates
The allowance rate for patents in the "Drugs and Medical Instruments" field has decreased substantially over time. According to a study, only 55.8% of patent applications in this field were granted without using continuation procedures[1].
Economic and Legal Implications
Market Protection
The patent provides TherapeuticsMD with exclusive rights to manufacture, use, and sell the described formulations and therapies, thereby protecting their market share and preventing infringement by competitors.
Litigation and Enforcement
Holding a patent like US9114146B2 also enables the company to enforce their rights through legal action if there is any infringement. This is crucial for maintaining the integrity of their intellectual property portfolio.
Key Takeaways
- Patent Scope: The patent covers specific formulations and therapies related to hormone replacement, emphasizing solubilized estradiol and particular solubilizing agents.
- Claims Analysis: The claims are detailed and specify the key components and therapeutic applications of the invention.
- Patent Landscape: The patent operates within a competitive field with decreasing allowance rates, highlighting the importance of robust patent protection.
- Global Protection: Companies often seek international patent protection to ensure global market exclusivity.
- Economic and Legal Implications: The patent provides market protection and legal enforcement rights, which are vital for the company's competitive position.
FAQs
Q: What is the primary focus of United States Patent 9,114,146?
A: The primary focus is on natural combination hormone replacement formulations and therapies, specifically solubilized estradiol and progesterone replacement.
Q: Who is the assignee of this patent?
A: The assignee is TherapeuticsMD, Inc.
Q: What are the key components mentioned in the patent claims?
A: The key components include solubilized estradiol and specific solubilizing agents like Capmul.
Q: How does this patent fit into the broader patent landscape?
A: It falls under the "Drugs and Medical Instruments" field, which has seen a decrease in patent allowance rates over time, indicating a more stringent examination process.
Q: What tools can be used to search and analyze this patent?
A: Tools such as the USPTO's Patent Public Search, Global Dossier, and PEDS can be used to track the prosecution history and analyze the patent.
Sources
- Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203.
- TherapeuticsMD. (n.d.). TherapeuticsMD Product Patents. Retrieved from https://www.therapeuticsmd.com/patents.php
- USPTO. (2017). Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- USPTO. (2018). Search for patents. Retrieved from https://www.uspto.gov/patents/search
- Google Patents. (n.d.). US9114146B2 - Natural combination hormone replacement formulations and therapies. Retrieved from https://patents.google.com/patent/US9114146B2/en
