United States Patent 11,103,517: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 11,103,517, titled "Pharmaceutical compositions for minocycline," is a significant patent in the pharmaceutical industry, particularly for the treatment of acne and other conditions using minocycline. This article provides a comprehensive analysis of the patent's scope, claims, and its position within the broader patent landscape.
Overview of the Patent
Publication and Legal Status
The patent, US11103517B2, was granted and is currently active. It was filed under the application number US15/093,673 and is part of the broader category of pharmaceutical compositions[1].
Scope of the Patent
Pharmaceutical Compositions
The patent pertains to specific pharmaceutical compositions containing minocycline, an antibiotic used primarily for treating acne and other bacterial infections. The compositions are designed for oral administration, specifically in the form of once-daily tablets[1].
Dosage Forms
The patent describes various dosage forms of minocycline tablets, including 90 mg, 105 mg, 115 mg, 135 mg, and 165 mg. These tablets are designed to be taken intact or divided into two or more equal subunits to provide a precise and adjustable dose based on the patient's body weight[1].
Dissolution Profiles
The dissolution profiles of these tablets are carefully defined to ensure consistent and predictable drug release. For instance, the tablets must release about 15% to 25% of minocycline in 15 minutes, about 35% to 50% in 30 minutes, about 50% to 65% in 60 minutes, and about 70% to 90% in 120 minutes when tested in simulated gastric fluid[1].
Inventory Optimization
The design of these tablets, particularly the scored tablets, allows for inventory optimization in pharmacies and warehouses by reducing the number of stock-keeping units. This is achieved by providing multiple strengths of minocycline in a single tablet form that can be divided as needed[1].
Claims of the Patent
Key Claims
- The patent includes claims for the specific composition of the minocycline tablets, including the amount of minocycline and other components such as cushioning agents.
- It also claims the method of orally administering these tablets, emphasizing the once-daily dosing regimen.
- The claims include the design of the tablets with scores or other means of separation to facilitate dividing the tablets into equal subunits for precise dosing[1].
Claim Construction
The claims are constructed to include specific numerical ranges and conditions, such as the dissolution profiles and the weight percentages of the components. For example, the amount of cushioning agents ranges from about 40% to about 60% by weight of the tablets[1].
Patent Landscape
Patent Scope Metrics
The scope of this patent can be analyzed using metrics such as independent claim length and independent claim count, which are indicators of patent breadth and clarity. Narrower claims, like those in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Global Patent System
The patent is part of the global patent system, and its file history and related applications can be accessed through services like the Global Dossier provided by the USPTO. This allows stakeholders to view the patent family, classification, and citation data for related applications[4].
Legal and Regulatory Considerations
Original Patent Requirement
The patent must comply with the "original patent" requirement under 35 U.S.C. § 251, which means that any reissue claims must be directed to the invention disclosed in the original patent. This ensures that the reissue claims do not cover a different invention than what was originally disclosed[2].
Public Access and Search Facilities
The USPTO provides public access to patent information through facilities like the Public Search Facility in Alexandria, VA. This allows the public to search and access patent documentation, including the details of this patent[4].
Practical Implications
Treatment of Acne
The practical implication of this patent is the provision of a convenient and precise dosing regimen for patients treated with minocycline for acne. The once-daily tablets, especially those that can be divided, offer flexibility and accuracy in dosing, which is crucial for effective treatment and patient compliance[1].
Inventory Management
For pharmacies and warehouses, the scored tablets offer significant inventory optimization. By having fewer stock-keeping units, these entities can manage their inventory more efficiently, reducing costs and improving logistics[1].
Key Takeaways
- Specific Dosage Forms: The patent covers specific dosage forms of minocycline tablets designed for once-daily administration.
- Dissolution Profiles: The tablets have defined dissolution profiles to ensure consistent drug release.
- Inventory Optimization: The scored tablets facilitate inventory optimization by reducing the number of stock-keeping units.
- Legal Compliance: The patent complies with the "original patent" requirement and other regulatory standards.
- Practical Benefits: The patent provides a convenient and precise dosing regimen for patients and efficient inventory management for pharmacies and warehouses.
FAQs
Q: What is the primary use of the minocycline tablets described in the patent?
A: The primary use is for the treatment of acne and other bacterial infections.
Q: How are the dosage forms of the minocycline tablets designed?
A: The tablets are designed to be taken once daily and come in various strengths (90 mg, 105 mg, 115 mg, 135 mg, and 165 mg) with scores for dividing into equal subunits.
Q: What are the dissolution profiles of the minocycline tablets?
A: The tablets must release about 15% to 25% of minocycline in 15 minutes, about 35% to 50% in 30 minutes, about 50% to 65% in 60 minutes, and about 70% to 90% in 120 minutes.
Q: How does the patent contribute to inventory optimization?
A: The scored tablets reduce the number of stock-keeping units, making inventory management more efficient for pharmacies and warehouses.
Q: What regulatory requirement must the patent comply with?
A: The patent must comply with the "original patent" requirement under 35 U.S.C. § 251.
Sources
- US11103517B2 - Pharmaceutical compositions for minocycline - Google Patents
- In Re FLOAT'N'GRILL LLC - Court of Appeals for the Federal Circuit
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO - United States Patent and Trademark Office
- U.S. Patent Small Claims Court - Administrative Conference of the United States
