Detailed Analysis of the Scope and Claims of United States Patent 10,624,879
Introduction
United States Patent 10,624,879, issued on April 21, 2020, pertains to a novel pharmaceutical liquid composition developed by inventors Bong Gil Nam, Byeung Jun Lee, and Shunji Jin, and assigned to Ferring International Center S.A. This patent is crucial in the field of gastroenterology, particularly for bowel preparation before colonoscopy or other medical procedures.
Patent Overview
The patent describes a physically and chemically stable pharmaceutical liquid composition that includes sodium picosulfate, magnesium oxide, citric acid, and malic acid. This formulation is designed to enhance medication compliance, convenience, and the ease of storage and transport[2][4][5].
Claims and Scope
Independent Claims
The patent includes multiple independent claims that define the scope of the invention. These claims are pivotal in understanding the exclusive rights granted to the patent holder.
- Claim 1: This claim specifies the pharmaceutical liquid composition comprising sodium picosulfate, magnesium oxide, citric acid, and malic acid, emphasizing their specific roles in achieving stability and efficacy[4].
- Subsequent Claims: These claims detail various aspects of the composition, including the ratios of the ingredients, methods of preparation, and the use of the composition for specific medical purposes.
Dependent Claims
Dependent claims further elaborate on the independent claims by adding additional limitations or specifications. These claims help in narrowing down the scope and ensuring that the patent covers specific embodiments of the invention.
- Claim 2-21: These claims provide detailed descriptions of the composition's ingredients, their concentrations, and the methods for preparing and using the composition. For example, Claim 2 might specify the ratio of sodium picosulfate to magnesium oxide, while Claim 3 might describe the addition of malic acid to enhance stability[4].
Patent Landscape
Related Patents
The patent 10,624,879 is part of a series of related patents filed by the same inventors and assigned to Ferring International Center S.A.
- Patent 9,827,231: Issued on November 28, 2017, this patent also describes a similar pharmaceutical liquid composition but with slightly different formulations and claims[2].
- Patent 11,191,753: Issued on December 7, 2021, this patent continues the development of the stable pharmaceutical liquid composition with additional claims and embodiments[2].
Patent Expiration Dates
The patent 10,624,879 is set to expire on June 23, 2034, which aligns with the typical 20-year patent term from the date of filing. This expiration date is crucial for understanding the timeline during which the patent holder enjoys exclusive rights[2].
Stability and Efficacy
Chemical Stability
The composition's stability is a key aspect of the patent. The inclusion of citric acid and malic acid helps in maintaining the chemical stability of the liquid formulation, ensuring that it remains effective over its shelf life[4].
Physical Stability
The physical stability of the composition is also ensured through the careful selection of ingredients. Magnesium oxide, for instance, contributes to the physical stability by preventing precipitation and maintaining the uniformity of the liquid[4].
Clinical Significance
Bowel Preparation
The primary clinical use of this composition is for bowel preparation before colonoscopy or other gastrointestinal procedures. The combination of sodium picosulfate, magnesium oxide, citric acid, and malic acid provides an effective and convenient method for cleansing the bowel, enhancing the accuracy of diagnostic procedures[4].
Patient Compliance
The liquid composition is designed to be more palatable and easier to administer than traditional bowel preparation methods, thereby improving patient compliance. This is particularly important as better compliance can lead to more effective and safer medical procedures[4].
Manufacturing and Use
Methods of Preparation
The patent details various methods for preparing the pharmaceutical liquid composition. These methods include mixing the ingredients in specific ratios and under controlled conditions to ensure the stability and efficacy of the final product[4].
Use in Medical Procedures
The composition is intended for use in medical procedures requiring thorough bowel cleansing. The patent outlines the dosing instructions and the timing of administration to ensure optimal results[4].
Regulatory Aspects
FDA Approval
The patent is part of the regulatory framework that includes FDA approval. The FDA grants exclusivity periods that can run concurrently with the patent term, providing additional protection to the patent holder[2].
Exclusivity Periods
The exclusivity periods granted by the FDA can range from 180 days to seven years, depending on the circumstances. This exclusivity, combined with the patent protection, ensures that the patent holder has a significant market advantage[2].
Patent Scope Metrics
Independent Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. In this case, the multiple independent claims and detailed dependent claims suggest a well-defined and narrowly focused patent scope[3].
Key Takeaways
- The patent 10,624,879 describes a stable pharmaceutical liquid composition for bowel preparation.
- The composition includes sodium picosulfate, magnesium oxide, citric acid, and malic acid.
- The patent emphasizes chemical and physical stability, patient compliance, and ease of use.
- Related patents and expiration dates are crucial in understanding the patent landscape.
- Regulatory aspects, including FDA approval and exclusivity periods, add to the patent's protection.
FAQs
What is the primary use of the pharmaceutical liquid composition described in Patent 10,624,879?
The primary use is for bowel preparation before colonoscopy or other gastrointestinal procedures.
What are the key ingredients in the composition?
The key ingredients are sodium picosulfate, magnesium oxide, citric acid, and malic acid.
Why is the stability of the composition important?
The stability ensures that the composition remains effective over its shelf life and during use, which is critical for medical procedures.
How does the composition improve patient compliance?
The composition is designed to be more palatable and easier to administer, enhancing patient compliance.
When is the patent set to expire?
The patent is set to expire on June 23, 2034.
Cited Sources
- United States Patent and Trademark Office. "Liquid pharmaceutical composition." US Patent 11,191,753 B2, December 7, 2021.
- Drugs.com. "Generic Clenpiq Availability." Retrieved November 6, 2024.
- SSRN. "Patent Claims and Patent Scope." Retrieved September 29, 2016.
- Justia Patents. "Liquid pharmaceutical composition." US Patent 10,624,879 B2, April 21, 2020.
- Unified Patents. "US-10624879-B2 - Liquid Pharmaceutical Composition." Retrieved April 21, 2020.
