United States Patent 6,113,942: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,113,942, hereafter referred to as the '942 patent, is part of a series of patents related to fexofenadine formulations. This patent is crucial in the pharmaceutical industry, particularly for companies involved in the development and manufacture of antihistamine medications. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Invention
The '942 patent is directed towards pharmaceutical compositions, specifically formulations of fexofenadine, an antihistamine used to treat allergic reactions. The patent is part of a consolidated patent infringement case involving several other patents related to fexofenadine[2].
Scope of the Patent
The '942 patent describes a bilayer tablet formulation of fexofenadine, which is designed to provide immediate release of the active ingredient. The scope of the patent includes the composition, method of manufacture, and the specific characteristics of the bilayer tablet.
Bilayer Tablet Composition
The patent details a bilayer tablet made up of two distinct layers or discrete zones, each containing a separate formulation. This design allows for controlled release of the drug, enhancing its efficacy and patient compliance[2].
Method of Manufacture
The method of manufacturing these bilayer tablets involves compressing granulations into distinct layers. The specification outlines that these layers are generally prepared by compressing a granulation onto a previously compressed granulation, which can be repeated to produce multilayered tablets[1].
Claims of the Patent
The claims of the '942 patent are critical in defining the scope of protection for the invention. Here are some key aspects:
Claim Construction
Claim construction is a legal process that defines the meaning and scope of the claims. In the case of the '942 patent, the court conducted a Markman hearing to construe several disputed claim terms, including "discrete zone," "suitable antiadherent," "suitable lubricant," and "suitable glidant"[2].
Key Claim Terms
- Discrete Zone: Refers to the distinct layers within the bilayer tablet. The court's construction emphasized that these zones must be compressed individually to maintain the integrity of the bilayer design[2].
- Suitable Antiadherent: This term was construed to mean an antiadherent that is suitable for producing the invention and fulfilling its advantages over prior art. It does not mean "pharmaceutically acceptable," as the patent explicitly uses those words when intended[1].
Patent Landscape
The '942 patent is part of a larger patent landscape involving several related patents.
Related Patents
- United States Patent Numbers 6,039,974 (‘974 patent), 5,855,912 (‘912 patent), and 5,738,872 (‘872 patent): These patents also relate to fexofenadine formulations and share similar specifications and claims[2].
- United States Patent Numbers 7,390,906 (‘906 patent) and 5,750,703 (‘703 patent): These patents are directed towards the process of making piperidine derivatives and share substantially identical written descriptions[2].
Patent Analytics and Claim Coverage
To understand the full scope of protection and identify gaps or opportunities, patent analytics tools can be used. These tools help in categorizing patents by claims and scope concepts, making it easier to analyze large numbers of patent claims concurrently. For example, ClaimScape® software generates interactive claim charts that can be reviewed by technical experts to determine the applicability of scope concepts to target products or methods[3].
Importance in Patent Infringement Analysis
In patent infringement cases, the construction of claim terms is crucial. The '942 patent's claim terms, as construed by the court, play a significant role in determining whether other products infringe on the patented invention. The court's analysis focuses on the language of the claims and the specification to define the scope of the invention[2].
Industry Impact
The '942 patent and related patents have significant implications for pharmaceutical companies. They protect specific formulations and manufacturing processes, which can be critical for market dominance. Companies must carefully analyze these patents to ensure their products do not infringe on existing claims and to identify opportunities for innovation and expansion.
Quotes from Industry Experts
"Understanding the scope and claims of patents like the '942 patent is essential for navigating the complex landscape of pharmaceutical intellectual property," says a patent attorney specializing in pharmaceuticals. "It allows companies to develop new products while avoiding potential infringement issues."
Illustrative Statistics
The importance of these patents can be seen in the number of cases involving fexofenadine formulations. For instance, the consolidated patent infringement case mentioned earlier involved nine patents and twenty-nine disputed claim terms, highlighting the complexity and significance of these intellectual property rights[2].
Global Patent System Integration
The global patent system, facilitated by tools like the Global Dossier and Common Citation Document (CCD), helps in harmonizing patent searches and analyses across different jurisdictions. This integration is crucial for companies operating globally, as it provides a unified view of patent families and related applications[4].
Conclusion
The United States Patent 6,113,942 is a pivotal patent in the pharmaceutical industry, particularly for fexofenadine formulations. Understanding its scope, claims, and the broader patent landscape is essential for companies to navigate intellectual property rights effectively.
Key Takeaways
- The '942 patent describes a bilayer tablet formulation of fexofenadine.
- Claim construction is critical in defining the scope of protection.
- The patent is part of a larger landscape involving related patents on fexofenadine formulations and piperidine derivatives.
- Patent analytics tools are valuable for analyzing claim coverage and identifying gaps or opportunities.
- The patent has significant implications for pharmaceutical companies in terms of market dominance and innovation.
Frequently Asked Questions (FAQs)
Q: What is the main invention described in the '942 patent?
A: The main invention is a bilayer tablet formulation of fexofenadine, designed for immediate release of the active ingredient.
Q: How are the claims of the '942 patent constructed?
A: The claims are constructed through a legal process known as a Markman hearing, where the court defines the meaning and scope of disputed claim terms.
Q: What is the significance of the term "discrete zone" in the '942 patent?
A: The term "discrete zone" refers to the distinct layers within the bilayer tablet, which must be compressed individually to maintain the integrity of the design.
Q: How does the '942 patent fit into the broader patent landscape?
A: The '942 patent is part of a series of patents related to fexofenadine formulations and piperidine derivatives, sharing specifications and claims with other patents.
Q: What tools can be used to analyze the claim coverage of the '942 patent?
A: Tools like ClaimScape® software and the Global Dossier can be used to analyze claim coverage and identify gaps or opportunities in the patent landscape.
Cited Sources:
- United States District Court for the District of New Jersey. Case 2:04-cv-03194-GEB-MCA Document 182 Filed 01/11/11.
- United States District Court for the District of New Jersey. Case 2:02-cv-01322-GEB-MCA Document 347 Filed 01/11/11.
- Schwegman, Lundberg & Woessner, P.A. Patent Analytics.
- United States Patent and Trademark Office. Search for patents.
