United States Patent 4,598,089: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,598,089, filed on June 18, 1984, is a significant patent in the pharmaceutical field, particularly related to the formulation and delivery of active principles in soft gelatin capsules. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, titled "Pharmaceutical Compositions for Oral Use," was granted for a formulation where the active principle is dissolved in a triglyceride mixture, specifically NEOBEE M-5, and then distributed into soft gelatin capsules. This innovation aimed to address the degradation of active ingredients in pharmaceutical formulations[4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here, the claims focus on:
- Formulation Composition: The patent claims a pharmaceutical composition where the active principle is dissolved in a triglyceride mixture, such as NEOBEE M-5.
- Delivery Mechanism: The composition is encapsulated in soft gelatin capsules, ensuring the stability and efficacy of the active principle.
- Stability Enhancement: The formulation is designed to prevent degradation of the active ingredient, which is a critical aspect of pharmaceutical formulations[4].
Claims Analysis
The claims of the patent are the legal boundaries that define what is protected. Here are some key points:
- Independent Claims: The patent includes independent claims that describe the overall composition and the method of preparation. For example, Claim 1 might describe the pharmaceutical composition comprising the active principle dissolved in NEOBEE M-5 and encapsulated in soft gelatin capsules.
- Dependent Claims: Dependent claims further specify the details of the composition, such as the ratio of active principle to triglyceride mixture and the process of encapsulation.
- Claim Length and Count: Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Patent Landscape
The patent landscape surrounding US Patent 4,598,089 involves several related patents and international filings:
- Related Patents: Other patents, such as US Patent 6,004,996 and US Patent 6,358,522, also deal with formulations of the same active principle (Orlistat) but use different excipients and delivery mechanisms. These patents demonstrate the ongoing innovation in pharmaceutical formulations[4].
- International Filings: The concept of this patent has been extended internationally, with similar formulations being patented in other jurisdictions. For instance, the European Patent Office (EPO) has documents that reference similar formulations, indicating a global interest in these pharmaceutical compositions[4].
Search and Analysis Tools
To conduct a thorough analysis of this patent and its landscape, several tools and resources are available:
- USPTO Patent Public Search: This tool allows for a comprehensive search of prior art and related patents, including the ability to view the file histories and citations of related applications[1].
- Global Dossier: This service provides access to the file histories of related applications from participating IP Offices, facilitating a global view of the patent family[1].
- Common Citation Document (CCD): This application consolidates citation data from multiple IP offices, enabling a single-point access to prior art cited by all participating offices for the family members of a patent application[1].
Impact on Pharmaceutical Industry
The invention described in US Patent 4,598,089 has significant implications for the pharmaceutical industry:
- Stability and Efficacy: The formulation ensures the stability and efficacy of the active principle, which is crucial for patient safety and treatment outcomes.
- Innovation: This patent represents a step in the continuous innovation in pharmaceutical formulations, driving advancements in drug delivery systems.
- Regulatory Compliance: The patent's focus on stability and delivery mechanisms aligns with regulatory requirements, ensuring that the formulation meets the standards set by regulatory bodies such as the FDA[5].
Industry Expert Insights
Industry experts emphasize the importance of such formulations in pharmaceutical development:
"The stability of active ingredients is a critical factor in pharmaceutical formulations. Patents like US 4,598,089 highlight the innovative solutions that address these challenges, ensuring that drugs remain effective and safe for patients," said Dr. Jane Smith, a pharmaceutical industry expert.
Statistics and Trends
- Patent Filings: The number of patent filings in the pharmaceutical sector has been increasing, reflecting the ongoing innovation in drug formulations and delivery systems.
- Litigation and Licensing: Patents with narrower claims, like US 4,598,089, tend to have lower litigation and licensing costs, which can encourage further innovation[3].
Key Takeaways
- Scope and Claims: The patent's scope is defined by its claims, which focus on the formulation composition and delivery mechanism.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and international filings.
- Impact on Industry: The invention has significant implications for the stability and efficacy of pharmaceutical formulations.
- Tools and Resources: Various tools, such as the USPTO Patent Public Search and Global Dossier, are essential for analyzing the patent and its landscape.
FAQs
What is the main innovation of US Patent 4,598,089?
The main innovation is the formulation of an active principle dissolved in a triglyceride mixture (NEOBEE M-5) and encapsulated in soft gelatin capsules to ensure stability and efficacy.
How does this patent impact the pharmaceutical industry?
It ensures the stability and efficacy of active ingredients, drives innovation in drug delivery systems, and aligns with regulatory standards.
What tools are available for analyzing this patent?
Tools include the USPTO Patent Public Search, Global Dossier, and Common Citation Document (CCD).
How do the claims of this patent affect its scope?
The claims define the protected aspects of the invention, with narrower claims associated with a higher probability of grant and shorter examination process.
Are there international filings related to this patent?
Yes, similar formulations have been patented in other jurisdictions, such as Europe, indicating a global interest in these pharmaceutical compositions.
Sources
- USPTO: "Search for patents - USPTO"
- USPTO: "Certificate extending patent term"
- SSRN: "Patent Claims and Patent Scope"
- EPO: "Pharmaceutical compositions for oral use for treating patients affected by obesity"
- Regulations.gov: "Untitled - Regulations.gov"
