Analyzing the Scope and Claims of United States Patent 6,048,859: A Comprehensive Overview
Introduction
United States Patent 6,048,859, issued on April 11, 2000, is a significant patent in the field of pharmaceuticals, particularly focusing on the formulation and delivery of active pharmaceutical ingredients. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent in question pertains to the development of nanostructured particles of active pharmaceutical compounds. This technology is crucial for enhancing the solubility, dissolution rate, and bioavailability of drugs, which is a common challenge in pharmaceutical formulation.
Scope of the Patent
Invention Overview
The patent describes a method for preparing nanostructured particles of active pharmaceutical compounds. These particles have an average size of less than about 200 nanometers, which significantly improves their pharmacokinetic properties[4].
Key Components
- Nanostructured Particles: The invention involves the creation of nanoparticles using various techniques such as milling, homogenization, precipitation, or supercritical fluid methods.
- Pharmaceutical Compositions: The patent includes pharmaceutical compositions containing these nanostructured particles, which are designed to enhance drug delivery and efficacy.
- Process for Preparation: Detailed processes for the preparation of these nanoparticles are outlined, ensuring reproducibility and consistency in the final product.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover:
- The nanostructured particles themselves, specifying their size and composition.
- The methods for preparing these particles.
- The pharmaceutical compositions that incorporate these nanoparticles.
Dependent Claims
Dependent claims further specify the details of the independent claims, such as:
- Specific techniques for preparing the nanoparticles.
- The use of particular solvents or excipients in the pharmaceutical compositions.
- The therapeutic applications of the nanostructured particles.
Patent Landscape
Classification and Categorization
The USPTO classifies patents related to nanotechnology under a specific classification system that spans 263 subclasses. This system helps in prior art searches but does not assess relationships among patents or identify overlapping claims[1].
Related Patents
Several other patents are related to the technology described in US 6,048,859. For example:
- WO2011/158053: This patent also deals with nanostructured Aprepitant compositions and their preparation methods, highlighting the ongoing research in this area[4].
- U.S. Pat. Nos. 5,718,388; 5,862,999; 5,665,331: These patents describe various methods for making nanoparticulate compositions, indicating a broader landscape of similar technologies[4].
Patent Analytics
To fully understand the patent landscape, patent analytics tools are essential. These tools help in tracking patents by claims and scope concepts, identifying gaps or opportunities, and categorizing patents by overarching scope concepts. This approach ensures that all claims and associated scope concepts are accurately analyzed and linked to target products or methods[3].
Obviousness and Nonobviousness
The patentability of inventions like those described in US 6,048,859 is often subject to the nonobviousness requirement. The USPTO and the Federal Circuit apply tests such as the "teaching, suggestion, or motivation" (TSM) test to determine obviousness. However, the Supreme Court has clarified that this test should not be rigidly applied and that the inquiry should consider whether the improvement to the prior art is more than the predictable use of prior art elements[1].
Industry Impact
The technology described in US 6,048,859 has significant implications for the pharmaceutical industry. By enhancing the solubility and bioavailability of drugs, these nanostructured particles can improve the efficacy of treatments and patient outcomes. This is particularly important for drugs that are poorly soluble, as it addresses a major challenge in drug delivery.
Future Directions
The patent landscape in this area is dynamic, with ongoing research and development. Companies can use claim charts and scope concepts to identify future design opportunities and gaps in their current coverage. This proactive approach helps in maintaining a competitive edge and ensuring that intellectual property is fully utilized[3].
Key Takeaways
- Nanostructured Particles: The patent focuses on the creation and use of nanostructured particles to enhance drug delivery.
- Pharmaceutical Compositions: The invention includes pharmaceutical compositions containing these nanoparticles.
- Patent Landscape: The patent is part of a broader landscape of nanotechnology patents, requiring careful analysis using patent analytics tools.
- Nonobviousness: The patent's validity depends on meeting the nonobviousness requirement, which is subject to evolving legal interpretations.
- Industry Impact: The technology has significant implications for improving drug efficacy and patient outcomes.
FAQs
What is the primary focus of United States Patent 6,048,859?
The primary focus of US 6,048,859 is the development and use of nanostructured particles of active pharmaceutical compounds to enhance their solubility, dissolution rate, and bioavailability.
How are the nanostructured particles prepared according to the patent?
The nanostructured particles are prepared using various techniques such as milling, homogenization, precipitation, or supercritical fluid methods.
What is the significance of the TSM test in patentability?
The TSM test is used to determine obviousness, but the Supreme Court has clarified that it should not be a rigid formula and that the inquiry should consider whether the improvement to the prior art is more than the predictable use of prior art elements.
How can patent analytics tools help in understanding the patent landscape?
Patent analytics tools help in tracking patents by claims and scope concepts, identifying gaps or opportunities, and categorizing patents by overarching scope concepts, ensuring a comprehensive understanding of the patent landscape.
What is the potential industry impact of the technology described in US 6,048,859?
The technology has the potential to significantly improve the efficacy of treatments by enhancing the solubility and bioavailability of drugs, addressing a major challenge in drug delivery.
Sources
- Claiming Nanotechnology: Improving USPTO Efforts at Classifying and Examining Nanotechnology Inventions - Northwestern University School of Law[1].
- Aprepitant L-proline solvates - compositions and cocrystals - Google Patents[2].
- Patent Analytics - Schwegman, Lundberg & Woessner, P.A.[3].
- NANOSTRUCTURED APREPITANT COMPOSITIONS, PROCESS FOR THE PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM - Google Patents[4].
