United States Patent 6,479,535 B1: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,479,535 B1, granted to James Harrison Pickar and Barry Samuel Komm on November 12, 2002, is a significant patent in the pharmaceutical sector. This patent, owned by Wyeth LLC, pertains to a pharmaceutical composition and methods of using the approved product, specifically conjugated estrogens/bazedoxifene. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Patent Details
- Patent Number: 6,479,535 B1
- Grant Date: November 12, 2002
- Expiration Date: May 6, 2019 (20 years from the filing date of May 6, 1999)[1].
Inventors and Assignee
- Inventors: James Harrison Pickar and Barry Samuel Komm
- Assignee: Wyeth LLC
Claims and Scope
Claim Structure
The patent includes several claims that define the scope of the invention:
- Claim 1: This claim describes a pharmaceutical composition comprising a pharmaceutically effective amount of 1-[4-(2-(Azepan-1-yl ethoxy)-benzyl]-2-(4-hydroxy-phenyl)-3-methyl-1H-indol-5-ol, or a pharmaceutically acceptable salt thereof, and a pharmaceutically effective amount of conjugated estrogens[1].
- Claims 2-5: These claims pertain to methods of using the approved product.
Patent Scope
The scope of the patent is defined by its claims, which cover both the composition and the methods of use. The patent scope is crucial as it determines the boundaries of what is protected under the patent. In this case, the patent protects a specific pharmaceutical composition and its therapeutic applications, particularly in the context of conjugated estrogens/bazedoxifene.
Regulatory Review and Patent Extension
Regulatory Background
The patent was subject to a regulatory review period, which is a critical factor in determining the eligibility for patent term extension under 35 U.S.C. § 156.
- IND Effective Date: March 15, 1998
- NDA Submission Date: October 3, 2012
- Approval Date: October 3, 2013[1][5].
Patent Term Extension
The patent was eligible for a term extension due to the lengthy regulatory review period. The total regulatory review period was 5,683 days, which included both the testing period and the application period. This period was used to calculate the maximum potential length of the patent extension[1][5].
Patent Landscape
Industry Context
The pharmaceutical industry is highly competitive and heavily reliant on intellectual property protection. Patents like 6,479,535 B1 are vital for companies to protect their innovations and maintain market exclusivity.
Related Patents and Applications
The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including all related applications filed at participating IP Offices. This can help in understanding the broader patent landscape and identifying potential competitors or collaborators[3].
Metrics for Patent Scope
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length and independent claim count. These metrics can provide insights into the breadth and complexity of the patent claims. Narrower claims, as measured by these metrics, are often associated with a higher probability of grant and a shorter examination process[4].
Economic and Legal Implications
Patent Quality and Innovation
The quality of patents, including their scope and clarity, can significantly impact innovation. Broader or overly broad patents can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation. The examination process for this patent, as for many others, tends to narrow the scope of claims, ensuring that the granted patent is more focused and clear[4].
Expert Insights
Industry Experts
Industry experts often emphasize the importance of well-defined patent claims in protecting intellectual property while avoiding unnecessary litigation. For example, Alan C. Marco and Joshua D. Sarnoff, in their research on patent claims and scope, highlight the need for clear and narrow claims to ensure patent quality and facilitate innovation[4].
Statistical Analysis
Regulatory Review Period
The regulatory review period for this patent was extensive, spanning over 5,683 days. This period is significant because it directly impacts the patent term extension. According to the FDA, the regulatory review period is a critical factor in determining the eligibility and length of patent term extensions[1][5].
Key Takeaways
- Patent Scope: The patent protects a specific pharmaceutical composition and methods of use related to conjugated estrogens/bazedoxifene.
- Regulatory Review: The patent underwent a lengthy regulatory review period, making it eligible for a patent term extension.
- Patent Landscape: The patent is part of a broader landscape in the pharmaceutical industry, where intellectual property protection is crucial.
- Metrics for Patent Scope: Independent claim length and count are important metrics in assessing patent scope and quality.
- Economic and Legal Implications: The clarity and breadth of patent claims can significantly impact innovation and litigation costs.
FAQs
What is the main subject of United States Patent 6,479,535 B1?
The main subject of this patent is a pharmaceutical composition comprising conjugated estrogens and bazedoxifene, along with methods of using this composition.
Who are the inventors of this patent?
The inventors are James Harrison Pickar and Barry Samuel Komm.
What is the significance of the regulatory review period for this patent?
The regulatory review period, which lasted 5,683 days, was crucial in determining the eligibility and length of the patent term extension under 35 U.S.C. § 156.
How does the scope of this patent impact its protection?
The scope, defined by the claims, protects the specific pharmaceutical composition and its therapeutic applications, ensuring that Wyeth LLC maintains exclusivity over this invention.
What metrics are used to measure patent scope?
Independent claim length and independent claim count are commonly used metrics to measure patent scope and assess the quality of the patent.
How does the patent term extension affect the patent's expiration date?
The patent term extension, based on the regulatory review period, can extend the patent's expiration date beyond the standard 20-year term from the filing date.
Sources
- Wyeth LLC. Application for Extension of the Term of United States Patent No. 6,479,535 B1 Under 35 U.S.C. § 156. Received November 29, 2013.
- USPTO. Patent Claims Research Dataset. August 28, 2017.
- USPTO. Search for Patents. October 18, 2018.
- Marco, Alan C., Sarnoff, Joshua D., and deGrazia, Charles. Patent Claims and Patent Scope. USPTO Economic Working Paper 2016-04. September 29, 2016.
- Federal Register. Department of Health and Human Services. January 31, 2018.
