United States Patent 8,329,216: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,329,216, titled "Oxymorphone controlled release formulations," is a significant patent in the pharmaceutical industry, particularly in the field of pain management. This patent, held by Endo Pharmaceuticals, has been the subject of various legal and technical analyses. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, issued on December 11, 2012, pertains to a method of relieving pain by administering a controlled release pharmaceutical tablet containing oxymorphone. Oxymorphone is an opioid analgesic used for the treatment of moderate to severe pain[4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are some key points:
- Controlled Release Formulation: The patent describes a controlled release formulation of oxymorphone, designed to provide a steady and prolonged release of the active ingredient, thereby managing pain effectively over an extended period.
- Pharmaceutical Composition: The formulation includes various excipients such as xanthan gum, hydroxypropyl cellulose, and other polymers that help in achieving the controlled release profile[4].
Claims of the Patent
The patent includes several claims that define the invention's scope:
- Independent Claims: Claims 72 and 77 are independent claims that stand alone and do not depend on other claims. These claims describe the overall composition and method of administering the controlled release formulation[5].
- Dependent Claims: Claims 73-76 and 81 depend on claim 72. These claims specify various aspects of the formulation, such as the types of excipients used, the method of preparation, and the release profile characteristics[5].
Key Components and Excipients
The patent details several key components and excipients that are crucial to the controlled release formulation:
- Active Ingredient: Oxymorphone hydrochloride is the active ingredient, which is released in a controlled manner.
- Matrix Material: The formulation includes matrix materials like xanthan gum, hydroxypropyl cellulose, and other polymers that help in controlling the release of oxymorphone[4].
- Pharmaceutical Excipients: Other excipients such as cellulose ether, acrylic resin, and granular materials are also mentioned, which contribute to the stability and efficacy of the formulation[4].
Patent Landscape
The patent landscape surrounding US 8,329,216 is complex and has been subject to various legal challenges:
- Inter Partes Review (IPR): Amneal Pharmaceuticals challenged the validity of several claims of this patent through an IPR trial. However, the Patent Trial and Appeal Board (PTAB) upheld the validity of the challenged claims, affirming the patent's strength[2][5].
- Global Patent System: The patent is part of a larger global patent family, with related applications filed in various international intellectual property offices. Tools like the Global Dossier and Common Citation Document (CCD) can be used to track and analyze the global patent landscape for this invention[1].
Economic and Technical Impact
The economic and technical impact of this patent is significant:
- Market Dominance: By securing this patent, Endo Pharmaceuticals has maintained a strong market position in the pain management sector, particularly for controlled release formulations of oxymorphone.
- Research and Development: The detailed information provided in the patent claims and description has contributed to the advancement of pharmaceutical research, especially in the development of controlled release formulations[3].
Legal and Regulatory Aspects
The legal and regulatory aspects surrounding this patent are crucial:
- Patent Validity: The patent has survived legal challenges, such as the IPR trial initiated by Amneal Pharmaceuticals, which underscores its validity and the robustness of its claims[2][5].
- Regulatory Compliance: The formulation must comply with regulatory standards set by bodies like the FDA, ensuring safety and efficacy for patients.
Public Access and Search Tools
For those interested in further research or analysis, several tools and resources are available:
- Patent Public Search: The USPTO's Patent Public Search tool provides enhanced access to prior art and patent documentation, including this patent[1].
- Global Dossier: This service allows users to access the file histories of related applications from participating IP offices, providing a comprehensive view of the patent family[1].
Conclusion
United States Patent 8,329,216 is a critical patent in the pharmaceutical industry, particularly for pain management. Its scope and claims define a controlled release formulation of oxymorphone, which has significant economic and technical implications. The patent's survival through legal challenges and its integration into the global patent system highlight its importance.
Key Takeaways
- Controlled Release Formulation: The patent describes a method for relieving pain using a controlled release formulation of oxymorphone.
- Key Components: The formulation includes oxymorphone hydrochloride and various excipients like xanthan gum and hydroxypropyl cellulose.
- Legal Challenges: The patent has survived an IPR trial, affirming its validity.
- Global Patent Landscape: The patent is part of a global patent family, with related applications in various IP offices.
- Economic Impact: The patent has helped Endo Pharmaceuticals maintain a strong market position in pain management.
FAQs
Q: What is the main subject of United States Patent 8,329,216?
A: The main subject is a controlled release formulation of oxymorphone for pain management.
Q: What are the key excipients mentioned in the patent?
A: Key excipients include xanthan gum, hydroxypropyl cellulose, and other polymers.
Q: Has the patent faced any legal challenges?
A: Yes, it survived an IPR trial initiated by Amneal Pharmaceuticals.
Q: How can one access detailed information about this patent?
A: The USPTO's Patent Public Search tool and the Global Dossier service provide comprehensive access to the patent and its related applications.
Q: What is the significance of this patent in the pharmaceutical industry?
A: It has helped Endo Pharmaceuticals maintain a strong market position in pain management and contributed to the advancement of controlled release formulations.
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- Harness IP - Endo Pharma Patent Survives IPR Trial. Retrieved from https://www.harnessip.com/blog/2015/07/23/endo-pharma-patent-survives-ipr-trial/
- USPTO - Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US8329216B2. Retrieved from https://patents.google.com/patent/US8329216B2/en
- Casetext - Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals, Inc. Retrieved from https://casetext.com/admin-law/amneal-pharmaceuticals-llc-v-endo-pharmaceuticals-inc-2
