United States Patent 5,344,658: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,344,658, titled "Process and composition using ondansetron," is a significant patent that pertains to a process for reducing the crystal size of ondansetron hydrochloride dihydrate. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, filed on September 6, 1991, and granted on August 30, 1994, is a continuation of earlier applications (Ser. No. 07/755,736 and Ser. No. 07/544,644), both of which were abandoned[4].
Scope of the Patent
The patent focuses on a specific process related to the pharmaceutical compound ondansetron hydrochloride dihydrate. The invention involves a method for reducing the crystal size of this compound through desolvation and resolvation. This process is crucial for improving the physical and chemical properties of the drug, such as its solubility and stability.
Desolvation and Resolvation Process
The patented process involves the removal of solvent from the ondansetron hydrochloride dihydrate crystals (desolvation) followed by the reintroduction of a solvent (resolvation). This cycle helps in achieving smaller crystal sizes, which can enhance the bioavailability and efficacy of the drug[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention. Here are some key claims:
Independent Claims
- Claim 1 describes the process of desolvating ondansetron hydrochloride dihydrate to remove solvent and then resolvating the desolvated material to form smaller crystals.
- Claim 2 specifies the conditions under which the desolvation and resolvation are carried out, including temperature and solvent composition.
Dependent Claims
- Dependent claims further detail the process, including the types of solvents used, the duration of the desolvation and resolvation steps, and the resulting crystal size.
These claims collectively define the boundaries of the patented process and ensure that any similar processes would infringe on this patent unless they fall outside these specified parameters[4].
Patent Landscape
Prior Art
The patent landscape for ondansetron hydrochloride dihydrate includes various prior art references that deal with the synthesis, crystallization, and formulation of this compound. The USPTO's Common Citation Document (CCD) would be a useful resource to consolidate prior art citations from multiple patent offices, helping to understand the global context of this invention[1].
Related Patents
Other patents related to ondansetron, such as those dealing with different formulations or synthesis methods, are part of the broader patent landscape. For example, patents like US 5,622,720, which also relate to ondansetron but focus on different aspects, contribute to the overall intellectual property environment surrounding this drug[5].
International Patent Offices
To fully understand the global patent landscape, it is essential to search databases from other international intellectual property offices such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[1].
Search Tools and Resources
Several tools and resources are available for conducting a thorough search of the patent landscape:
Patent Public Search
The USPTO's Patent Public Search tool is a powerful resource for searching prior art and related patents. It offers enhanced access to prior art and modern interfaces for a more efficient search process[1].
Global Dossier
The Global Dossier service provides access to the file histories of related applications from participating IP Offices, allowing users to see the patent family for a specific application and related data such as classification and citation information[1].
Patent and Trademark Resource Centers (PTRCs)
Local PTRCs offer training in patent search techniques and maintain local search resources, which can be invaluable for a detailed analysis of the patent landscape[1].
Economic and Legal Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset can provide insights into the scope and trends of patent claims, including those related to pharmaceutical processes. This dataset can help in understanding the economic implications of patent claims and their impact on innovation[3].
Legal Status
As of the current date, the legal status of US 5,344,658 is listed as expired, indicating that the patent is no longer in force. This means that the process described in the patent is now in the public domain and can be freely used without infringing on any patent rights[4].
Conclusion
United States Patent 5,344,658 is a significant contribution to the field of pharmaceuticals, particularly in the processing of ondansetron hydrochloride dihydrate. Understanding the scope, claims, and broader patent landscape is crucial for researchers, manufacturers, and legal professionals involved in this field.
Key Takeaways
- Process Innovation: The patent describes a novel process for reducing the crystal size of ondansetron hydrochloride dihydrate through desolvation and resolvation.
- Claims Analysis: The patent includes several claims that define the specific conditions and steps of the process.
- Patent Landscape: The landscape includes prior art, related patents, and international patent offices.
- Search Tools: Utilize tools like Patent Public Search, Global Dossier, and PTRCs for a comprehensive search.
- Economic and Legal Implications: The patent's expiration means the process is now in the public domain.
FAQs
Q: What is the main focus of US Patent 5,344,658?
A: The main focus is a process for reducing the crystal size of ondansetron hydrochloride dihydrate through desolvation and resolvation.
Q: What are the key claims of the patent?
A: The key claims include the process of desolvation and resolvation, and the conditions under which these steps are carried out.
Q: Is the patent still in force?
A: No, the patent has expired and is no longer in force.
Q: What tools can be used to search for related patents?
A: Tools such as Patent Public Search, Global Dossier, and resources from PTRCs can be used.
Q: Why is understanding the patent landscape important?
A: Understanding the patent landscape helps in identifying prior art, related patents, and potential legal implications, which is crucial for innovation and compliance.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Unified Patents Portal - US-5344658-A: https://portal.unifiedpatents.com/patents/patent/US-5344658-A
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US5344658A: https://patents.google.com/patent/US5344658
- Google APIs - US5622720: http://patentimages.storage.googleapis.com/pdfs/US5622720.pdf
