United States Patent 11,717,555: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,717,555, titled "Pharmaceutical compositions having a selected release duration," is a significant patent in the field of pharmaceuticals, particularly in the development of controlled release delivery systems. This article will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent, filed under application number US16/954,984, pertains to stabilized biodegradable polymeric compositions designed for the controlled release of peptide agents. These compositions are crucial in pharmaceuticals for delivering drugs over an extended period, enhancing efficacy and patient compliance.
Scope of the Patent
Pharmaceutical Compositions
The patent focuses on pharmaceutical compositions that incorporate biodegradable polymers. These polymers are engineered to release peptide agents at a controlled rate, ensuring a sustained therapeutic effect. The compositions are stabilized to maintain their integrity and effectiveness over time[4].
Controlled Release Mechanism
The controlled release mechanism is a key aspect of this patent. The biodegradable polymers degrade at a predictable rate, releasing the peptide agents in a manner that is tailored to the specific therapeutic needs. This mechanism is vital for maintaining consistent drug levels in the body, reducing the need for frequent dosing[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the composition itself, the method of preparing the composition, and the method of using the composition for therapeutic purposes.
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the types of polymers used, the specific peptide agents, and the methods for manufacturing and administering the compositions. These claims help to narrow down the invention and provide additional protection against infringement[4].
Key Components and Features
Biodegradable Polymers
The patent emphasizes the use of biodegradable polymers, which are essential for the controlled release of peptide agents. These polymers must be biocompatible and degrade in a manner that is safe for the patient[4].
Peptide Agents
The peptide agents are the active therapeutic components of the composition. The patent covers various types of peptide agents, including those used for treating different medical conditions.
Manufacturing and Administration
The patent also includes claims related to the methods of manufacturing these compositions and their administration. This ensures that the invention is not only about the composition but also about how it is made and used[4].
Patent Landscape
Related Patents
The patent landscape in the field of pharmaceutical compositions and controlled release systems is complex and crowded. Other patents, such as those listed on the Orange Book Companion, cover similar areas like nanoparticle compositions, formulations for treating gastrointestinal disorders, and methods for delivering therapeutics into the eyes[5].
Competing Technologies
Competing technologies include other types of controlled release systems, such as those using different polymers or delivery mechanisms. For example, patents like US8110553 and US8911786 cover methods and compositions for treating various medical conditions using different formulations and delivery systems[5].
Expiration and Generic Entry
The patent US11,717,555 is currently active, but its expiration date will be crucial for generic entry. The patent term calculator provided by the USPTO can help estimate the expiration date, which is typically 20 years from the filing date of the application[2][4].
Maintenance and Enforcement
Maintenance Fees
To keep the patent in force, the patent holder must pay maintenance fees at specified intervals. Failure to pay these fees can result in the patent expiring prematurely. The USPTO provides tools and resources, such as the Patent Maintenance Fees Storefront, to manage these fees[2].
Infringement and Litigation
The enforcement of the patent involves ensuring that others do not infringe on the claimed inventions. Cases like Silver State Intellectual Techs., Inc. vs. Foursquare Labs, Inc. highlight the importance of detailed descriptions in provisional patent applications to support litigation claims[1].
Industry Impact
Therapeutic Advancements
The controlled release compositions covered by this patent have significant therapeutic implications. They can improve patient compliance, reduce side effects, and enhance the overall efficacy of peptide agents.
Market Competition
In a competitive market, patents like US11,717,555 provide a competitive edge by protecting innovative technologies. This protection allows companies to invest in research and development without the immediate threat of generic competition.
Expert Insights
Industry experts emphasize the importance of detailed and clear descriptions in patent applications, as seen in the requirements outlined in Article 112 of the US Patent Law. This ensures that the invention can be made and used by persons skilled in the art without undue experimentation[1].
Statistics and Examples
- Biodegradable Polymers: The use of biodegradable polymers in pharmaceuticals has seen significant growth, with market projections indicating a substantial increase in the coming years.
- Peptide Agents: Peptide agents are increasingly being used in various therapeutic areas, including diabetes, cancer, and autoimmune diseases.
- Controlled Release Systems: Controlled release systems have improved patient compliance by up to 50% in some cases, highlighting their clinical significance.
"The specification for a provisional patent application must contain a written description of the invention and the methods and procedures for making and using the invention, which shall be complete, clear, concise and precise so that persons skilled in the art can manufacture and use the invention."[1]
Key Takeaways
- Detailed Descriptions: The patent application must include detailed, clear, and precise descriptions of the invention and its methods.
- Biodegradable Polymers: The use of biodegradable polymers is crucial for controlled release compositions.
- Therapeutic Impact: Controlled release compositions can significantly improve therapeutic outcomes and patient compliance.
- Patent Landscape: The patent landscape is complex, with many related patents and competing technologies.
- Maintenance and Enforcement: Regular maintenance fees and robust enforcement strategies are essential to protect the patent.
Frequently Asked Questions (FAQs)
What is the primary focus of United States Patent 11,717,555?
The primary focus of this patent is on stabilized biodegradable polymeric compositions designed for the controlled release of peptide agents.
What are the key components of the patented compositions?
The key components include biodegradable polymers and peptide agents, which are engineered to release at a controlled rate.
How do maintenance fees impact the patent?
Maintenance fees are required to keep the patent in force. Failure to pay these fees can result in the patent expiring prematurely.
What is the significance of Article 112 of the US Patent Law in this context?
Article 112 requires that the patent specification include a complete, clear, concise, and precise written description of the invention and its methods, ensuring that persons skilled in the art can manufacture and use the invention.
How does the patent landscape affect this invention?
The patent landscape is crowded with related patents and competing technologies, making it essential to ensure that the invention is clearly defined and protected.
Cited Sources:
- The Analysis of the Temporary Patent Application System in the US - Clausius Press.
- Maintain your patent - USPTO - United States Patent and Trademark Office.
- Details for Patent: 12048695 - DrugPatentWatch.
- Pharmaceutical compositions having a selected release duration - Google Patents.
- Company - Orange Book Companion - Orange Book Companion.
