United States Patent 7,041,319: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,041,319, titled "Fenofibrate Pharmaceutical Composition Having High Bioavailability," is a significant patent in the pharmaceutical industry, particularly in the realm of lipid-lowering drugs. This patent, owned by Laboratoires Fournier S.A. and exclusively licensed to Abbott Laboratories, plays a crucial role in protecting the intellectual property related to fenofibrate formulations.
Background of the Patent
The patent 7,041,319 is part of a series of patents related to fenofibrate, a drug used to lower cholesterol levels and treat conditions such as hyperlipidemia. The patent was issued to Laboratoires Fournier S.A. and is one of the "Patents-in-Suit" in a notable patent infringement case against Teva Pharmaceuticals USA, Inc.[2].
Scope of the Patent
The scope of the patent 7,041,319 is focused on a specific pharmaceutical composition of fenofibrate that enhances its bioavailability. Bioavailability refers to the extent to which the body can absorb and utilize the drug. The patent describes formulations and methods for preparing fenofibrate compositions that achieve higher bioavailability, which is critical for the drug's efficacy.
Claims of the Patent
The patent includes several claims that define the scope of the invention. These claims typically cover:
- The specific composition of fenofibrate and other ingredients that enhance its bioavailability.
- The methods of preparing these compositions.
- The use of these compositions for treating conditions related to high cholesterol levels.
For instance, the claims might specify the exact formulation, the process of manufacturing, and the therapeutic uses of the fenofibrate composition[2].
Patent Landscape
Related Patents
The patent 7,041,319 is part of a family of patents related to fenofibrate formulations. Other patents in this family include U.S. Patent Nos. 6,277,405 and 7,037,529, which also pertain to fenofibrate compositions and methods of preparation. These patents collectively protect the intellectual property surrounding the high-bioavailability fenofibrate formulations[2].
International Patents
The patent landscape extends beyond the United States. Similar patents have been filed in other countries to protect the global intellectual property rights of the fenofibrate compositions. For example, the European Patent Office (EPO) and other international intellectual property offices have corresponding patents that cover similar claims and compositions[1].
Expiration and Generic Entry
The patent 7,041,319, along with the other related patents, expired on January 9, 2018. The expiration of these patents allowed generic versions of fenofibrate to enter the market, which significantly impacted the pharmaceutical landscape for lipid-lowering drugs. Generic entry often leads to increased competition and reduced prices, benefiting consumers but potentially affecting the market share of the original patent holders[5].
Patent Infringement and Litigation
The patent 7,041,319 was at the center of a significant patent infringement case. Abbott Laboratories and Laboratoires Fournier S.A. sued Teva Pharmaceuticals USA, Inc. for filing an Abbreviated New Drug Application (ANDA) with the FDA to market a generic version of fenofibrate before the patent's expiration. The plaintiffs alleged that Teva's actions constituted an act of infringement under 35 U.S.C. § 271(e)(2)[2].
Search and Analysis Tools
For professionals and researchers interested in analyzing patents like 7,041,319, several tools are available:
USPTO Patent Public Search
The USPTO's Patent Public Search tool provides a comprehensive platform to search for patents, including those related to fenofibrate. This tool offers enhanced access to prior art and allows users to search through various interfaces[1].
Global Dossier
The Global Dossier service allows users to view the file histories of related applications from participating IP Offices, including the IP5 Offices. This service is particularly useful for understanding the global patent landscape and identifying office actions related to the patent family[1].
Common Citation Document (CCD)
The CCD application consolidates citation data from participating IP Offices, enabling users to visualize search results for the same invention produced by several offices on a single page. This tool is invaluable for conducting thorough prior art searches and understanding the broader patent landscape[1].
Key Takeaways
- Patent Scope: The patent 7,041,319 specifically covers fenofibrate compositions with enhanced bioavailability.
- Claims: The patent includes claims related to the composition, preparation methods, and therapeutic uses.
- Related Patents: It is part of a family of patents protecting similar fenofibrate formulations.
- International Protection: Corresponding patents exist in other countries to protect global intellectual property rights.
- Expiration and Generic Entry: The patent expired in 2018, allowing generic versions to enter the market.
- Litigation: The patent was involved in a significant infringement case against Teva Pharmaceuticals.
FAQs
Q: What is the main focus of United States Patent 7,041,319?
A: The main focus is on a fenofibrate pharmaceutical composition that has high bioavailability.
Q: Who are the owners of the patent 7,041,319?
A: The patent is owned by Laboratoires Fournier S.A. and exclusively licensed to Abbott Laboratories.
Q: What happened when the patent 7,041,319 expired?
A: The expiration allowed generic versions of fenofibrate to enter the market, increasing competition and reducing prices.
Q: What tools can be used to search and analyze patents like 7,041,319?
A: Tools such as the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) can be used.
Q: Why was Teva Pharmaceuticals sued in relation to this patent?
A: Teva was sued for filing an ANDA to market a generic version of fenofibrate before the patent's expiration, which was alleged to be an act of infringement.
Sources
- USPTO: Search for patents - USPTO
- Abbott Laboratories vs. Teva Pharmaceuticals: Complaint for Patent Infringement
- USPTO: Patent Claims Research Dataset
- NCSU Libraries: Patents Belonging to a Person or Organization
- DrugPatentWatch: Pharmaceutical drugs covered by patent 7,041,319
