Understanding the Scope and Claims of United States Patent 9,023,401
Introduction
The United States Patent 9,023,401, part of a series of patents related to controlled-release pharmaceutical formulations, is a crucial component in the intellectual property portfolio of companies like Purdue Pharma. This patent, along with others, protects innovative formulations of drugs such as hydrocodone, which are designed to provide controlled and sustained release of the active ingredient.
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent No. 9,023,401, titled "Solid Oral Controlled-Release Dosage Forms."
Background and Invention
This patent pertains to solid oral controlled-release dosage forms, particularly those containing hydrocodone or its salts. The invention aims to provide a formulation that maintains therapeutic blood concentrations of the drug over an extended period, typically 12 hours or longer, while avoiding toxic levels[2][4].
Claim Scope and Construction
Key Terms and Definitions
- Controlled Release Matrix Material: This term is defined as "a material other than the active ingredient that causes the release of the drug 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].
- Steady-State: As defined in the '667 patent specification, "steady state" refers to the condition when "the amount of the drug reaching the system is approximately the same as the amount of the drug leaving the system"[1].
Claim Specifics
The claims of the '401 patent include various aspects of the controlled-release dosage form:
- Dosage Form Composition: The patent claims cover a solid oral dosage form comprising an analgesically effective amount of hydrocodone and a controlled-release matrix material.
- Matrix Material: The matrix material is designed to control the release of hydrocodone, ensuring sustained therapeutic levels.
- Multiple Matrices: Some claims discuss the use of multiple matrices to achieve the desired release profile[1].
Patent Landscape and Litigation
Asserted Patents and Litigation
The '401 patent is part of a larger set of patents asserted by Purdue Pharma against generic manufacturers like Alvogen. These patents are listed in the FDA's Orange Book and cover various aspects of Purdue's Hysingla® ER product, a hydrocodone bitartrate extended-release formulation[2].
Legal Challenges
Purdue Pharma has been involved in several patent infringement lawsuits related to these patents. For instance, the case against Alvogen Pine Brook, LLC, involved the construction of key terms in the patents, including the definition of "controlled release matrix material" and "steady-state"[1].
Importance of Claim Scope
Broad vs. Narrow Claims
The scope of the claims in the '401 patent is critical. While broader claims might offer more extensive protection, they are also more susceptible to invalidation. The Federal Circuit has emphasized the need for claims to be anchored in the embodiments disclosed in the specification to avoid issues like the abstract idea exception[3].
Avoiding Overly Broad Claims
The '401 patent's claims are carefully crafted to avoid being overly broad. For example, the definition of "controlled release matrix material" is specific and tied to the therapeutic and safety goals of the dosage form. This specificity helps in maintaining the validity of the patent[1][3].
Technical and Economic Considerations
Prior Art and Technical Field
The technical field of controlled-release pharmaceuticals is highly developed, with numerous prior art references. The '401 patent must navigate this landscape by ensuring its claims are novel and non-obvious over existing technologies. The patent's references to prior art, such as the work by Oshlack et al., highlight the evolutionary nature of the invention[4].
Economic Impact
The economic impact of this patent is significant, as it protects a valuable product in the market. The litigation surrounding these patents underscores the commercial importance of maintaining patent validity and enforcing intellectual property rights[2].
Examples and Illustrations
Formulation Examples
The patent provides examples of how the controlled-release matrix material can be formulated using various polymers, such as polyethylene oxide. These examples illustrate the practical application of the invention and help in understanding the scope of the claims[1].
Clinical Significance
The controlled-release formulation of hydrocodone, as protected by the '401 patent, has significant clinical benefits. It ensures that patients receive a consistent and therapeutic dose of the medication over an extended period, enhancing patient compliance and reducing the risk of overdose[4].
Industry Expert Insights
Importance of Patent Claims
Industry experts emphasize the importance of getting the claim scope right in patent applications. As noted, "getting the claim scope right is arguably more important than getting a patent" because it directly impacts the patent's validity and enforceability[3].
Statistics and Market Impact
Market Dominance
Patents like the '401 patent play a crucial role in maintaining market dominance for pharmaceutical companies. For instance, Purdue Pharma's Hysingla® ER, protected by this and other related patents, holds a significant market share in the extended-release opioid market.
Generic Competition
The expiration of these patents can lead to generic competition, which significantly impacts the market dynamics. For example, the expiration of key patents can reduce the market share of the original product and increase competition from generic manufacturers[5].
Key Takeaways
- Specific Claim Construction: The '401 patent's claims are specifically constructed to define key terms like "controlled release matrix material" and "steady-state."
- Litigation and Enforcement: The patent is part of ongoing litigation efforts by Purdue Pharma to protect its intellectual property rights.
- Technical and Economic Significance: The patent is significant both technically and economically, protecting a valuable product in the controlled-release pharmaceutical market.
- Industry Best Practices: The patent highlights the importance of careful claim drafting to avoid invalidation and ensure enforceability.
FAQs
Q: What is the main invention protected by U.S. Patent 9,023,401?
A: The main invention is a solid oral controlled-release dosage form containing hydrocodone or its salts, designed to maintain therapeutic blood concentrations over an extended period.
Q: What is the definition of "controlled release matrix material" in the '401 patent?
A: It is defined as a material other than the active ingredient that causes the release of the drug at a rate maintaining therapeutic blood concentrations over about 12 hours or longer.
Q: Why is the scope of the claims in the '401 patent important?
A: The scope of the claims is crucial because it determines the patent's validity and enforceability, and overly broad claims can be more easily invalidated.
Q: What is the significance of the '401 patent in the pharmaceutical market?
A: The patent protects a valuable product, Hysingla® ER, and plays a key role in maintaining market dominance for Purdue Pharma.
Q: How does the expiration of the '401 patent impact the market?
A: The expiration can lead to generic competition, reducing the market share of the original product and increasing competition from generic manufacturers.
Sources
- Purdue Pharma L.P. v. Alvogen Pine Brook, LLC - Casetext
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Insight.RPXcorp.com
- The Importance of Getting the Claim Scope Right in a US Patent Application - Rimon Law
- United States Patent 9,669,023 - Google APIs
- Patent 9,023,401 drug patent claims, expiration, and FTO - DrugPatentWatch.com
