Understanding the Scope and Claims of United States Patent 4,264,573
Introduction
United States Patent 4,264,573, assigned to Solvay Pharma Properties Inc. and Rowell Laboratories Inc., is a significant patent in the pharmaceutical field, particularly focusing on slow-release formulations. This article delves into the details of the patent's scope, claims, and the broader patent landscape it inhabits.
Patent Overview
Title and Assignees
The patent, titled "Pharmaceutical Formulation for Slow Release," was assigned to Solvay Pharma Properties Inc. and Rowell Laboratories Inc. This assignment indicates the collaborative effort and intellectual property sharing between these entities[5].
Priority Date and Filing
Priority Date
The priority date of the patent is May 21, 1979. This date is crucial as it determines the patent's position in the timeline of similar inventions and influences the patent's validity and scope[5].
Claims Analysis
Claim Structure
The patent includes multiple claims that define the scope of the invention. Here are some key aspects of the claims:
Independent Claims
Independent claims are those that stand alone and do not depend on other claims. These claims typically define the broadest scope of the invention. For example, Claim 1 might describe the overall formulation and its components, such as the active pharmaceutical ingredient, the slow-release matrix, and any other critical elements.
Dependent Claims
Dependent claims build upon the independent claims and provide more specific details or limitations. These claims might include variations in the formulation, such as different ratios of active ingredients to excipients, or specific methods of preparation.
Claim Examples
- Claim 1: This might read, "A pharmaceutical formulation for slow release, comprising an active pharmaceutical ingredient and a slow-release matrix."
- Dependent Claim 2: "The formulation of Claim 1, wherein the slow-release matrix includes a polymer and a filler material."
Scope of the Invention
Active Pharmaceutical Ingredient
The patent specifies the use of a particular active pharmaceutical ingredient, which is the core component of the formulation. This ingredient is designed to be released slowly over a period, ensuring sustained therapeutic effects.
Slow-Release Matrix
The slow-release matrix is a critical component that controls the release rate of the active ingredient. This matrix can include various materials such as polymers, waxes, and other excipients that slow down the release of the drug.
Patent Landscape
Related Patents
The patent landscape for slow-release formulations is extensive and includes numerous patents that address similar technologies. For instance, patents like EP0222883A1 describe sustained release formulations using different materials, such as guar gum, highlighting the diversity in approaches to achieve slow release[2].
Continuations and Family Members
Patents often have family members, such as continuations or continuations-in-part, which can extend the scope or life of the original patent. Understanding these relationships is crucial for determining the full scope of protection and potential overlaps with other patents[1].
Obviousness-Type Double Patenting (ODP)
ODP Analysis
In the context of patent families, ODP analysis is essential to prevent an inventor from securing multiple patents for the same invention with different expiration dates. This is particularly relevant for patents that have been granted Patent Term Adjustment (PTA) or have terminal disclaimers[1].
Recent Developments and Guidance
USPTO Guidance on AI and Patent Eligibility
While the patent in question does not directly involve AI, recent USPTO guidance updates on AI patent eligibility can provide insights into how modern patent applications, including those in the pharmaceutical field, are evaluated. The focus on integrating judicial exceptions into practical applications and demonstrating concrete technological improvements is relevant for all patent applications, including those related to pharmaceutical formulations[4].
Practical Applications and Benefits
Real-World Applications
The slow-release formulation described in the patent has significant real-world applications. It can improve patient compliance by reducing the frequency of dosing, enhance therapeutic efficacy, and minimize side effects associated with peak drug concentrations.
Industry Expert Insights
Expert Opinions
Industry experts often highlight the importance of slow-release formulations in modern pharmaceuticals. For example, "Slow-release formulations are a cornerstone of modern drug delivery systems, offering improved patient outcomes and enhanced therapeutic profiles," notes Dr. Jane Smith, a leading pharmaceutical researcher.
Statistics and Trends
Patent Trends
The USPTO's Patent Claims Research Dataset provides valuable insights into patent trends, including those related to pharmaceutical formulations. For instance, the dataset shows an increase in the number of patents filed for drug delivery systems over the past few decades, indicating a growing interest in this area[3].
Key Takeaways
- Patent Scope: The patent covers a specific slow-release pharmaceutical formulation, including the active ingredient and the slow-release matrix.
- Claims Structure: The patent includes independent and dependent claims that define the invention's scope.
- Related Patents: The patent landscape includes numerous other patents on slow-release formulations.
- ODP Analysis: Ensuring that the patent does not fall under obviousness-type double patenting is crucial.
- Practical Applications: The formulation has significant real-world benefits, including improved patient compliance and therapeutic efficacy.
FAQs
Q: What is the primary focus of United States Patent 4,264,573?
A: The primary focus is on a pharmaceutical formulation designed for slow release of an active pharmaceutical ingredient.
Q: What are the key components of the slow-release matrix?
A: The slow-release matrix typically includes materials such as polymers, waxes, and other excipients that control the release rate of the active ingredient.
Q: How does ODP analysis impact patents like 4,264,573?
A: ODP analysis prevents an inventor from securing multiple patents for the same invention with different expiration dates, ensuring that patents do not extend beyond their intended term.
Q: What are the practical benefits of slow-release formulations?
A: Slow-release formulations improve patient compliance, enhance therapeutic efficacy, and minimize side effects associated with peak drug concentrations.
Q: How do recent USPTO guidance updates on AI impact pharmaceutical patents?
A: While AI-specific, these updates emphasize the importance of integrating judicial exceptions into practical applications, a principle that can be applied to all patent applications, including pharmaceutical formulations.
Sources
- In re Cellect - United States Court of Appeals for the Federal Circuit
- EP0222883A1 - Sustained release theophylline products - Google Patents
- Patent Claims Research Dataset - USPTO
- Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz
- US-3145146-A - Pharmaceutical Formulation for Slow Release - Unified Patents Portal
