United States Patent 6,838,464: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,838,464, titled "2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineoplastic agents," is a patent that revolves around the discovery and application of specific pyrimidine compounds as anticancer agents. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention
The patent, issued on January 4, 2005, is based on the discovery that certain 2,4-pyrimidine compounds exhibit selective inhibition of cell cycle kinases, which are crucial in the proliferation of cancer cells. These compounds are designed to target and inhibit specific kinases involved in the cell cycle, thereby acting as antineoplastic agents[4][5].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific inventions and their applications that are protected.
Independent Claims
The patent includes multiple independent claims that define the core of the invention. These claims typically describe the chemical structure of the 2,4-pyrimidine compounds, their synthesis, and their use as antineoplastic agents.
Dependent Claims
Dependent claims further specify the invention by detailing various aspects such as specific substituents, methods of preparation, and pharmaceutical compositions. These claims build upon the independent claims and provide additional protection for specific embodiments of the invention.
Claim Analysis
Independent Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be significant metrics. Independent claim length (ICL) and independent claim count (ICC) are used to measure the breadth and complexity of patent claims. In the case of US 6,838,464, the independent claims are detailed and specific, indicating a focused scope rather than overly broad claims[3].
Claim Clarity and Validity
The clarity and validity of claims are critical for patent quality. The claims in this patent are detailed and specific, reducing the likelihood of ambiguity and potential litigation issues. This clarity is essential for ensuring that the patent provides a clear boundary of protection without encroaching on prior art or other existing patents.
Patent Landscape
Prior Art and Related Patents
The patent landscape surrounding US 6,838,464 includes other patents related to antineoplastic agents and pyrimidine compounds. Prior art in this field is extensive, with numerous patents covering various aspects of cancer treatment. The unique aspect of this patent lies in the specific chemical structures and their selective inhibition of cell cycle kinases[4].
Competitors and Litigation
In the pharmaceutical industry, patent litigation is common, especially when generic versions of drugs are involved. While US 6,838,464 does not appear to be involved in high-profile litigation, the broader landscape includes cases like those involving Gilead Sciences, where generic manufacturers seek to market versions of patented drugs before the expiration of the original patents[2].
Examination Process and Maintenance
The examination process for this patent would have involved a thorough review by the USPTO to ensure that the claims were novel, non-obvious, and enabled. The patent's maintenance involves periodic payments to keep the patent in force. The examination process tends to narrow the scope of patent claims, ensuring that they are more specific and less likely to be challenged[3].
Statistical and Economic Impact
Forward Citations and Patent Maintenance Payments
Patents with narrower claims at publication tend to have a higher probability of grant and shorter examination processes. For US 6,838,464, the forward citations and patent maintenance payments can indicate its impact and relevance in the field. Higher forward citations suggest that the patent has influenced subsequent research and innovation[3].
Economic Impact
The economic impact of this patent is tied to the development and commercialization of the antineoplastic agents described. The protection provided by the patent allows the inventor to recoup investment in research and development, which can lead to further innovation in cancer treatment.
Expert Insights and Industry Trends
Industry experts often highlight the importance of clear and specific patent claims in the pharmaceutical sector. For example, the Federal Trade Commission has noted concerns about overly broad and unclear claims in software and biotechnology patents, which can impede innovation[3].
Illustrative Statistics
- Patent Scope Metrics: Studies have shown that patents with narrower claims have a higher grant rate and shorter examination times. For instance, a study by the USPTO found that patents with shorter independent claims had a higher probability of grant[3].
- Forward Citations: Patents that receive more forward citations are generally considered more influential. As of the last update, US 6,838,464 has been cited in several subsequent patents, indicating its relevance in the field of antineoplastic agents.
Key Takeaways
- Specific Claims: The patent's claims are specific and detailed, reducing ambiguity and potential litigation.
- Patent Landscape: The patent is part of a broader landscape of patents related to antineoplastic agents and pyrimidine compounds.
- Economic Impact: The patent's protection allows for the commercialization of the antineoplastic agents, contributing to innovation in cancer treatment.
- Industry Trends: Clear and specific claims are crucial in the pharmaceutical sector to avoid litigation and ensure innovation.
FAQs
What is the main invention described in US 6,838,464?
The main invention is the discovery and application of 2,4-pyrimidine compounds as antineoplastic agents, specifically targeting cell cycle kinases.
How does the patent landscape affect this invention?
The patent landscape includes numerous patents related to antineoplastic agents and pyrimidine compounds. The specific claims in US 6,838,464 distinguish it from prior art and other existing patents.
What are the implications of claim clarity and validity?
Clear and valid claims ensure that the patent provides a clear boundary of protection, reducing the likelihood of ambiguity and potential litigation issues.
How does the examination process impact the patent?
The examination process tends to narrow the scope of patent claims, ensuring they are more specific and less likely to be challenged. This process is crucial for maintaining the patent's validity.
What is the economic impact of this patent?
The patent allows the inventor to commercialize the antineoplastic agents, recoup investment in research and development, and contribute to further innovation in cancer treatment.
Cited Sources
- US Patent and Trademark Office, "IN THE UNITED STATES PATENT AND TRADEMARK OFFICE" [PDF].
- RPX Insight, "IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE GILEAD SCIENCES, INC., Plaintiff, v. APOTEX, INC., LUPIN LIMITED, LAURUS LABS LIMITED, SHILPA MEDICARE LIMITED, SUNSHINE LAKE PHARMA CO., LTD., NATCO PHARMA LIMITED, CIPLA LIMITED, MACLEODS PHARMACEUTICALS LTD., HETERO USA INC., HETERO LABS LIMITED UNIT-V, AND HETERO LABS LIMITED" [PDF].
- Hoover Institution, "Patent Claims and Patent Scope" [PDF].
- Google Patents, "US6838464B2 - 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents".
- PubChem, "2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents".
