United States Patent 9,522,919: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,522,919, titled "Oxycodone compositions," is a significant patent in the pharmaceutical industry, particularly in the realm of pain management medications. This patent, issued to Purdue Pharma, pertains to specific compositions and processes related to oxycodone, a widely used opioid analgesic.
Background and Context
Oxycodone is a potent opioid used for managing moderate to severe pain. The patent in question focuses on improving the formulation and delivery of oxycodone, specifically in the context of extended-release formulations like OxyContin®[2].
Patent Claims and Scope
Claim Construction
When analyzing the patent claims, it is crucial to consider the literal language of the claim, the patent specification, and the prosecution history. The court's approach to claim construction involves evaluating these elements to determine the scope of the invention[2].
- Literal Language: The claims of the '919 patent specify compositions of oxycodone hydrochloride with particular impurity levels, such as less than 25 ppm of certain impurities[1].
- Patent Specification: The specification details the processes for preparing these compositions, including methods like melt granulation and extrusion[1].
- Prosecution History: This includes any amendments, arguments, and communications between the patent applicant and the USPTO during the patent application process. For instance, the court may consider whether the applicants intended to equate certain numerical values with specific impurity levels[2].
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the invention broadly, while dependent claims narrow down the scope by adding specific limitations.
- Independent Claims: These claims outline the core invention, such as the composition of oxycodone hydrochloride with specified impurity levels and the process for its preparation[1].
- Dependent Claims: These claims build upon the independent claims by adding additional features, such as specific excipients, coating agents, or dosage forms[1].
Process and Composition Details
Preparation Methods
The patent describes several methods for preparing the oxycodone compositions, including:
- Melt Granulation: A process where the active ingredient and excipients are melted together to form granules[1].
- Extrusion: A method involving the forcing of a mixture through a die to create a specific shape or form[1].
Composition Components
The compositions may include various components such as:
- Oxycodone Hydrochloride: The active ingredient with specified impurity levels[1].
- Excipients: Substances like poly(ethylene oxide) and hydroxy alkyl cellulose that aid in the formulation[1].
- Coating Agents: Used to control the release of the active ingredient, such as in extended-release formulations[1].
Patent Landscape and Related Patents
Family of Patents
The '919 patent is part of a family of patents related to OxyContin®, including other patents like the '976, '933, '389, and '391 patents. These patents collectively cover various aspects of the formulation, process, and use of oxycodone extended-release products[2].
Global Patent System
The USPTO's Global Dossier service provides access to the file histories of related applications from participating IP Offices, allowing for a comprehensive view of the global patent landscape for these inventions[4].
Litigation and Claim Construction Issues
The '919 patent has been involved in litigation, particularly regarding claim construction. Courts have considered the intrinsic evidence, including the patent specification and prosecution history, to determine the scope of the claims. For example, the court has addressed the interpretation of terms like "molecular weight" and "ppm" levels in the context of the patent claims[2].
Impact on Innovation and Industry
Patent Scope and Quality
The scope of the '919 patent, like other patents, is a subject of debate in the context of patent quality. Metrics such as independent claim length and count can be used to measure patent scope, which can influence innovation and litigation costs[3].
Licensing and Litigation
The breadth and clarity of the patent claims can affect licensing agreements and litigation outcomes. Narrower claims, as seen in the '919 patent, can lead to a higher probability of grant and shorter examination processes, which can facilitate innovation by providing clearer boundaries for competitors[3].
Key Takeaways
- Specific Claims: The '919 patent includes detailed claims about the composition and process for preparing oxycodone hydrochloride with specified impurity levels.
- Process Methods: The patent describes methods like melt granulation and extrusion for preparing the compositions.
- Litigation: The patent has been involved in claim construction issues, highlighting the importance of intrinsic evidence in determining patent scope.
- Global Landscape: The patent is part of a broader family of patents related to OxyContin®, with implications for the global patent system.
- Innovation Impact: The patent's scope and clarity can influence innovation and licensing costs in the pharmaceutical industry.
FAQs
Q: What is the main subject of the United States Patent 9,522,919?
A: The main subject is the composition and process for preparing oxycodone hydrochloride with specified impurity levels.
Q: What methods are described for preparing the oxycodone compositions in the patent?
A: The methods include melt granulation and extrusion.
Q: How is the scope of the patent claims determined?
A: The scope is determined by considering the literal language of the claim, the patent specification, and the prosecution history.
Q: What is the significance of the '919 patent in the context of OxyContin®?
A: The patent is part of a family of patents related to OxyContin®, covering various aspects of its formulation and use.
Q: How does the patent's scope affect innovation and licensing in the pharmaceutical industry?
A: The clarity and breadth of the patent claims can influence innovation by providing clear boundaries and affecting licensing and litigation costs.
Sources
- US9522919B2 - Oxycodone compositions - Google Patents
- 17-392.pdf - District of Delaware
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO
