United States Patent 8,168,218: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 8,168,218, titled "Delayed-Release Glucocorticoid Formulations," is assigned to HZNP Limited and was invented by Achim Schaeffler. This patent is part of a series of filings related to delayed-release glucocorticoid formulations, particularly for the treatment of rheumatoid arthritis and other inflammatory conditions.
Background and Context
The patent is a continuation of several earlier applications, indicating a long-standing development process. It is related to other patents such as U.S. Patent Nos. 6,488,960, 6,677,326, 8,309,124, and 8,394,407, all of which are associated with the drug RAYOS®[2][5].
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
- Delayed-Release Formulation: The patent claims cover a delayed-release formulation of a glucocorticoid, such as prednisone, designed to release the active ingredient at a specific time after administration. This is crucial for managing chronic conditions like rheumatoid arthritis[1].
- Pharmaceutical Composition: The claims specify the pharmaceutical composition, including the type of glucocorticoid, the delayed-release mechanism, and the excipients used. This ensures that the formulation meets specific standards for efficacy and safety[1].
- Method of Treatment: The patent also claims methods of treating inflammatory diseases using the delayed-release glucocorticoid formulations. This includes specific dosing regimens and administration times to optimize therapeutic effects[1].
Independent and Dependent Claims
- Independent Claims: These claims stand alone and define the broadest scope of the invention. For example, Claim 1 might describe the general composition of the delayed-release formulation.
- Dependent Claims: These claims build upon the independent claims and provide more specific details. For instance, a dependent claim might specify the type of glucocorticoid used or the exact timing of the release mechanism[3].
Patent Landscape
Related Patents
The patent is part of a larger portfolio related to glucocorticoid formulations. Other relevant patents include:
- U.S. Patent No. 6,488,960: Covers aspects of the delayed-release formulation and its application.
- U.S. Patent No. 6,677,326: Relates to specific excipients and their role in the formulation.
- U.S. Patent No. 8,309,124: Focuses on the method of manufacturing the delayed-release formulation.
- U.S. Patent No. 8,394,407: Deals with additional aspects of the formulation and its therapeutic use[2][5].
Litigation and Enforcement
Horizon Pharma AG, the assignee of the patent, has been involved in several patent infringement lawsuits related to these patents. For example, a lawsuit was filed against Watson Laboratories, Inc. (now part of Actavis), alleging infringement of U.S. Patent Nos. 6,488,960, 6,677,326, 8,168,218, 8,309,124, and 8,394,407. The lawsuit sought to prevent the approval of a generic version of RAYOS® until the patents expire[2][5].
Patent Scope Metrics
Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can indicate the breadth and complexity of the patent. Narrower claims with shorter lengths and fewer counts are often associated with a higher probability of grant and a shorter examination process. In the case of U.S. Patent 8,168,218, the claims are carefully crafted to balance specificity with breadth, ensuring strong protection for the invention while avoiding overly broad claims that might be challenged[3].
Expiration and Exclusivity
The patent is listed in the FDA's Orange Book, with the latest expiration date of January 7, 2028. This means that any generic versions of the drug cannot be approved until this date, unless the patents are found to be invalid or unenforceable[2].
Therapeutic Impact
The delayed-release glucocorticoid formulations covered by this patent are significant for managing chronic inflammatory conditions. By releasing the glucocorticoid at a specific time, these formulations can improve patient compliance and therapeutic outcomes. For example, RAYOS®, which is protected by this and related patents, is used to treat rheumatoid arthritis and other inflammatory diseases, providing a once-daily dosing regimen that enhances patient adherence[4].
Key Takeaways
- Delayed-Release Formulation: The patent covers a specific type of glucocorticoid formulation designed to release the active ingredient at a delayed time.
- Broad and Specific Claims: The patent includes both independent and dependent claims to ensure comprehensive protection.
- Litigation and Enforcement: The patent has been involved in significant litigation to protect its exclusivity.
- Therapeutic Impact: The formulations covered by this patent are crucial for managing chronic inflammatory conditions.
- Patent Scope Metrics: The claims are balanced to ensure specificity and breadth, aligning with best practices in patent drafting.
FAQs
What is the primary focus of U.S. Patent 8,168,218?
The primary focus is on delayed-release glucocorticoid formulations, particularly for treating inflammatory diseases like rheumatoid arthritis.
Which company is the assignee of this patent?
The assignee is HZNP Limited.
What other patents are related to U.S. Patent 8,168,218?
Related patents include U.S. Patent Nos. 6,488,960, 6,677,326, 8,309,124, and 8,394,407, all associated with the drug RAYOS®.
What is the significance of the delayed-release mechanism?
The delayed-release mechanism improves patient compliance and therapeutic outcomes by releasing the glucocorticoid at a specific time, often once daily.
When does the patent expire?
The patent expires on January 7, 2028, as listed in the FDA's Orange Book.
What is the therapeutic application of the formulations covered by this patent?
The formulations are used to treat inflammatory diseases, such as rheumatoid arthritis, by providing a controlled release of glucocorticoids.
