United States Patent 6,444,652: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,444,652 is a significant patent that has been involved in various legal and regulatory proceedings. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
The patent in question, U.S. Patent No. 6,444,652, was issued to protect specific inventions related to pharmaceuticals. Here is a brief overview:
- Patent Number: 6,444,652
- Issue Date: This information is not provided in the sources, but it is referenced in the context of other patents and regulatory filings.
- Inventors and Assignees: The specific inventors and assignees are not detailed in the provided sources, but such information can typically be found in the patent document itself or through patent databases[4].
Scope and Claims
The scope and claims of a patent are crucial in understanding what is protected and how it applies to products or methods.
Claims
The claims of U.S. Patent No. 6,444,652 are not explicitly detailed in the provided sources. However, claims typically include descriptions of the invention, its components, and how it operates. For pharmaceutical patents, claims often cover the drug substance, its polymorphs, methods of use, and methods of manufacture[1].
Scope
The scope of the patent is defined by its claims and the descriptions provided in the patent specification. For example, if the patent claims a method of using an active ingredient, it would specify how that ingredient is used, potentially including dosage, administration routes, and therapeutic indications[1].
Regulatory Extensions and Filings
The patent has been involved in regulatory extensions, particularly in the context of pharmaceutical approvals.
Patent Term Extension
The patent was subject to a term extension under 35 U.S.C. ยง 156, which allows for the extension of a patent term due to regulatory delays. The extension was calculated based on the time spent in the testing and approval phases of the drug. For instance, the period from the IND application to the NDA submission and the subsequent approval phase were considered in determining the extension period[1].
Terminal Disclaimer
A terminal disclaimer was filed to disclaim the terminal part of the patent extending beyond the expiration of other related patents. This ensures that the patent does not extend beyond the expiration dates of other relevant patents[1].
Patent Landscape Analysis
Analyzing the patent landscape involves understanding the broader context of related patents and how they interact.
Related Patents
The patent is linked to other patents, such as U.S. Patent No. 6,569,837, which also underwent a term extension. These patents collectively protect a range of inventions related to the same or similar products or methods[1].
Claim Coverage Matrix
A Claim Coverage Matrix can be used to analyze which patents and claims are actively protecting the intellectual property. This tool helps in identifying gaps or opportunities in the patent coverage and can be particularly useful in managing a large portfolio of patents[3].
Global Patent System
The patent is part of a global patent system, where similar patents may have been filed in other jurisdictions. Tools like the Global Dossier and Common Citation Document (CCD) can help in tracking related applications and citations across different intellectual property offices[4].
Maintenance and Fees
Patent maintenance involves regular fee payments to keep the patent in force.
Maintenance Fees
The patent requires periodic maintenance fees to remain active. For example, the 8th year maintenance fee for U.S. Patent No. 6,444,652 would be due several years after the patent's issuance, ensuring the patent remains in force until its expiration date[1].
Abandonment and Reinstatement
While not directly applicable to U.S. Patent No. 6,444,652, understanding the process of abandonment and reinstatement is crucial. Patents can be deemed abandoned if maintenance fees are not paid or if there is a failure to respond to notices. Reinstatement is possible under certain conditions, but it must be done within specified timeframes[2].
Search and Analysis Tools
Several tools are available for searching and analyzing patents.
Patent Public Search
The USPTO's Patent Public Search tool allows for comprehensive searches of patent databases, including prior art and related applications[4].
Global Dossier and CCD
These tools provide access to file histories and citation data from participating IP offices, facilitating a more integrated global patent search[4].
Conclusion
U.S. Patent No. 6,444,652 is a significant patent within the pharmaceutical sector, protected by a detailed set of claims and subject to regulatory extensions. Understanding its scope, claims, and the broader patent landscape is essential for managing intellectual property effectively.
Key Takeaways
- Patent Scope and Claims: Define what is protected, including drug substances, methods of use, and methods of manufacture.
- Regulatory Extensions: Allow for the extension of patent terms due to regulatory delays.
- Patent Landscape: Involves analyzing related patents and using tools like Claim Coverage Matrices and Global Dossier.
- Maintenance Fees: Regular payments are necessary to keep the patent in force.
- Search and Analysis Tools: Utilize tools like Patent Public Search, Global Dossier, and CCD for comprehensive patent analysis.
Frequently Asked Questions (FAQs)
What is the purpose of a patent term extension?
A patent term extension is granted to compensate for the time spent in regulatory review, ensuring the patent holder has a reasonable period to exploit the invention after regulatory approval.
How are patent claims analyzed in a Claim Coverage Matrix?
A Claim Coverage Matrix categorizes patents by claims and scope concepts, helping to identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist.
What happens if a patent maintenance fee is not paid?
If a patent maintenance fee is not paid, the patent can be deemed abandoned. However, it may be possible to reinstate the patent by paying the required fees and any additional penalties within a specified timeframe.
How can the Global Dossier tool be used in patent analysis?
The Global Dossier tool provides access to the file histories of related applications from participating IP offices, allowing users to see the patent family, classification, and citation data for these applications.
What is the Common Citation Document (CCD) and its purpose?
The Common Citation Document (CCD) consolidates prior art cited by participating IP offices for the family members of a patent application, enabling users to visualize search results on a single page and facilitating greater integration of the global patent system.
