United States Patent 8,431,154: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,431,154, titled "Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidone as excipient," is a significant patent in the field of pharmaceutical technology. This patent, issued to address specific challenges in drug formulation, provides valuable insights into the development and protection of intellectual property in the pharmaceutical sector.
Background and Invention Overview
The patent describes an oral dosage form designed for the administration of a PDE 4 inhibitor, a class of drugs used to treat conditions such as asthma and airway obstructions. The invention involves the use of polyvinylpyrrolidone (PVP) as an excipient to enhance the solubility and stability of the PDE 4 inhibitor, which has slight solubility in water[2].
Scope of the Invention
The scope of this patent is focused on the specific formulation and process for creating an oral dosage form that effectively delivers a PDE 4 inhibitor. Key aspects include:
- Active Ingredient: The PDE 4 inhibitor, which is the primary therapeutic component.
- Excipient: Polyvinylpyrrolidone (PVP), used to improve the solubility and stability of the active ingredient.
- Dosage Form: The invention encompasses tablet or pellet forms suitable for oral administration[2].
Claims
The patent includes several claims that define the scope of the invention:
- Independent Claims: These claims define the broadest aspects of the invention, such as the composition of the oral dosage form and the process of its manufacture.
- Dependent Claims: These claims narrow down the invention by specifying particular aspects, such as the ratio of the active ingredient to the excipient or specific methods of preparation[2].
Patent Landscape Analysis
Technology Area
The patent falls within the pharmaceutical technology field, specifically in the area of drug formulation and delivery systems. This area is highly saturated with numerous patents, making a comprehensive patent landscape analysis crucial for understanding the competitive and technological landscape.
Prior Art and Saturation
A patent landscape analysis would reveal that the area of PDE 4 inhibitors and their formulations is highly competitive. The analysis would help identify prior art, such as other patents and publications related to similar formulations, and assess the level of saturation in this technology area. This information is vital for making strategic decisions about research and development and for identifying potential areas for innovation[3].
Competitors and Market Position
The patent landscape analysis would also identify key competitors and their patent portfolios. For instance, it might show that certain companies have a significant number of patents related to PDE 4 inhibitors, indicating their strong market position in this area. This analysis can help in understanding the competitive dynamics and in planning strategies to differentiate or innovate within this space[3].
Continuations and Priority Dates
The patent US8431154B2 is a continuation of earlier patent applications, including U.S. patent application Ser. No. 10/505,138, which is a national stage entry of PCT/EP03/01650. This chain of continuations allows the patent to claim priority dates back to earlier filings, such as the European Patent Office application filed on February 20, 2002. This strategy is common in patent practice to extend the life of the patent and to ensure that the invention is protected from the earliest possible date[2].
International Patent Protection
The patent US8431154B2 is part of a broader international patent family, with corresponding applications filed in various jurisdictions, including Europe and Germany. This international protection is crucial for ensuring that the invention is safeguarded globally, especially in regions where the pharmaceutical market is significant[2].
Search and Analysis Tools
For a detailed analysis of this patent and its landscape, several tools and resources are available:
- USPTO Patent Public Search: This tool allows for comprehensive searches of prior art and related patents.
- Global Dossier: This service provides access to the file histories of related applications from participating IP Offices, helping to identify the patent family and related citations.
- Common Citation Document (CCD): This application consolidates prior art citations from multiple offices, facilitating a more integrated view of the patent landscape[4].
Strategic Insights
A thorough patent landscape analysis of US8431154B2 can provide several strategic insights:
- Identifying Gaps: By analyzing the existing patents and prior art, one can identify gaps in the current technology that could be targeted for future innovation.
- Competitor Analysis: Understanding the patent portfolios of competitors can help in developing strategies to differentiate or challenge existing patents.
- Long-term Decisions: The analysis can inform long-term decisions about whether to continue investing in a particular technology area or to pivot to newer inventive spaces[3].
Conclusion
United States Patent 8,431,154 represents a significant innovation in the formulation of PDE 4 inhibitors for oral administration. The patent's scope, claims, and position within the broader patent landscape are critical for understanding its impact and potential for future development.
Key Takeaways
- Specific Formulation: The patent describes a specific oral dosage form using PVP as an excipient to enhance the solubility of the PDE 4 inhibitor.
- Continuations and Priority Dates: The patent is part of a chain of continuations, allowing it to claim priority dates from earlier filings.
- International Protection: The patent is protected internationally through corresponding applications in various jurisdictions.
- Strategic Insights: A patent landscape analysis can provide valuable insights into competitive dynamics, technological gaps, and long-term strategic decisions.
FAQs
Q: What is the primary purpose of the invention described in US8431154B2?
A: The primary purpose is to create an oral dosage form for a PDE 4 inhibitor using polyvinylpyrrolidone (PVP) as an excipient to improve solubility and stability.
Q: How does the patent claim priority dates?
A: The patent claims priority dates through a chain of continuations, including earlier U.S. and international patent applications.
Q: What tools can be used for a comprehensive patent landscape analysis?
A: Tools such as the USPTO Patent Public Search, Global Dossier, and Common Citation Document (CCD) can be used for a comprehensive patent landscape analysis.
Q: Why is international patent protection important for this invention?
A: International patent protection ensures that the invention is safeguarded globally, particularly in significant pharmaceutical markets.
Q: How can a patent landscape analysis inform strategic decisions?
A: It can help identify gaps in current technology, analyze competitors' patent portfolios, and inform decisions about whether to continue investing in a particular technology area or to pivot to newer areas.
Sources
- Carley, M., & Hegde, D. "What Is the Probability of Receiving a US Patent?" Emory Law Journal, 58(1), 101-107.
- US8431154B2 - Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidone as excipient. Google Patents.
- Patent Landscape Analysis - Uncovering Strategic Insights. AcclaimIP.
- Search for patents - USPTO. United States Patent and Trademark Office.
