Understanding the Scope and Claims of United States Patent 8,921,374
Introduction
United States Patent 8,921,374, titled "Itraconazole compositions and dosage forms, and methods of using the same," is a significant patent in the pharmaceutical industry, particularly in the field of antifungal treatments. This patent, held by Mayne Pharma International Pty Ltd., covers various aspects of itraconazole formulations and their applications.
Patent Overview
The patent was granted on December 30, 2014, and is part of a series of patents related to itraconazole compositions and dosage forms. Here, we will delve into the key components of this patent, including its scope, claims, and the broader patent landscape.
Scope of the Patent
The scope of US Patent 8,921,374 is defined by its claims, which outline the specific inventions and innovations covered by the patent.
Pharmaceutical Compositions
The patent focuses on pharmaceutical compositions, particularly solid oral dosage forms, that contain itraconazole. Itraconazole is an antifungal medication used to treat various fungal infections. The compositions described in the patent include specific formulations that enhance the bioavailability and stability of itraconazole[4].
Dosage Forms
The patent details various dosage forms, including tablets, capsules, and other solid oral formulations. These dosage forms are designed to improve the efficacy and patient compliance of itraconazole treatment. The formulations may include various excipients such as silicon dioxide, starch, and polyvinyl acetate phthalate to enhance the drug's performance[4].
Methods of Use
The patent also covers methods of using these itraconazole compositions for treating fungal infections. This includes specific dosing regimens and administration methods to ensure optimal therapeutic outcomes.
Claims of the Patent
The claims of US Patent 8,921,374 are crucial as they define the legal boundaries of the invention.
Independent Claims
The patent includes several independent claims that describe the core inventions. These claims typically outline the composition, dosage form, and method of use in detail. For example, Claim 1 might describe a specific pharmaceutical composition comprising itraconazole and certain excipients, while Claim 2 might detail a method of treating a fungal infection using this composition[4].
Dependent Claims
Dependent claims build upon the independent claims, providing additional specificity and limitations. These claims help to narrow down the scope of the invention and provide further protection against infringement.
Patent Claims Analysis
The analysis of patent claims is essential for understanding the patent's scope and validity.
Claim Length and Count
Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Claim Language
The language used in the claims is critical. Clear and specific language helps in defining the invention precisely, reducing the likelihood of disputes over patent scope. The claims in US Patent 8,921,374 are detailed and specific, ensuring that the invention is well-defined and protected.
Patent Landscape
The patent landscape surrounding US Patent 8,921,374 includes several related patents and generic filings.
Related Patents
Mayne Pharma International Pty Ltd. holds several related patents, including US Patent 10,806,792 B2 and US Patent 9,272,046 B2, all of which pertain to itraconazole compositions and dosage forms. These patents collectively form a robust intellectual property portfolio for itraconazole formulations[2].
Generic Filings
Generic versions of itraconazole have been filed by companies such as Zydus Pharmaceuticals Usa Inc. However, these generic versions are subject to the expiration dates of the original patents, which in this case is June 21, 2033[2].
Expiration and Maintenance
The patent is set to expire on June 21, 2033, unless extended or adjusted under specific legal provisions. Maintenance fees are periodically paid to keep the patent in force. Recent records show that maintenance fees have been paid to maintain the patent's active status[2].
Impact on the Pharmaceutical Industry
This patent has significant implications for the pharmaceutical industry, particularly in the development and commercialization of antifungal medications.
Innovation and Competition
The patent encourages innovation by protecting the intellectual property rights of Mayne Pharma International Pty Ltd. However, it also limits competition by preventing other companies from producing identical formulations until the patent expires.
Patient Access
The availability of protected formulations ensures that patients have access to high-quality, effective treatments for fungal infections. The patent also incentivizes further research and development in antifungal therapies.
Key Takeaways
- Patent Scope: The patent covers specific itraconazole compositions, dosage forms, and methods of use.
- Claims: The claims are detailed and specific, defining the invention clearly.
- Patent Landscape: The patent is part of a broader portfolio of related patents and is subject to generic filings.
- Expiration and Maintenance: The patent expires on June 21, 2033, and is maintained through periodic fee payments.
- Industry Impact: The patent influences innovation, competition, and patient access to antifungal treatments.
FAQs
Q: What is the primary focus of US Patent 8,921,374?
A: The primary focus is on itraconazole compositions, dosage forms, and methods of using the same for treating fungal infections.
Q: Who is the assignee of US Patent 8,921,374?
A: The assignee is Mayne Pharma International Pty Ltd.
Q: When is the patent set to expire?
A: The patent is set to expire on June 21, 2033.
Q: Are there generic versions of itraconazole filed?
A: Yes, companies like Zydus Pharmaceuticals Usa Inc. have filed for generic versions of itraconazole.
Q: What is the significance of maintenance fees for this patent?
A: Maintenance fees are paid periodically to keep the patent in force and ensure its active status.
Sources
- United States Patent and Trademark Office - US10806792.pdf
- Pharsight - Drug Patents containing Itraconazole
- SSRN - Patent Claims and Patent Scope
- Google Patents - US8921374B2 - Itraconazole compositions and dosage forms, and methods of using the same
