United States Patent 5,543,150: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,543,150, titled "Method of progesterone delivery and affect thereof," is a significant patent in the field of medical science, particularly in the area of drug delivery systems. This patent, granted in 1996, introduces a novel method for the vaginal delivery of progesterone to prevent endometrial cancer. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Motivation
The patent addresses the need for an effective and targeted method of delivering progesterone to prevent endometrial cancer. Traditional drug delivery systems often fail to maintain the drug in the vagina for extended periods, leading to inadequate therapeutic effects. The inventors aimed to develop a system that would ensure prolonged contact between the drug and the vaginal epithelium, thereby enhancing the efficacy of progesterone delivery[4].
Scope of the Patent
The patent covers a method and system for delivering progesterone using a bioadhesive polymeric system. Here are the key aspects of the scope:
Bioadhesive Polymeric System
The patent describes a bioadhesive polymeric system that holds the progesterone and slowly releases it over time. This system is designed to remain in the vagina for 48 to 72 hours, significantly longer than most conventional drug delivery systems[4].
Targeted Delivery
The system allows for direct contact with the vaginal epithelium, ensuring targeted delivery of progesterone to the endometrium. This targeted approach maintains low circulatory levels of progesterone while delivering sufficient amounts to the target organ[4].
Adjustable Release Rate
The polymers used in the system can be adjusted to control the release rate of progesterone. This is achieved by varying the amount of cross-linking agent, allowing for a tailored release profile to meet specific therapeutic needs[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the method of delivering progesterone using a bioadhesive polymeric system.
- Claim 2 outlines the composition of the polymeric system, including the type of polymers and the cross-linking agents used.
Dependent Claims
- These claims further specify the characteristics of the polymeric system, such as the percentage of monomers containing carboxyl functionality and the method of adjusting the release rate[4].
Patent Landscape
Related Patents and Applications
The patent is part of a broader family of patents and applications filed in various jurisdictions, including the European Patent Office (EPO), Japan Patent Office (JPO), and others. These related patents cover similar methods and systems for progesterone delivery, highlighting the global interest in this technology[4].
Prior Art and Citations
The patent cites several prior art references, including other patents and publications related to drug delivery systems and polymeric materials. This indicates that the inventors built upon existing knowledge to create an innovative solution[4].
International Patent Databases
To understand the global patent landscape, one can refer to international patent databases such as the European Patent Office's esp@cenet, the Japan Patent Office's database, and the World Intellectual Property Organization's (WIPO) PATENTSCOPE service. These resources provide access to patent documentation from various countries, helping to identify similar or related inventions[1].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset, which includes detailed information on claims from US patents granted between 1976 and 2014, can be used to analyze the scope and impact of this patent. This dataset helps in understanding the trends and measurements of patent scope, which can be crucial for economic and research analyses[3].
Industry Impact
The invention has significant implications for the pharmaceutical and medical device industries. The targeted delivery system can improve the efficacy of progesterone therapy, reducing the risk of endometrial cancer. This innovation can also inspire further research into bioadhesive polymeric systems for other therapeutic applications.
Legal Status and Expiration
The patent has expired, as indicated by its legal status. This means that the technology described in the patent is now in the public domain, allowing other entities to use and build upon this invention without infringing on the original patent rights[4].
Practical Applications and Future Directions
Clinical Use
The method described in the patent has practical applications in clinical settings for preventing endometrial cancer. The bioadhesive polymeric system offers a reliable and efficient way to deliver progesterone, enhancing patient outcomes.
Future Research
The expiration of the patent opens up opportunities for further research and development. Scientists and manufacturers can now explore new applications of bioadhesive polymeric systems, potentially leading to breakthroughs in other areas of drug delivery.
Key Takeaways
- Innovative Drug Delivery System: The patent introduces a novel bioadhesive polymeric system for the vaginal delivery of progesterone.
- Targeted Therapy: The system ensures targeted delivery to the endometrium, maintaining low circulatory levels of progesterone.
- Adjustable Release Rate: The polymers can be adjusted to control the release rate of progesterone.
- Global Patent Landscape: The patent is part of a broader family of patents filed in various jurisdictions.
- Economic and Research Implications: The invention has significant economic and research implications, particularly in the pharmaceutical and medical device industries.
- Legal Status: The patent has expired, making the technology available for public use.
FAQs
What is the main innovation of United States Patent 5,543,150?
The main innovation is a bioadhesive polymeric system for the vaginal delivery of progesterone, ensuring prolonged contact with the vaginal epithelium and targeted delivery to the endometrium.
How does the bioadhesive polymeric system work?
The system holds the progesterone and slowly releases it over time, allowing for direct contact with the vaginal epithelium and maintaining low circulatory levels of progesterone.
Can the release rate of progesterone be adjusted?
Yes, the release rate can be adjusted by varying the amount of cross-linking agent used in the polymers.
Is the patent still in force?
No, the patent has expired, making the technology available for public use.
What are the potential future directions for this technology?
Future directions include further research into bioadhesive polymeric systems for other therapeutic applications and potential breakthroughs in drug delivery technologies.
Sources
- USPTO - Search for patents: "How to Conduct a Preliminary U.S. Patent Search: A Step by Step Strategy."
- Google Patents: "WO1998037897A1 - Method for reducing coronary..."
- USPTO - Patent Claims Research Dataset: "Patent Claims Research Dataset."
- Google Patents: "US5543150A - Method of progesterone delivery and affect thereof."
- Mondaq: "Patent and Trademark Bulletin for the District of Massachusetts."
