United States Patent 10,548,859: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,548,859, titled "Methods for storing Cysteamine formulations and related methods of treatment," is a significant patent in the pharmaceutical industry, particularly in the realm of cysteamine formulations. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Publication Details
- Publication Number: US10548859B2
- Authority: United States
- Prior Art Date: The patent is based on an application filed on June 25, 2019, with a priority date of June 26, 2018[4].
Invention Summary
The patent describes methods for storing and stabilizing pharmaceutical compositions containing cysteamine or its pharmaceutically acceptable salts. Cysteamine is used in the treatment of cystinosis, a rare genetic disorder, and other conditions. The methods outlined aim to improve the stability and shelf life of cysteamine formulations, which is crucial for maintaining their efficacy[4].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
- Claim 1: A method for storing a pharmaceutical composition comprising cysteamine or a pharmaceutically acceptable salt thereof, wherein the composition is stored in a container under conditions that maintain the composition's stability.
- Claim 2: The method of claim 1, wherein the container is sealed and the composition is stored at a temperature between 2°C and 8°C.
- Claim 3: The method of claim 1, wherein the composition is stored in a light-protected container[4].
These claims highlight the specific conditions and methods for storing cysteamine formulations to ensure their stability.
Claims Analysis
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims (such as Claim 1) stand alone and define the invention broadly, while dependent claims (such as Claims 2 and 3) build upon the independent claims and provide more specific details.
Claim Scope and Limitations
The claims are narrowly tailored to cover specific methods of storing cysteamine formulations. For example, Claim 2 specifies the temperature range and the need for a sealed container, which limits the scope to very specific storage conditions. This narrow scope helps in avoiding potential infringement issues while still protecting the core invention[4].
Patent Landscape
Related Patents and Applications
The patent landscape for cysteamine formulations is complex, with several patents and applications related to the storage, stabilization, and use of cysteamine. For instance, other patents may cover different aspects of cysteamine formulations, such as manufacturing processes or different therapeutic uses.
Global Dossier and International Patent Offices
To understand the global patent landscape, tools like the Global Dossier provided by the USPTO can be useful. This service allows users to see the patent family for a specific application, including related applications filed at participating IP Offices. This can help in identifying similar patents or applications in other countries[1].
Prior Art and Citation Data
The Common Citation Document (CCD) application consolidates prior art cited by participating IP Offices, providing a single point of access to citation data. This tool can help in understanding the prior art landscape and how the current patent fits into it[1].
Market Impact and Commercial Significance
Protected Drugs
The patent protects PROCYSBI, a cysteamine bitartrate delayed-release capsule used for the treatment of cystinosis. This protection is crucial for the market exclusivity of PROCYSBI, ensuring that the manufacturer can recoup investment in research and development without immediate generic competition[5].
Expiration Date
Understanding the expiration date of the patent is vital for market planning. The patent's expiration date will determine when generic versions of the drug can enter the market, potentially altering the competitive landscape.
Legal Status and Enforcement
Active Status
As of the last update, the patent is listed as active, indicating that it is currently enforceable. However, the legal status can change due to various factors such as litigation, re-examination, or expiration[4].
Litigation and Disputes
Patent litigation can significantly impact the enforceability and scope of a patent. Any ongoing or potential disputes related to this patent would need to be monitored closely to understand its current and future legal status.
Search and Analysis Tools
USPTO Resources
The USPTO provides several tools for searching and analyzing patents, including the Patent Public Search tool, which replaced legacy search tools like PubEast and PubWest. This tool offers enhanced access to prior art and can be instrumental in conducting thorough patent searches[1].
International Databases
For a comprehensive analysis, it is essential to search international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO). These databases can reveal similar patents or applications filed in other jurisdictions[1].
Conclusion
United States Patent 10,548,859 is a critical patent in the pharmaceutical sector, particularly for the storage and stabilization of cysteamine formulations. Understanding its scope, claims, and the broader patent landscape is essential for both the patent holder and potential competitors.
Key Takeaways
- Scope and Claims: The patent covers specific methods for storing and stabilizing cysteamine formulations.
- Market Impact: The patent protects PROCYSBI, ensuring market exclusivity.
- Legal Status: The patent is currently active but subject to change based on litigation or other factors.
- Search and Analysis: Utilizing tools like the USPTO's Patent Public Search and international databases is crucial for a comprehensive analysis.
FAQs
Q: What is the primary focus of United States Patent 10,548,859?
A: The primary focus is on methods for storing and stabilizing pharmaceutical compositions containing cysteamine or its pharmaceutically acceptable salts.
Q: Which drug is protected by this patent?
A: The patent protects PROCYSBI, a cysteamine bitartrate delayed-release capsule.
Q: How can one search for similar patents internationally?
A: One can use databases provided by international intellectual property offices such as the EPO, JPO, and WIPO.
Q: What is the significance of the Global Dossier in patent searching?
A: The Global Dossier provides access to the file histories of related applications from participating IP Offices, helping users see the patent family for a specific application.
Q: Where can one find detailed information on claims from US patents?
A: The USPTO's Patent Claims Research Dataset provides detailed information on claims from US patents granted between 1976 and 2014 and US patent applications published between 2001 and 2014[3].
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US10548859B2: https://patents.google.com/patent/US10548859B2/en
- DrugPatentWatch - Patent 10,548,859: https://www.drugpatentwatch.com/p/patent/10548859
