United States Patent 4,882,452: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 4,882,452, titled "Process for the preparation of ifosfamide having improved properties," is a significant patent in the field of pharmaceuticals, particularly in the synthesis and purification of ifosfamide, a chemotherapeutic agent. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Ifosfamide
Ifosfamide is a widely used anticancer drug, belonging to the class of alkylating agents. It is employed in the treatment of various types of cancers, including testicular cancer, ovarian cancer, and certain types of lymphoma. The quality and purity of ifosfamide are crucial for its therapeutic efficacy and safety.
Patent Overview
Publication Details
- Patent Number: US 4,882,452
- Publication Date: August 22, 1989
- Assignee: Not specified in the provided source, but typically assigned to the inventors or their affiliated institutions/companies.
- Inventors: The inventors are not specified in the provided source, but they are likely chemists or pharmaceutical researchers involved in the development of ifosfamide.
Scope of the Patent
The patent describes a process for preparing ifosfamide with improved properties, focusing on the crystallization method to enhance the drug's purity and stability.
Key Aspects of the Scope
- Crystallization Method: The patent outlines a specific crystallization process using a solvent mixture. This method involves selecting solvents such as diethyl ether, diisopropyl ether, or methanol to achieve high-quality crystals of ifosfamide[1].
- Improved Properties: The process aims to produce ifosfamide with improved properties, such as higher purity, better stability, and potentially enhanced therapeutic efficacy.
- Process Steps: The patent details various steps including solution preparation, cooling, nucleation, stirring, and drying to ensure the formation of high-quality crystals.
Claims of the Patent
The claims of the patent are critical as they define the legal boundaries of the invention.
Independent Claims
- The patent includes claims related to the specific method of crystallization, including the use of particular solvent mixtures and the conditions under which the crystallization is performed.
- For example, Claim 1 might specify the process of crystallizing ifosfamide from a solution containing a mixture of diethyl ether and methanol under controlled temperature and stirring conditions[1].
Dependent Claims
- Dependent claims further elaborate on the independent claims by specifying additional details such as the ratio of solvents, the temperature range, and the duration of the crystallization process.
- These claims help to narrow down the scope and ensure that the invention is clearly defined and distinguishable from prior art.
Patent Landscape
Prior Art
The patent landscape for ifosfamide preparation involves a review of prior art related to the synthesis and purification of ifosfamide. The inventors would have conducted a thorough search to ensure their method was novel and non-obvious over existing techniques.
Related Patents
Other patents related to ifosfamide may cover different aspects such as synthesis routes, formulation methods, or specific applications. These patents would be part of the broader patent landscape and could influence the scope and validity of US 4,882,452.
International Patent Considerations
Ifosfamide is a globally used drug, and patents related to its preparation might be filed in various jurisdictions. The global patent landscape would include similar patents filed in other countries, which could affect the international validity and enforcement of US 4,882,452.
Practical Implications
Manufacturing and Quality Control
The patented process has significant implications for the manufacturing of ifosfamide. Pharmaceutical companies can use this method to ensure consistent quality and purity of the drug, which is critical for patient safety and therapeutic efficacy.
Regulatory Compliance
Regulatory bodies such as the FDA would require compliance with the patented process if it is the standard method for producing ifosfamide. This ensures that all manufactured batches meet the specified quality standards.
Legal and Policy Considerations
Patent Litigation
The scope and claims of the patent are crucial in patent litigation. Any infringement claims would need to be evaluated based on the specific language and boundaries set by the patent claims.
Patent Validity
The validity of the patent could be challenged based on prior art or obviousness. The examination process, as discussed in other patent studies, tends to narrow the scope of patent claims, ensuring that only novel and non-obvious inventions are granted[3].
Conclusion
United States Patent 4,882,452 is a significant contribution to the field of pharmaceuticals, particularly in the synthesis and purification of ifosfamide. The patent's scope and claims are carefully defined to ensure the production of high-quality ifosfamide, which is essential for its therapeutic use.
Key Takeaways
- Crystallization Method: The patent describes a specific crystallization process using solvent mixtures to enhance the purity and stability of ifosfamide.
- Improved Properties: The process aims to produce ifosfamide with improved properties, such as higher purity and better stability.
- Legal and Practical Implications: The patent has significant implications for manufacturing, quality control, and regulatory compliance.
- Patent Landscape: The patent is part of a broader landscape that includes prior art, related patents, and international considerations.
FAQs
What is the main focus of United States Patent 4,882,452?
The main focus of the patent is a process for preparing ifosfamide with improved properties through a specific crystallization method.
What solvents are used in the crystallization process described in the patent?
The patent specifies the use of solvents such as diethyl ether, diisopropyl ether, or methanol for the crystallization process.
Why is the purity of ifosfamide important?
The purity of ifosfamide is crucial for its therapeutic efficacy and patient safety, as impurities can affect the drug's performance and safety profile.
How does the patent impact the manufacturing of ifosfamide?
The patented process ensures consistent quality and purity of ifosfamide, which is critical for regulatory compliance and patient safety.
Can the validity of the patent be challenged?
Yes, the validity of the patent can be challenged based on prior art or obviousness, and the examination process tends to narrow the scope of patent claims to ensure novelty and non-obviousness.
Sources
- US4882452A - Process for the preparation of ifosfamide having improved properties - Google Patents
- U.S. Patent Small Claims Court - Administrative Conference of the United States
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO - United States Patent and Trademark Office
- Report on Filing Patent/Trademark - United States Courts
