United States Patent 11,246,866: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,246,866, titled "Solid pharmaceutical compositions for treating HCV," is a significant patent in the field of pharmaceuticals, particularly for the treatment of Hepatitis C Virus (HCV). This article provides a comprehensive analysis of the patent's scope, claims, and the broader patent landscape in which it resides.
Background of the Patent
Overview of HCV Treatment
Hepatitis C Virus (HCV) is a major public health concern, and the development of effective treatments has been a priority in the pharmaceutical industry. The patent in question addresses this need by introducing solid pharmaceutical compositions designed to treat HCV effectively.
Patent Details
- Publication Number: US11246866B2
- Authority: United States
- Prior Art Date: The patent builds upon previous research and developments in the field of HCV treatment, incorporating compounds and formulations that have been refined over time[4].
Scope of the Patent
Definition and Purpose
The patent describes solid pharmaceutical compositions that include specific compounds and formulations aimed at treating HCV. These compositions are designed to enhance the bioavailability and efficacy of the treatment.
Key Components
- Compounds 1 and 2: The patent specifies the use of two primary compounds, each combined with pharmaceutically acceptable hydrophilic polymers and surfactants. These compounds are formulated into amorphous solid dispersions, which are then compressed into tablets or mini-tablets[4].
Formulations
The patent outlines various formulations, including:
- Tablets: Comprising layers of amorphous solid dispersions with specific compounds.
- Mini-tablets: Sized between 2 mm to 5 mm, these are designed for easier administration and better patient compliance[4].
Claims of the Patent
Independent and Dependent Claims
The patent includes several independent and dependent claims that define the scope of the invention. These claims are crucial as they delineate what is protected under the patent.
- Independent Claims: These claims define the core aspects of the invention, such as the composition of the solid pharmaceuticals, the specific compounds used, and the method of preparation[4].
- Dependent Claims: These claims build upon the independent claims, providing additional details and variations of the invention, such as different sizes of mini-tablets and specific dosages[4].
Claim Language and Scope
The language used in the claims is precise and technical, ensuring that the scope of the patent is well-defined. For example, the claims specify the exact composition of the amorphous solid dispersions and the process of manufacturing the tablets or mini-tablets. This precision is critical in patent law to avoid ambiguity and potential infringement issues[3].
Patent Landscape
Global Patent System
The patent is part of a broader global patent system that involves multiple intellectual property offices. Tools like the Global Dossier and Common Citation Document (CCD) facilitate the integration of patent information across different jurisdictions, ensuring that similar inventions are not patented multiple times[1].
Related Patents and Applications
- Prior Art: The patent builds on existing research and prior art in the field of HCV treatment. Other patents and applications related to HCV treatments can be found through databases such as the USPTO's Patent Public Search and international databases like the European Patent Office's esp@cenet[1].
- Competing Patents: There are other patents and applications that address similar aspects of HCV treatment, such as interferon- and ribavirin-free therapies. These competing patents highlight the ongoing innovation in this field[5].
International Search and Examination
The patent has likely undergone international search and examination processes, which involve evaluating the novelty, non-obviousness, and utility of the invention. Tools like the CCD help in consolidating prior art citations from multiple offices, ensuring that the patent meets global standards[1].
Impact on Innovation
Patent Quality and Scope
The scope and claims of the patent are critical in determining its impact on innovation. Narrower claims, as validated by research, are associated with a higher probability of grant and a shorter examination process. This patent, with its well-defined claims, contributes to the clarity and validity of the intellectual property landscape in pharmaceuticals[3].
Licensing and Litigation
The clarity and specificity of the patent claims also influence licensing and litigation. Well-defined patents reduce the likelihood of disputes and make it easier for other innovators to understand what is protected, thereby fostering further innovation[3].
Practical Applications
Patient Compliance
The mini-tablet formulations described in the patent are designed to improve patient compliance by making the medication easier to administer. This is a significant practical application, as it can lead to better treatment outcomes[4].
Manufacturing Process
The patent details a specific manufacturing process, which includes milling and mixing the compounds with excipients and then compressing them into tablets. This process ensures the consistency and quality of the final product[4].
Key Takeaways
- Specific Compounds and Formulations: The patent focuses on specific compounds and formulations for treating HCV.
- Well-Defined Claims: The claims are precise and technical, ensuring clarity and validity.
- Global Integration: The patent is part of a global system that ensures consistency and avoids duplication.
- Impact on Innovation: The patent contributes to innovation by providing clear boundaries and encouraging further research.
- Practical Applications: The mini-tablet formulations improve patient compliance and the manufacturing process ensures product quality.
FAQs
What is the main focus of United States Patent 11,246,866?
The main focus of this patent is on solid pharmaceutical compositions designed to treat Hepatitis C Virus (HCV).
What are the key components of the pharmaceutical compositions described in the patent?
The key components include specific compounds (Compound 1 and Compound 2) combined with pharmaceutically acceptable hydrophilic polymers and surfactants.
How do the mini-tablet formulations improve patient compliance?
The mini-tablet formulations are designed to be easier to administer, which can lead to better patient compliance and treatment outcomes.
What tools are available for searching and analyzing patents related to this invention?
Tools such as the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) are available for searching and analyzing related patents.
How does the patent's scope and claims impact innovation in the pharmaceutical industry?
The well-defined scope and claims of the patent contribute to clarity and validity, reducing the likelihood of disputes and fostering further innovation by providing clear boundaries for other researchers.
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- U.S. Patent and Trademark Office (USPTO) | USAGov. Retrieved from https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- Patent Claims and Patent Scope. SSRN. Retrieved from https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- US11246866B2 - Solid pharmaceutical compositions for treating HCV. Google Patents. Retrieved from https://patents.google.com/patent/US11246866B2/en
- US-20130102558-A1 - Methods for Treating Hcv. Unified Patents. Retrieved from https://portal.unifiedpatents.com/patents/patent/US-20130102558-A1