United States Patent 6,858,596: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 6,858,596, titled "Formulation containing anti-inflammatory androstane derivative," is a pharmaceutical patent that describes a specific formulation for an anti-inflammatory medication. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Publication Number and Authority
The patent, numbered US6858596B2, was issued by the United States Patent and Trademark Office (USPTO)[4].
Prior Art and Background
The patent builds upon prior art related to pharmaceutical formulations, particularly those involving anti-inflammatory compounds. The background section of the patent highlights the need for effective formulations that can deliver anti-inflammatory agents efficiently.
Claims
Independent and Dependent Claims
The patent includes several claims that define the scope of the invention. Here are the key aspects:
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Independent Claims: These claims stand alone and define the core invention. For example, Claim 1 describes a pharmaceutical formulation comprising an aqueous suspension of a particulate compound of a specific formula (I) or a solvate thereof[4].
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Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. For instance, dependent claims might specify the particle size range (e.g., between 0.5-10 μm) or the concentration of the active compound (e.g., between 0.005% and 1% w/w)[4].
Scope of the Invention
Pharmaceutical Formulation
The patent describes a pharmaceutical formulation that includes an aqueous suspension of an anti-inflammatory androstane derivative. The formulation is characterized by:
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Particle Size: The particles of the active compound have a mass mean diameter (MMD) of less than 20 μm, preferably between 0.5-10 μm, and especially around 3-5 μm[4].
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Suspension Characteristics: The formulation assumes a gel-like appearance at rest due to the thixotropic nature of the suspending agent. This ensures the particulate medicament is dispersed and suspended uniformly[4].
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Viscosity: The viscosity of the formulation decreases to enable it to flow readily through a spray device, forming a mist that can infiltrate nasal passages. It increases to a sufficient level to resist being cleared by mucociliary forces in the nasal cavities[4].
Patent Landscape
Related Patents and Publications
The patent landscape for pharmaceutical formulations, especially those involving anti-inflammatory agents, is extensive. Other patents and publications may cover similar formulations or different aspects of drug delivery systems.
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Patent Claims Research Dataset: The USPTO provides datasets that include detailed information on claims from US patents, which can be used to analyze trends and scope in pharmaceutical patents[3].
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International Patent Applications: The patent references an international patent application (PCT/GB99/04368) that describes a process for preparing the particulate compound, indicating a global context for similar inventions[4].
Legal and Regulatory Considerations
Patentability and Infringement
Patents must meet specific criteria to be considered patentable, such as being novel, non-obvious, and useful. The claims of US6858596B2 must be evaluated against these standards.
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Section 101 of the Patent Act: This section outlines what can be patented, excluding abstract ideas, laws of nature, and natural phenomena. The claims of this patent must be directed to a patent-eligible subject matter[5].
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Infringement Litigation: Patent holders must be vigilant about potential infringement. The case of Contour IP Holding LLC v. GoPro, Inc. illustrates the complexities of patent litigation and the importance of claim construction in determining infringement[5].
Economic and Practical Implications
Market Impact
The patent could have significant economic implications for the pharmaceutical industry, particularly in the market for anti-inflammatory medications.
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Competitive Advantage: Holding a patent for a unique formulation can provide a competitive advantage, allowing the patent holder to dominate a segment of the market[3].
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Research and Development: The patent could influence research directions, as other companies may need to develop alternative formulations to avoid infringement.
Stakeholder Engagement
Public Comments and Consultations
The process of patenting and enforcing patents often involves stakeholder engagement. For example, the Administrative Conference of the United States (ACUS) has engaged in studies and public comment periods to understand the needs and impacts of patent courts and proceedings[2].
Key Takeaways
- Unique Formulation: US6858596B2 describes a specific pharmaceutical formulation with detailed characteristics that distinguish it from other anti-inflammatory medications.
- Patent Scope: The claims define the scope of the invention, including particle size, suspension characteristics, and viscosity.
- Legal Considerations: The patent must comply with patentability criteria and be defended against potential infringement.
- Market Impact: The patent could provide a competitive advantage and influence research directions in the pharmaceutical industry.
FAQs
What is the main subject of United States Patent 6,858,596?
The main subject is a pharmaceutical formulation containing an anti-inflammatory androstane derivative.
What are the key characteristics of the formulation described in the patent?
The formulation is an aqueous suspension with particles of a specific size range (0.5-10 μm), a thixotropic suspending agent, and a viscosity that allows it to flow through a spray device and resist clearance by mucociliary forces.
How does the patent landscape affect this invention?
The patent landscape includes related patents and international applications, which can influence the scope and enforcement of the patent.
What legal standards must the claims of this patent meet?
The claims must meet the criteria of novelty, non-obviousness, and usefulness, and must not be directed to abstract ideas, laws of nature, or natural phenomena.
What are the potential economic implications of this patent?
The patent could provide a competitive advantage in the market for anti-inflammatory medications and influence research and development directions in the pharmaceutical industry.
Sources
- USPTO Search: https://www.uspto.gov/patents/search
- ACUS Study on Small Claims Patent Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
- Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- US6858596B2 - Formulation containing anti-inflammatory androstane derivative: https://patents.google.com/patent/US6858596B2/en
- CONTOUR IP HOLDING LLC v. GOPRO, INC.: https://cafc.uscourts.gov/opinions-orders/22-1654.OPINION.9-9-2024_2381170.pdf
