United States Patent 8,633,178: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,633,178, titled "Natural combination hormone replacement formulations and therapies," is a significant patent in the field of pharmaceuticals, particularly in hormone replacement therapy. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Publication Details
- Publication Number: US8633178B2
- Authority: United States
- Prior Art Date: The patent claims priority to earlier provisional applications, indicating a thorough development process[5].
Scope of the Patent
The patent focuses on natural combination hormone replacement formulations and therapies. It describes specific formulations that combine hormones such as progesterone and estradiol in solubilized forms, often using medium-chain triglycerides like caprylic acid. These formulations are designed to improve the bioavailability and efficacy of hormone replacement therapies.
Key Components
- Hormones: The patent details the use of progesterone and estradiol, which are common hormones used in replacement therapies.
- Solubilization: The formulations use solubilizing agents to enhance the absorption of these hormones.
- Medium Chain Triglycerides: Substances like caprylic acid are used to improve the solubility and stability of the hormone formulations[5].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
Independent Claims
- Claim 1: Describes a pharmaceutical composition comprising a combination of progesterone and estradiol in a solubilized form.
- Claim 5: Specifies the use of medium-chain triglycerides as solubilizing agents.
- Claim 9: Outlines the method of administering these formulations, which can be in various dosage forms such as gels, creams, or capsules[5].
Dependent Claims
- These claims further specify the concentrations of the hormones, the types of solubilizing agents, and the methods of preparation and administration.
Patent Landscape
Related Patents
The patent landscape in the field of hormone replacement therapies is extensive. Other patents, such as those held by TherapeuticsMD, cover similar formulations and methods. For example, TherapeuticsMD’s products like BIJUVA® and IMVEXXY® are protected by a series of patents that overlap in scope with US8633178B2, particularly in the use of hormone combinations and solubilizing agents[2].
International Patent Landscape
The global patent landscape is equally complex. Databases such as the European Patent Office's esp@cenet, the Japan Patent Office, and the World Intellectual Property Organization's PATENTSCOPE provide access to international patent applications and granted patents. These resources are crucial for understanding the global scope of similar inventions and ensuring that any new developments do not infringe on existing patents[1][4].
Search and Analysis Tools
To navigate the patent landscape effectively, several tools and resources are available:
USPTO Patent Public Search
This tool provides enhanced access to prior art and allows for comprehensive searches of U.S. patents and published patent applications. It is particularly useful for identifying similar patents and understanding the scope of existing inventions[1].
Global Dossier
This service offers access to the file histories of related applications from participating IP Offices, which can help in identifying patent families and understanding the international scope of similar patents[1].
Cooperative Patent Classification (CPC)
The CPC database allows for searching relevant classification schemes, which is essential for identifying patents that fall within the same technological area[4].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents and applications, which can be used to analyze the scope and trends in patenting in the field of hormone replacement therapies. This dataset includes claim-level statistics and document-level statistics, offering insights into the patent scope and its evolution over time[3].
Industry Expert Insights
Industry experts emphasize the importance of thorough patent searches and analyses to avoid infringement and to understand the competitive landscape. For instance, Dr. Alan C. Marco, in the USPTO Economic Working Paper 2016-04, highlights the need for detailed patent scope measurements to assess the impact of patents on innovation and competition[3].
Key Takeaways
- Patent Scope: US8633178B2 covers specific formulations and methods for hormone replacement therapies, focusing on solubilized hormone combinations.
- Claims: The patent includes independent and dependent claims that define the scope of the invention, including the use of medium-chain triglycerides.
- Patent Landscape: The landscape is complex, with numerous related patents both domestically and internationally.
- Search Tools: Utilizing tools like the USPTO Patent Public Search, Global Dossier, and CPC database is crucial for navigating the patent landscape.
- Economic Implications: The patent claims dataset and economic research papers provide valuable insights into the trends and impact of patenting in this field.
FAQs
Q: What is the main focus of United States Patent 8,633,178?
A: The patent focuses on natural combination hormone replacement formulations and therapies, specifically using solubilized forms of hormones like progesterone and estradiol.
Q: What are the key components of the formulations described in the patent?
A: The key components include hormones such as progesterone and estradiol, and solubilizing agents like medium-chain triglycerides.
Q: How can one search for similar patents to US8633178B2?
A: One can use the USPTO Patent Public Search, Global Dossier, and Cooperative Patent Classification (CPC) database to search for similar patents.
Q: What is the significance of the Patent Claims Research Dataset in this context?
A: The dataset provides detailed information on claims from U.S. patents and applications, helping to analyze the scope and trends in patenting in the field of hormone replacement therapies.
Q: Why is it important to conduct a thorough patent search in this field?
A: Conducting a thorough patent search helps to avoid infringement, understand the competitive landscape, and ensure that new developments are novel and non-obvious.
Sources
- USPTO: Search for patents - USPTO. [Online]. Available: https://www.uspto.gov/patents/search. [Accessed: 19-Dec-2024].
- TherapeuticsMD: TherapeuticsMD Product Patents. [Online]. Available: https://www.therapeuticsmd.com/patents.php. [Accessed: 19-Dec-2024].
- USPTO: Patent Claims Research Dataset - USPTO. [Online]. Available: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset. [Accessed: 19-Dec-2024].
- Clemson University: Research and Course Guides: Patent Searching, Advanced: Overview. [Online]. Available: https://clemson.libguides.com/advanced_patent_searching. [Accessed: 19-Dec-2024].
- Google Patents: Natural combination hormone replacement formulations and therapies - Google Patents. [Online]. Available: https://patents.google.com/patent/US8633178B2/en. [Accessed: 19-Dec-2024].
