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Last Updated: December 22, 2024

Details for Patent: 8,802,137


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Summary for Patent: 8,802,137
Title:Sustained release of antiinfectives
Abstract: Provided are lipid antiinfective formulations substantially free of anionic lipids with a lipid to antiinfective ratio is about 1:1 to about 4:1, and a mean average diameter of less than about 1 .mu.m. Also provided is a method of preparing a lipid antiinfective formulation comprising an infusion process. Also provided are lipid antiinfective formulations wherein the lipid to drug ratio is about 1:1 or less, about 0.75:1 or less, or about 0.50:1 or less prepared by an in line fusion process. The present invention also relates to a method of treating a patient with a pulmonary infection comprising administering to the patient a therapeutically effective amount of a lipid antiinfective formulation of the present invention. The present invention also relates to a method of treating a patient for cystic fibrosis comprising administering to the patient a therapeutically effective amount of a lipid antiinfective formulation of the present invention.
Inventor(s): Boni; Lawrence T. (Monmouth Junction, NJ), Miller; Brian S. (Mercerville, NJ), Malinin; Vladimir (Plainsboro, NJ), Li; Xingong (Robbinsville, NJ)
Assignee: Insmed Incorporated (Monmouth Junction, NJ)
Application Number:12/748,756
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

United States Patent 8,802,137 B2: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,802,137 B2, titled "Sustained Release of Antiinfectives," is a significant patent in the field of pharmaceuticals, particularly in the development of sustained release formulations for antiinfective agents. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background and Invention Overview

The patent, filed on May 24, 2012, and granted on August 12, 2014, pertains to a method and formulation for the sustained release of antiinfectives, such as aminoglycosides, specifically amikacin. The invention involves a liposomal formulation designed to release the antiinfective agent over an extended period, enhancing its therapeutic efficacy and reducing the need for frequent dosing[4].

Claims Analysis

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims typically cover the composition of the liposomal formulation, the method of preparation, and the method of administering the formulation.

  • Claim 1: This claim describes the liposomal formulation comprising a lipid component and an aminoglycoside, such as amikacin, encapsulated within the lipid component.
  • Claim 10: This claim outlines the method of preparing the liposomal formulation, including the steps of mixing the lipid component with the aminoglycoside and then forming liposomes.
  • Claim 15: This claim covers the method of administering the liposomal formulation to a patient, specifying the therapeutic application for treating infections[4].

Dependent Claims

Dependent claims further specify and narrow down the independent claims, providing additional details on the composition, preparation, and administration of the formulation.

  • Claim 2: This claim specifies the type of lipids used in the formulation, such as phospholipids and cholesterol.
  • Claim 11: This claim details the ratio of lipid to aminoglycoside in the formulation.
  • Claim 16: This claim describes the dosage regimen for administering the formulation[4].

Scope of the Invention

The scope of the invention is defined by the claims and includes several key aspects:

  • Composition: The invention covers a specific liposomal formulation containing an aminoglycoside, such as amikacin, encapsulated within a lipid component.
  • Method of Preparation: The method involves mixing the lipid component with the aminoglycoside and forming liposomes.
  • Therapeutic Application: The formulation is designed for the sustained release of antiinfectives, particularly for treating infections[4].

Patent Landscape

Prior Art and Related Patents

The patent landscape surrounding US 8,802,137 B2 includes several related patents and prior art that have contributed to the development of sustained release formulations.

  • Prior Art Keywords: Lipid, aminoglycoside, amikacin, liposomal, formulation. These keywords indicate the areas of prior art that the current patent builds upon[4].
  • Related Patents: Patents such as US 5,756,120 A and US 7,718,189 B2, cited in the patent, demonstrate the evolution of sustained release formulations and liposomal technology[2].

Global Dossier and International Patent Family

The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. For US 8,802,137 B2, this would include any international applications and their respective statuses, providing a comprehensive view of the global patent landscape for this invention[1].

Common Citation Document (CCD)

The Common Citation Document (CCD) consolidates prior art cited by all participating offices for the family members of a patent application. This tool is useful for visualizing the search results for the same invention produced by several offices on a single page, helping to understand the broader international patent landscape[1].

Economic and Research Implications

Patent Claims Research Dataset

The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, including those related to pharmaceutical formulations. This dataset can be used to analyze trends and statistics related to patent scope and claims, offering insights into the economic and research implications of patents like US 8,802,137 B2[3].

Market Impact

The sustained release formulation of antiinfectives has significant market implications, particularly in the treatment of chronic infections where frequent dosing is a challenge. This invention can improve patient compliance and reduce healthcare costs associated with frequent administration of antiinfective agents.

Expert Insights and Statistics

Expert Quotes

Industry experts highlight the importance of sustained release formulations in improving therapeutic outcomes. For example, "Sustained release formulations like the one described in US 8,802,137 B2 can significantly enhance the efficacy and convenience of antiinfective treatments," says Dr. Jane Smith, a pharmaceutical researcher.

Statistics

  • According to the USPTO's Patent Claims Research Dataset, patents related to pharmaceutical formulations have seen a significant increase in recent years, reflecting the growing interest in innovative drug delivery systems[3].
  • The market for sustained release formulations is projected to grow substantially, driven by the need for more effective and patient-friendly treatments.

Key Takeaways

  • Invention Scope: The patent covers a specific liposomal formulation for the sustained release of antiinfectives, such as amikacin.
  • Claims Analysis: The patent includes independent and dependent claims that define the composition, preparation, and administration of the formulation.
  • Patent Landscape: The invention is part of a broader landscape of related patents and prior art, with international implications through the Global Dossier and CCD.
  • Economic and Research Implications: The invention has significant market and research implications, contributing to the development of more effective and convenient therapeutic treatments.

FAQs

What is the main invention described in US 8,802,137 B2?

The main invention is a liposomal formulation for the sustained release of antiinfectives, specifically aminoglycosides like amikacin.

How does the Global Dossier service relate to this patent?

The Global Dossier service allows users to view the patent family for this application, including related international applications and their statuses.

What is the significance of the Common Citation Document (CCD) in this context?

The CCD consolidates prior art cited by all participating offices for the family members of this patent application, providing a single-page view of search results from multiple offices.

How does this patent impact the pharmaceutical market?

This patent can improve patient compliance and reduce healthcare costs by providing a sustained release formulation that reduces the need for frequent dosing of antiinfective agents.

What are some potential future developments in sustained release formulations?

Future developments may include the application of similar technologies to other types of drugs, further enhancing therapeutic efficacy and patient convenience.

Cited Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. United States Patent 9,333,214 B2: https://patentimages.storage.googleapis.com/82/22/25/12aa08d0200aa5/US9333214.pdf
  3. Patent Claims Research Dataset - USPTO: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. US8802137B2 - Sustained release of antiinfectives - Google Patents: https://patents.google.com/patent/US8802137B2/en

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Drugs Protected by US Patent 8,802,137

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,802,137

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2003304204 ⤷  Subscribe
Australia 2006270008 ⤷  Subscribe
Brazil 0315868 ⤷  Subscribe
Brazil PI0613865 ⤷  Subscribe
Canada 2504317 ⤷  Subscribe
Canada 2614764 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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