United States Patent 11,344,520: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,344,520, titled "Method of improving the release of non-steroidal anti-inflammatory drugs (NSAIDs) from a plaster or bandage," presents a significant innovation in the field of transdermal drug delivery. This patent, granted to improve the efficacy of NSAID delivery, is a crucial development for pharmaceutical and medical device companies. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Motivation
The patent addresses a common issue in transdermal drug delivery: the efficient release of NSAIDs from plasters or bandages. Traditional methods often suffer from inconsistent drug release, which can lead to reduced efficacy and patient discomfort. The invention aims to overcome these limitations by incorporating heparin or heparinoids into the hydrogel matrix of the plaster, enhancing the release of NSAIDs.
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific elements and methods that are protected. Here are the key aspects:
Hydrogel Matrix Composition
- The patent describes a hydrogel matrix composed of a polymeric hydrogel, an effective amount of a pharmaceutically acceptable NSAID (such as diclofenac), and heparin or a heparinoid[1].
- The matrix also includes at least one thickening agent, at least one wetting agent, and at least one cross-linking agent.
Wetting Agents
- The wetting agents are crucial for maintaining the moisture content of the hydrogel matrix. Common wetting agents include glycerol, propylene glycol, polyethylene glycol, 1,3-butanediol, and an aqueous solution of D-sorbitol[1].
- The concentration of these wetting agents is specified to be between 5% and 70% of the total weight of the composition, with optimal performance between 10% and 60%[1].
Surfactants
- The hydrogel matrix may also include a surfactant, such as sodium ethylenediamine tetraacetate, to enhance the stability and effectiveness of the NSAID release[1].
Claims of the Patent
The patent includes several claims that define the invention's scope:
Independent Claims
- Claim 1 describes the method of improving the release of NSAIDs from a plaster or bandage by incorporating heparin or a heparinoid into the hydrogel matrix[1].
- Subsequent claims detail specific components and their concentrations, such as the types of wetting agents and their optimal concentrations.
Dependent Claims
- These claims further specify the conditions and components of the hydrogel matrix, including the presence of thickening agents, cross-linking agents, and surfactants[1].
Patent Landscape
Related Patents and Technologies
The patent landscape in transdermal drug delivery is highly competitive, with numerous patents focusing on improving drug release mechanisms. For instance, other patents may address different types of drugs, delivery systems, or materials used in the hydrogel matrix.
Global Dossier and Patent Families
Using the Global Dossier service provided by the USPTO, one can identify related patent applications filed at participating IP Offices. This helps in understanding the global patent family and any prior art cited by multiple offices[4].
Patent Scope Metrics
Metrics such as independent claim length and independent claim count can be used to measure the scope of this patent. These metrics help in assessing the breadth and clarity of the patent claims, which are crucial for evaluating patent quality[3].
Impact on Pharmaceutical and Medical Device Industries
Enhanced Efficacy
The incorporation of heparin or heparinoids into the hydrogel matrix significantly enhances the release of NSAIDs, leading to improved pain management and reduced muscle hyperalgesia[1].
Market Competition
This patent could influence market competition by providing a more effective transdermal drug delivery system. Companies that adopt this technology may gain a competitive edge in terms of product efficacy and patient satisfaction.
Regulatory Considerations
The USPTO's proposed changes to terminal disclaimer practices could impact the prosecution and litigation strategies related to this patent. For example, the new rules may affect how patents tied by terminal disclaimers are challenged and enforced[5].
Practical Applications and Benefits
Improved Patient Outcomes
The enhanced release of NSAIDs from plasters or bandages can lead to better pain management and reduced side effects, improving overall patient outcomes.
Cost-Effectiveness
By improving the efficacy of NSAID delivery, this invention can reduce the need for multiple applications or higher doses, potentially lowering treatment costs.
Challenges and Future Directions
Formulation Challenges
Achieving the optimal concentration of wetting agents and other components can be challenging. If the concentration is too low, the wetting effect may be insufficient, and if too high, mixing the components can become difficult[1].
Regulatory Hurdles
Navigating the regulatory landscape, especially with proposed changes to terminal disclaimer practices, will be crucial for maintaining and enforcing patent rights.
Key Takeaways
- Improved NSAID Release: The patent introduces a method to enhance the release of NSAIDs from plasters or bandages using heparin or heparinoids.
- Hydrogel Matrix Composition: The hydrogel matrix includes specific components like wetting agents, thickening agents, cross-linking agents, and surfactants.
- Regulatory Impact: Proposed changes to terminal disclaimer practices may affect the patent's enforcement and litigation strategies.
- Market Competition: This invention could provide a competitive edge in the pharmaceutical and medical device markets.
- Patient Benefits: Enhanced drug release can lead to better pain management and reduced side effects.
FAQs
Q: What is the primary innovation of United States Patent 11,344,520?
A: The primary innovation is the method of improving the release of NSAIDs from plasters or bandages by incorporating heparin or heparinoids into the hydrogel matrix.
Q: What are the key components of the hydrogel matrix described in the patent?
A: The key components include a pharmaceutically acceptable NSAID, heparin or a heparinoid, thickening agents, wetting agents, cross-linking agents, and optionally a surfactant.
Q: Why are wetting agents crucial in the hydrogel matrix?
A: Wetting agents are essential for maintaining the moisture content of the hydrogel matrix, ensuring effective drug release. Optimal concentrations range between 5% and 70% of the total weight of the composition.
Q: How might the proposed changes to terminal disclaimer practices affect this patent?
A: The proposed changes could impact how patents tied by terminal disclaimers are challenged and enforced, potentially affecting the patent's prosecution and litigation strategies.
Q: What are the potential benefits of this invention for patients?
A: The enhanced release of NSAIDs can lead to better pain management, reduced muscle hyperalgesia, and potentially lower treatment costs due to improved efficacy.
Sources
- US Patent 11,344,520: "Method of improving the release of non-steroidal anti-inflammatory drugs (NSAIDs) from a plaster or bandage."
- USPTO Patent Claims Research Dataset: Detailed information on claims from US patents granted between 1976 and 2014.
- Patent Claims and Patent Scope: Metrics for measuring patent scope based on claim language.
- USPTO Public Search Facility: Resources for searching patent and trademark information.
- USPTO Proposed Changes to Terminal Disclaimer Practice: Notice of proposed rulemaking in the Federal Register.
