Detailed Analysis of the Scope and Claims of United States Patent 11,191,753
Introduction
United States Patent 11,191,753, titled "Liquid Pharmaceutical Composition," is a significant patent in the field of medical science, particularly in the development of stable pharmaceutical liquid compositions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignees
The patent was invented by Nam Bong Gil, Lee Byeung Jun, and Jin Shunji, and is assigned to Ferring International Center S.A.[4][5].
Publication and Expiration Dates
The patent was issued on December 7, 2021, and is set to expire on June 23, 2034[5].
Scope of the Invention
The patent describes a physically and chemically stable pharmaceutical liquid composition that includes sodium picosulfate, magnesium oxide, and citric acid, along with optional ingredients such as malic acid. This composition is designed for medical use, particularly in the preparation of medicinal products.
Key Components
- Sodium Picosulfate: A key active ingredient known for its use in bowel preparation and as a laxative.
- Magnesium Oxide: An inorganic active ingredient that contributes to the stability and efficacy of the composition.
- Citric Acid: A carboxylic acid that helps in maintaining the chemical stability of the liquid composition.
- Malic Acid: An optional ingredient that can be included to enhance the stability and efficacy of the formulation[4][5].
Claims
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 typically defines the broadest scope of the invention, describing the pharmaceutical liquid composition and its key components.
- Subsequent claims may narrow down the scope by specifying particular ratios of ingredients, methods of preparation, or specific uses of the composition[4].
Dependent Claims
These claims build upon the independent claims, providing additional details such as specific concentrations of ingredients, methods of manufacturing, or particular applications of the composition.
Patent Classification
The patent is classified under various categories within the International Patent Classification (IPC) system:
- A61K31/00: Medicinal preparations containing organic active ingredients.
- A61K31/33: Heterocyclic compounds.
- A61K31/435: Heterocyclic compounds having nitrogen as a ring hetero atom.
- A61K33/06: Aluminium, calcium or magnesium; Compounds thereof[4].
Prior Art and Citation Data
The Common Citation Document (CCD) application can be used to consolidate prior art cited by participating IP offices, including the IP5 Offices. This helps in understanding the prior art landscape and how the current patent fits into it[1].
Global Patent Family
The Global Dossier service allows users to see the patent family for this specific application, including all related applications filed at participating IP Offices. This provides a comprehensive view of the global patent landscape for this invention[1].
Examination Process and Patent Scope
Research indicates that the patent examination process tends to narrow the scope of patent claims, particularly in terms of claim length and claim count. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Market and Commercial Implications
The patent grants exclusive legal rights to Ferring International Center S.A. to protect the proprietary chemical formulation. This exclusivity can significantly impact the market by preventing other companies from manufacturing or selling similar compositions until the patent expires. The patent expiration date of June 23, 2034, marks the end of this exclusivity period[5].
Drug Exclusivity and Patent Interplay
In addition to patent protection, the FDA may grant exclusivity periods that run simultaneously with the patent. These exclusivity periods can range from 180 days to seven years, depending on the circumstances, and further reinforce the market exclusivity of the drug[5].
Competitive Landscape
The presence of multiple patents related to similar liquid pharmaceutical compositions (e.g., US9827231B2 and US10624879) indicates a competitive landscape in this field. Companies must navigate these patents carefully to avoid infringement while developing their own products[2][5].
Key Takeaways
- Stable Composition: The patent describes a stable pharmaceutical liquid composition with specific ingredients.
- Exclusive Rights: Ferring International Center S.A. holds exclusive rights until the patent expires in 2034.
- Global Patent Family: The Global Dossier service provides insights into related international patent applications.
- Market Impact: The patent significantly influences the market by preventing similar compositions from being manufactured or sold.
- Examination Process: The patent examination process narrowed the scope of the claims, ensuring clarity and validity.
FAQs
What is the main purpose of United States Patent 11,191,753?
The main purpose of this patent is to describe a physically and chemically stable pharmaceutical liquid composition for medical use.
Who are the inventors of this patent?
The inventors are Nam Bong Gil, Lee Byeung Jun, and Jin Shunji.
What are the key components of the liquid composition?
The key components include sodium picosulfate, magnesium oxide, and citric acid, with optional malic acid.
When does the patent expire?
The patent expires on June 23, 2034.
How does this patent affect the market?
This patent grants exclusive rights to Ferring International Center S.A., preventing other companies from manufacturing or selling similar compositions until the patent expires.
Cited Sources
- USPTO - Search for patents https://www.uspto.gov/patents/search
- Google Patents - US9827231B2 https://patents.google.com/patent/US9827231B2/en
- SSRN - Patent Claims and Patent Scope https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Google Patents - US11191753B2 https://patents.google.com/patent/US11191753B2/en
- Drugs.com - Generic Clenpiq Availability https://www.drugs.com/availability/generic-clenpiq.html
