United States Patent 5,430,057: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,430,057, titled "Parenteral busulfan for treatment of malignant disease," is a significant patent in the field of pharmaceuticals, particularly in the treatment of malignant diseases. This patent, issued to the inventors, describes a method and composition for the parenteral administration of busulfan, a chemotherapeutic agent. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
Busulfan is a chemotherapeutic agent used in the treatment of various malignant diseases, including leukemia. However, its administration has been challenging due to erratic intestinal absorption and associated toxicity when given orally. The invention described in US 5,430,057 addresses these issues by providing a method for parenteral administration of busulfan, ensuring stable and effective delivery without the adverse effects associated with oral administration[4].
Scope of the Invention
The scope of the invention is centered around the formulation and method of administering busulfan parenterally. Here are the key aspects:
Formulation
The patent describes a method of dissolving busulfan in a liquid vehicle that is physiologically acceptable. The vehicles used include polyethylene glycol (PEG) and dimethylacetamide (DMA), which are known for their safety and efficacy in clinical settings. The formulation ensures that busulfan remains chemically stable and can be administered without unexpected toxicity from undissolved busulfan or the liquid vehicle[4].
Method of Administration
The method involves parenteral administration of a pharmaceutically effective amount of busulfan dissolved in a water-miscible, physiologically acceptable solvent. This approach avoids the erratic intestinal absorption associated with oral administration, thereby reducing the risk of unpredictable and sometimes lethal toxicity[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1
The first claim describes a pharmaceutical composition for parenteral administration consisting essentially of busulfan dissolved in a physiologically acceptable solvent, such as PEG or DMA[4].
Subsequent Claims
Subsequent claims elaborate on the composition, including the concentration of busulfan, the type of solvents used, and the method of administration. These claims ensure that the invention is protected across various aspects of the formulation and administration process[4].
Patent Landscape
Related Patents
The patent landscape around US 5,430,057 includes other patents related to the parenteral administration of chemotherapeutic agents. For example, US Patent 5,877,205 describes a stable non-toxic formulation for parenteral paclitaxel, another chemotherapeutic agent, using similar solvents like DMA and PEG[5].
International Patent Offices
To understand the global patent landscape, one would need to search international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO). These databases offer insights into similar inventions and their status in different jurisdictions[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) application can be useful in consolidating prior art cited by various patent offices for the same invention. This helps in understanding the global context and potential overlaps or differences in patent claims across different regions[1].
Search and Analysis Tools
Patent Public Search
Tools like the USPTO's Patent Public Search can be used to search for prior art and related patents. This tool provides enhanced access to prior art and can help in conducting a comprehensive search to understand the patent landscape surrounding US 5,430,057[1].
Patent and Trademark Resource Centers (PTRCs)
Local PTRCs can offer additional resources and training in patent search techniques, which can be invaluable in analyzing the scope and claims of a patent like US 5,430,057[1].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from US patents, including those related to pharmaceutical inventions. This dataset can be used to analyze trends and scope measurements of patents like US 5,430,057, offering insights into the economic and research implications of such inventions[3].
Conclusion
United States Patent 5,430,057 represents a significant advancement in the treatment of malignant diseases by providing a stable and effective method for the parenteral administration of busulfan. Understanding the scope, claims, and broader patent landscape is crucial for researchers, pharmaceutical companies, and legal professionals involved in this field.
Key Takeaways
- Formulation and Administration: The patent describes a method for dissolving busulfan in physiologically acceptable solvents like PEG and DMA for parenteral administration.
- Claims Protection: The patent includes multiple claims that protect the composition and method of administration.
- Global Patent Landscape: Searching international patent databases and using tools like CCD can provide a comprehensive view of the global patent landscape.
- Search and Analysis Tools: Utilizing tools like Patent Public Search and PTRCs can aid in conducting thorough searches and analyses.
- Economic and Research Implications: Datasets like the Patent Claims Research Dataset can offer insights into the economic and research trends related to pharmaceutical patents.
FAQs
Q: What is the main issue addressed by US Patent 5,430,057?
A: The main issue addressed is the erratic intestinal absorption and associated toxicity of busulfan when administered orally, which is resolved by providing a method for parenteral administration.
Q: What solvents are used in the formulation described in US 5,430,057?
A: The solvents used include polyethylene glycol (PEG) and dimethylacetamide (DMA).
Q: How can one search for related patents globally?
A: One can use databases provided by international patent offices such as the EPO, JPO, and WIPO, and tools like the Common Citation Document (CCD) application.
Q: What tools are available for conducting a comprehensive patent search?
A: Tools like the USPTO's Patent Public Search, PTRCs, and the Patent Examination Data System (PEDS) can be used for conducting comprehensive patent searches.
Q: What is the significance of the Patent Claims Research Dataset in analyzing pharmaceutical patents?
A: The dataset provides detailed information on claims from US patents, allowing for the analysis of trends and scope measurements, which can offer insights into the economic and research implications of pharmaceutical patents.
