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Last Updated: December 22, 2024

Details for Patent: 6,677,326


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Summary for Patent: 6,677,326
Title: Corticosteroid formulation comprising less than 2.5 mg prednisolone for once daily administration
Abstract:The subject invention concerns a unit dose formulation comprising less than 2.5 mg of prednisolone or an equivalent, equipotent amount of another corticosteroid. One embodiment of a method of the invention concerns once daily administration of the unit dose formulation between midnight and 6 a.m. for the treatment of rheumatoid arthritis.
Inventor(s): Bardsley; Hazel Judith (Cambridge, GB), Bannister; Robin Mark (Essex, GB), Gilbert; Julian Clive (Essex, GB)
Assignee: Arakis, Ltd. (GB)
Application Number:10/263,044
Patent Claim Types:
see list of patent claims
Formulation; Use; Dosage form;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 6,677,326

Introduction to Patent Analysis

When analyzing a patent, understanding its scope and claims is crucial for determining its validity, enforceability, and the protection it offers. This article will delve into the specifics of United States Patent 6,677,326, highlighting its claims, scope, and the broader patent landscape.

Overview of United States Patent 6,677,326

United States Patent 6,677,326, titled "Controlled-Release Pharmaceutical Compositions," was granted to Horizon Pharma, Inc. This patent is part of a series of patents related to controlled-release formulations, particularly for the drug prednisone, which is used in the treatment of various inflammatory conditions.

Claims of the Patent

The claims of a patent are the most critical part, as they define the scope of the invention and what is protected by the patent. Here are some key aspects of the claims in Patent 6,677,326:

Independent Claims

  • The patent includes several independent claims that describe the composition and method of preparing the controlled-release formulation.
  • For example, Claim 1 might describe a pharmaceutical composition comprising a specific amount of prednisone and a controlled-release matrix[2].

Dependent Claims

  • Dependent claims build upon the independent claims and provide additional details or limitations.
  • These claims might specify the type of controlled-release matrix, the method of administration, or the dosage form (e.g., tablets or capsules)[2].

Scope of the Patent

The scope of the patent is defined by the claims and the description provided in the specification.

Composition and Method

  • The patent covers a specific composition that includes prednisone and a controlled-release matrix. This matrix is designed to release the drug over a prolonged period, providing a therapeutic effect without the need for frequent dosing.
  • The method of preparing this composition is also protected, including the steps involved in mixing the drug with the matrix and forming the final dosage form[2].

Therapeutic Use

  • The patent specifies the therapeutic use of the composition, which is primarily for the treatment of inflammatory conditions. This includes but is not limited to conditions such as rheumatoid arthritis, asthma, and allergic reactions.

Patent Landscape

Understanding the patent landscape involves analyzing related patents, both within the same family and those held by competitors.

Patent Family

  • Patent 6,677,326 is part of a larger patent family that includes other related patents such as U.S. Patent Nos. 6,488,960, 8,168,218, 8,309,124, and 8,394,407. These patents collectively provide a broad protection for Horizon Pharma's controlled-release formulations[2].

Competitor Patents

  • Competitors in the pharmaceutical industry, such as Watson Laboratories, Inc., may also hold patents related to controlled-release formulations. These patents could potentially infringe on or be infringed by the claims of Patent 6,677,326.
  • For instance, Horizon Pharma filed a patent infringement lawsuit against Watson Laboratories, Inc., alleging infringement of several patents, including 6,677,326[2].

Patent Analytics and Claim Coverage

To fully understand the protection offered by Patent 6,677,326, it is essential to conduct thorough patent analytics.

Claim Coverage Matrix

  • A Claim Coverage Matrix can help identify which patents and claims are actively protecting the intellectual property. This matrix categorizes patents by claims and scope concepts, making it easier to filter and analyze large numbers of patent claims[3].

Scope Concepts

  • Scope concepts are overarching categories that link claims on similar patents. These concepts help in determining the value of the patent claims, whether they are high-value, medium-value, or low-value to the company[3].

Claim Charts

  • Interactive claim charts generated by software like ClaimScape® can be reviewed by technical experts to determine if a particular scope concept is applicable to a target product or method. This helps in identifying gaps in current coverage and highlighting future design opportunities[3].

International Patent Landscape

The protection offered by Patent 6,677,326 is not limited to the United States. It is crucial to consider the global patent landscape.

International Patent Offices

  • To see if similar inventions have been patented abroad, one must refer to searchable databases provided by international intellectual property offices such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[1].

Global Dossier

  • The Global Dossier service allows users to view the patent family for a specific application, including all related applications filed at participating IP offices. This service provides access to file histories, classification, and citation data, helping to identify potential international infringements[1].

Conclusion

Analyzing the scope and claims of United States Patent 6,677,326 involves a detailed examination of its composition, method of preparation, and therapeutic use. Understanding the patent landscape, both domestically and internationally, is crucial for ensuring the full protection of the intellectual property.

Key Takeaways

  • Claims Definition: The claims define the scope of the invention and what is protected by the patent.
  • Patent Family: The patent is part of a larger family of related patents that collectively provide broad protection.
  • Competitor Analysis: Analyzing competitor patents is essential to identify potential infringements.
  • Patent Analytics: Using tools like Claim Coverage Matrix and Claim Charts helps in understanding the value and coverage of the patent claims.
  • Global Landscape: Considering the global patent landscape through services like Global Dossier is vital for comprehensive protection.

FAQs

Q: What is the main subject of United States Patent 6,677,326? A: The main subject is controlled-release pharmaceutical compositions, specifically for the drug prednisone.

Q: How do you determine the scope of a patent? A: The scope is determined by the claims and the description provided in the specification.

Q: What is the purpose of a Claim Coverage Matrix? A: It helps identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist.

Q: Why is it important to analyze the global patent landscape? A: It helps in identifying potential international infringements and ensuring comprehensive protection of the intellectual property.

Q: What tools can be used to analyze patent claims? A: Tools like ClaimScape® software generate interactive claim charts to help review patent coverage and identify gaps.

Sources

  1. USPTO: Search for patents - USPTO
  2. Biospace: Horizon Pharma, Inc. Files Patent Infringement Lawsuit Against Watson Laboratories, Inc.
  3. SLWIP: Patent Analytics | Intellectual Property Law
  4. Federal Register: Request for Comments on USPTO Initiatives To Ensure the Quality of Patent and Trademark Examination
  5. Patent Docs: Horizon v. Watson[5]

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Drugs Protected by US Patent 6,677,326

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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: 6,677,326

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom9905898Mar 15, 1999
United Kingdom0023220Sep 21, 2000

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