United States Patent 11,065,197: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,065,197, titled "Soluble estradiol capsule for vaginal insertion," is a significant patent in the field of pharmaceutical formulations, particularly those related to hormonal therapies. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Number and Authority
The patent, numbered US11,065,197B2, was granted by the United States Patent and Trademark Office (USPTO)[4].
Inventors and Assignees
While the specific inventors and assignees are not detailed here, it is crucial to identify them for a comprehensive understanding of the patent's ownership and potential licensing or collaboration opportunities.
Prior Art and Related Patents
The patent builds upon prior art related to vaginal inserts, estradiol formulations, and soft gelatin capsules. Understanding the prior art is essential to grasp the novelty and non-obviousness of the invention[4].
Scope of the Invention
Pharmaceutical Formulations
The patent describes pharmaceutical formulations comprising solubilized estradiol, designed for vaginal insertion. These formulations aim to address issues such as estrogen deficiency and associated symptoms like vaginal dryness and discomfort[4].
Key Components
- Estradiol: The primary active ingredient, estradiol, is a form of estrogen used to treat various symptoms associated with estrogen deficiency.
- Soft Gelatin Capsules: The formulation is encapsulated in soft gelatin capsules, which provide a convenient and effective delivery method.
- Fatty Acids and Excipients: The patent mentions the use of fatty acids and other excipients to enhance the solubility and stability of estradiol within the capsule[4].
Claims Analysis
Independent and Dependent Claims
The patent includes both independent and dependent claims that define the scope of the invention.
Independent Claims
Independent claims typically define the broadest scope of the invention. For example, Claim 1 might describe the overall composition of the soluble estradiol capsule, including the active ingredient, the soft gelatin capsule, and any necessary excipients[4].
Dependent Claims
Dependent claims narrow down the scope by adding specific details or limitations to the independent claims. These could include specific types of fatty acids used, the concentration of estradiol, or the method of preparing the capsule.
Claim Examples
- Claim 1: A pharmaceutical composition comprising a soluble estradiol formulation encapsulated in a soft gelatin capsule.
- Dependent Claim: The composition of Claim 1, wherein the fatty acid is selected from the group consisting of octanoic acid and propylene glycol[4].
Patent Landscape
Global Patent Family
To understand the full scope of protection, it is essential to identify the global patent family. This involves searching databases such as the Global Dossier provided by the USPTO, which allows users to see related applications filed at participating IP Offices[1].
Competing Patents
Analyzing competing patents in the same field helps in understanding the competitive landscape. For instance, other patents related to vaginal inserts or estradiol formulations can provide insights into similar technologies and potential infringement risks[1].
International Search
Searching international patent offices such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) through databases like PATENTSCOPE can reveal whether similar inventions have been patented abroad[1].
Economic and Market Impact
Market Need
The patent addresses a significant market need by providing an effective treatment for symptoms associated with estrogen deficiency. This can have a substantial economic impact by improving the quality of life for patients and reducing healthcare costs related to these symptoms.
Competitive Advantage
The unique formulation and delivery method described in the patent can provide a competitive advantage over existing treatments. This can lead to increased market share and revenue for the patent holder.
Legal Status and Enforcement
Legal Status
The legal status of the patent, as indicated by Google Patents, is active, but this status is an assumption and not a legal conclusion. It is crucial to verify the legal status through official channels[4].
Enforcement
Enforcing the patent involves monitoring for potential infringement and taking legal action if necessary. The USPTO provides resources such as the Patent Examination Data System (PEDS) to help in tracking and managing patent data[1].
Conclusion
The United States Patent 11,065,197 represents a significant advancement in pharmaceutical formulations for treating estrogen deficiency. Understanding the scope, claims, and broader patent landscape is crucial for both the patent holder and competitors in the field.
Key Takeaways
- Novel Formulation: The patent introduces a novel formulation of soluble estradiol in soft gelatin capsules.
- Market Need: It addresses a significant market need by providing an effective treatment for symptoms associated with estrogen deficiency.
- Competitive Advantage: The unique formulation can provide a competitive advantage in the market.
- Global Patent Family: Understanding the global patent family is essential for comprehensive protection.
- Legal Enforcement: Monitoring and enforcing the patent is crucial to protect the intellectual property.
FAQs
Q: What is the primary active ingredient in the patent US11,065,197?
A: The primary active ingredient is estradiol, a form of estrogen.
Q: What is the delivery method described in the patent?
A: The delivery method involves encapsulating the estradiol formulation in soft gelatin capsules for vaginal insertion.
Q: How can one verify the legal status of the patent?
A: The legal status should be verified through official channels such as the USPTO rather than relying on assumptions.
Q: What databases can be used to search for related international patents?
A: Databases such as PATENTSCOPE by WIPO, esp@cenet by EPO, and JPO's patent database can be used to search for related international patents.
Q: What is the significance of the Global Dossier in patent searching?
A: The Global Dossier provides access to the file histories of related applications from participating IP Offices, helping users to see the patent family for a specific application and related data.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US11065197B2: https://patents.google.com/patent/US11065197B2/en
