United States Patent 8,388,941: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,388,941, titled "Self preserved aqueous pharmaceutical compositions," is a significant patent in the pharmaceutical industry. This patent, granted to protect a specific formulation of aqueous pharmaceutical compositions, involves a complex interplay of chemical components and their interactions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Number and Authority
The patent in question is identified by the publication number US8388941B2 and is authorized by the United States Patent and Trademark Office (USPTO)[4].
Prior Art and Legal Status
The patent was filed on October 22, 2009, and granted on March 19, 2013. The legal status of the patent is active, although this status is subject to change based on various factors such as maintenance fees and potential legal challenges[4].
Scope of the Patent
Invention Description
The patent describes a self-preserved aqueous pharmaceutical composition that enhances antimicrobial activity using a borate/polyol and zinc system. This composition is designed to maintain the stability and efficacy of multi-dose pharmaceutical formulations without the need for additional preservatives[4].
Key Components
- Borate/Polyol System: This system is crucial for enhancing antimicrobial activity. Borates and polyols work synergistically to inhibit microbial growth.
- Zinc: Zinc ions further enhance the antimicrobial properties of the composition.
- Other Components: The composition may include various other substances such as sorbitol, travoprost, and other therapeutic agents to achieve specific pharmaceutical effects[4].
Claims of the Patent
Independent and Dependent Claims
The patent includes a series of claims that define the scope of the invention. These claims can be categorized into independent and dependent claims.
- Independent Claims: These claims stand alone and define the core aspects of the invention. For example, Claim 1 might describe the basic composition of the self-preserved aqueous pharmaceutical formulation.
- Dependent Claims: These claims build upon the independent claims and provide additional details or variations of the invention. For instance, a dependent claim might specify the concentration range of borate or the type of polyol used[4].
Claim Examples
- Claim 1: A self-preserved aqueous pharmaceutical composition comprising a borate/polyol system and zinc ions.
- Dependent Claim: The composition of Claim 1, wherein the borate is present in a concentration range of 0.1% to 2.0% w/v[4].
Patent Landscape
Related Patents and Applications
The patent landscape for self-preserved pharmaceutical compositions is complex and involves numerous related patents and applications. These include:
- Family Members: The patent US8388941B2 may have family members filed in other jurisdictions, such as the European Patent Office (EPO) or the Japan Patent Office (JPO), which can be accessed through databases like the Global Dossier provided by the USPTO[1].
- Prior Art: The Common Citation Document (CCD) application can be used to consolidate prior art citations from multiple patent offices, providing a comprehensive view of the prior art landscape relevant to this patent[1].
International Patent Databases
To understand the global patent landscape, one can refer to international patent databases such as:
- European Patent Office (EPO) - esp@cenet: Provides access to Europe's patent databases and machine translations of European patents[1].
- World Intellectual Property Organization (WIPO) - PATENTSCOPE: Offers a full-text search of published international patent applications and machine translations for some documents[1].
Search and Analysis Tools
USPTO Resources
The USPTO provides several tools for searching and analyzing patents:
- Patent Public Search: A modern web-based patent search application that replaced legacy tools like PubEast and PubWest. It offers enhanced access to prior art and flexible search capabilities[1].
- Patent Examination Data System (PEDS): Allows public users to search, view, and download bibliographic data for all publicly available patent applications[1].
Global Dossier
The Global Dossier service provides access to the file histories of related applications from participating IP Offices, including the IP5 Offices. This service helps in identifying office actions, saving documents for later review, and downloading relevant documents[1].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents granted between 1976 and 2014 and U.S. patent applications published between 2001 and 2014. This dataset can be used to analyze trends and measurements of patent scope, including those related to pharmaceutical compositions[3].
Industry Impact
Pharmaceutical Industry
The invention described in US8388941B2 has significant implications for the pharmaceutical industry, particularly in the development of multi-dose formulations that do not require additional preservatives. This can enhance product safety, reduce costs, and improve patient compliance.
Regulatory Considerations
The use of borate/polyol and zinc systems must comply with regulatory standards set by health authorities such as the FDA. The patent's claims and scope must be aligned with these regulations to ensure the commercial viability of the product.
Key Takeaways
- Invention Scope: The patent covers a self-preserved aqueous pharmaceutical composition using a borate/polyol and zinc system.
- Claims Structure: The patent includes independent and dependent claims that define the core and variant aspects of the invention.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and applications globally.
- Search and Analysis Tools: Various USPTO resources and international databases are available for searching and analyzing patents.
- Industry Impact: The invention has significant implications for the pharmaceutical industry, particularly in multi-dose formulations.
FAQs
Q: What is the main invention described in US8388941B2?
A: The main invention is a self-preserved aqueous pharmaceutical composition that uses a borate/polyol and zinc system to enhance antimicrobial activity.
Q: How can I search for related patents globally?
A: You can use databases such as the Global Dossier, European Patent Office's esp@cenet, and WIPO's PATENTSCOPE to search for related patents globally[1].
Q: What tools does the USPTO provide for patent searching?
A: The USPTO provides tools like Patent Public Search, Global Dossier, and the Patent Examination Data System (PEDS) for searching and analyzing patents[1].
Q: How does the Patent Claims Research Dataset help in analyzing patents?
A: The dataset provides detailed information on claims from U.S. patents and applications, allowing for the analysis of trends and measurements of patent scope[3].
Q: What are the regulatory considerations for this patent?
A: The use of the borate/polyol and zinc system must comply with regulatory standards set by health authorities such as the FDA to ensure the commercial viability of the product.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US8388941B2: https://patents.google.com/patent/US8388941B2/en
