United States Patent 5,912,268: A Detailed Analysis of Scope and Claims
Introduction to the Patent
The United States Patent 5,912,268, titled "Dosage Form and Method for Treating Incontinence," was granted on June 15, 1999, to inventors George V. Guittard and others. This patent is significant in the field of pharmaceuticals, particularly for the treatment of incontinence using oxybutynin.
Inventors and Assignees
The patent was invented by George V. Guittard and others, with the assignee being Alza Corporation. Alza Corporation is a well-known entity in the pharmaceutical industry, especially in the development of drug delivery systems[4].
Patent Claims
The patent contains eight claims that outline the specific aspects of the invention. Here are the key claims:
Claim 1
The first claim describes a dosage form for delivering oxybutynin to a patient, comprising a drug layer containing oxybutynin and an osmotic layer that controls the release of the drug[4].
Claim 2-5
These claims detail the composition of the dosage form, including the presence of an osmotic salt and a semipermeable membrane that regulates the release of oxybutynin[4].
Claim 6-8
These claims specify the method of administering oxybutynin using the described dosage form, emphasizing the controlled release mechanism that ensures a steady and effective delivery of the drug[4].
Scope of the Invention
The scope of the invention is focused on a specific dosage form designed to deliver oxybutynin, a medication used to treat urinary incontinence. Here are the key aspects:
Dosage Form
The dosage form is designed as an osmotic device that contains a drug layer with oxybutynin and an osmotic layer. This design ensures a controlled release of the drug over a prolonged period[4].
Osmotic Layer
The osmotic layer is crucial as it absorbs water, swelling and creating osmotic pressure that pushes the drug out through a semipermeable membrane. This mechanism ensures a consistent and predictable release of oxybutynin[4].
Semipermeable Membrane
The semipermeable membrane is a critical component that regulates the release of the drug. It allows water to enter the device while preventing the drug from escaping too quickly, thus maintaining a controlled release profile[4].
Patent Landscape Analysis
Defining Scope and Keywords
To analyze the patent landscape around US Patent 5,912,268, one must define the scope and relevant keywords. Key terms include "oxybutynin," "osmotic device," "controlled release," and "urinary incontinence treatment"[5].
Search and Organize Patents
Using patent databases, one can search for patents related to these keywords. Organizing these patents by factors such as filing date, assignee, and technology subcategories helps in understanding the evolution and current state of the technology[5].
Identify Trends and Key Players
Analyzing the patent filings reveals trends in the development of drug delivery systems, particularly those involving osmotic devices. Key players in this field include Alza Corporation, as well as other pharmaceutical companies that have developed similar technologies[5].
Analyze Citations and Evolution
Studying the citations and references within the patent and related patents provides insights into the development and impact of this technology. For example, the patent cites earlier works by Theeuwes et al., indicating a continuous improvement in drug delivery systems[4].
Generate Insights for Decisions
The analysis generates practical insights for strategic decisions. For instance, it helps in identifying gaps in current technologies, potential legal vulnerabilities, and opportunities for future innovations. This is crucial for companies looking to develop or improve their drug delivery systems[5].
Competitive Landscape
The competitive landscape around US Patent 5,912,268 is characterized by several key players in the pharmaceutical industry. Here are some insights:
Key Players
Companies like Alza Corporation, IMPAX Laboratories, and others have been involved in the development of similar drug delivery systems. The competition is fierce, with multiple patents and legal battles over infringement and validity[1][4].
Legal Considerations
The patent has been subject to legal challenges, such as the lawsuit between Alza Corporation and IMPAX Laboratories over patent infringement. This highlights the importance of thorough patent landscape analysis to avoid legal vulnerabilities[1].
Technological Trends
The technological trends in this domain are focused on improving drug delivery systems, particularly those using osmotic devices. Here are some key trends:
Osmotic Devices
There is a continuous innovation in osmotic devices, with improvements in materials, design, and functionality. Patents like WO2006056145A2 illustrate advancements in this area, such as the use of drug salts and osmotic salts to enhance the release profile[2].
Controlled Release Mechanisms
The development of controlled release mechanisms is a significant trend. These mechanisms ensure that drugs are delivered consistently over a prolonged period, enhancing the efficacy and patient compliance[4].
Practical Applications and Impact
Treatment of Incontinence
The dosage form described in the patent has a direct practical application in the treatment of urinary incontinence. Oxybutynin, delivered through this controlled release mechanism, provides effective relief from symptoms of incontinence[4].
Patient Compliance
The controlled release profile of the dosage form improves patient compliance by reducing the frequency of dosing. This is a significant advantage over traditional immediate-release formulations[4].
Conclusion
US Patent 5,912,268 is a pivotal invention in the field of pharmaceuticals, particularly for the treatment of urinary incontinence. The detailed analysis of its scope and claims, along with the patent landscape, provides valuable insights into the technological trends, competitive landscape, and practical applications.
Key Takeaways
- Invention Scope: The patent describes a dosage form for delivering oxybutynin using an osmotic device.
- Claims: The patent includes eight claims detailing the composition and method of administering the drug.
- Patent Landscape: The analysis reveals key players, technological trends, and legal considerations in the field of drug delivery systems.
- Competitive Landscape: The competition is intense, with multiple companies involved in similar technologies.
- Technological Trends: Continuous innovation in osmotic devices and controlled release mechanisms is a significant trend.
FAQs
What is the main invention described in US Patent 5,912,268?
The main invention is a dosage form for delivering oxybutynin using an osmotic device that ensures a controlled release of the drug.
Who are the inventors and assignees of the patent?
The inventors include George V. Guittard and others, with Alza Corporation as the assignee.
What are the key components of the dosage form?
The key components include a drug layer containing oxybutynin, an osmotic layer, and a semipermeable membrane.
How does the osmotic layer function?
The osmotic layer absorbs water, swelling and creating osmotic pressure that pushes the drug out through the semipermeable membrane.
What is the significance of the patent in the pharmaceutical industry?
The patent is significant for its contribution to the development of controlled release drug delivery systems, particularly for treating urinary incontinence.
Sources
- FDA Approval Letter: IMPAX Laboratories, Inc. - ANDA 76-745[1].
- Google Patents: WO2006056145A2 - Osmotic device containing a salt of a drug and an osmotic salt[2].
- Schwegman Patent Analytics: Claim Coverage Matrix and Claim Charts[3].
- US Patent Document: United States Patent 5,912,268[4].
- Goldstein Patent Law: How to Do Patent Landscape Analysis[5].
