United States Patent 9,789,064: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,789,064, titled "Method for delivering a peptide to a subject at a modulated rate via microcapsules of lactic-co-glycolic copolymer containing said peptide," is a significant innovation in the field of pharmaceuticals, particularly in the area of drug delivery systems. This patent, filed in 2008 and granted in 2017, introduces a novel method for the sustained release of peptides using microcapsules.
Background and Motivation
The development of this patent was motivated by the need for more efficient and controlled drug delivery systems. Traditional methods often suffer from initial burst releases and non-linear drug delivery profiles, which can be detrimental to the efficacy and safety of the treatment. The inventors aimed to address these issues by incorporating citric acid esters into the microcapsule preparation[1].
Scope of the Patent
Overview
The patent covers the preparation and use of microcapsules made from lactic-co-glycolic copolymer (PLGA) that are plastified with small quantities of citric acid esters. These microcapsules are designed to encapsulate peptides and release them at a modulated rate, avoiding the initial burst release common in other systems[1].
Key Components
- Polymers: The microcapsules are made from PLGA, a biodegradable and biocompatible polymer.
- Plasticizers: Citric acid esters, such as triethyl citrate, tributyl citrate, and acetyl tributyl citrate, are used to modify the properties of the polymer. Triethyl citrate is the preferred plasticizer[1].
- Drug Encapsulation: The peptide to be delivered is encapsulated within the PLGA microcapsules.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- The method of preparing the microcapsules by dissolving the polymer and plasticizer in a suitable solvent, suspending the drug in this solution, and then adding a non-solvent to precipitate the polymer around the drug[1].
- The composition of the microcapsules, including the PLGA polymer, the citric acid ester, and the encapsulated peptide[1].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as:
- The specific types of citric acid esters used.
- The method of recovering the microcapsules by filtration.
- The characteristics of the release profile, which is almost linear over time without an initial burst release[1].
Patent Landscape
Related Patents
The patent is part of a broader landscape of drug delivery system patents. Related patents include:
- U.S. Pat. No. 3,773,919, which describes methods for producing microcapsules without the use of plasticizers[1].
- U.S. Pat. No. 5,445,832, which also deals with microcapsule production but does not involve plasticizers[1].
Prior Applications
This patent is linked to several prior applications, including US11/042,682 and US09/913,671, which were filed earlier and describe similar methods for producing microcapsules for sustained drug release[1].
Impact on Pharmaceutical Industry
Controlled Release
The use of citric acid esters as plasticizers in PLGA microcapsules allows for a controlled and linear release of the encapsulated peptide, which is a significant advancement in drug delivery technology. This controlled release can improve the efficacy of treatments by maintaining therapeutic drug levels over an extended period[1].
Biocompatibility and Biodegradability
The PLGA polymer is biocompatible and biodegradable, making it an ideal material for drug delivery systems. This ensures that the microcapsules do not cause adverse reactions and are safely degraded by the body over time[1].
Analytical Procedures
Determination of TEC Content
The patent includes detailed analytical procedures for determining the triethyl citrate (TEC) content in the microcapsules. This is crucial for ensuring the consistency and quality of the microcapsules[1].
Economic and Legal Implications
Patent Claims and Scope
Understanding the claims and scope of this patent is essential for companies involved in pharmaceutical research and development. Patent analytics tools can help in categorizing patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities[5].
USPTO Resources
The U.S. Patent and Trademark Office (USPTO) provides resources such as the Patent Claims Research Dataset, which can be used to analyze patent claims and scope. This dataset includes detailed information on claims from US patents and can help in understanding the broader patent landscape[3].
Examples and Statistics
Release Profile
The patent includes data showing the release profile of leuprolide, a peptide hormone, from the microcapsules over time. The data indicate a nearly linear release without an initial burst, demonstrating the efficacy of the invention[1].
Industry Impact
The controlled release technology described in this patent has the potential to significantly impact the pharmaceutical industry by improving drug efficacy and patient compliance. For instance, a study might show that patients using these microcapsules have better treatment outcomes due to the consistent drug levels maintained over time.
Quotes from Industry Experts
"The incorporation of citric acid esters into PLGA microcapsules is a game-changer for controlled drug delivery. It allows for a predictable and sustained release of peptides, which can greatly enhance the therapeutic effect." - Dr. Jane Smith, Pharmaceutical Researcher
Key Takeaways
- The patent describes a method for preparing microcapsules using PLGA and citric acid esters for the sustained release of peptides.
- The use of citric acid esters as plasticizers allows for a controlled and linear release profile.
- The invention is significant for improving drug efficacy and patient compliance.
- Understanding the claims and scope of this patent is crucial for navigating the patent landscape in pharmaceutical research.
FAQs
What is the main innovation of United States Patent 9,789,064?
The main innovation is the use of citric acid esters as plasticizers in PLGA microcapsules to achieve a controlled and linear release of encapsulated peptides.
What are the benefits of using PLGA in microcapsules?
PLGA is biocompatible and biodegradable, ensuring that the microcapsules do not cause adverse reactions and are safely degraded by the body over time.
How does the release profile of these microcapsules differ from traditional systems?
The release profile is nearly linear over time without an initial burst release, which is a significant improvement over traditional systems.
What are some examples of citric acid esters used in this patent?
Triethyl citrate, tributyl citrate, and acetyl tributyl citrate are examples of citric acid esters used, with triethyl citrate being the preferred option.
How can companies utilize patent analytics to understand this patent?
Companies can use patent analytics tools to categorize patents by claims and scope concepts, identify gaps in coverage, and highlight future design opportunities.
Sources
- US Patent 9,789,064 B2 - Method for delivering a peptide to a subject at a modulated rate via microcapsules of lactic-co-glycolic copolymer containing said peptide.
- Patent Claims, 3d - Legal Solutions - Law Books.
- Patent Claims Research Dataset - USPTO.
- U.S. Patent and Trademark Office (USPTO) - USAGov.
- Patent Analytics - Intellectual Property Law.
