United States Patent 8,158,156: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,158,156, titled "Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist," is a significant patent in the pharmaceutical industry, particularly in the context of opioid formulations. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, assigned to Purdue Pharma LP, addresses a critical issue in pharmaceuticals: the abuse of opioid medications. The invention describes a multi-layer pharmaceutical composition designed to deter abuse by incorporating both an opioid agonist and an opioid antagonist.
Scope of the Patent
Purpose and Objectives
The primary objective of this patent is to create a pharmaceutical composition that provides effective pain relief while minimizing the potential for abuse. This is achieved through a multi-layer formulation that includes an opioid agonist for pain relief and an opioid antagonist to deter misuse[4].
Key Components
- Opioid Agonist: Substances like morphine, codeine, or buprenorphine that bind to opioid receptors to provide pain relief.
- Opioid Antagonist: Substances like naloxone that block opioid receptors, thereby reducing the euphoric effects associated with opioid abuse.
- Seal Coat and Sequestering Polymer: These components help in controlling the release of the active ingredients and preventing tampering or extraction of the opioid agonist[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims outline the specific composition and structure of the multi-layer pharmaceutical formulation, including:
- The presence of an opioid agonist and an opioid antagonist.
- The use of a seal coat to prevent immediate release of the opioid agonist.
- The inclusion of a sequestering polymer to control the release of the opioid antagonist[4].
Dependent Claims
Dependent claims further specify the details of the composition, such as the types of polymers used, the layering structure, and the methods of preparation. These claims provide a detailed description of how the invention can be implemented and varied while still falling within the scope of the patent[4].
Patent Landscape
Related Patents and Applications
The patent landscape for abuse-deterrent opioid formulations is extensive and includes several related patents and applications. For example:
- US-20030026838-A1: This patent application, also assigned to Purdue Pharma LP, describes a pharmaceutical formulation containing an opioid agonist, an opioid antagonist, and a gelling agent to deter abuse[5].
- International Patent Databases: Searching international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) reveals numerous other patents and applications focused on similar abuse-deterrent technologies[1].
Global Dossier and Common Citation Document (CCD)
Using tools like the Global Dossier and the Common Citation Document (CCD), one can access the file histories and citation data for related applications across multiple intellectual property offices. This helps in understanding the global patent family and prior art cited by different offices, which is crucial for navigating the patent landscape[1].
Search and Analysis Tools
USPTO Resources
The United States Patent and Trademark Office (USPTO) provides several resources for searching and analyzing patents, including:
- Patent Public Search: A modern interface for searching prior art and accessing patent documentation.
- Patent and Trademark Resource Centers (PTRCs): Local resources that offer training in patent search techniques.
- Patent Examination Data System (PEDS): Allows users to search, view, and download bibliographic data for patent applications[1].
International Databases
Access to international patent databases, such as esp@cenet by the EPO and PATENTSCOPE by WIPO, is essential for a comprehensive analysis of the global patent landscape. These databases provide full-text searches and machine translations for some documents, facilitating a broader understanding of related inventions[1].
Economic and Market Impact
Market Need
The need for abuse-deterrent opioid formulations is driven by the opioid epidemic, which has significant economic and social implications. Patents like US 8,158,156 play a crucial role in addressing this need by providing innovative solutions that balance efficacy with safety.
Competitive Landscape
The competitive landscape in this field is highly active, with multiple pharmaceutical companies investing in research and development of abuse-deterrent technologies. The economic impact of these patents can be substantial, influencing market share and revenue streams for companies involved in opioid formulations.
Legal and Regulatory Considerations
Patent Validity and Enforcement
The validity and enforcement of patents like US 8,158,156 are critical for protecting intellectual property rights. Legal status, including any challenges or litigations, must be closely monitored to ensure the patent remains enforceable.
Regulatory Approvals
Regulatory approvals from bodies like the FDA are essential for bringing these formulations to market. The patent landscape must be navigated carefully to ensure compliance with regulatory requirements and to avoid infringement on existing patents.
Conclusion
United States Patent 8,158,156 represents a significant innovation in the field of opioid formulations, addressing the critical issue of abuse deterrence. Understanding the scope, claims, and broader patent landscape is essential for any entity involved in pharmaceutical research, development, and commercialization.
Key Takeaways
- Innovative Formulation: The patent describes a multi-layer pharmaceutical composition with an opioid agonist and antagonist.
- Abuse Deterrence: The formulation is designed to deter abuse by controlling the release of active ingredients.
- Global Patent Landscape: The patent is part of a larger global landscape of abuse-deterrent technologies.
- Economic Impact: The patent has significant economic implications in the pharmaceutical market.
- Legal and Regulatory Considerations: Ensuring patent validity and regulatory compliance is crucial.
FAQs
Q: What is the primary purpose of US Patent 8,158,156?
A: The primary purpose is to create an abuse-deterrent opioid formulation that provides effective pain relief while minimizing the potential for misuse.
Q: What are the key components of the patented formulation?
A: The key components include an opioid agonist, an opioid antagonist, a seal coat, and a sequestering polymer.
Q: How can one search for related patents and applications?
A: Using resources like the USPTO's Patent Public Search, Global Dossier, and international patent databases such as esp@cenet and PATENTSCOPE.
Q: What is the significance of the Common Citation Document (CCD)?
A: The CCD provides a single point access to citation data relating to the patent applications of the IP5 Offices, helping to visualize search results from multiple offices.
Q: How does this patent impact the pharmaceutical market?
A: It influences market share and revenue streams by providing innovative solutions to address the opioid epidemic, thereby affecting the competitive landscape.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US8158156B2: https://patents.google.com/patent/US8158156B2/en
- Unified Patents Portal - US-20030026838-A1: https://portal.unifiedpatents.com/patents/patent/US-20030026838-A1
