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Last Updated: December 22, 2024

Details for Patent: 7,658,944


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Summary for Patent: 7,658,944
Title:Solid dosage form comprising a fibrate
Abstract:The invention provides stable, solid dosage forms and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved in an non-aqueous vehicle in order to ensure improved bioavailability of the active ingredient upon oral administration relative to known fibrate formulations.
Inventor(s): Holm; Per (Vanlose, DK), Norling; Tomas (Lyngby, DK)
Assignee: LifeCycle Pharma A/S (Horsholm, DK)
Application Number:10/513,807
Patent Claim Types:
see list of patent claims
Dosage form; Formulation; Composition; Use;
Patent landscape, scope, and claims:

United States Patent 7,658,944: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 7,658,944, titled "Solid dosage form comprising a fibrate," is a patent that pertains to the pharmaceutical field, specifically focusing on the formulation and manufacture of solid dosage forms containing fibrates. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Invention Description

The patent describes stable, solid dosage forms and pharmaceutical compositions in particulate form that include a fibrate, such as fenofibrate. These compositions are designed to be hydrophobic, hydrophilic, or water-miscible and may include an oil-sorption material to maintain stability and effectiveness[4].

Publication and Legal Status

The patent was published on February 9, 2010, and is currently active, although the expiration date is not specified in the provided sources. It is crucial to verify the legal status through official channels as it may change over time.

Scope of the Invention

Claims

The patent includes several claims that define the scope of the invention:

  • Claim 1: A pharmaceutical composition comprising a fibrate in a vehicle, which can be hydrophobic, hydrophilic, or water-miscible.
  • Claim 2: A solid pharmaceutical composition in particulate form comprising a fibrate, a vehicle, and an oil-sorption material, with an oil threshold value of at least 10%.
  • Method Claims: The patent also covers methods of manufacturing these solid oral dosage forms and pharmaceutical compositions[4].

Classification

The patent is classified under various categories within the International Patent Classification (IPC) system:

  • A61K31/192: Carboxylic acids, including those with aromatic groups.
  • A61K9/00: Medicinal preparations characterized by special physical form, such as particulate forms, pills, tablets, and discs.
  • A61P19/00: Drugs for skeletal disorders, although this classification may be broader than the specific focus of the patent[4].

Claims Analysis

Independent Claims

The independent claims (e.g., Claim 1) define the core aspects of the invention, including the composition of the fibrate and the vehicle. These claims are critical in determining the patent's scope and what would constitute infringement.

Dependent Claims

Dependent claims (e.g., Claim 2) build upon the independent claims and provide additional specifics, such as the inclusion of an oil-sorption material and the oil threshold value. These claims help to narrow down the scope and provide more detailed protection for the invention.

Patent Landscape

Prior Art

The patent landscape includes prior art related to pharmaceutical compositions and solid dosage forms. For instance, other patents and publications may discuss similar formulations or manufacturing methods, but the unique combination and specific claims of US 7,658,944 distinguish it from prior art[4].

Global Dossier and International Patent Offices

To understand the global patent landscape, tools like the Global Dossier and databases from international patent offices such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) can be utilized. These resources help in identifying related applications and prior art across different jurisdictions[1].

Common Citation Document (CCD)

The Common Citation Document (CCD) application consolidates citation data from participating IP offices, allowing for a comprehensive view of prior art cited for the same invention across different offices. This tool is essential for understanding the broader patent landscape and potential overlaps or conflicts[1].

Search and Analysis Tools

Patent Public Search

The USPTO's Patent Public Search tool is a powerful resource for conducting thorough searches of prior art and related patents. This tool replaces legacy search tools and provides enhanced access to prior art, which is crucial for analyzing the scope and claims of US 7,658,944[1].

Patent and Trademark Resource Centers (PTRCs)

Local PTRCs offer training and resources for patent search techniques, which can be invaluable for detailed analysis and ensuring that the patent does not infringe on existing patents[1].

Economic and Research Implications

Patent Claims Research Dataset

The USPTO's Patent Claims Research Dataset provides detailed information on claims from US patents and applications, which can be used to analyze trends and scope measurements. This dataset can help in understanding the broader context of patent claims and their economic implications[3].

Manufacturing and Commercialization

Method of Manufacture

The patent covers specific methods of manufacturing the solid oral dosage forms and pharmaceutical compositions. This is crucial for commercialization, as it ensures that the manufacturing process aligns with the patented claims[4].

Key Takeaways

  • Unique Composition: The patent protects a unique composition of fibrates in solid dosage forms with specific vehicles and oil-sorption materials.
  • Claims and Scope: The claims define the core aspects of the invention, with independent and dependent claims providing detailed protection.
  • Patent Landscape: Understanding the global patent landscape through tools like Global Dossier and CCD is essential for identifying prior art and potential conflicts.
  • Search and Analysis: Utilizing tools like Patent Public Search and PTRCs is vital for thorough analysis and ensuring non-infringement.
  • Economic Implications: The Patent Claims Research Dataset can provide insights into the economic and research implications of the patent.

FAQs

Q: What is the main focus of United States Patent 7,658,944?

A: The main focus is on stable, solid dosage forms and pharmaceutical compositions in particulate form that include a fibrate, such as fenofibrate.

Q: How can one verify the legal status of the patent?

A: The legal status should be verified through official channels, such as the USPTO database, as it may change over time.

Q: What tools can be used to analyze the patent landscape for this invention?

A: Tools such as the Global Dossier, Common Citation Document (CCD), and Patent Public Search can be used to analyze the patent landscape.

Q: What is the significance of the oil-sorption material in the patent?

A: The oil-sorption material is crucial as it helps maintain the stability and effectiveness of the solid dosage form by ensuring an oil threshold value of at least 10%.

Q: Where can one find detailed information on claims from US patents and applications?

A: The USPTO's Patent Claims Research Dataset provides detailed information on claims from US patents and applications.

Sources

  1. USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
  2. Patent Docs - Court Report. Retrieved from https://www.patentdocs.org/2013/02/court-r.html
  3. USPTO - Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. Google Patents - US7658944B2. Retrieved from https://patents.google.com/patent/US7658944B2/en
  5. Unified Patents Portal - WO-1995006460-A1. Retrieved from https://portal.unifiedpatents.com/patents/patent/WO-1995006460-A1

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Drugs Protected by US Patent 7,658,944

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Salix FENOGLIDE fenofibrate TABLET;ORAL 022118-001 Aug 10, 2007 DISCN Yes No 7,658,944 ⤷  Subscribe Y ⤷  Subscribe
Salix FENOGLIDE fenofibrate TABLET;ORAL 022118-002 Aug 10, 2007 DISCN Yes No 7,658,944 ⤷  Subscribe Y ⤷  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

Foreign Priority and PCT Information for Patent: 7,658,944

PCT Information
PCT FiledOctober 01, 2004PCT Application Number:PCT/DK2004/000667
PCT Publication Date:April 21, 2005PCT Publication Number: WO2005/034920

International Family Members for US Patent 7,658,944

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2004279661 ⤷  Subscribe
Australia 2009201881 ⤷  Subscribe
Brazil PI0415121 ⤷  Subscribe
Canada 2540984 ⤷  Subscribe
Canada 2541382 ⤷  Subscribe
Canada 2582403 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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