Analyzing the Scope and Claims of United States Patent 8,592,450: A Comprehensive Guide
Introduction
United States Patent 8,592,450, titled "Methods of treating dry eye," is associated with the drug product known by the tradename XIIDRA® (lifitegrast). This patent is significant in the pharmaceutical industry, particularly in the treatment of dry eye syndrome. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
U.S. Patent 8,592,450 was issued on November 26, 2013, and it covers methods of using lifitegrast, a drug developed for treating dry eye syndrome. The patent is part of a series of patents related to lifitegrast, including U.S. Patent Nos. 7,314,938, 7,790,743, 8,084,047, and 8,168,655[2].
Scope of the Patent
The scope of U.S. Patent 8,592,450 is defined by its claims, which outline the specific methods and uses of lifitegrast in treating dry eye. The claims include various dosages, administration methods, and the therapeutic effects of the drug. Here is a breakdown of the key aspects:
Claims Overview
The patent includes multiple claims that detail the methods of treatment, dosage regimens, and the specific indications for lifitegrast. These claims are crucial in defining the intellectual property rights associated with the drug.
Method of Treatment
The patent describes methods of treating dry eye syndrome by administering lifitegrast, either alone or in combination with other therapeutic agents. The claims specify the dosage forms, such as eye drops, and the frequency of administration[2].
Dosage Regimens
The patent outlines various dosage regimens, including the concentration of lifitegrast and the duration of treatment. These regimens are designed to optimize the therapeutic effect while minimizing side effects.
Therapeutic Effects
The claims also describe the therapeutic effects of lifitegrast, including its ability to reduce inflammation and improve tear production in patients with dry eye syndrome.
Patent Claims Analysis
To understand the patent claims in depth, it is essential to analyze the claim structure and the dependencies between claims.
Claim Structure
The claims in U.S. Patent 8,592,450 are structured in a hierarchical manner, with independent claims and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding additional limitations.
Claim Dependencies
The dependencies between claims are critical in understanding the overall scope of the patent. For example, dependent claims may specify particular dosages or administration methods that are subsets of the broader methods described in the independent claims[3].
Patent Landscape
The patent landscape surrounding U.S. Patent 8,592,450 includes other related patents and international filings.
Related Patents
As mentioned earlier, there are several other patents related to lifitegrast, including U.S. Patent Nos. 7,314,938, 7,790,743, 8,084,047, and 8,168,655. These patents cover various aspects of the drug, such as its composition, synthesis, and other methods of treatment[2].
International Filings
The patent family for lifitegrast includes filings in multiple countries, accessible through databases such as the European Patent Office's esp@cenet, the Japan Patent Office, and the World Intellectual Property Organization's PATENTSCOPE® Search Service[1].
Patent Term Extension
U.S. Patent 8,592,450 was eligible for a patent term extension under 35 U.S.C. § 156 due to the regulatory review period for the drug product. The extension period was calculated based on the time spent in regulatory review, resulting in a 731-day extension[2].
Search and Analysis Tools
For a comprehensive analysis of the patent landscape, several tools and resources are available:
USPTO Patent Public Search
The USPTO's Patent Public Search tool provides enhanced access to prior art and allows users to search for patents and published patent applications[1].
Global Dossier
The Global Dossier service offers access to the file histories of related applications from participating IP Offices, including the IP5 Offices. This service is useful for analyzing the global patent family of lifitegrast[1].
Common Citation Document (CCD)
The CCD application consolidates prior art cited by multiple offices for the same invention, facilitating a more integrated view of the global patent landscape[1].
Economic and Research Implications
The Patent Claims Research Dataset provided by the USPTO can be used to analyze the scope and claims of U.S. Patent 8,592,450 in a broader economic context. This dataset includes detailed information on claims from U.S. patents and patent applications, which can help in understanding the trends and measurements of patent scope[3].
Key Takeaways
- Patent Scope: U.S. Patent 8,592,450 covers specific methods of treating dry eye syndrome using lifitegrast.
- Claims Analysis: The patent includes independent and dependent claims that define the scope of the invention.
- Patent Landscape: The patent is part of a larger family of patents related to lifitegrast, with international filings and related patents.
- Patent Term Extension: The patent was eligible for a 731-day extension due to regulatory review.
- Search and Analysis Tools: Various USPTO tools, such as Patent Public Search and Global Dossier, are essential for analyzing the patent landscape.
FAQs
What is the main subject of U.S. Patent 8,592,450?
U.S. Patent 8,592,450 covers methods of treating dry eye syndrome using the drug lifitegrast, known by the tradename XIIDRA®.
How was the patent term extension for U.S. Patent 8,592,450 calculated?
The patent term extension was calculated based on the regulatory review period for the drug product, resulting in a 731-day extension under 35 U.S.C. § 156[2].
What tools can be used to analyze the patent landscape for U.S. Patent 8,592,450?
Tools such as the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) can be used to analyze the patent landscape[1].
Are there other related patents to U.S. Patent 8,592,450?
Yes, there are several other patents related to lifitegrast, including U.S. Patent Nos. 7,314,938, 7,790,743, 8,084,047, and 8,168,655[2].
How can the Patent Claims Research Dataset be used in analyzing U.S. Patent 8,592,450?
The Patent Claims Research Dataset can be used to analyze the claims and scope of U.S. Patent 8,592,450 in a broader economic and research context, providing insights into patent scope measurements and trends[3].
Sources
- USPTO: Search for patents - USPTO. [Online]. Available: https://www.uspto.gov/patents/search
- USPTO: NOTICE OF FINAL DETERMINATION AND REQUIREMENT FOR ELECTION. [Online]. Available: https://downloads.regulations.gov/FDA-2018-E-3184-0007/attachment_1.pdf
- USPTO: Patent Claims Research Dataset - USPTO. [Online]. Available: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
