United States Patent 8,802,628: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,802,628, titled "Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration," is a significant patent in the pharmaceutical sector, particularly in the development of treatments for gastrointestinal disorders. This patent, held by Ironwood Pharmaceuticals, Inc., pertains to the formulation and preparation of linaclotide, a GC-C receptor agonist used in the treatment of constipation and other gastrointestinal conditions.
Background
Linaclotide is a synthetic peptide that activates the guanylate cyclase C (GC-C) receptor, leading to increased intestinal fluid secretion and facilitating bowel movements. The patent focuses on the development of stable solid formulations of linaclotide suitable for oral administration, which is crucial for the effective and safe delivery of the drug.
Scope of the Patent
The scope of US Patent 8,802,628 encompasses several key aspects:
Formulation
The patent describes stable solid formulations of linaclotide, including capsules, tablets, and other dosage forms. These formulations are designed to maintain the stability of the peptide under various environmental conditions, such as temperature and humidity, which is essential for ensuring the efficacy and shelf life of the drug[4].
Preparation Methods
The patent details methods for preparing these stable solid formulations, including the use of desiccants, binding agents, and other excipients to prevent degradation. Techniques such as spray drying and hydrolysis reactions are also discussed to ensure the formulation remains stable over time[4].
Pharmaceutical Composition
The patent specifies the pharmaceutical composition of the formulations, including the use of microcrystalline cellulose, starch, and polyethylene glycol as excipients. These components help in maintaining the stability and bioavailability of linaclotide[4].
Claims
The claims of US Patent 8,802,628 are critical in defining the scope of protection for the invention. Here are some key claims:
Claim 1
Claim 1 generally describes a stable solid formulation of a GC-C receptor agonist polypeptide, specifically linaclotide, suitable for oral administration. This claim sets the foundation for the patent by outlining the core invention[4].
Dependent Claims
Subsequent claims (Claims 2-19) provide additional details and variations of the formulation, including specific excipients, methods of preparation, and dosage forms. For example, Claim 6 describes a capsule formulation containing linaclotide and a desiccant to prevent moisture-induced degradation[4].
Patent Landscape
The patent landscape surrounding US Patent 8,802,628 is complex and involves several related patents and legal actions.
Related Patents
Other patents related to linaclotide, such as US Patent 8,748,573 and US Patent 8,933,030, cover different aspects of the drug's formulation, synthesis, and use. These patents collectively form a robust intellectual property portfolio protecting Ironwood Pharmaceuticals' innovations in this area[2][4].
Litigation
The patent has been involved in litigation, particularly in cases related to generic drug manufacturers seeking to commercialize generic versions of linaclotide before the expiration of the relevant patents. For instance, the filing of an Abbreviated New Drug Application (ANDA) by Sun Pharmaceutical Industries led to a lawsuit alleging patent infringement[2].
Global Dossier and International Implications
The Global Dossier system, which provides access to the file histories of related applications from participating IP Offices, is relevant for understanding the international patent landscape of US Patent 8,802,628. This system allows users to see the patent family for a specific application, including related applications filed at participating IP Offices, which can be crucial for managing global intellectual property rights[1].
Economic and Research Implications
The Patent Claims Research Dataset provided by the USPTO offers insights into the scope and claims of patents, including those related to US Patent 8,802,628. This dataset can be used to analyze trends in patent scope and claims, which is valuable for researchers and businesses navigating the patent landscape[3].
Conclusion
US Patent 8,802,628 is a pivotal patent in the field of pharmaceuticals, particularly for the treatment of gastrointestinal disorders. Its scope and claims are meticulously defined to protect the innovative formulations and preparation methods of linaclotide. Understanding this patent and its place within the broader patent landscape is essential for both industry professionals and researchers.
Key Takeaways
- Stable Formulations: The patent focuses on stable solid formulations of linaclotide suitable for oral administration.
- Preparation Methods: Detailed methods for preparing these formulations are provided, including the use of desiccants and specific excipients.
- Pharmaceutical Composition: The patent specifies the pharmaceutical composition, including microcrystalline cellulose, starch, and polyethylene glycol.
- Claims: The claims define the scope of protection, including variations of the formulation and dosage forms.
- Patent Landscape: The patent is part of a larger intellectual property portfolio and has been involved in litigation related to generic drug applications.
- Global Implications: The Global Dossier system provides insights into the international patent landscape.
FAQs
What is the main subject of US Patent 8,802,628?
The main subject of US Patent 8,802,628 is the stable solid formulation of a GC-C receptor agonist polypeptide, specifically linaclotide, suitable for oral administration.
What are the key components of the formulations described in the patent?
The key components include linaclotide, desiccants, binding agents, microcrystalline cellulose, starch, and polyethylene glycol.
How does the patent protect the invention?
The patent protects the invention through a series of claims that define the scope of the stable solid formulations, preparation methods, and specific pharmaceutical compositions.
Has this patent been involved in any litigation?
Yes, the patent has been involved in litigation related to generic drug manufacturers seeking to commercialize generic versions of linaclotide before the expiration of the relevant patents.
What is the significance of the Global Dossier system in relation to this patent?
The Global Dossier system provides access to the file histories of related applications from participating IP Offices, allowing users to see the patent family for a specific application and manage global intellectual property rights effectively.
Where can one find detailed information on the claims and scope of this patent?
Detailed information on the claims and scope can be found through the USPTO's Patent Public Search tool, the Global Dossier system, and the Patent Claims Research Dataset.
