United States Patent 7,955,619: A Detailed Analysis of Scope and Claims
Overview of the Patent
United States Patent 7,955,619, titled "Abuse resistant drugs, method of use and method of making," is a patent that addresses the development of abuse-resistant oral pharmaceutical compositions. This patent is crucial in the field of pharmaceuticals, particularly in the context of drug abuse prevention.
Patent Details
- Publication Number: US7955619B2
- Authority: United States
- Prior Art Date: The patent was granted based on prior art dating back to the filing of the application[4].
Scope of the Patent
The patent focuses on the creation and use of abuse-resistant oral pharmaceutical compositions. Here are the key aspects of its scope:
Pharmaceutical Composition
The patent describes a pharmaceutical composition that includes a barrier layer and a diffusion layer. The barrier layer is composed of a first polymer, and the diffusion layer is composed of a second polymer. This design is intended to prevent the rapid release of the active pharmaceutical ingredient, thereby reducing the potential for abuse[4].
Layers and Polymers
- Barrier Layer: This layer is designed to prevent the immediate release of the drug, acting as a physical barrier.
- Diffusion Layer: This layer allows the controlled release of the drug over a specified period, reducing the likelihood of abuse through methods like crushing or dissolving the drug[4].
Physical Form
The patent covers various physical forms of the pharmaceutical composition, including pills, tablets, discs, and rods. These forms are characterized by special physical structures such as layered tablets, coated tablets, and tablets with specific break lines or identification marks[4].
Claims of the Patent
The claims of the patent are the most critical part, as they define the legal scope of the invention.
Independent Claims
The patent includes several independent claims that outline the core aspects of the invention:
- Claim 1 typically describes the overall composition, including the barrier and diffusion layers.
- Subsequent claims may detail specific aspects such as the types of polymers used, the structure of the layers, and the methods of manufacturing the composition[4].
Dependent Claims
Dependent claims further specify the invention by adding additional limitations to the independent claims. These could include specific polymer compositions, layer thicknesses, or manufacturing processes.
Patent Landscape Analysis
To understand the patent landscape surrounding US7955619B2, it is essential to analyze related patents and the broader intellectual property context.
Related Patents
- International Patents: Similar patents may exist in other jurisdictions, such as those found through the European Patent Office (EPO), Japan Patent Office (JPO), or the World Intellectual Property Organization (WIPO)[1].
- Competitor Patents: Other pharmaceutical companies may have similar patents or pending applications that could impact the market and legal landscape.
Patent Analytics
Using patent analytics tools, such as those described by Schwegman, can help in categorizing and analyzing the claims and scope concepts of this patent. This involves creating a Claim Coverage Matrix and using Claim Charts to visualize the coverage and identify gaps or opportunities[3].
Claim Coverage Matrix
A Claim Coverage Matrix would show which patents and claims are actively protecting the intellectual property related to abuse-resistant pharmaceutical compositions. This matrix helps in identifying where the claims of US7955619B2 fit within the broader patent landscape and where there might be gaps in coverage[3].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® can be used to review the patent coverage with technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, and they can highlight future design opportunities or gaps in current coverage[3].
Practical Applications and Impact
The practical applications of this patent are significant in the pharmaceutical industry:
Abuse Prevention
The primary application is in preventing the abuse of pharmaceutical drugs by making them more difficult to manipulate for rapid release.
Regulatory Compliance
Compliance with regulatory requirements for abuse-resistant formulations is crucial. This patent helps in meeting these standards by providing a specific method and composition for achieving abuse resistance.
Market Positioning
Companies holding this patent can leverage it to position their products as safer and more compliant with regulatory standards, potentially gaining a competitive edge in the market.
Challenges and Future Directions
While the patent provides a robust solution for abuse-resistant drugs, there are challenges and future directions to consider:
Technological Advancements
Continuous advancements in pharmaceutical technology may lead to new methods of creating abuse-resistant formulations. Staying updated with these developments is crucial for maintaining a strong patent position.
Regulatory Changes
Changes in regulatory requirements can impact the validity and applicability of the patent. Monitoring regulatory updates and adapting the patent strategy accordingly is essential.
Market Demand
The demand for abuse-resistant drugs is likely to increase, driven by public health concerns and regulatory pressures. Companies must be prepared to scale production and innovate further to meet this demand.
Key Takeaways
- Abuse-Resistant Formulations: The patent focuses on creating pharmaceutical compositions that are resistant to abuse.
- Layered Structure: The composition includes a barrier layer and a diffusion layer to control the release of the active ingredient.
- Patent Landscape: Analyzing related patents and using patent analytics tools is crucial for understanding the broader intellectual property context.
- Practical Applications: The patent has significant practical applications in preventing drug abuse and ensuring regulatory compliance.
- Future Directions: Staying updated with technological advancements, regulatory changes, and market demand is essential for maintaining a strong patent position.
FAQs
What is the main purpose of the US7955619B2 patent?
The main purpose of the US7955619B2 patent is to describe and protect the invention of abuse-resistant oral pharmaceutical compositions.
How does the patent achieve abuse resistance?
The patent achieves abuse resistance through a layered structure consisting of a barrier layer and a diffusion layer, which control the release of the active pharmaceutical ingredient.
What tools can be used to analyze the patent landscape?
Tools such as the USPTO's Patent Public Search, Global Dossier, and patent analytics software like ClaimScape® can be used to analyze the patent landscape and understand the scope and claims of the patent.
How can companies leverage this patent in the market?
Companies can leverage this patent by positioning their products as safer and more compliant with regulatory standards, potentially gaining a competitive edge in the market.
What are the potential future directions for this technology?
Future directions include staying updated with technological advancements, adapting to regulatory changes, and innovating to meet increasing market demand for abuse-resistant drugs.
Sources
- USPTO: "Search for patents - USPTO"
- Unified Patents Portal: "WO-2021137147-A1"
- Schwegman: "Patent Analytics | Intellectual Property Law"
- Google Patents: "US7955619B2 - Abuse resistant drugs, method of use and method of making"
- Unified Patents Portal: "WO-2017099974-A1"
