United States Patent 5,202,128: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 5,202,128, titled "Sustained Release Pharmaceutical Composition," is a significant patent in the pharmaceutical industry, particularly in the field of drug delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, granted on April 13, 1993, relates to a pharmaceutical pellet composition designed for sustained release of highly soluble active ingredients. This innovation was crucial in the development of controlled-release formulations, which have become a cornerstone in modern pharmacology[2].
Scope of the Patent
Invention Overview
The patent describes a pharmaceutical pellet composition with a core element containing at least one highly soluble active ingredient. The core is coated with a specific layer to control the release of the active ingredient, ensuring a sustained release profile. This design is particularly useful for drugs that need to be released over an extended period, enhancing patient compliance and therapeutic efficacy[2].
Key Components
- Core Element: The core contains the highly soluble active ingredient, which is the primary therapeutic component.
- Coating Layer: The coating is designed to regulate the release of the active ingredient. The patent specifies various materials that can be used for this coating, including organic macromolecular compounds like polyethylene glycol and poly(lactide-co-glycolide)[2].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1: Describes the pharmaceutical pellet composition with a core element and a coating layer.
- Claim 5: Specifies the materials used for the coating layer, including organic macromolecular compounds.
- Claim 7: Details the process of preparing the pellet composition[2].
Dependent Claims
These claims further elaborate on the specific aspects of the invention, such as the types of active ingredients, the thickness of the coating layer, and the methods of manufacturing the pellets.
Patent Landscape
Related Patents and Technologies
The patent landscape surrounding US 5,202,128 includes a variety of related patents and technologies focused on sustained release pharmaceutical compositions.
- Prior Art: The patent cites several prior art patents related to pharmaceutical compositions and coating technologies. For example, patents like US 3,391,142 and US 3,546,141 are referenced for their contributions to the field of sustained release formulations[4].
- Subsequent Patents: Later patents, such as US 11,541,018, build upon the concepts introduced in US 5,202,128. These patents often improve or modify the coating materials and the release profiles, reflecting ongoing innovation in the field[4].
International Patent Landscape
The global patent landscape is equally important, as similar technologies are developed and patented in other countries.
- European Patent Office (EPO): Databases like esp@cenet provide access to European patents related to pharmaceutical compositions, including those with similar sustained release mechanisms[1].
- World Intellectual Property Organization (WIPO): The PATENTSCOPE search service offers a global perspective on patent applications, including those related to pharmaceutical delivery systems[1].
Search and Analysis Tools
To conduct a comprehensive analysis of the patent landscape, several tools and resources are available:
- Patent Public Search: This tool, provided by the USPTO, allows for advanced searches of prior art and related patents. It replaces legacy tools like PubEast and PubWest[1].
- Global Dossier: This service provides access to the file histories of related applications from participating IP Offices, facilitating a more integrated global patent search[1].
- Patent Claims Research Dataset: This dataset, maintained by the USPTO, contains detailed information on claims from US patents and applications, which can be used to analyze the scope and trends of patent claims[3].
Economic and Legal Implications
Economic Impact
The invention described in US 5,202,128 has had a significant economic impact on the pharmaceutical industry. Controlled-release formulations have become a major segment of the market, improving patient outcomes and reducing healthcare costs.
Legal Considerations
The patent's legal status is crucial for understanding its current impact. As of the current date, the patent has expired, meaning that the technology is now in the public domain. This expiration allows other companies to develop similar products without infringing on the original patent[2].
Expert Insights
Industry experts emphasize the importance of sustained release formulations in modern pharmacology. For example, Dr. Alan C. Marco, an economist with the USPTO, has highlighted the significance of patent scope measurements in understanding the impact of patents like US 5,202,128 on the broader pharmaceutical landscape[3].
Statistics and Trends
- Patent Filings: The number of patent filings related to sustained release pharmaceutical compositions has increased significantly since the grant of US 5,202,128, indicating a growing interest in this technology.
- Market Growth: The market for controlled-release formulations has seen substantial growth, with these products now accounting for a significant portion of pharmaceutical sales.
Conclusion
United States Patent 5,202,128 represents a pivotal innovation in the field of pharmaceutical delivery systems. Its scope and claims have defined a critical area of research and development, and its impact is evident in the broader patent landscape.
Key Takeaways
- Innovation in Drug Delivery: The patent introduced a novel approach to sustained release pharmaceutical compositions.
- Global Impact: The technology has influenced global patent filings and market trends in the pharmaceutical industry.
- Economic and Legal Implications: The patent's expiration has opened up opportunities for other companies to develop similar products.
- Ongoing Research: The field continues to evolve with new patents and technologies building upon the original invention.
FAQs
What is the main invention described in US 5,202,128?
The main invention is a pharmaceutical pellet composition designed for sustained release of highly soluble active ingredients.
What are the key components of the pellet composition?
The key components include a core element containing the active ingredient and a coating layer to control the release.
Is the patent still in force?
No, the patent has expired, meaning the technology is now in the public domain.
How has the patent impacted the pharmaceutical industry?
It has led to significant advancements in controlled-release formulations, improving patient outcomes and reducing healthcare costs.
What tools can be used to analyze the patent landscape?
Tools like Patent Public Search, Global Dossier, and the Patent Claims Research Dataset are useful for analyzing the patent landscape.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Google Patents - US5202128A: https://patents.google.com/patent/US5202128A/en
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google APIs - US11541018.pdf: https://patentimages.storage.googleapis.com/e0/4f/0d/0330792eb22fc9/US11541018.pdf
