Detailed Analysis of the Scope and Claims of United States Patent 5,792,477
Introduction
United States Patent 5,792,477, titled "Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent," is a significant patent in the field of pharmaceuticals, particularly in the development of controlled-release drug formulations. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
The patent addresses the need for biodegradable and biocompatible microparticles that can encapsulate biologically active agents, ensuring their controlled release over an extended period. This is crucial for improving the efficacy and reducing the frequency of drug administration[4].
Scope of the Invention
The invention focuses on a method for preparing microparticles that are designed for the controlled release of drugs. Here are the key aspects of the scope:
Biodegradable and Biocompatible Microparticles
The patent describes the preparation of microparticles using biodegradable and biocompatible polymers. These microparticles are intended to degrade in the body over time, releasing the encapsulated drug in a controlled manner[4].
Active Agents
The preferred active agents for encapsulation include norethindrone, risperidone, and testosterone. These agents are encapsulated within the microparticles to achieve sustained release[4].
Solvent System
The method involves using a solvent system, typically a blend of benzyl alcohol and ethyl acetate, to dissolve the core material and the wall material. This solvent system is critical for the formation of stable microparticles[4].
Claims of the Patent
The claims of the patent are the most critical part as they define the scope of the invention. Here are some key claims:
Method of Preparation
The patent claims a method for preparing biodegradable, biocompatible microparticles by dissolving or dispersing a core material in a solution of a wall material, followed by emulsification and solvent evaporation[4].
Reduced Residual Solvent
A significant claim is the reduction of residual processing solvent to minimize the degradation of the microparticles. This step is crucial for increasing the shelf-life of the product[4].
Controlled Release
The claims also include the controlled release of the biologically active agent over an extended period, which is a key feature of the invention[4].
Patent Landscape Analysis
Geographical Spread
Understanding the geographical spread of similar patents is vital. The patent in question is filed in the United States, but similar technologies may be patented in other jurisdictions. Companies looking to expand globally need to consider filing patents in key markets to ensure broad enforcement potential[3].
Patent Saturation
The patent landscape analysis reveals that the field of controlled-release drug formulations is highly saturated. This saturation indicates that entering this space can be challenging and costly. A comprehensive assessment of existing and pending patents, along with competitor data, is essential for deciding whether to invest in this technology area[3].
Competitor Analysis
Several other patents and publications relate to similar technologies, such as:
Related Patents
Patents like US 6,667,061 B2, which deals with the preparation of injectable suspensions having improved injectability, are relevant. These patents often overlap in their methods and materials, highlighting the competitive nature of the field[2].
Industry Experts and Publications
Publications by industry experts, such as Akers et al. in the "Journal of Parenteral Science and Technology," provide additional context and best practices in the formulation and development of parenteral suspensions[1].
Impact on the Industry
Extended Shelf-Life
The invention significantly impacts the pharmaceutical industry by providing a method to increase the shelf-life of biodegradable microparticles. By reducing residual processing solvents, the rate of degradation is minimized, allowing for a shelf-life of about two or more years[4].
Controlled Release Formulations
The controlled release aspect of the microparticles enhances patient compliance and reduces the need for frequent dosing. This is particularly beneficial for drugs that require sustained release over an extended period.
Key Takeaways
- Biodegradable and Biocompatible Microparticles: The patent focuses on preparing microparticles that are both biodegradable and biocompatible.
- Controlled Release: The method ensures the controlled release of the encapsulated drug over an extended period.
- Reduced Residual Solvent: Minimizing residual processing solvent is crucial for increasing the shelf-life of the microparticles.
- Patent Landscape: The field is highly saturated, indicating challenges and costs associated with entering this technology space.
- Industry Impact: The invention improves shelf-life and enhances patient compliance through controlled release formulations.
Frequently Asked Questions (FAQs)
Q: What is the primary focus of United States Patent 5,792,477?
A: The primary focus is on the preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent.
Q: Which active agents are preferred for encapsulation in this patent?
A: The preferred active agents include norethindrone, risperidone, and testosterone.
Q: What is the significance of reducing residual processing solvent in this method?
A: Reducing residual processing solvent minimizes the degradation of the microparticles, thereby increasing their shelf-life.
Q: How does this patent impact the pharmaceutical industry?
A: It provides a method to increase the shelf-life of biodegradable microparticles and enhances patient compliance through controlled release formulations.
Q: What is the geographical spread of similar patents in this field?
A: While the patent in question is filed in the United States, similar technologies may be patented in other jurisdictions, highlighting the need for a broad geographical spread for global enforcement.
Cited Sources
- United States Patent 6,667,061 B2 - Preparation of injectable suspensions having improved injectability[1].
- Google Patents - US6667061B2 - Preparation of injectable suspensions having improved injectability[2].
- Drug Patent Watch - Patent Landscape Analysis - Importance of patent landscape analysis[3].
- Google Patents - US5792477A - Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent[4].
