United States Patent 8,372,872: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,372,872, hereafter referred to as the '872 patent, is a critical patent in the pharmaceutical sector, particularly involving the drug Febuxostat, which is used to treat gout. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The '872 patent is owned by Takeda Pharmaceutical Company and is related to Febuxostat, a xanthine oxidase inhibitor marketed under the brand name Uloric®. This patent is part of a series of patents that protect the formulation, use, and manufacturing process of Febuxostat[2][5].
Scope of the Patent
The '872 patent specifically covers the formulation and use of Febuxostat in treating gout. Here are some key aspects of its scope:
Claims
The patent includes claims that are directed towards the composition of Febuxostat, its method of use, and the process of manufacturing it. These claims are crucial in defining the boundaries of what is protected under this patent. For instance, the claims might include specific dosages, formulations, and administration methods that are unique to Uloric®[2].
Infringement
Any generic version of Febuxostat that matches the protected claims would be considered an infringement. This is evident from the legal actions taken by Takeda against generic manufacturers like Aurobindo Pharma and Torrent, who filed Abbreviated New Drug Applications (ANDAs) with the FDA, which were deemed to infringe on the '872 patent[2][5].
Claims Analysis
Independent and Dependent Claims
The '872 patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding additional limitations. For example, an independent claim might cover the composition of Febuxostat, while a dependent claim might specify a particular dosage form or method of administration[3].
Claim Construction
The construction of claims is critical in determining the scope of protection. In patent litigation, claim construction is often a contentious issue, as it can significantly impact the outcome of infringement cases. The courts use various tools, including the patent specification, prosecution history, and expert testimony, to interpret the claims[2].
Patent Landscape
Related Patents
The '872 patent is part of a family of patents related to Febuxostat. Other patents in this family include the '474, '676, and '912 patents, which collectively provide comprehensive protection for Uloric®. These patents cover various aspects such as the chemical composition, manufacturing process, and therapeutic uses of Febuxostat[2][5].
Global Patent Protection
The protection of Febuxostat is not limited to the United States. Takeda has secured patents in multiple jurisdictions through the Patent Cooperation Treaty (PCT) and national patent offices. This global protection ensures that generic versions of Febuxostat cannot be easily introduced in other markets without infringing on Takeda's patents[1].
Patent Expiration and Extensions
The expiration dates of these patents are crucial for generic manufacturers. The '872 patent, like other patents in its family, has a specific expiration date, which can be extended under certain conditions such as patent term extensions or exclusivity periods. These extensions can delay the entry of generic competitors into the market[2][5].
Legal and Regulatory Aspects
ANDA Filings and Certification
Generic manufacturers seeking to market their versions of Febuxostat must file an ANDA with the FDA. As part of this process, they must certify their product does not infringe on the existing patents or that the patents are invalid. Takeda has successfully argued in court that such certifications by generic manufacturers constitute an act of infringement under 35 U.S.C. § 271(e)(2)(A)[2][5].
Injunctions and Relief
In cases of infringement, Takeda has sought and obtained preliminary and permanent injunctions to prevent the commercial manufacture, use, sale, or importation of generic versions of Febuxostat. These injunctions are critical in protecting Takeda's market exclusivity until the patents expire[2][5].
Tools and Resources for Patent Searching
To navigate the complex landscape surrounding the '872 patent, several tools and resources are available:
Patent Public Search
The USPTO's Patent Public Search tool allows for comprehensive searching of U.S. patents and published patent applications. This tool is essential for identifying prior art and understanding the scope of existing patents[4].
Global Dossier
The Global Dossier service provides access to the file histories of related applications from participating IP offices, helping users to see the patent family for a specific application and identify potential infringement issues[4].
Patent and Trademark Resource Centers (PTRCs)
PTRCs offer local search resources and training in patent search techniques, which can be invaluable for conducting thorough searches related to the '872 patent[4].
Key Takeaways
- Scope and Claims: The '872 patent covers specific formulations, uses, and manufacturing processes of Febuxostat.
- Infringement: Generic manufacturers must avoid infringing on the protected claims to market their products.
- Patent Landscape: The '872 patent is part of a broader family of patents providing comprehensive protection for Uloric® globally.
- Legal and Regulatory: ANDA filings, certifications, and court injunctions are critical in protecting patent rights.
- Tools and Resources: Utilizing tools like Patent Public Search, Global Dossier, and PTRCs is essential for navigating the patent landscape.
FAQs
Q: What is the '872 patent related to?
A: The '872 patent is related to Febuxostat, a xanthine oxidase inhibitor marketed under the brand name Uloric®, used to treat gout.
Q: What are the key claims of the '872 patent?
A: The key claims include the composition of Febuxostat, its method of use, and the process of manufacturing it.
Q: How do generic manufacturers infringe on the '872 patent?
A: Generic manufacturers infringe on the '872 patent by filing ANDAs with the FDA that certify their product does not infringe on the existing patents or that the patents are invalid.
Q: What tools are available for searching patents related to the '872 patent?
A: Tools such as the USPTO's Patent Public Search, Global Dossier, and Patent and Trademark Resource Centers (PTRCs) are available.
Q: What is the significance of patent expiration and extensions for the '872 patent?
A: Patent expiration and extensions determine when generic versions of Febuxostat can enter the market, with extensions potentially delaying generic competition.
Sources
- Clemson University Libraries - Research and Course Guides: Patent Searching, Advanced[1]
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Case 1:17-cv-01314-VAC-MPT Document 1 Filed 09/15/17[2]
- USPTO - Patent Claims Research Dataset[3]
- USPTO - Search for patents[4]
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Case related to Uloric® and generic manufacturers[5]
