United States Patent 5,674,850: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,674,850, titled "High purity desmopressin produced in large single batches," is a significant patent in the field of pharmaceuticals, particularly for the production of desmopressin, a hormone analog used in treating various medical conditions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Desmopressin
Desmopressin, also known as 1-deamino-8-D-arginine vasopressin (DDAVP), is a synthetic analog of the natural hormone vasopressin. It is widely used for treating conditions such as diabetes insipidus, nocturnal enuresis, urine incontinence, and certain bleeding disorders like hemophilia A and von Willebrand's disease[1].
Scope of the Patent
The patent US5674850A focuses on a method for producing high-purity desmopressin in large single batches. This method is crucial for ensuring the consistent quality and efficacy of the drug. Here are the key aspects of the scope:
- Production Method: The patent describes a synthetic process involving the dissolution of a specific peptide sequence in a protic solvent under neutral or slightly acidic conditions, followed by the introduction of iodine to form the final product[1].
- Batch Size: The method is designed to produce substantial batches, with preferences for batch sizes of at least 100 g, preferably 200 g, and particularly preferred at least about 500 g[1].
- Applications: The high-purity desmopressin produced is intended for the treatment of various medical conditions, including diabetes insipidus and bleeding disorders.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Claim 1: A method for producing high-purity desmopressin involving the dissolution of a specific peptide sequence in a protic solvent and the introduction of iodine[1].
- Claim 2-5: These claims further specify the conditions and reagents used in the synthetic process, including the use of acetamidomethyl and triphenylmethyl groups and the stoichiometric amount of iodine[1].
Patent Landscape Analysis
To understand the position of US5674850A within the broader patent landscape, several key aspects need to be considered:
Define Scope and Keywords
The analysis begins by defining the technology field, which in this case is the production of synthetic hormone analogs, particularly desmopressin. Key terms include "desmopressin," "high-purity," "synthetic method," and "large batch production"[3].
Search and Organize Patents
Using databases such as the USPTO's Patent Public Search tool, relevant patents can be identified and organized based on factors like filing date, assignee, and technological relevance. Visual aids like heat maps can help in visualizing the patent landscape[4].
Identify Trends and Key Players
The analysis reveals trends in patent filings related to desmopressin production. Key players include pharmaceutical companies and research institutions that have been actively involved in developing and improving synthetic methods for hormone analogs. For instance, the patent US5674850A itself is a continuation of an earlier abandoned application, indicating ongoing research and development in this area[1].
Analyze Citations and Evolution
Studying how patents reference each other helps in understanding the impact and development of the technology. The patent US5674850A builds upon earlier research and methods, as indicated by its continuation from an earlier application. This shows a progression in the technology aimed at improving the purity and efficiency of desmopressin production[3].
Generate Insights for Decisions
The analysis provides practical guidance for strategic decisions. For example, understanding the competitive landscape and potential legal vulnerabilities can help in navigating the intellectual property landscape. The high-purity desmopressin production method patented here could be a critical differentiator for companies seeking to improve their product quality and compliance with regulatory standards[3].
Competitive Landscape
The competitive landscape for desmopressin production is characterized by several players, including pharmaceutical companies and research institutions. The patent US5674850A holds a significant position due to its focus on high-purity production in large batches, which is a critical factor in ensuring the efficacy and safety of the drug.
Technological Trends
Technological trends in the field of synthetic hormone analogs are moving towards more efficient and scalable production methods. The use of advanced synthetic techniques and the optimization of reaction conditions are key areas of focus. The patent US5674850A aligns with these trends by providing a method that enhances the purity and yield of desmopressin.
Legal and Regulatory Considerations
The patent landscape is also influenced by legal and regulatory considerations. The nonobviousness of the invention, as defined by the Supreme Court in cases like Graham v. John Deere Co. of Kansas City and KSR, is crucial for the validity of the patent. The method described in US5674850A must demonstrate significant improvements over prior art to be considered nonobvious[2].
International Patent Landscape
The global patent landscape for desmopressin production involves various international intellectual property offices. Databases such as the European Patent Office's esp@cenet, the Japan Patent Office, and the World Intellectual Property Organization's PATENTSCOPE provide access to international patent filings. This helps in understanding the global competitive landscape and potential legal vulnerabilities[4].
Key Takeaways
- High-Purity Production: The patent US5674850A focuses on a method for producing high-purity desmopressin in large single batches.
- Synthetic Method: The method involves the dissolution of a specific peptide sequence in a protic solvent and the introduction of iodine.
- Competitive Landscape: The patent holds a significant position in the competitive landscape due to its focus on high-purity production.
- Technological Trends: The method aligns with technological trends towards more efficient and scalable production of synthetic hormone analogs.
- Legal and Regulatory Considerations: The patent's validity depends on demonstrating nonobviousness over prior art.
FAQs
What is the main focus of United States Patent 5,674,850?
The main focus of this patent is a method for producing high-purity desmopressin in large single batches.
What are the key steps in the synthetic method described in the patent?
The method involves dissolving a specific peptide sequence in a protic solvent under neutral or slightly acidic conditions and then introducing iodine to form the final product.
Why is high-purity desmopressin important?
High-purity desmopressin is crucial for ensuring the efficacy and safety of the drug, particularly in treating conditions like diabetes insipidus and bleeding disorders.
Who are the key players in the patent landscape for desmopressin production?
Key players include pharmaceutical companies and research institutions that have been actively involved in developing and improving synthetic methods for hormone analogs.
How does the patent US5674850A align with current technological trends?
The patent aligns with trends towards more efficient and scalable production methods for synthetic hormone analogs, focusing on high-purity production in large batches.
Cited Sources
- US5674850A - High purity desmopressin produced in large single batches - Google Patents
- LKQ Corporation v. GM Global Technology Operations LLC - CAFC
- How to Do Patent Landscape Analysis - Goldstein Patent Law
- Search for patents - USPTO - United States Patent and Trademark Office
