United States Patent 5,114,948: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,114,948, titled "Stabilized Pergolide Compositions," is a significant patent in the pharmaceutical field, particularly in the development of dopamine agonists. This patent, granted in 1992, addresses the stabilization of pergolide, an ergoline derivative with potent dopaminergic agonist activity. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Pergolide
Pergolide is a dopamine agonist that has been used in the treatment of Parkinson's disease and other conditions. It exhibits potent dopaminergic activity and also decreases plasma prolactin concentrations. However, pergolide is prone to oxidation, which can lead to the formation of pergolide sulfoxide, a less stable and less effective form of the drug[4].
Scope of the Patent
The patent US 5,114,948 focuses on stabilizing pergolide compositions to prevent the formation of pergolide sulfoxide during the manufacturing process. The scope includes:
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Pharmaceutical Composition: The patent describes a pharmaceutical composition containing a therapeutically effective amount of pergolide or a salt thereof, along with stabilizing agents such as methionine, cysteine, or cysteine hydrochloride. These agents are added in amounts sufficient to retard the formation of pergolide sulfoxide[4].
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Stabilizing Agents: The use of methionine, cysteine, and cysteine hydrochloride as stabilizing agents is a key aspect of this patent. These agents can be used separately or in combination with light stabilizing agents like polyvinylpyrrolidone, α-tocopherol succinate, or propyl gallate[4].
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Method of Stabilization: The patent also includes a method for stabilizing the pharmaceutical composition. This involves incorporating the stabilizing agents into the composition during the manufacturing process to prevent oxidation[4].
Claims of the Patent
The claims of US 5,114,948 are detailed and specific, ensuring broad protection for the invention:
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Claim 1: This claim describes the pharmaceutical composition comprising pergolide or a salt thereof, a stabilizing agent selected from methionine, cysteine, or cysteine hydrochloride, and pharmaceutically acceptable excipients[4].
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Claim 2: This claim specifies the method of stabilizing the composition by incorporating the stabilizing agents during the manufacturing process[4].
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Dependent Claims: The patent includes several dependent claims that further specify the types of salts, the amounts of stabilizing agents, and the combination with other stabilizers[4].
Patent Landscape
Understanding the patent landscape around US 5,114,948 involves looking at related patents, international filings, and the broader context of pharmaceutical stabilization.
Related Patents
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U.S. Pat. No. 4,797,405: This patent is referenced in US 5,114,948 and deals with the use of light stabilizing agents like polyvinylpyrrolidone, α-tocopherol succinate, or propyl gallate. These agents can be used in combination with the stabilizing agents described in US 5,114,948[4].
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International Filings: The invention described in US 5,114,948 may have been filed in other countries as well. For instance, searching databases like the European Patent Office's esp@cenet or the World Intellectual Property Organization's PATENTSCOPE can reveal similar patents filed internationally[1].
Broader Context
The stabilization of pharmaceutical compositions is a critical area in drug development. Patents like US 5,114,948 contribute to the body of knowledge in this field by providing innovative solutions to common problems such as oxidation.
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Global Dossier: Tools like the Global Dossier, provided by the USPTO, allow users to see the patent family for a specific application, including related applications filed at participating IP Offices. This can help in understanding the global patent landscape for similar inventions[1].
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Patent Claims Research Dataset: The USPTO's Patent Claims Research Dataset provides detailed information on claims from US patents, including those related to pharmaceutical compositions. This dataset can be useful in analyzing trends and scope measurements in patent claims[3].
Practical Applications
The practical applications of US 5,114,948 are significant in the pharmaceutical industry:
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Manufacturing Process: The method described in the patent ensures that pergolide compositions remain stable during the manufacturing process, which is crucial for maintaining the efficacy of the drug[4].
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Dosage Forms: The patent specifies that the stabilizing agents are particularly useful in tablets of smaller size and pergolide content, where the drug concentration is relatively low. This ensures that the tablets remain effective and stable[4].
Legal Status
As of the current date, the legal status of US 5,114,948 is expired, as indicated by the patent's lifetime expiration. This means that the invention is now in the public domain, and the specific claims and methods described in the patent can be freely used without infringing on any existing patent rights[4].
Conclusion
United States Patent 5,114,948 is a pivotal patent in the field of pharmaceutical stabilization, particularly for dopamine agonists like pergolide. The scope and claims of this patent provide a comprehensive solution to the problem of oxidation in pergolide compositions. Understanding the broader patent landscape and the practical applications of this invention is essential for both researchers and industry professionals.
Key Takeaways
- Stabilization Method: The patent describes a method for stabilizing pergolide compositions using methionine, cysteine, or cysteine hydrochloride.
- Pharmaceutical Composition: The composition includes a therapeutically effective amount of pergolide or a salt thereof, along with stabilizing agents and pharmaceutically acceptable excipients.
- Related Patents: Other patents, such as U.S. Pat. No. 4,797,405, are relevant and can be used in combination with the methods described in US 5,114,948.
- Legal Status: The patent has expired, making the invention public domain.
- Practical Applications: The method is particularly useful in manufacturing small-sized tablets with low drug concentrations.
FAQs
Q: What is the main issue addressed by US 5,114,948?
A: The main issue addressed is the stabilization of pergolide compositions to prevent the formation of pergolide sulfoxide during the manufacturing process.
Q: What are the stabilizing agents used in the patent?
A: The stabilizing agents used are methionine, cysteine, and cysteine hydrochloride.
Q: Can the stabilizing agents be used in combination with other agents?
A: Yes, the stabilizing agents can be used in combination with light stabilizing agents like polyvinylpyrrolidone, α-tocopherol succinate, or propyl gallate.
Q: What is the legal status of US 5,114,948?
A: The patent has expired, making the invention public domain.
Q: How can one search for related patents internationally?
A: One can use databases like the European Patent Office's esp@cenet or the World Intellectual Property Organization's PATENTSCOPE to search for related patents filed internationally[1].
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Unified Patents - AU-6485390-A: https://portal.unifiedpatents.com/patents/patent/AU-6485390-A
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US5114948A: https://patents.google.com/patent/US5114948A/en
- Unified Patents - US-20040092544-A1: https://portal.unifiedpatents.com/patents/patent/US-20040092544-A1
