United States Patent 7,682,634: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,682,634, titled "Pharmaceutical Compositions," is a significant patent in the field of pharmaceuticals, particularly focusing on compositions that include both an agonist and an antagonist. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, issued on March 23, 2010, pertains to pharmaceutical compositions designed to prevent the misuse of opioid medications. The invention involves a multi-layer composition where an opioid agonist and an opioid antagonist are separated by a seal coat, ensuring that the antagonist is not released during normal use but can be released if the composition is tampered with[4].
Scope of the Invention
The scope of the invention is centered around the creation of a pharmaceutical composition that includes:
- An opioid agonist
- An opioid antagonist
- A seal coat that physically separates the agonist and antagonist
- A sequestering polymer to control the release of the antagonist
This composition is designed to deter abuse by ensuring that the antagonist is released only if the composition is manipulated or tampered with, thereby preventing the intended narcotic effect of the agonist[4].
Claims of the Patent
The patent includes several key claims that define the scope of the invention:
Independent Claims
- Claim 1 describes a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, where the seal coat forms a layer physically separating the antagonist from the agonist.
- Claim 2 outlines a multi-layer pharmaceutical composition where the agonist and antagonist are not in contact with each other in the intact form of the composition[4].
Dependent Claims
- These claims further specify the components and their functions, such as the use of a controlled-release composition, the inclusion of a blocking agent to prevent the release of the antagonist in the gastrointestinal tract, and the measurement of in vitro and in vivo release of the active agents[4].
Patent Landscape
Prior Art
The patent references several prior art patents that deal with similar concepts but lack the specific innovations introduced by this patent. For example:
- U.S. Patents 8,673,355 and 7,749,542 discuss the combination of an opioid agonist and antagonist but do not address the use of seal coatings or the optimization of antagonist absorption[2].
- U.S. Patent 8,475,832 mentions the use of buffers to limit the absorption of naloxone but does not cover the stabilization of the antagonist during storage[2].
International Context
The patent landscape extends beyond the U.S., with similar innovations being explored globally. For instance, the European Patent Office (EPO) and other international intellectual property offices provide databases and tools for searching prior art and related patents, such as the esp@cenet network and the PATENTSCOPE ® Search Service by WIPO[1].
Related Patents
Other patents in the same domain include EP3177270A1, which describes chemically stable and oromucosally absorbable gel compositions of a pharmaceutical active agent in a multi-chambered delivery system. While this patent deals with a different delivery system, it highlights the ongoing innovation in pharmaceutical compositions aimed at preventing drug abuse[2].
Search and Analysis Tools
For conducting a thorough search and analysis of patents related to this invention, several tools are available:
- The USPTO's Patent Public Search tool provides enhanced access to prior art and is a powerful resource for searching U.S. patents.
- The Global Dossier service allows users to view the patent family for a specific application, including related applications from participating IP offices.
- The Common Citation Document (CCD) application consolidates citation data from multiple offices, facilitating a comprehensive view of prior art[1].
Economic and Research Implications
The Patent Claims Research Dataset by the USPTO provides detailed information on claims from U.S. patents and applications, which can be used to analyze trends and scope measurements in patent claims. This dataset can help researchers and economists understand the impact of patents like 7,682,634 on the pharmaceutical industry and intellectual property landscape[3].
Practical Applications
The practical applications of this patent are significant in the context of opioid abuse prevention. By ensuring that the antagonist is released only upon tampering, the composition deters patients from diverting the product for illicit use. This innovation aligns with broader efforts to combat opioid abuse and misuse.
Legal Status and Infringement
The patent has expired due to fee-related issues, but its impact on the pharmaceutical industry remains. Infringement cases related to this patent, such as those reported in the Court Report by Patent Docs, highlight the legal significance and the need for careful analysis of patent claims and scope[5].
Key Takeaways
- Innovation in Pharmaceutical Compositions: The patent introduces a novel multi-layer composition to prevent opioid abuse.
- Scope and Claims: The patent's claims are specific to the separation and controlled release of agonist and antagonist.
- Prior Art and Landscape: The patent builds upon but differs significantly from prior art in the field.
- Global Context: Similar innovations are being explored internationally.
- Economic and Research Implications: The patent contributes to the broader understanding of patent claims and their economic impact.
FAQs
Q: What is the main innovation of United States Patent 7,682,634?
A: The main innovation is a pharmaceutical composition that includes an opioid agonist and an opioid antagonist separated by a seal coat, designed to prevent misuse of opioid medications.
Q: How does the seal coat function in the composition?
A: The seal coat physically separates the agonist from the antagonist, ensuring that the antagonist is not released during normal use but can be released if the composition is tampered with.
Q: What are the practical applications of this patent?
A: The practical applications include deterring patients from diverting opioid medications for illicit use, thereby contributing to efforts to combat opioid abuse.
Q: Is the patent still in force?
A: No, the patent has expired due to fee-related issues.
Q: How can one conduct a thorough search for related patents?
A: One can use tools like the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) application to conduct a thorough search for related patents.
