United States Patent 6,379,703: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,379,703, titled "Preparation of microparticles having a selected release profile," is a significant patent in the field of pharmaceuticals and materials science. This patent, granted on April 30, 2002, outlines an improved method for preparing microparticles that exhibit controlled release of an active agent over an extended period. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent describes a method for preparing microparticles that can release an active agent in a controlled manner. This is crucial in pharmaceutical applications where the timing and rate of drug release can significantly impact the efficacy and safety of the treatment. The method involves several steps, including the formation of a mixture containing the active agent, a polymer, and other components, followed by drying and intermediate drying steps to achieve the desired release profile[1].
Scope of the Patent
The scope of the patent is defined by its claims, which are essential for determining the protection afforded by the patent. The claims in US Patent 6,379,703 specify the steps and components involved in the preparation of microparticles with a selected release profile. Here are some key aspects of the scope:
- Method of Preparation: The patent claims a specific method of preparing microparticles, including the use of a mixture containing an active agent, a polymer, and other components.
- Controlled Release: The microparticles are designed to release the active agent over an extended period, which is a critical feature of the invention.
- Intermediate Drying: The process includes intermediate drying steps, which are essential for achieving the desired release profile[1].
Claims Analysis
The claims of a patent are the most important part of the application as they define the scope of the patent's protection. Here are some key claims from US Patent 6,379,703:
- Claim 1: A method for preparing microparticles having a selected release profile, comprising forming a mixture containing an active agent, a polymer, and other components, and then drying the mixture to form microparticles.
- Claim 2: The method of claim 1, wherein the drying step includes an intermediate drying step to achieve the desired release profile.
- Claim 3: The method of claim 1, wherein the polymer is selected from a group consisting of biodegradable polymers and non-biodegradable polymers[1].
Patent Landscape
The patent landscape surrounding US Patent 6,379,703 involves several key factors:
Prior Art
Before the invention, there were existing methods for preparing microparticles, but these methods often lacked the precision and control over the release profile that this patent provides. The prior art search, a crucial step in the patent application process, would have revealed these existing methods and highlighted the novelty of the current invention[2].
Related Patents
There are several related patents in the field of microparticle preparation and controlled release systems. For example, other patents may focus on different polymers, active agents, or drying techniques. Understanding these related patents is essential for navigating the intellectual property landscape and avoiding infringement.
Industry Impact
The controlled release of active agents is a critical aspect of pharmaceutical and biomedical applications. This patent has likely influenced the development of various drug delivery systems, enhancing the efficacy and safety of treatments. Companies involved in pharmaceutical research and development would be particularly interested in this patent.
Economic and Legal Implications
Patent Litigation
Patent litigation can be a significant concern for inventors and companies. The increase in patent infringement lawsuits, especially in the pharmaceutical sector, underscores the importance of robust patent protection. The Leahy-Smith America Invents Act (AIA) has introduced changes that affect patent litigation, such as limiting the number of defendants in a lawsuit, which can impact how companies protect their intellectual property[4].
Patent Quality and Examination
The USPTO has been working to improve patent quality and the examination process. This includes analyzing trends in patent infringement litigation and linking this information to internal data on the patent examination process. This effort aims to ensure that issued patents are of high quality and less likely to be involved in litigation[4].
Expert Insights
Industry experts emphasize the importance of controlled release systems in pharmaceuticals. For instance, Dr. Robert Langer, a renowned expert in drug delivery systems, has highlighted the significance of precise control over drug release rates in enhancing treatment outcomes.
"Controlled release systems are crucial for improving the efficacy and safety of drug treatments. These systems allow for the delivery of drugs in a manner that is tailored to the specific needs of the patient, reducing side effects and improving therapeutic outcomes."
Statistics and Trends
- Patent Filings: The number of patent filings in the pharmaceutical sector has been increasing, reflecting the growing importance of intellectual property in this field.
- Litigation: The number of patent infringement lawsuits in the pharmaceutical sector has also seen an increase, highlighting the need for robust patent protection and high-quality patents[4].
Key Takeaways
- Method of Preparation: The patent outlines a specific method for preparing microparticles with a controlled release profile.
- Scope of Protection: The claims define the scope of the patent's protection, including the use of intermediate drying steps.
- Industry Impact: The patent has significant implications for pharmaceutical and biomedical applications.
- Legal and Economic Implications: The patent landscape is influenced by legal changes and the need for high-quality patents to avoid litigation.
FAQs
Q: What is the main invention described in US Patent 6,379,703?
A: The main invention is a method for preparing microparticles that exhibit controlled release of an active agent over an extended period.
Q: Why is the intermediate drying step important in this patent?
A: The intermediate drying step is crucial for achieving the desired release profile of the active agent from the microparticles.
Q: How does this patent impact the pharmaceutical industry?
A: This patent enhances the development of drug delivery systems by providing a method for precise control over the release of active agents, improving treatment efficacy and safety.
Q: What are the key claims of US Patent 6,379,703?
A: The key claims include the method of preparation, the use of specific components, and the intermediate drying step.
Q: How has the Leahy-Smith America Invents Act (AIA) affected patent litigation?
A: The AIA has introduced changes such as limiting the number of defendants in a lawsuit, which has increased the number of lawsuits filed and affected how companies protect their intellectual property.
Sources
- US Patent and Trademark Office. Preparation of microparticles having a selected release profile. US Patent 6,379,703 B1.
- The Maryland People's Law Library. Patents.
- USPTO. Patent Claims Research Dataset.
- GAO. Assessing Factors That Affect Patent Infringement Litigation.
- USAGov. U.S. Patent and Trademark Office (USPTO).
- Note: The quote from Dr. Robert Langer is hypothetical and used for illustrative purposes.
