United States Patent 5,376,645: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,376,645, titled "Derivatives of Cyclodextrins Exhibiting Enhanced Aqueous Solubility and the Use Thereof," was granted to Valentino J. Stella and Roger Rajewski, assigned to the University of Kansas. This patent is significant in the field of pharmaceuticals, particularly in the enhancement of drug solubility and stability. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Scope of the Patent
The patent focuses on the development of cyclodextrin derivatives that exhibit enhanced aqueous solubility. Cyclodextrins are cyclic oligosaccharides that can form inclusion complexes with various guest molecules, improving their solubility and stability. The scope of this patent includes the synthesis, purification, and application of these derivatives, especially in pharmaceutical formulations.
Key Aspects of the Invention
- Synthesis and Purification: The patent describes a method for synthesizing cyclodextrin derivatives with enhanced solubility characteristics. It emphasizes the importance of purifying these derivatives to remove unreacted cyclodextrin and other impurities, ensuring that the final compositions contain at least 95% of the cyclodextrin derivative[4].
- Pharmaceutical Applications: The derivatives are designed for parenteral administration, offering improved solubility and reduced toxicity. They are particularly beneficial for drugs that require high solubility to be effective.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the cyclodextrin derivatives with specific substitutions that enhance aqueous solubility.
- Claim 2 outlines the method of preparing these derivatives.
- Claim 3 specifies the pharmaceutical compositions containing these derivatives.
Dependent Claims
- These claims further detail the preferred embodiments, such as the degree of substitution, the purity of the compositions, and the specific applications in drug delivery systems[4].
Patent Landscape Analysis
To understand the broader context and impact of this patent, a patent landscape analysis is essential.
Defining Scope and Keywords
The analysis begins by defining the technology field (cyclodextrin derivatives and pharmaceutical formulations) and identifying relevant keywords (e.g., cyclodextrin, solubility, pharmaceutical formulations)[3].
Search and Organize Patents
Using databases such as the USPTO's Patent Public Search, European Patent Office's esp@cenet, and other international patent databases, relevant patents are identified and organized based on factors like filing date, assignee, and technological area[1][3].
Identify Trends and Key Players
The analysis reveals trends in patent filings related to cyclodextrin derivatives. Key players include academic institutions like the University of Kansas and pharmaceutical companies that have developed similar technologies. This helps in understanding the competitive landscape and identifying potential collaborators or competitors.
Analyze Citations and Evolution
By studying how patents reference each other, the impact and development of the technology can be understood. For example, the patent 5,376,645 references earlier patents on cyclodextrin derivatives, indicating a continuous improvement in the field[4].
Generate Insights for Decisions
The analysis provides actionable insights for strategic decisions. It helps in evaluating the strength of the patent portfolio, identifying potential legal vulnerabilities, and predicting technological trends. For instance, the enhanced solubility and reduced toxicity of the cyclodextrin derivatives in this patent suggest a strong position in the market for pharmaceutical formulations[3].
Insights from Patent Landscape Analysis
Technological Trends
- The analysis shows a consistent trend in the development of cyclodextrin derivatives for improving drug solubility and stability.
- There is a growing interest in using these derivatives for parenteral administration, indicating a shift towards more effective and safer drug delivery systems.
Key Players
- Academic institutions and research centers are significant contributors to this field, highlighting the importance of collaborative research.
- Pharmaceutical companies are also actively involved, reflecting the commercial potential of these derivatives.
Competitive Landscape
- The patent landscape reveals a competitive environment with multiple players developing similar technologies.
- The strength of the patent portfolio, including patent 5,376,645, is crucial for maintaining a competitive edge.
Impact and Applications
Pharmaceutical Formulations
- The cyclodextrin derivatives described in the patent have been used to improve the solubility and stability of various drugs, enhancing their efficacy and safety.
- These derivatives are particularly useful for drugs that are poorly soluble in water, making them more suitable for parenteral administration.
Regulatory Compliance
- The patent's emphasis on purification and the removal of impurities aligns with regulatory requirements for pharmaceutical products, ensuring compliance with safety and efficacy standards.
Conclusion
United States Patent 5,376,645 is a pivotal invention in the field of pharmaceutical formulations, particularly in enhancing the solubility and stability of drugs using cyclodextrin derivatives. The detailed analysis of its scope, claims, and the broader patent landscape provides valuable insights into technological trends, key players, and the competitive environment. This information is crucial for inventors, researchers, and pharmaceutical companies looking to develop and commercialize similar technologies.
Key Takeaways
- Enhanced Solubility: The patent describes cyclodextrin derivatives with significantly improved aqueous solubility.
- Pharmaceutical Applications: These derivatives are designed for parenteral administration, offering improved safety and efficacy.
- Competitive Landscape: The patent landscape analysis reveals a competitive environment with multiple players developing similar technologies.
- Regulatory Compliance: The patent's focus on purification ensures compliance with regulatory standards for pharmaceutical products.
- Technological Trends: The analysis shows a consistent trend in the development of cyclodextrin derivatives for pharmaceutical use.
FAQs
Q: What is the main focus of United States Patent 5,376,645?
A: The main focus is on the development of cyclodextrin derivatives that exhibit enhanced aqueous solubility, particularly for pharmaceutical applications.
Q: How are the cyclodextrin derivatives synthesized and purified according to the patent?
A: The patent describes a method for synthesizing these derivatives and emphasizes the importance of purifying them to remove unreacted cyclodextrin and other impurities.
Q: What are the key applications of the cyclodextrin derivatives described in the patent?
A: The derivatives are primarily used for parenteral administration of drugs, improving their solubility and reducing toxicity.
Q: Who are the key players in the development of cyclodextrin derivatives?
A: Key players include academic institutions like the University of Kansas and pharmaceutical companies actively involved in developing similar technologies.
Q: How does the patent landscape analysis help in understanding the competitive environment?
A: The analysis reveals trends, identifies key players, and provides insights into the competitive landscape, helping in strategic decision-making and evaluating the strength of the patent portfolio.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- FDA - eCopy, Inc.: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022325s000_AdminCorres.pdf
- Goldstein Patent Law - How to Do Patent Landscape Analysis: https://www.goldsteinpatentlaw.com/how-to-patent-landscape-analysis/
- United States Patent 5,376,645: https://patentimages.storage.googleapis.com/9e/6b/a1/e909efb5bab72b/US5376645.pdf
- PubChem - Novel parenteral carbamazepine formulation: https://pubchem.ncbi.nlm.nih.gov/patent/US-2014080812-A1
