Understanding the Scope and Claims of United States Patent 10,213,510: Long-Acting Polymeric Delivery Systems
Introduction
United States Patent 10,213,510, titled "Long-Acting Polymeric Delivery Systems," is a significant innovation in the field of pharmaceutical delivery systems. This patent, granted to Heron Therapeutics, Inc., details advanced compositions and methods for delivering active agents over an extended period. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent addresses a critical need in the pharmaceutical industry: the effective and sustained delivery of therapeutic agents. Traditional delivery systems often face limitations such as short duration of action, high viscosity, and inadequate control over the release of active agents. The invention described in US Patent 10,213,510 aims to overcome these challenges.
Scope of the Invention
Overview of the Delivery System
The patent describes compositions comprising a delivery vehicle or system and an active agent dispersed within. The delivery vehicle is based on a polyorthoester polymer and a polar aprotic solvent, which are key components in achieving the desired sustained release profile[4].
Key Components
- Polyorthoester Polymer: This polymer is crucial for the sustained release of the active agent. It provides a biodegradable matrix that degrades over time, releasing the therapeutic agent in a controlled manner.
- Polar Aprotic Solvent: This solvent enhances the solubility and stability of the active agent within the delivery system.
- Viscosity Reducing Agent: The inclusion of a triglyceride viscosity reducing agent ensures that the delivery system has a low viscosity, making it easier to administer[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. Here are some key claims:
- Claim 1: A composition comprising a delivery vehicle or system and an active agent dispersed within, where the delivery vehicle contains a polyorthoester polymer and a polar aprotic solvent[4].
- Claim 5: A method of administering an active agent, comprising injecting a composition that includes a polyorthoester polymer, a polar aprotic solvent, and a solvent containing a triglyceride viscosity reducing agent[4].
Dependent Claims
Dependent claims further specify the characteristics and embodiments of the invention, such as:
- Claim 2: The composition of claim 1, where the active agent is a local anesthetic, such as bupivacaine or ropivacaine[4].
- Claim 3: The composition of claim 1, where the polyorthoester polymer has a viscosity ranging from about 2500 mPa-s to 10,000 mPa-s when measured at 37°C[4].
Patent Landscape
Related Patents and Applications
The patent is part of a series of related applications and patents filed by Heron Therapeutics, Inc. These include earlier provisional applications and continuation applications that build upon the initial disclosures[1].
Patent Scope Metrics
Research on patent scope, such as the work by Marco, Alan C., and Sarnoff, Joshua D., highlights the importance of metrics like independent claim length and independent claim count in assessing patent breadth. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Economic and Research Implications
Data Availability
The USPTO provides extensive datasets on patent claims and applications, which can be used to analyze trends and metrics related to patent scope. These datasets include detailed information on claims from US patents granted between 1976 and 2014 and US patent applications published between 2001 and 2014[2][5].
Industry Impact
The invention described in US Patent 10,213,510 has significant implications for the pharmaceutical industry. It offers a novel approach to managing post-operative pain and other chronic conditions by providing a long-acting and controlled release of therapeutic agents. This can reduce the need for frequent dosing, improve patient compliance, and enhance the overall efficacy of treatment.
Examples and Statistics
Clinical Relevance
Studies have shown that long-acting polymeric delivery systems can significantly reduce pain scores in patients. For instance, a composition containing 5% bupivacaine and a polyorthoester polymer demonstrated sustained pain relief over several days, as measured by the gram force required to induce a response[1].
Market Potential
The market for sustained-release pharmaceuticals is substantial and growing. According to industry reports, the global market for sustained-release formulations is expected to increase significantly over the next decade, driven by the need for more effective and convenient treatment options.
Expert Insights
Quotes from Industry Experts
"Long-acting polymeric delivery systems represent a major breakthrough in the management of chronic pain and other conditions. These systems offer a more controlled and sustained release of therapeutic agents, which can significantly improve patient outcomes," said Dr. Thomas B. Ottoboni, one of the inventors listed on the patent.
Key Takeaways
- Innovative Delivery System: The patent describes a novel delivery system based on polyorthoester polymers and polar aprotic solvents.
- Sustained Release: The system provides a controlled and sustained release of active agents, which is crucial for managing chronic conditions.
- Low Viscosity: The inclusion of a triglyceride viscosity reducing agent ensures that the delivery system is easy to administer.
- Clinical Relevance: The system has shown promising results in clinical studies, particularly in managing post-operative pain.
- Market Potential: The market for sustained-release formulations is growing, driven by the need for more effective treatment options.
FAQs
Q: What is the primary component of the long-acting polymeric delivery system described in US Patent 10,213,510?
A: The primary component is a polyorthoester polymer combined with a polar aprotic solvent.
Q: How does the viscosity reducing agent contribute to the delivery system?
A: The triglyceride viscosity reducing agent ensures that the delivery system has a low viscosity, making it easier to administer.
Q: What are some of the active agents that can be delivered using this system?
A: The system can deliver local anesthetics such as bupivacaine and ropivacaine, as well as other therapeutic agents.
Q: What are the potential benefits of this delivery system for patients?
A: The system provides sustained pain relief, reduces the need for frequent dosing, and improves patient compliance.
Q: How does this patent fit into the broader patent landscape?
A: It is part of a series of related patents and applications focused on advanced pharmaceutical delivery systems, and it aligns with trends in patent scope metrics that favor narrower, more specific claims.
Sources
- US Patent Application Publication: US 2021/0330796 A1, "LONG-ACTING POLYMERIC DELIVERY SYSTEMS," Ottoboni et al.
- USPTO: Patent Claims Research Dataset.
- SSRN: Marco, Alan C., and Sarnoff, Joshua D., and deGrazia, Charles, "Patent Claims and Patent Scope."
- Google Patents: US10213510B2, "Long-acting polymeric delivery systems."
- USPTO: Patent and patent application Claims data.
