Detailed Analysis of the Scope and Claims of United States Patent 5,612,054
Introduction
United States Patent 5,612,054, titled "Pharmaceutical compositions for treating gastrointestinal distress," is a significant patent in the pharmaceutical industry, particularly in the treatment of gastrointestinal issues. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Details
- Publication Number: US5612054A
- Authority: United States
- Prior Art Date: June 22, 1993
- Legal Status: Expired - Lifetime[4].
Invention Description
The patent describes a pharmaceutical composition designed to treat gastrointestinal distress. This composition includes an effective amount of an antidiarrheal agent, typically loperamide, and an antiflatulent agent, such as simethicone. The invention also encompasses various formulations, including oral solid dosage forms, chewable forms, and liquid dosage forms, which can be enhanced with additional components like antispasmodic and anticholinergic compositions, and digestive enzymes[4].
Scope of the Invention
Active Ingredients
The patent specifies the use of loperamide as the antidiarrheal agent and simethicone as the antiflatulent agent. These ingredients are combined to provide a comprehensive treatment for gastrointestinal distress, including diarrhea and flatulence[4].
Formulations
The composition can be formulated in various ways to suit different patient needs:
- Oral Solid Dosage Forms: Tablets or capsules.
- Chewable and Liquid Dosage Forms: Enhanced with flavoring compositions.
- Sustained Release Formulation: For the treatment of chronic gastrointestinal distress[4].
Additional Components
The invention allows for the inclusion of other pharmaceutical agents to enhance its efficacy:
- Antispasmodic and Anticholinergic Compositions: Such as phenobarbital, dicyclomine HCl, belladonna alkaloids, and atropine.
- Digestive Enzymes: Like lipase, amylase, and protease to reduce and relieve gastrointestinal distress[4].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention:
- Claim 1: A pharmaceutical composition comprising an effective amount of loperamide and an effective amount of simethicone.
- Claim 2: A method of treating gastrointestinal distress using the composition of Claim 1[4].
Dependent Claims
Dependent claims further specify the formulations and additional components:
- Claim 3: The composition of Claim 1, further comprising an antispasmodic or anticholinergic composition.
- Claim 4: The composition of Claim 1, further comprising one or more digestive enzymes[4].
Patent Landscape
Classification
The patent is classified under the International Patent Classification (IPC) system:
- A61K31/00: Medicinal preparations containing organic active ingredients.
- A61K31/695: Silicon compounds, specifically simethicone[4].
Related Patents
The patent is part of a series of continuations and related patents:
- Continuation of Application Ser. No. 08/081,740: Filed June 22, 1993, now abandoned.
- Continuation of Ser. No. 07/852,355: Filed March 17, 1992, issued as U.S. Pat. No. 5,248,505 on September 28, 1993[4].
Global Patent Family
To understand the global reach of this patent, one would need to use tools like the Global Dossier provided by the USPTO, which allows users to see the patent family for a specific application, including related applications filed at participating IP Offices[1].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
Using patent analytics tools, such as those described by Schwegman, one can create a Claim Coverage Matrix to determine which patents and claims are actively protecting the intellectual property related to this invention. This involves categorizing patents by claims and scope concepts to identify gaps or opportunities in the patent landscape[3].
Interactive Claim Charts
Interactive claim charts generated by tools like ClaimScape® can help technical experts review the patent coverage and determine if there are gaps in the current coverage or future design opportunities. These charts can be updated over time as more patents are filed or as new avenues of development are explored[3].
Practical Implications
Commercial Use
The expired status of this patent means that the pharmaceutical composition described is now in the public domain, allowing other companies to manufacture and market similar products without infringing on the original patent.
Research and Development
The detailed description and claims of this patent can serve as a foundation for further research and development in the treatment of gastrointestinal distress. Researchers can build upon the existing knowledge to create new formulations or improve existing ones.
Key Takeaways
- Pharmaceutical Composition: The patent describes a combination of loperamide and simethicone for treating gastrointestinal distress.
- Formulations: Various formulations are possible, including oral solid, chewable, and liquid forms.
- Additional Components: The invention allows for the inclusion of antispasmodic, anticholinergic compositions, and digestive enzymes.
- Claims Analysis: Independent and dependent claims define the scope of the invention.
- Patent Landscape: The patent is classified under specific IPC categories and is part of a series of related patents.
- Patent Analytics: Tools like Claim Coverage Matrix and interactive claim charts can help analyze and manage the patent landscape.
FAQs
Q: What are the main active ingredients in the pharmaceutical composition described in US Patent 5,612,054?
A: The main active ingredients are loperamide (an antidiarrheal agent) and simethicone (an antiflatulent agent).
Q: What types of formulations are described in the patent?
A: The patent describes oral solid dosage forms, chewable forms, liquid dosage forms, and sustained release formulations.
Q: Can other pharmaceutical agents be included in the composition?
A: Yes, the invention allows for the inclusion of antispasmodic and anticholinergic compositions, as well as digestive enzymes.
Q: Is the patent still in force?
A: No, the patent has expired and is now in the public domain.
Q: How can patent analytics tools help in managing the patent landscape related to this invention?
A: Patent analytics tools can help create a Claim Coverage Matrix and generate interactive claim charts to identify gaps or opportunities in the patent landscape.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
- SLWIP - Patent Analytics: https://www.slwip.com/services/patent-analytics/
- Google Patents - US5612054A: https://patents.google.com/patent/US5612054A/en
