United States Patent 8,846,104: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,846,104, titled "Pharmaceutical Compositions for the Deterrence and/or Prevention of Abuse," was granted on September 30, 2014. This patent is assigned to Alpharma Pharmaceuticals LLC and involves innovative formulations designed to deter or prevent the abuse of pharmaceuticals, particularly opioids.
Inventors and Assignees
The inventors listed on the patent are Frank Matthews, Edison, NJ; N. Garth Boehm, Westfield, NJ; Lijuan Tang, Flemington, NJ; and Alfred Liang, Edison, NJ. The assignee is Alpharma Pharmaceuticals LLC, based in Bridgewater, NJ[1].
Background and Motivation
The patent addresses a critical issue in the pharmaceutical industry: the abuse of opioid medications. The inventors aimed to develop formulations that would prevent or deter such abuse, thereby reducing the risk of overdose and other adverse effects associated with misuse.
Summary of the Invention
The patent describes pharmaceutical compositions that include an antagonist, an agonist, a seal coat, and a sequestering agent. These components work together to prevent the rapid release of the active opioid ingredient, thereby deterring abuse through methods such as crushing or dissolving the medication[1].
Key Components of the Invention
Antagonist and Agonist
The composition includes an opioid agonist, which provides the therapeutic effect, and an opioid antagonist, which counteracts the agonist's effects if the medication is tampered with. This balance ensures that the medication remains effective only when taken as prescribed[1].
Seal Coat
A seal coat is applied to the formulation to prevent the rapid release of the active ingredients. This coat can be made from various materials and is designed to break down slowly, maintaining the controlled release of the medication[1].
Sequestering Agent
The sequestering agent is included to further prevent the abuse of the medication by binding to the antagonist, thereby preventing its premature release. This ensures that the antagonist is only activated if the medication is tampered with[1].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention. These claims cover various aspects of the composition, including:
- The combination of an opioid agonist and an opioid antagonist.
- The use of a seal coat to control the release of the active ingredients.
- The inclusion of a sequestering agent to bind the antagonist.
- Specific methods of manufacturing the composition[1].
Dependent and Independent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific details or limitations. For example, Claim 1 is an independent claim that describes the basic composition, while subsequent claims add additional details such as the type of seal coat or the method of application[1].
Patent Landscape and Prior Art
The patent landscape for abuse-deterrent pharmaceutical formulations is extensive and includes numerous prior art references. The patent cites several earlier patents related to controlled-release formulations and abuse-deterrent technologies, such as those by Theeuwes et al. and Portoghese et al.[1].
Competing Patents and Technologies
Other patents, such as US-20030026838-A1 assigned to Purdue Pharma LP, also address abuse-deterrent formulations using opioid agonists, antagonists, and gelling agents. These competing patents highlight the ongoing innovation in this field and the various approaches being taken to address the issue of pharmaceutical abuse[2].
Impact on the Pharmaceutical Industry
The invention described in US 8,846,104 has significant implications for the pharmaceutical industry. By providing formulations that deter abuse, pharmaceutical companies can reduce the risk associated with opioid medications and comply with regulatory requirements aimed at mitigating the opioid crisis.
Regulatory and Legal Considerations
The development and approval of such formulations are subject to stringent regulatory oversight. The FDA has guidelines for the development of abuse-deterrent formulations, and patents like US 8,846,104 must align with these regulations to ensure safety and efficacy[1].
Future Directions and Innovations
The field of abuse-deterrent pharmaceuticals is continuously evolving. Future innovations may include new materials for seal coats, advanced sequestering agents, and novel methods of manufacturing. The patent landscape will likely continue to expand as more companies invest in research and development to address the ongoing issue of pharmaceutical abuse.
Economic and Social Implications
The economic and social implications of these formulations are substantial. By reducing the potential for abuse, these medications can help decrease healthcare costs associated with overdose and treatment, as well as reduce the social impact of opioid addiction.
Conclusion
United States Patent 8,846,104 represents a significant advancement in the development of abuse-deterrent pharmaceutical formulations. The combination of an antagonist, agonist, seal coat, and sequestering agent provides a robust mechanism to prevent the misuse of opioid medications. Understanding the scope, claims, and patent landscape of this invention is crucial for both industry professionals and researchers looking to contribute to this critical area of pharmaceutical development.
Key Takeaways
- The patent involves a pharmaceutical composition designed to deter the abuse of opioids.
- Key components include an opioid agonist, an opioid antagonist, a seal coat, and a sequestering agent.
- The patent includes multiple claims defining the scope of the invention.
- The patent landscape is extensive, with numerous prior art references and competing patents.
- The invention has significant regulatory, economic, and social implications.
Frequently Asked Questions (FAQs)
Q1: What is the primary purpose of the pharmaceutical composition described in US 8,846,104?
A1: The primary purpose is to deter or prevent the abuse of opioid medications by controlling the release of the active ingredients.
Q2: Who are the inventors and assignees of the patent?
A2: The inventors are Frank Matthews, N. Garth Boehm, Lijuan Tang, and Alfred Liang. The assignee is Alpharma Pharmaceuticals LLC.
Q3: How does the seal coat function in the composition?
A3: The seal coat prevents the rapid release of the active ingredients, ensuring controlled release of the medication.
Q4: What is the role of the sequestering agent in the composition?
A4: The sequestering agent binds to the antagonist, preventing its premature release and ensuring it is only activated if the medication is tampered with.
Q5: How does this patent impact the pharmaceutical industry?
A5: It provides a new approach to developing abuse-deterrent formulations, reducing the risk associated with opioid medications and complying with regulatory requirements.
Sources Cited
- United States Patent and Trademark Office, "Pharmaceutical Compositions for the Deterrence and/or Prevention of Abuse," US 8,846,104 B2, September 30, 2014.
- Unified Patents Portal, "Pharmaceutical Formulation Containing Opioid Agonist, Opioid Antagonist and Gelling Agent," US-20030026838-A1.
- USPTO, "Patent Claims Research Dataset," August 28, 2017.
- USPTO, "Search for patents," October 18, 2018.
- Unified Patents Portal, "Composition for Treating Pain," US-5998434-A.
