Understanding the Scope and Claims of United States Patent 6,458,924
Introduction
United States Patent 6,458,924, issued on October 1, 2002, is a significant patent in the field of pharmaceuticals, particularly involving methods and compositions related to GLP-1 (Glucagon-Like Peptide-1) analogues. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape it inhabits.
Background and Invention
The patent, titled "GLP-1 analogs and their use in the treatment of diabetes," is part of a series of continuations and continuations-in-part, indicating a long history of research and development in this area. The invention pertains to analogues of GLP-1, a hormone involved in glucose metabolism, and their use in treating diabetes and other metabolic disorders[4].
Claims of the Patent
The patent includes multiple claims that can be categorized into several types:
Composition Claims
These claims pertain to the specific chemical structures of the GLP-1 analogues. For example, Claim 1 describes a peptide analogue of GLP-1 with specific modifications that enhance its stability and efficacy[4].
Method Claims
These claims cover the methods of using these analogues for therapeutic purposes. For instance, Claim 10 describes a method for treating diabetes by administering a GLP-1 analogue to a patient in need thereof[4].
Use Claims
These claims specify the therapeutic uses of the GLP-1 analogues. Claim 15, for example, describes the use of a GLP-1 analogue for reducing blood glucose levels in a patient[4].
Scope of the Patent
The scope of the patent is defined by its claims and the detailed description provided in the specification.
Chemical Modifications
The patent details various chemical modifications to the GLP-1 molecule that improve its pharmacokinetic properties, such as half-life and stability. These modifications include substitutions, deletions, and additions of amino acids[4].
Therapeutic Applications
The patent covers the use of these analogues in treating diabetes, particularly type 2 diabetes, as well as other conditions related to glucose metabolism. It also touches on potential applications in weight management and cardiovascular health[4].
Patent Landscape
The patent landscape surrounding U.S. Patent 6,458,924 is complex and involves numerous related patents and applications.
Related Patents
This patent is part of a family of patents that include earlier and later filings. For example, it is a continuation-in-part of U.S. application Ser. No. 09/265,141 and Ser. No. 09/258,750, which were filed in 1999. These earlier applications laid the groundwork for the research and development leading to the issuance of U.S. Patent 6,458,924[4].
International Patents
The patent has international counterparts, such as European Patent EP 0708179, which indicates a global strategy for protecting the intellectual property related to these GLP-1 analogues[4].
Litigation and Challenges
Patents in the pharmaceutical sector are often subject to litigation and challenges. For instance, similar patents have been involved in inter partes reviews (IPRs) and other legal proceedings, highlighting the competitive nature of the field[5].
Regulatory Considerations
Patents like U.S. Patent 6,458,924 often undergo regulatory review periods before the commercial marketing or use of the product. This process can lead to patent term extensions under specific conditions, such as those outlined in 35 U.S.C. §156, which allows for the extension of a patent term if the product was subject to a regulatory review period before its commercial marketing[1].
Impact on the Pharmaceutical Industry
The issuance and maintenance of this patent have significant implications for the pharmaceutical industry.
Competitive Landscape
The patent protects the intellectual property of the inventors and their assignees, providing a competitive advantage in the market for GLP-1 analogues. This can influence the development and marketing strategies of other companies in the sector[4].
Research and Development
The detailed description and claims of the patent contribute to the broader scientific understanding of GLP-1 analogues. This can stimulate further research and innovation in related areas, such as the development of new therapeutic agents for metabolic disorders[3].
Key Takeaways
- Composition and Method Claims: The patent covers specific GLP-1 analogues and their therapeutic uses.
- Scope and Therapeutic Applications: It includes detailed chemical modifications and therapeutic applications, particularly in diabetes treatment.
- Patent Landscape: The patent is part of a complex landscape involving related patents, international counterparts, and potential litigation.
- Regulatory Considerations: The patent may be subject to term extensions based on regulatory review periods.
- Industry Impact: The patent influences the competitive landscape and stimulates further research in the pharmaceutical sector.
FAQs
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What is the primary focus of U.S. Patent 6,458,924?
- The primary focus is on GLP-1 analogues and their use in treating diabetes and other metabolic disorders.
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What types of claims are included in the patent?
- The patent includes composition claims, method claims, and use claims related to the GLP-1 analogues.
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How does the patent fit into the broader patent landscape?
- It is part of a family of patents and has international counterparts, and is subject to the competitive and litigious nature of the pharmaceutical sector.
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What are the potential regulatory implications for this patent?
- The patent may be eligible for term extensions under 35 U.S.C. §156 if it underwent a regulatory review period before commercial marketing.
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How does this patent impact the pharmaceutical industry?
- It protects intellectual property, influences competitive strategies, and contributes to ongoing research and development in the field of GLP-1 analogues.
Sources
- FDA Document: "IN THE UNITED STATES PATENT AND TRADEMARK OFFICE" - FDA-2017-E-5040-0001.
- FDA Application: "application number - accessdata.fda.gov".
- BioRxiv Article: "A novel approach to understand patents from the drug discovery" - 10.1101/2023.02.10.527980v1.
- United States Patent: "GLP-1 analogs and their use in the treatment of diabetes" - U.S. Patent 6,458,924.
- Unified Patents Case: "IPR2020-01252 - Pfizer Inc v. Novo Nordisk AS et al." - Unified Patents.
