United States Patent 9,763,933: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,763,933, hereafter referred to as the "Mannion ’933 patent," is a significant patent in the pharmaceutical industry, particularly in the realm of extended-release pain medications. This patent is associated with Purdue Pharma's OxyContin® (oxycodone hydrochloride), a well-known extended-release opioid formulation.
Background
The Mannion ’933 patent is part of a series of patents that Purdue Pharma has asserted against various generic and pharmaceutical companies for alleged infringement. These patents are listed in the FDA's Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the "Orange Book"[2][5].
Patent Scope
The scope of the Mannion ’933 patent revolves around specific formulations and methods related to extended-release pain medications.
Claims Overview
The patent includes several claims that define the scope of the invention. Key claims include:
- Independent Claims: These claims are crucial as they define the broadest scope of the invention. For example, independent claims 1 and 11 of the Mannion ’933 patent describe specific formulations and methods for providing effective pain relief using controlled-release opioid formulations[2].
- Dependent Claims: These claims further narrow down the scope by adding additional limitations to the independent claims.
Controlled Release Formulations
A central aspect of the patent is the controlled release formulation of oxycodone hydrochloride. This formulation is designed to maintain therapeutic blood concentrations of the drug over an extended period, typically 12 hours or longer, while avoiding toxic levels[1].
Key Terms and Definitions
- Controlled Release Material: This term is defined as a material other than the active ingredient that causes the release of the drug at a rate that maintains blood concentrations within the therapeutic range but below toxic levels over a specified period[1].
- Matrix: The term "matrix" refers to a pharmaceutical preparation that incorporates a dispersed or embedded active ingredient or agent. This does not necessarily imply a discrete solid structure but rather a preparation that includes the active ingredient[1].
Patent Infringement Litigation
The Mannion ’933 patent has been at the center of several patent infringement lawsuits. Purdue Pharma has alleged that various generic pharmaceutical companies have infringed upon this patent by filing Abbreviated New Drug Applications (ANDAs) or New Drug Applications (NDAs) with the FDA for their own extended-release oxycodone formulations[2][5].
Recent Litigation
In one notable case, Purdue Pharma asserted that Intellipharmaceutics International Inc. infringed the Mannion ’933 patent, along with other related patents, by filing an NDA for an extended-release oxycodone-hydrochloride tablet. This litigation highlights the ongoing battles in the pharmaceutical industry to protect intellectual property related to controlled-release formulations[5].
Patent Landscape
The patent landscape surrounding the Mannion ’933 patent is complex and highly contested.
Related Patents
The Mannion ’933 patent is part of a larger portfolio of patents held by Purdue Pharma, including other patents such as the ’808, ’886, ’610, and ’497 patents. These patents collectively cover various aspects of extended-release opioid formulations and their methods of use[2][5].
Challenges and Controversies
The scope and validity of these patents have been subject to legal challenges. The pharmaceutical industry often sees debates over patent quality, with some arguing that overly broad patents can stifle innovation and increase litigation costs[3].
Impact on the Pharmaceutical Industry
The Mannion ’933 patent and similar patents have significant implications for the pharmaceutical industry.
Innovation and Competition
These patents can influence the development of new pain management treatments by setting a high bar for generic competitors. While they protect the intellectual property of the patent holders, they can also limit competition and innovation in the field[3].
Patient Access
The litigation surrounding these patents can affect patient access to affordable pain medications. Generic versions of extended-release opioids, if approved, could provide more affordable alternatives, but patent infringement lawsuits can delay their market entry[5].
Conclusion
The Mannion ’933 patent is a critical component of Purdue Pharma's intellectual property portfolio, particularly in the context of extended-release pain medications. Understanding the scope and claims of this patent is essential for navigating the complex landscape of pharmaceutical patents.
Key Takeaways
- The Mannion ’933 patent covers specific formulations and methods for extended-release oxycodone hydrochloride.
- Key terms include "controlled release material" and "matrix," which are defined within the patent claims.
- The patent has been central to several patent infringement lawsuits against generic pharmaceutical companies.
- The patent landscape is complex, with multiple related patents and ongoing legal challenges.
- The patent's impact extends to innovation, competition, and patient access in the pharmaceutical industry.
Frequently Asked Questions (FAQs)
Q: What is the primary focus of the Mannion ’933 patent?
A: The primary focus is on extended-release formulations of oxycodone hydrochloride for pain management.
Q: What is meant by "controlled release material" in the context of this patent?
A: It refers to a material that causes the release of the drug at a rate maintaining therapeutic blood concentrations over an extended period.
Q: How does the term "matrix" relate to the patent?
A: The term "matrix" refers to a pharmaceutical preparation incorporating a dispersed or embedded active ingredient.
Q: What are the implications of this patent for generic pharmaceutical companies?
A: Generic companies may face legal challenges and delays in bringing their own extended-release opioid formulations to market.
Q: How does this patent affect patient access to pain medications?
A: It can impact the availability and affordability of generic alternatives, potentially limiting patient access to more affordable options.
Cited Sources:
- United States District Court for the District of Delaware, "Opinion" (PDF), accessed December 19, 2024.
- United States District Court, "Complaint" (PDF), accessed December 19, 2024.
- SSRN, "Patent Claims and Patent Scope" by J. P. Walsh et al., accessed December 19, 2024.
- USPTO, "Patents", accessed December 19, 2024.
- United States District Court for the District of Delaware, "Amended and Supplemental Complaint" (PDF), accessed December 19, 2024.
