Understanding the Scope and Claims of United States Patent 9,056,052
Introduction
The United States Patent 9,056,052, assigned to Purdue Pharma L.P., is part of a broader portfolio of patents related to controlled-release formulations, particularly those involving hydrocodone. This patent is crucial in the pharmaceutical industry, especially in the development and manufacturing of opioid pain medications.
Patent Overview
The patent 9,056,052 is one of several related patents that Purdue Pharma has filed and been granted, focusing on controlled-release formulations of hydrocodone. Here is a detailed breakdown of its key components:
Claims and Construction
Controlled Release Material
The term "controlled release material" in this patent, as well as in related patents such as the '783, '499, '520, '667, '401, '052, and '940 patents, is construed to mean "a material other than the active ingredient that causes the release of the drug (e.g., hydrocodone) at such a rate that blood concentrations are maintained within the therapeutic range but below toxic concentrations over a period of time of about 12 hours or longer"[1].
Matrix Material
The patent specifies that the "controlled release matrix material" must serve to control the release of the active ingredient. This construction is supported by the patent's description of using materials like polyethylene oxide in the matrix to achieve controlled release rates[1].
Patent Scope
Independent Claims and Claim Count
The scope of a patent can be measured by metrics such as independent claim length and independent claim count. These metrics are indicative of the patent's breadth and clarity. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process compared to broader claims[3].
Forward Citations and Patent Maintenance
The patent 9,056,052, being part of a large family of related patents, likely has significant forward citations, which are indicative of its influence on subsequent innovations. Additionally, the maintenance payments for this patent would be substantial, reflecting its importance and the ongoing interest in its technology[3].
Technical Details
Dosage Form Composition
The patent describes a solid oral controlled-release dosage form of hydrocodone. This dosage form includes an analgesically effective amount of hydrocodone or a hydrocodone salt, embedded in a controlled release matrix material. The matrix material is designed to release the hydrocodone at a controlled rate over an extended period, typically 12 hours or longer[4].
Materials Used
The patent lists various materials that can be used in the controlled release matrix, including polyethylene oxide, which is mentioned as being contained in both components of the dosage form. Other materials like hydroxypropyl methylcellulose and ethylcellulose are also cited as suitable controlled release materials[4].
Litigation and Legal Context
Patent Infringement Cases
Purdue Pharma has been involved in several patent infringement cases related to these controlled-release formulations. For example, the case of Purdue Pharma L.P. v. Alvogen Pine Brook, LLC, involves the assertion of multiple patents, including the '056 patent, against alleged infringers[2][5].
Court Rulings
In these cases, the court has had to construe the terms of the patents to determine the scope of the claims. For instance, the court has ruled that the term "matrix" does not necessarily imply a solid structure, but rather any material that controls the release of the active ingredient[1].
Industry Impact
Innovation and Licensing
The patent 9,056,052 and its related patents have significant implications for innovation in the pharmaceutical industry. They set a standard for controlled-release opioid formulations, influencing both the development of new drugs and the licensing agreements between pharmaceutical companies[3].
Regulatory Considerations
Given the opioid crisis, regulatory bodies closely scrutinize controlled-release opioid formulations. Patents like 9,056,052 must comply with stringent regulatory requirements to ensure safety and efficacy while preventing abuse[4].
Key Takeaways
- Controlled Release Material: The patent defines this term as a material that maintains therapeutic blood concentrations of the drug over an extended period.
- Matrix Material: The matrix must control the release of the active ingredient, such as hydrocodone.
- Patent Scope: Measured by independent claim length and count, narrower claims are associated with higher grant probabilities and shorter examination processes.
- Technical Details: The dosage form includes hydrocodone in a controlled release matrix, using materials like polyethylene oxide.
- Litigation: Purdue Pharma has been involved in several infringement cases related to these patents.
- Industry Impact: These patents influence innovation, licensing, and regulatory compliance in the pharmaceutical industry.
FAQs
What is the primary purpose of the controlled release material in US Patent 9,056,052?
The primary purpose is to maintain therapeutic blood concentrations of the drug, such as hydrocodone, over an extended period, typically 12 hours or longer.
What materials are commonly used in the controlled release matrix?
Materials such as polyethylene oxide, hydroxypropyl methylcellulose, and ethylcellulose are commonly used.
How does the court construe the term "matrix" in this patent?
The court construes "matrix" to mean any material that controls the release of the active ingredient, not necessarily a solid structure.
What is the significance of forward citations for this patent?
Forward citations indicate the influence of the patent on subsequent innovations and are a measure of its importance in the field.
How do regulatory considerations impact patents like 9,056,052?
Regulatory bodies closely scrutinize these patents to ensure compliance with safety and efficacy standards, particularly in the context of the opioid crisis.
Sources
- Purdue Pharma L.P. v. Alvogen Pine Brook, LLC - Casetext
- United States District Court - RPX Insight
- Patent Claims and Patent Scope - SSRN
- United States Patent 9,669,023 - Google Patents
- Purdue Pharma L.P. v. Alvogen Pine Brook, LLC - CaseMine
