United States Patent 6,500,829: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,500,829, titled "Substantially pure diastereoisomers of tetrahydrofolate derivatives," is a patent that has significant implications in the pharmaceutical industry, particularly in the field of cancer treatment and folate chemistry. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent, filed by Spectrum Pharmaceuticals, Inc., pertains to the preparation and use of substantially pure diastereoisomers of tetrahydrofolate derivatives. These compounds are crucial in pharmaceutical compositions, especially in treatments involving leucovorin, a form of folate used in cancer therapy[4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are the key elements:
Claims
The patent includes multiple claims that cover various aspects of the invention:
- Composition Claims: These claims pertain to pharmaceutical compositions comprising substantially pure diastereoisomers of tetrahydrofolate derivatives combined with pharmaceutically acceptable carriers[4].
- Method Claims: These claims cover the methods for preparing these diastereoisomers, emphasizing the purity and specificity of the compounds[4].
- Use Claims: The patent also claims the use of these diastereoisomers in therapeutic applications, particularly in cancer treatment and other conditions where folate derivatives are beneficial[4].
Detailed Analysis of Claims
Composition Claims
These claims are central to the patent, as they define the specific compositions that are protected. For example, Claim 1 might specify a pharmaceutical composition comprising a substantially pure diastereoisomer of a tetrahydrofolate derivative and a pharmaceutically acceptable carrier. This claim ensures that any similar composition would infringe on this patent unless it significantly differs from the described composition[4].
Method Claims
The method claims detail the processes for preparing the diastereoisomers. These claims are important because they protect the specific steps and conditions under which the compounds are synthesized, ensuring that others cannot replicate the process without infringing on the patent.
Use Claims
Use claims are critical as they specify the therapeutic applications of the diastereoisomers. These claims ensure that the patent holder has exclusive rights to use these compounds in treatments such as cancer therapy, which is a significant market.
Patent Landscape
Related Patents and Applications
The patent is part of a larger family of patents and applications related to tetrahydrofolate derivatives. For instance:
- Priority Applications: The patent has priority dates back to 1986, with earlier applications such as US07/403,917 and US08/426,458, which indicate a long-standing research and development effort in this area[4].
- Continuation Applications: There are continuation applications like US10/228,820, which further expand on the original invention, indicating ongoing innovation and protection of related intellectual property[4].
International Patent Landscape
The invention is not isolated to the United States; it has international implications. Similar patents and applications may exist in other countries, such as those filed with the European Patent Office (EPO), Japan Patent Office (JPO), or the World Intellectual Property Organization (WIPO)[1].
Search and Analysis Tools
To understand the broader patent landscape, several tools and resources are available:
- Patent Public Search: This tool, provided by the USPTO, allows for comprehensive searches of prior art and related patents, helping to identify potential infringements or overlapping claims[1].
- Global Dossier: This service provides access to file histories and related applications from participating IP offices, facilitating a global view of the patent family[1].
- Common Citation Document (CCD): This application consolidates citation data from multiple offices, enabling a unified view of prior art citations related to the patent family[1].
Legal and Litigation Context
The patent has been involved in legal proceedings, such as the case of Spectrum Pharms., Inc. v. Sandoz Inc., where the claims were construed and the patent's validity was challenged. Such cases highlight the importance of precise claim construction and the potential for litigation in protecting intellectual property[2][5].
Economic and Market Impact
The economic impact of this patent is significant, given the importance of folate derivatives in cancer treatment. The exclusive rights granted by the patent allow the holder to control the market for these specific compounds, influencing pricing and availability. This can have broader implications for healthcare costs and treatment accessibility.
Key Takeaways
- Scope and Claims: The patent protects specific pharmaceutical compositions, methods of preparation, and therapeutic uses of substantially pure diastereoisomers of tetrahydrofolate derivatives.
- Patent Landscape: The patent is part of a larger family of related patents and applications, both domestically and internationally.
- Legal Context: The patent has been involved in legal proceedings, highlighting the importance of claim construction and litigation in intellectual property protection.
- Economic Impact: The patent has significant economic implications for the pharmaceutical industry, particularly in cancer treatment.
FAQs
What is the main subject of United States Patent 6,500,829?
The main subject is the preparation and use of substantially pure diastereoisomers of tetrahydrofolate derivatives in pharmaceutical compositions.
What are the key claims of the patent?
The key claims include composition claims for pharmaceutical compositions, method claims for preparing the diastereoisomers, and use claims for therapeutic applications.
How does the patent fit into the broader patent landscape?
The patent is part of a family of related patents and applications, with priority dates back to 1986 and international filings in various jurisdictions.
What tools can be used to analyze the patent landscape?
Tools such as Patent Public Search, Global Dossier, and Common Citation Document (CCD) can be used to analyze the patent landscape.
Has the patent been involved in any legal proceedings?
Yes, the patent was involved in the case of Spectrum Pharms., Inc. v. Sandoz Inc., where the claims were construed and the patent's validity was challenged.
What is the economic impact of this patent?
The patent has significant economic implications for the pharmaceutical industry, particularly in controlling the market for specific folate derivatives used in cancer treatment.
