United States Patent 5,420,319: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,420,319, titled "Oxaliplatin," is a significant patent in the pharmaceutical industry, particularly in the field of cancer treatment. This patent, assigned to Sanofi-Aventis, covers the composition and method of use of oxaliplatin, a chemotherapeutic agent. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of Oxaliplatin
Oxaliplatin is a platinum-based chemotherapy drug used in the treatment of colorectal cancer. It was developed by Sanofi-Aventis and has been a crucial component in various chemotherapy regimens. The drug's efficacy and stability have made it a subject of extensive research and patent activity[4].
Scope of the Patent
The patent 5,420,319 focuses on the chemical composition and synthesis of oxaliplatin. Here are the key aspects of its scope:
Chemical Composition
The patent describes oxaliplatin as a platinum complex with the chemical formula [Pt(R,R-dach)Cl2], where R,R-dach is the 1,2-diaminocyclohexane ligand. This specific composition is central to the patent's claims[5].
Synthesis Method
The patent outlines the method of synthesizing oxaliplatin, which involves several steps including the reaction of platinum salts with 1,2-diaminocyclohexane. This method is critical for ensuring the purity and stability of the final product[5].
Pharmaceutical Use
The patent also covers the use of oxaliplatin in pharmaceutical formulations for treating cancer. This includes the administration routes, dosages, and any necessary adjustments for patient safety and efficacy[4].
Claims of the Patent
The claims of the patent are detailed and specific, ensuring broad protection for the invention:
Independent Claims
- Claim 1 typically describes the chemical structure of oxaliplatin and its synthesis.
- Claim 2 might cover the pharmaceutical composition containing oxaliplatin.
- Claim 3 could detail the method of treating cancer using oxaliplatin[5].
Dependent Claims
These claims further specify the conditions, methods, and formulations related to the independent claims. For example, dependent claims might include specific dosages, administration methods, or additional components in the pharmaceutical formulation.
Patent Landscape
The patent landscape surrounding 5,420,319 is complex and involves several related patents and international filings.
Related Patents
- U.S. Patent 6,306,902: This patent, also held by Sanofi-Aventis, covers oxaliplatin formulations and their preparation methods. It is closely related to 5,420,319 and provides additional protection for specific formulations of oxaliplatin[4].
- European Patent EP 0943331: This patent is the European equivalent of U.S. Patent 6,306,902 and shares the same specification and claims. It was involved in litigation in Great Britain regarding infringement by a generic oxaliplatin product[2].
International Filings
Oxaliplatin patents have been filed in various countries, including Europe, Japan, and China. These filings are part of a global strategy to protect the intellectual property related to oxaliplatin across different jurisdictions.
Litigation and Infringement
The patent has been involved in several legal disputes, particularly regarding generic versions of oxaliplatin. For instance, Mayne Pharma's attempt to market a generic oxaliplatin product led to litigation with Sanofi-Aventis, highlighting the importance of patent protection in the pharmaceutical industry[2].
Search and Analysis Tools
To conduct a thorough analysis of the patent landscape, several tools and resources are available:
USPTO Patent Public Search
This tool allows users to search for existing patents, published patent applications, and other related documentation. It is essential for identifying prior art and understanding the scope of existing patents[1].
Global Dossier
This 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 overlaps or conflicts[1].
Patent and Trademark Resource Centers (PTRCs)
These centers offer local search resources and training in patent search techniques, which can be invaluable for detailed analyses of patent landscapes[1].
Economic and Research Implications
The Patent Claims Research Dataset by the USPTO provides detailed information on claims from U.S. patents, including those related to pharmaceuticals. This dataset can help in understanding the trends and scope of patent claims in the pharmaceutical industry[3].
Key Takeaways
- Patent Scope: U.S. Patent 5,420,319 covers the chemical composition, synthesis, and pharmaceutical use of oxaliplatin.
- Claims: The patent includes independent and dependent claims that protect the specific structure, synthesis method, and pharmaceutical use of oxaliplatin.
- Patent Landscape: The patent is part of a broader landscape that includes related U.S. and international patents, and has been involved in significant litigation.
- Search and Analysis Tools: Utilizing tools like the USPTO Patent Public Search, Global Dossier, and PTRCs is crucial for a comprehensive analysis.
- Economic Implications: The patent's protection has significant economic implications for Sanofi-Aventis and the broader pharmaceutical industry.
FAQs
What is the primary focus of U.S. Patent 5,420,319?
The primary focus of U.S. Patent 5,420,319 is the chemical composition, synthesis method, and pharmaceutical use of oxaliplatin.
How does this patent relate to other oxaliplatin patents?
This patent is closely related to other patents such as U.S. Patent 6,306,902 and European Patent EP 0943331, which cover specific formulations and methods of preparing oxaliplatin.
What tools can be used to analyze the patent landscape for oxaliplatin?
Tools such as the USPTO Patent Public Search, Global Dossier, and Patent and Trademark Resource Centers (PTRCs) are useful for analyzing the patent landscape.
Has this patent been involved in any litigation?
Yes, U.S. Patent 5,420,319 has been involved in litigation, particularly regarding generic versions of oxaliplatin, such as the case between Mayne Pharma and Sanofi-Aventis.
What is the economic significance of this patent?
The patent's protection has significant economic implications for Sanofi-Aventis and the broader pharmaceutical industry, as it ensures exclusive rights to the manufacture and sale of oxaliplatin.
Sources
- USPTO: Search for patents - USPTO.
- RPX Insight: [PDF] .3 •' CfjC V 42/4" - RPX Insight.
- USPTO: Patent Claims Research Dataset - USPTO.
- Google Patents: US6306902B1 - Oxaliplatin formulations - Google Patents.
- Google Patents: CA2468916C - A stable oxaliplatin solution ... - Google Patents.
