United States Patent 6,790,459: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,790,459, hereafter referred to as the '459 Patent, is a significant intellectual property asset that requires a thorough analysis to understand its scope, claims, and position within the broader patent landscape. This article will delve into the details of the patent, its claims, and the surrounding patent environment.
Background of the Patent
The '459 Patent, titled "Pharmaceutical Composition and Uses Thereof," is related to pharmaceutical formulations, specifically focusing on extended release and immediate release formulations of certain active pharmaceutical ingredients (APIs). This patent is part of a larger family of patents related to pharmaceutical compositions and drug delivery systems.
Scope of the Patent
Overview of the Invention
The '459 Patent describes a pharmaceutical composition that includes an inner core formulation of metformin hydrochloride, a commonly used drug for treating type 2 diabetes, combined with an extended release material. The composition also features an outer coat of another API, such as linagliptin, in an immediate release polymer film. This dual-release system allows for controlled and efficient delivery of the medications[4].
Key Components
- Inner Core Formulation: This consists of metformin hydrochloride dispersed in a matrix formulation containing an extended release material. The extended release material ensures that the metformin is released over a prolonged period.
- Outer Coat: The outer coat is an immediate release formulation of another API, such as linagliptin, encapsulated in a polymer film. This immediate release component provides a rapid onset of action for the second API.
Claims of the Patent
The claims of the '459 Patent are crucial as they define the scope of protection for the invention. Here are some key aspects:
Independent Claims
- The patent includes claims for the pharmaceutical composition itself, including the specific formulation of the inner core and the outer coat.
- Claims also cover the method of manufacturing such compositions and the use of these compositions for treating specific medical conditions, such as type 2 diabetes.
Dependent Claims
- Dependent claims further specify the types of extended release materials and immediate release polymers that can be used.
- These claims also detail the specific ratios and concentrations of the APIs and excipients in the formulation.
Patent Landscape Analysis
Related Patents
The '459 Patent is part of a larger family of patents related to pharmaceutical compositions and drug delivery systems. Other patents in this family include U.S. Patents No. 6,340,475, 6,488,962, 6,635,280, and others, which also disclose various extended release formulations of metformin and other APIs[4].
Global Dossier and International Filings
To understand the global reach of this patent, it is essential to look at the Global Dossier, which provides access to the file histories of related applications from participating IP Offices. This tool helps in identifying the patent family for a specific application, including all related applications filed at participating IP Offices[1].
Prior Art and Citation Data
The Common Citation Document (CCD) application is useful for consolidating prior art cited by all participating offices for the family members of a patent application. This helps in visualizing the search results for the same invention produced by several offices on a single page[1].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To fully understand the protection offered by the '459 Patent, a Claim Coverage Matrix can be used. This matrix shows which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist. This is particularly useful for companies with a large portfolio of patents to manage[3].
Scope Concepts and Claim Charts
Categorizing patents by scope concepts rather than individual claims helps in filtering, searching, and analyzing large numbers of patent claims concurrently. Interactive claim charts generated by tools like ClaimScape® can be reviewed by technical experts to determine the applicability of scope concepts to target products or methods. This approach highlights areas where claim coverage is lacking and identifies future design opportunities[3].
Litigation and Enforcement
Patent Infringement Actions
The '459 Patent has been involved in patent infringement actions, as seen in various court documents. Understanding these legal proceedings is crucial for assessing the patent's enforceability and the potential risks or opportunities associated with it[2].
Conclusion
The '459 Patent is a significant asset in the pharmaceutical industry, particularly in the realm of extended and immediate release drug delivery systems. By analyzing its scope, claims, and the broader patent landscape, companies can better understand the protection it offers and identify areas for further innovation or potential legal challenges.
Key Takeaways
- The '459 Patent covers a pharmaceutical composition with an inner core of metformin hydrochloride and an outer coat of another API like linagliptin.
- The patent includes claims for the composition, method of manufacture, and use for treating medical conditions.
- It is part of a larger family of patents related to pharmaceutical compositions and drug delivery systems.
- Tools like the Global Dossier and CCD are essential for understanding the global and prior art context.
- Patent analytics and claim coverage matrices are vital for managing and optimizing the patent portfolio.
FAQs
What is the main subject of United States Patent 6,790,459?
The main subject of the '459 Patent is a pharmaceutical composition that includes an inner core formulation of metformin hydrochloride with an extended release material and an outer coat of another API, such as linagliptin, in an immediate release polymer film.
How does the '459 Patent fit into the broader patent landscape?
The '459 Patent is part of a larger family of patents related to pharmaceutical compositions and drug delivery systems. It is connected to other patents through the Global Dossier and prior art citations.
What tools can be used to analyze the claims and scope of the '459 Patent?
Tools such as the Claim Coverage Matrix, scope concepts, and interactive claim charts generated by software like ClaimScape® can be used to analyze the claims and scope of the patent.
Has the '459 Patent been involved in any litigation?
Yes, the '459 Patent has been involved in patent infringement actions, as documented in various court proceedings.
How can companies benefit from analyzing the '459 Patent?
Companies can benefit by understanding the protection offered by the patent, identifying gaps or opportunities in their own patent portfolio, and leveraging this information to drive innovation and strategic decision-making.
Sources
- USPTO, "Search for patents - USPTO," October 18, 2018.
- Insight.RPXcorp, "1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ...," [PDF].
- SLWIP, "Patent Analytics | Intellectual Property Law."
- Google Patents, "US20160106677A1 - Pharmaceutical composition and uses thereof - Google Patents."
