Understanding the Scope and Claims of United States Patent 10,130,580
Introduction
United States Patent 10,130,580, titled "Taste-masked pharmaceutical compositions," is a patent that addresses a specific issue in pharmaceutical formulations: the unpleasant taste of certain drugs. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
The patent, granted on October 16, 2018, describes pharmaceutical compositions designed to mask the unpleasant taste of drugs, particularly when administered orally. The invention focuses on creating formulations that ensure the active pharmaceutical ingredient (API) does not come into contact with the taste buds in the mouth, thereby reducing the unpleasant taste[4].
Claim Scope
The claim scope of a patent is crucial as it defines the boundaries of what is protected by the patent. Here are some key points regarding the claims of US Patent 10,130,580:
Independent Claims
- The patent includes several independent claims that define the core aspects of the invention. For example, Claim 1 describes a pharmaceutical composition comprising a core particle containing the API, a taste-masking layer, and optionally, a disintegrant. This claim sets the foundation for the specific formulation that achieves taste masking[4].
Dependent Claims
- Dependent claims further specify the details of the independent claims. These claims may include specific types of polymers used in the taste-masking layer, the composition of the core particle, or the method of preparing the pharmaceutical composition. For instance, Claim 2 depends on Claim 1 and specifies the type of polymer used in the taste-masking layer[4].
Claim Limitations
- The claims must be anchored to the embodiments described in the specification to avoid being overly broad. This is a critical aspect, as overly broad claims can be easier to invalidate due to prior art or failure to meet the written description requirement[3].
Key Components of the Invention
The patent describes several key components that are essential to the taste-masking effect:
Core Particle
- The core particle contains the active pharmaceutical ingredient. This particle is designed to release the API in a controlled manner, ensuring that the taste is masked[4].
Taste-Masking Layer
- This layer is crucial for preventing the API from coming into contact with the taste buds. It is typically made from polymers such as ethyl cellulose, polyvinylpyrrolidone, or other suitable materials[4].
Disintegrant
- The disintegrant helps in the rapid disintegration of the tablet or formulation in the mouth, ensuring that the API is released quickly without the unpleasant taste being perceived[4].
Patent Landscape
Understanding the broader patent landscape is essential for assessing the novelty and non-obviousness of the invention.
Prior Art
- The patent landscape in pharmaceutical formulations, especially those related to taste masking, is extensive. Prior art includes various methods and compositions designed to mask the taste of drugs. The USPTO's Patent Public Search tool and other international databases like the European Patent Office's esp@cenet and the World Intellectual Property Organization's PATENTSCOPE can be used to search for prior art[1].
Related Patents
- Other patents in the same field, such as US Patent 4,957,745, which describes controlled release preparations, can provide insights into the evolution of taste-masking technologies. These patents often share similar components or methods but may differ in their specific applications or formulations[5].
Global Dossier and International Patent Offices
For a comprehensive understanding, it is important to look at the global patent family of the invention:
Global Dossier
- The Global Dossier service provided by the USPTO allows users to access the file histories of related applications from participating IP Offices. This can help in identifying similar patents filed in other countries and understanding the international patent landscape[1].
International Patent Offices
- Searching databases from other international intellectual property offices, such as the European Patent Office, Japan Patent Office, and the World Intellectual Property Organization, can provide a broader view of the patent landscape and help in identifying potential prior art or similar inventions[1].
Legal and Regulatory Considerations
The scope and claims of a patent must comply with legal and regulatory requirements to ensure validity and enforceability.
Abstract Idea Exception
- Claims that are too broad and directed to abstract ideas can be invalidated. The Supreme Court's Alice decision has significantly impacted the legal framework regarding what is patentable and what is not. Patent drafters must ensure that claims are specific and anchored to the embodiments described in the specification to avoid running afoul of this exception[3].
Written Description Requirement
- The claims must be supported by the written description in the patent specification. Overly broad claims that are not adequately described in the specification can be invalidated for failure to meet this requirement[3].
Practical Implications
Understanding the scope and claims of US Patent 10,130,580 has practical implications for pharmaceutical companies and researchers:
Development of New Formulations
- The patent provides a framework for developing new taste-masked pharmaceutical compositions. Companies can use this information to create their own formulations, ensuring they do not infringe on the existing patent while still achieving the desired taste-masking effect.
Licensing and Collaboration
- The patent can serve as a basis for licensing agreements or collaborations between companies. Understanding the scope of the patent is crucial for negotiating these agreements and ensuring that all parties comply with the patent's terms.
Key Takeaways
- Specific Claim Scope: The claims of US Patent 10,130,580 are specific and anchored to the embodiments described in the specification, avoiding the risks associated with overly broad claims.
- Taste-Masking Components: The patent highlights the importance of core particles, taste-masking layers, and disintegrants in achieving the desired taste-masking effect.
- Global Patent Landscape: Understanding the global patent family and prior art is essential for assessing the novelty and non-obviousness of the invention.
- Legal Compliance: The patent complies with legal requirements such as the written description requirement and avoids the abstract idea exception.
FAQs
Q: What is the main purpose of US Patent 10,130,580?
A: The main purpose is to describe pharmaceutical compositions that mask the unpleasant taste of drugs when administered orally.
Q: What are the key components of the taste-masked pharmaceutical compositions described in the patent?
A: The key components include core particles containing the API, a taste-masking layer, and optionally, a disintegrant.
Q: How can companies ensure they do not infringe on US Patent 10,130,580 while developing their own taste-masked formulations?
A: Companies should carefully review the claims and specification of the patent to ensure their formulations do not fall within the scope of the protected invention.
Q: What is the significance of the Global Dossier in understanding the patent landscape?
A: The Global Dossier allows users to access the file histories of related applications from participating IP Offices, providing a comprehensive view of the international patent landscape.
Q: Why is it important to avoid overly broad claims in patent applications?
A: Overly broad claims can be easier to invalidate due to prior art or failure to meet the written description requirement, and they may also run afoul of the abstract idea exception.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Unified Patents Portal - US-6103263-A: https://portal.unifiedpatents.com/patents/patent/US-6103263-A
- Rimon Law - The Importance of Getting the Claim Scope Right in a US Patent Application: https://www.rimonlaw.com/the-importance-of-getting-the-claim-scope-right-in-a-us-patent-application-i/
- Google Patents - US10130580B2: https://patents.google.com/patent/US10130580B2/en
- Unified Patents Portal - US-4957745-A: https://portal.unifiedpatents.com/patents/patent/US-4957745-A
