United States Patent 5,795,864: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,795,864, titled "Stable omega conopetide formulations," is a significant patent in the field of pharmaceuticals, particularly in the stabilization of omega conotoxin peptide preparations. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Context
The patent, granted to Elan Pharmaceuticals, Inc., addresses the stabilization of omega conotoxin peptides, which are crucial for various medical applications. Omega conotoxins are known for their potent analgesic properties and are used in drugs like PRIALT (ziconotide), which is a synthetic version of the omega-conotoxin MVIIA[5].
Scope of the Patent
The scope of the patent revolves around the formulation and stabilization of omega conotoxin peptides. Here are the key aspects:
Formulations
The patent describes novel formulations designed to stabilize omega conotoxin peptide preparations at elevated temperatures. These formulations are critical for maintaining the efficacy and shelf life of the peptides[5].
Stabilization Methods
The patent outlines various methods for stabilizing the peptides, including the use of specific buffers, pH levels, and other stabilizing agents. These methods ensure that the peptides remain effective over a longer period, even under adverse conditions[5].
Claims of the Patent
The claims of the patent are the heart of its legal protection and define the scope of the invention. Here are some key claims:
Claim 1: Formulation Composition
The first claim typically describes the broadest aspect of the invention, which in this case involves a formulation comprising an omega conotoxin peptide, a buffer, and at least one stabilizing agent[5].
Claim 2-10: Specific Formulations and Methods
Subsequent claims narrow down the scope by specifying particular buffers, pH ranges, and other components that enhance stability. These claims also cover various methods of preparing these formulations[5].
Patent Landscape
Understanding the patent landscape is crucial for assessing the patent's impact and potential challenges.
Related Patents
Other patents related to omega conotoxin peptides and their stabilization include U.S. Patent No. 5,364,842, also held by Elan Pharmaceuticals. These patents collectively form a robust portfolio protecting the company's intellectual property in this area[1].
Competitors and Market
The patent landscape in the pharmaceutical industry is highly competitive. Companies like Pfizer, Merck, and others are actively involved in developing and patenting new formulations and delivery methods for analgesic peptides. The presence of these competitors highlights the importance of robust patent protection[4].
Regulatory Review and Patent Term Extension
The regulatory review process for drugs like PRIALT, which is protected by this patent, is extensive. The FDA's verification of the regulatory review period is crucial for determining patent term extensions. For U.S. Patent No. 5,795,864, the regulatory review period was significant, with 1,973 days during the testing phase and 1,828 days during the approval phase, leading to a request for a patent term extension of 1,228 days[1].
Patent Analytics and Claim Coverage
To fully understand the value and coverage of this patent, patent analytics tools are essential. These tools help in categorizing patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities. For example, a Claim Coverage Matrix can show which patents and claims are actively protecting the intellectual property related to omega conotoxin peptides[4].
Global Dossier and International Implications
The Global Dossier service provided by the USPTO allows users to access file histories of related applications from participating IP Offices. This service is crucial for understanding the global patent landscape and ensuring that the patent protection is comprehensive across different jurisdictions[3].
Public Search and Access
The USPTO's Patent Public Search tool and other resources like the Patent and Trademark Resource Centers (PTRCs) provide public access to patent information. These tools are vital for conducting thorough searches and ensuring that any new developments do not infringe on existing patents like U.S. Patent No. 5,795,864[3].
Common Citation Document (CCD)
The CCD application consolidates prior art cited by all participating offices for the family members of a patent application. This tool helps in visualizing the search results for the same invention produced by several offices, ensuring that the patent's claims are well-supported and distinct from prior art[3].
Patent Assignment and Ownership
Tracking patent assignments and changes in ownership is crucial for maintaining the integrity of the patent portfolio. The Patent Assignment Search website provided by the USPTO facilitates this process, ensuring that all stakeholders are aware of the current ownership status of patents like U.S. Patent No. 5,795,864[3].
Key Takeaways
- Stabilization Formulations: The patent provides novel formulations for stabilizing omega conotoxin peptides.
- Regulatory Review: The extensive regulatory review period is a critical factor in determining patent term extensions.
- Patent Analytics: Tools like Claim Coverage Matrix are essential for understanding the patent's value and identifying gaps in coverage.
- Global Implications: The patent's protection extends globally, with tools like the Global Dossier facilitating international patent management.
- Public Access: Resources like the Patent Public Search tool ensure that the patent information is publicly accessible.
FAQs
Q: What is the primary focus of U.S. Patent No. 5,795,864?
A: The primary focus is on the stabilization of omega conotoxin peptide preparations through novel formulations.
Q: How does the regulatory review period impact the patent?
A: The regulatory review period is crucial for determining the patent term extension, with significant periods spent in testing and approval phases.
Q: What tools are available for analyzing the patent's claims and coverage?
A: Tools like the Claim Coverage Matrix and patent analytics software help in categorizing patents by claims and scope concepts.
Q: How can one access information about this patent globally?
A: The Global Dossier service provided by the USPTO allows access to file histories of related applications from participating IP Offices.
Q: What is the significance of the Common Citation Document (CCD) in patent searching?
A: The CCD consolidates prior art cited by all participating offices, helping to visualize search results for the same invention across different offices.
Cited Sources
- Federal Register/Vol. 71, No. 50/Wednesday, March 15, 2006/Notices - GovInfo
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- Patent Analytics | Intellectual Property Law - SLWIP
- Stable omega conopetide formulations - Patent US-5795864-A - PubChem
