United States Patent 7,550,434: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,550,434, titled "Stabilized teriparatide solutions," is a significant patent in the pharmaceutical industry, particularly in the field of parenteral administration of parathyroid hormone. This analysis will delve into the scope and claims of the patent, as well as the broader patent landscape surrounding this technology.
Patent Overview
Publication Number and Authority
The patent, US7550434B2, was granted by the United States Patent and Trademark Office (USPTO)[4].
Prior Art and Background
The patent addresses the stabilization of teriparatide, a recombinant form of parathyroid hormone used in the treatment of osteoporosis. Prior art in this field often struggled with the instability of teriparatide solutions due to oxidation and other degradation processes.
Claims
The patent includes several key claims that define the scope of the invention:
- Claim 1: A stabilized pharmaceutical composition in the form of a solution for parenteral administration of a parathyroid hormone, comprising teriparatide, a buffer, and at least one stabilizer.
- Claim 2: The composition of claim 1, where the buffer is selected from the group consisting of acetate, citrate, and phosphate.
- Claim 3: The composition of claim 1, where the stabilizer is selected from the group consisting of benzalkonium chloride, benzethonium chloride, and phenol[4].
Scope of the Invention
Pharmaceutical Composition
The patent describes a stabilized pharmaceutical composition that is specifically designed for parenteral administration. This composition includes teriparatide, a buffer to maintain pH stability, and at least one stabilizer to prevent degradation of the teriparatide.
Stabilizers and Buffers
The use of specific stabilizers such as benzalkonium chloride, benzethonium chloride, and phenol is crucial. These stabilizers help prevent oxidation and other forms of degradation that can occur in teriparatide solutions. The buffers, such as acetate, citrate, and phosphate, ensure that the pH of the solution remains stable, which is essential for the stability and efficacy of teriparatide[4].
Patent Landscape Analysis
Competitors and Related Patents
A patent landscape analysis reveals that the field of stabilized parathyroid hormone formulations is highly competitive. Other patents, such as JP2015504087A, also focus on stabilizing parathyroid hormone formulations, but they may use different stabilizers and buffers. For example, the Japanese patent JP2015504087A uses mannitol and glycerine as stabilizers and mentions the importance of preventing oxidation of methionine residues in the parathyroid hormone[5].
Global Patent Family
The patent US7550434B2 is part of a larger global patent family. Using tools like the Global Dossier provided by the USPTO, one can see the related applications filed at participating IP Offices. This helps in understanding the global protection and strategic positioning of the patent[1].
Time-Slicing and Technology Trends
Analyzing the patent landscape over time can reveal trends and shifts in technology focus. For instance, if a company has a high number of patents in a particular area but then ceases to file new patents in that area, it may indicate a pivot to newer technologies. This kind of analysis can be crucial for business and R&D management to make long-term strategic decisions[3].
Search and Analysis Tools
USPTO Resources
To conduct a thorough analysis of the patent landscape, several tools provided by the USPTO are invaluable:
- Patent Public Search: This tool offers enhanced access to prior art and allows for comprehensive searches.
- Global Dossier: This service provides access to file histories of related applications from participating IP Offices.
- Common Citation Document (CCD): This tool consolidates prior art citations from multiple offices, making it easier to visualize the global patent landscape[1].
International Patent Databases
Searching international patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), is essential to ensure that the idea has not been patented abroad. These databases often include machine translations, which can be particularly useful for non-English patents[1].
Strategic Insights
Going Beyond Known Competitors
A comprehensive patent landscape analysis helps in identifying not just known competitors but also emerging players in the field. This can reveal niche technologies that are gaining traction and where significant resources are being allocated. For example, a company might have a small number of patents in a specific area, but these patents could represent a significant portion of their overall portfolio, indicating a strategic focus[3].
Long-Term Decisions
Understanding patent saturation in a technology area is crucial for making long-term decisions. If a technology area is highly saturated with patents, it may be wise to pivot to newer inventive spaces to avoid potential infringement issues and to stay competitive[3].
Key Takeaways
- Stabilized Composition: The patent US7550434B2 provides a stabilized pharmaceutical composition for teriparatide, using specific buffers and stabilizers.
- Competitive Landscape: The field of stabilized parathyroid hormone formulations is highly competitive, with multiple patents and players involved.
- Global Protection: Understanding the global patent family and using tools like the Global Dossier is essential for strategic positioning.
- Trend Analysis: Analyzing patent trends over time can help in making long-term strategic decisions.
- Comprehensive Search: Utilizing USPTO resources and international patent databases is crucial for a thorough patent landscape analysis.
FAQs
Q: What is the main focus of the United States Patent 7,550,434?
A: The main focus of the patent is on a stabilized pharmaceutical composition for the parenteral administration of teriparatide, a form of parathyroid hormone.
Q: What stabilizers are mentioned in the patent?
A: The patent mentions benzalkonium chloride, benzethonium chloride, and phenol as stabilizers.
Q: How can one analyze the global patent landscape for this technology?
A: Using tools like the Global Dossier and Common Citation Document (CCD) provided by the USPTO, along with searching international patent databases.
Q: Why is time-slicing important in patent landscape analysis?
A: Time-slicing helps in understanding trends and shifts in technology focus over time, which can inform long-term strategic decisions.
Q: What are some key resources for conducting a comprehensive patent search?
A: Key resources include the USPTO's Patent Public Search, Global Dossier, and international patent databases such as those provided by the EPO, JPO, and WIPO.
Sources
- USPTO - Search for patents - USPTO
- USA.gov - U.S. Patent and Trademark Office (USPTO) | USAGov
- AcclaimIP - Patent Landscape Analysis - Uncovering Strategic Insights
- Google Patents - US7550434B2 - Stabilized teriparatide solutions
- Google Patents - JP2015504087A - Stabilized PTH formulation
