United States Patent 11,154,521: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,154,521, issued to Acer Therapeutics and Relief Therapeutics, is a significant development in the field of pharmaceuticals, particularly in the formulation of taste-masked, multi-particulate dosage forms. This patent covers a specific pharmaceutical composition related to ACER-001, a formulation designed for oral administration.
Patent Overview
Publication Number and Authority
The patent, numbered US11,154,521B2, was issued by the United States Patent and Trademark Office (USPTO)[4][5].
Prior Art and Legal Status
The patent builds on prior art related to pharmaceutical compositions, particularly those involving sodium phenylbutyrate. The legal status of the patent is active, indicating it is currently in force[4].
Scope of the Patent
Pharmaceutical Composition
The patent covers a pharmaceutical composition that includes a taste-masked, multi-particulate dosage formulation of sodium phenylbutyrate. This formulation is designed to improve patient compliance by making the drug more palatable[4][5].
Key Components
- Sodium Phenylbutyrate: The active ingredient, known for its biological activity and therapeutic benefits.
- Taste-Masking: The formulation incorporates various excipients and methods to mask the unpleasant taste of sodium phenylbutyrate.
- Multi-Particulate Dosage Form: The drug is formulated into multiple small particles, which helps in uniform distribution and better bioavailability[4].
Claims of the Patent
Composition Claims
The patent includes claims related to the specific composition of the pharmaceutical formulation. These claims detail the ingredients, their proportions, and the methods used to prepare the formulation. Key claims include:
- The use of sodium phenylbutyrate as the active ingredient.
- The incorporation of taste-masking agents and excipients such as microcrystalline cellulose, hydroxypropyl methyl cellulose, and polyethylene glycol.
- The method of coating the particles to achieve the desired taste-masking effect[4].
Method Claims
The patent also covers method claims related to the preparation and administration of the formulation. These include:
- Methods for coating the particles to mask the taste.
- Methods for ensuring the stability and bioavailability of the active ingredient.
- Testing methods to verify the efficacy and safety of the formulation[4].
Patent Landscape
Related Patents and Applications
The patent landscape for pharmaceutical compositions, especially those involving taste-masked formulations, is extensive. Other patents and applications may cover similar or related technologies, such as different methods of taste masking or alternative formulations of sodium phenylbutyrate. For example, the European Patent Office (EPO) and other international patent offices may have similar patents or applications that could impact the global market[1].
Global Dossier and International Search
To understand the broader patent landscape, tools like the Global Dossier and international patent databases (such as those provided by the European Patent Office, Japan Patent Office, and World Intellectual Property Organization) can be utilized. These resources help in identifying related applications and patents filed in other jurisdictions, ensuring that the patent holder is aware of potential global competitors or collaborators[1].
Economic and Market Impact
Market Domination
The issuance of this patent strengthens Acer Therapeutics and Relief Therapeutics' proprietary position in the U.S. market until 2036. This exclusivity can lead to market domination in the specific segment of taste-masked sodium phenylbutyrate formulations, allowing the companies to set market standards and prices[2][5].
Competitive Advantage
The unique formulation and taste-masking technology provide a competitive advantage over other pharmaceutical companies. This can lead to higher patient compliance and better therapeutic outcomes, further solidifying the market position of the patent holders[4].
Technical Harmonization and Global Integration
Common Citation Document (CCD)
The Common Citation Document (CCD) application, which consolidates prior art citations from multiple patent offices, can be useful in understanding the global patent landscape for similar inventions. This tool helps in visualizing the search results from several offices on a single page, facilitating greater integration of the global patent system[1].
International Cooperation
The patent's global implications are also influenced by international cooperation among patent offices. The IP5 Offices (USPTO, EPO, JPO, KIPO, and CNIPA) work together to modernize the global patent system, which can affect how patents like US11,154,521 are viewed and enforced internationally[1].
Conclusion
United States Patent 11,154,521 is a significant development in pharmaceutical formulations, particularly in the area of taste-masked, multi-particulate dosage forms. The patent's scope and claims are detailed and specific, covering both the composition and methods related to ACER-001. Understanding the broader patent landscape through tools like the Global Dossier and international patent databases is crucial for navigating the global market and ensuring the patent's full potential is realized.
Key Takeaways
- Specific Composition: The patent covers a taste-masked, multi-particulate dosage formulation of sodium phenylbutyrate.
- Method Claims: Includes methods for preparation, coating, and testing the formulation.
- Market Impact: Strengthens proprietary position in the U.S. market until 2036, providing a competitive advantage.
- Global Landscape: Utilize tools like Global Dossier and international patent databases to understand related patents and applications.
- Technical Harmonization: Benefits from international cooperation among patent offices to integrate the global patent system.
FAQs
Q: What is the main focus of United States Patent 11,154,521?
A: The main focus is on a taste-masked, multi-particulate dosage formulation of sodium phenylbutyrate for oral administration.
Q: Who are the patent holders of US11,154,521?
A: Acer Therapeutics and Relief Therapeutics are the patent holders.
Q: How long is the patent valid?
A: The patent is valid until 2036.
Q: What tools can be used to understand the global patent landscape for similar inventions?
A: Tools like the Global Dossier and international patent databases such as those provided by the EPO, JPO, and WIPO can be used.
Q: How does this patent impact the market position of Acer Therapeutics and Relief Therapeutics?
A: It strengthens their proprietary position and provides a competitive advantage in the U.S. market.
