United States Patent 11,020,387: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,020,387, titled "Abuse-resistant pharmaceutical composition for the treatment of opioid dependence," is a significant patent in the field of pharmaceuticals, particularly in the treatment of opioid dependence. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, granted to an undisclosed assignee, addresses the critical issue of opioid dependence by introducing an abuse-resistant pharmaceutical composition. This composition is designed to mitigate the risks associated with opioid abuse, a pressing concern in public health.
Scope of the Patent
Purpose and Application
The patent describes pharmaceutical compositions intended for the treatment of opioid dependence. These compositions are formulated to be abuse-resistant, which is a crucial aspect given the widespread misuse of opioid medications. The compositions are specifically designed for sublingual administration, which involves placing the medication under the tongue for rapid absorption[4].
Key Components
The patent outlines several key components of the pharmaceutical composition:
- Buprenorphine: A pharmacologically-effective amount of buprenorphine or its pharmaceutically-acceptable salt is a primary active ingredient. Buprenorphine is known for its use in treating opioid dependence.
- Naloxone: Particles of naloxone, an opioid antagonist, are included to deter abuse. Naloxone can counteract the effects of opioids if the composition is misused.
- Weak Acid or Buffer Forming Materials: These are used to maintain a specific pH range after oral administration, enhancing the stability and efficacy of the composition.
- Disintegrant: A disintegrating agent is included to accelerate the disintegration and dispersion of the composition[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention:
- Claim 1 describes a pharmaceutical composition in the form of a compressed tablet suitable for sublingual administration, comprising buprenorphine or its salt, and naloxone.
- Other claims detail variations of the composition, including different formulations and the presence of weak acid or buffer forming materials[5].
Dependent Claims
Dependent claims further specify the characteristics and components of the composition, such as the particle size of the active ingredients, the method of preparation, and the preferred salts of buprenorphine and naloxone.
Patent Landscape
Prior Art
The patent references several prior art documents, including international patent applications and U.S. patent applications, that disclose similar drug delivery systems. For example, WO 2008/068471 describes a formulation with opioid agonist and antagonist particles, which is similar to the concept presented in this patent[4].
Classification
The patent is classified under the International Patent Classification (IPC) system as A61P25/30, which pertains to drugs for disorders of the nervous system for treating abuse or dependence. This classification indicates the patent's relevance to neurological treatments and addiction therapies[4].
Global Patent Family
To understand the global reach of this invention, it is essential to look at the patent family. The Global Dossier service provided by the USPTO allows users to see related applications filed at participating IP Offices, including the IP5 Offices (USPTO, EPO, JPO, KIPO, and CNIPA). This helps in identifying the international scope and protection of the patent[1].
Search and Analysis Tools
USPTO Resources
For conducting a thorough search and analysis of this patent, several USPTO resources are available:
- Patent Public Search: This tool provides enhanced access to prior art and can be used to search for similar patents and published patent applications.
- Global Dossier: This service allows users to view the file histories of related applications from participating IP Offices.
- Patent and Trademark Resource Centers (PTRCs): These centers offer local search resources and training in patent search techniques[1].
International Databases
To see if similar ideas have been patented abroad, databases from other international intellectual property offices can be consulted, such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[1].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents and applications, which can be used to analyze the scope and trends of patent claims. This dataset can help in understanding the broader context of patent scope measurements and trends in the pharmaceutical sector[3].
Economic Impact
The development of abuse-resistant pharmaceutical compositions has significant economic implications. It can reduce healthcare costs associated with opioid abuse and treatment, as well as impact the pharmaceutical industry's research and development investments.
Key Takeaways
- Abuse-Resistant Composition: The patent introduces a novel abuse-resistant pharmaceutical composition for treating opioid dependence.
- Key Components: Buprenorphine, naloxone, weak acid or buffer forming materials, and a disintegrant are crucial components.
- Claims and Scope: The patent includes detailed claims defining the composition and its variations.
- Prior Art and Classification: The patent references prior art and is classified under A61P25/30.
- Global Patent Family: The Global Dossier service helps in understanding the international scope.
- Economic Implications: The invention has significant economic and research implications.
FAQs
What is the primary purpose of United States Patent 11,020,387?
The primary purpose is to introduce an abuse-resistant pharmaceutical composition for the treatment of opioid dependence.
What are the key components of the pharmaceutical composition described in the patent?
The key components include buprenorphine or its pharmaceutically-acceptable salt, naloxone, weak acid or buffer forming materials, and a disintegrant.
How does the composition deter abuse?
The inclusion of naloxone, an opioid antagonist, helps deter abuse by counteracting the effects of opioids if the composition is misused.
What is the classification of this patent under the International Patent Classification (IPC) system?
The patent is classified under A61P25/30, which pertains to drugs for disorders of the nervous system for treating abuse or dependence.
Where can one find more information about related international patent applications?
The Global Dossier service provided by the USPTO allows users to view related applications filed at participating IP Offices.
Sources
- USPTO: Search for patents - USPTO.
- PubChem: Abuse-resistant pharmaceutical composition for the treatment of opioid dependence.
- USPTO: Patent Claims Research Dataset.
- Google Patents: US11020387B2 - Abuse-resistant pharmaceutical composition for the treatment of opioid dependence.
- Drug Patent Watch: Patent 11,020,387 drug patent claims, expiration, and FTO.