United States Patent 6,039,974: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,039,974, hereafter referred to as the '974 patent, is a significant patent in the pharmaceutical sector, particularly related to fexofenadine formulations. This patent is part of a larger portfolio of patents associated with fexofenadine, a widely used antihistamine. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Invention
The '974 patent is directed to fexofenadine formulations, specifically focusing on bilayer tablets that provide immediate release of the active ingredient. Fexofenadine is an antihistamine used to treat allergic reactions, and the formulation described in this patent aims to enhance its delivery and efficacy[2].
Scope of the Patent
The scope of the '974 patent is defined by its claims and the detailed description provided in the specification. The patent describes a bilayer tablet, which is a tablet made up of two distinct layers or discrete zones of granulations compressed together. This design allows for the immediate release of fexofenadine, which is crucial for its therapeutic effect[1].
Key Components of the Invention
- Bilayer Tablet: The patent emphasizes the two-layer nature of the tablet, where each layer is composed of different formulations. This design is critical for the immediate release of the active ingredient[1].
- Granulations: The specification highlights that the discrete zones must be "compressed together" and not individually compressed. This ensures that the layers are integrated into a single tablet[1].
Claims Construction
The claims of the '974 patent have been subject to detailed construction in various legal proceedings. Here are some key points:
Markman Hearing
During a Markman hearing, the court construed several terms related to the patent. The term "bilayer tablet" was found to be a defining aspect of the invention, limiting the scope of the claims. The court emphasized that the specification and the prosecution history are crucial in understanding the intended meaning of the claim language[2].
Definition of Terms
- Discrete Zone: The court defined "discrete zone" as "a separate region of granulation, including for example a separate layer." This definition is derived from the specification, which describes the layered tablet as having distinct layers compressed together[1].
- Layered Tablet: The specification defines a layered tablet as one made up of two or more distinct layers or discrete zones of granulations compressed together[1].
Patent Landscape
The '974 patent is part of a larger landscape of patents related to fexofenadine formulations and processes.
Related Patents
- Formulation Patents: Besides the '974 patent, there are other patents directed to fexofenadine formulations, including United States Patent Numbers 5,855,912, 6,113,942, and 5,738,872. These patents share similar specifications and claims directed to different populations[2].
- Method Patents: There are also patents related to the process of making piperidine derivatives, such as United States Patent Numbers 7,390,906 and 5,750,703. These patents share substantially identical written descriptions[2].
Global Patent System
The '974 patent is part of an international patent family, with related applications filed in various IP offices. Tools like the Global Dossier and Common Citation Document (CCD) facilitate the management and search of these related applications across different jurisdictions[4].
Importance in Pharmaceutical Industry
The '974 patent holds significant importance in the pharmaceutical industry for several reasons:
Immediate Release Formulation
The bilayer tablet design allows for immediate release of fexofenadine, which is crucial for its therapeutic efficacy. This formulation enhances patient compliance and ensures rapid onset of action[1].
Market Impact
Patents like the '974 patent protect innovative formulations, allowing pharmaceutical companies to recoup their investment in research and development. This protection is essential for driving innovation in the pharmaceutical sector.
Legal and Regulatory Considerations
The construction of claims in the '974 patent has been influenced by various legal precedents.
Claim Construction Principles
Courts consider the specification, prosecution history, and the intrinsic evidence when construing claim terms. The principle that the claims must be read in light of the specification is paramount, as it provides the single best guide to the meaning of a disputed term[2].
Prosecution History
The prosecution history of the patent can inform the meaning of the claim language, demonstrating how the inventor understood the invention and whether the inventor limited the invention during prosecution[2].
Key Takeaways
- Bilayer Tablet Design: The '974 patent describes a bilayer tablet with immediate release properties, enhancing the delivery of fexofenadine.
- Claims Construction: The court has defined key terms like "discrete zone" and "layered tablet," which are crucial for understanding the scope of the patent.
- Related Patents: The patent is part of a broader portfolio of patents related to fexofenadine formulations and processes.
- Global Patent System: Tools like the Global Dossier and CCD facilitate the management of related applications across different jurisdictions.
- Importance in Pharmaceutical Industry: The patent protects an innovative formulation that enhances patient compliance and therapeutic efficacy.
FAQs
What is the main subject of United States Patent 6,039,974?
The main subject of the '974 patent is a bilayer tablet formulation of fexofenadine, designed for immediate release.
How does the bilayer tablet design enhance the delivery of fexofenadine?
The bilayer tablet design allows for the immediate release of fexofenadine, ensuring rapid onset of action and enhancing patient compliance.
What are the key components of the invention described in the '974 patent?
The key components include the bilayer tablet design and the granulations that are compressed together to form the distinct layers.
How have courts construed the claims of the '974 patent?
Courts have construed the claims by considering the specification, prosecution history, and intrinsic evidence, defining terms like "discrete zone" and "layered tablet."
What is the significance of the '974 patent in the pharmaceutical industry?
The patent protects an innovative formulation that enhances therapeutic efficacy and patient compliance, driving innovation in the pharmaceutical sector.
Sources
- United States District Court: "NOT FOR PUBLICATION UNITED STATES DISTRICT COURT" - Case 3:10-cv-01471-GEB-TJB Document 75 Filed 01/11/11.
- United States District Court: "NOT FOR PUBLICATION UNITED STATES DISTRICT COURT" - Case 2:02-cv-01322-GEB-MCA Document 348 Filed 01/13/11.
- USPTO: "Patent Claims Research Dataset" - USPTO Economic Working Paper 2016-04.
- USPTO: "Search for patents - USPTO" - Public Search Facility and Global Dossier.
