United States Patent 11,229,647: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 11,229,647, titled "Methods for treating cholestasis," is a significant patent in the field of liver disease treatment. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
Cholestasis is a condition characterized by the reduction or stoppage of bile flow, often resulting from liver diseases. The patent in question addresses methods for treating this condition, which is crucial for patients suffering from various liver disorders.
Scope of the Patent
The patent 11,229,647 focuses on methods for treating cholestasis in subjects with liver diseases. Here are the key aspects of its scope:
Treatment Methods
The patent describes the administration of specific compounds to treat cholestasis. This includes the use of apical sodium-dependent bile acid transporter (ASBT) inhibitors, which play a critical role in bile acid transport and metabolism[1].
Compounds and Formulations
The patent details various chemical compounds and their formulations that can be used to inhibit ASBT and thereby treat cholestasis. These compounds include substituted heteroalkyl groups, benzyl groups, and other specific chemical structures[1].
Disease Coverage
The patent covers treatments for several liver diseases, including benign recurrent intrahepatic cholestasis and sclerosing cholangitis. This broad coverage makes the patent relevant to a range of clinical conditions[1].
Claims of the Patent
The claims of the patent are the most critical part, as they define the legal boundaries of the invention.
Independent Claims
The patent includes several independent claims that outline the core methods of treating cholestasis. These claims specify the administration of ASBT inhibitors and the chemical structures of the compounds used[1].
Dependent Claims
Dependent claims further detail the specific conditions under which the treatment methods are applied, including the dosage, duration of treatment, and patient populations. These claims provide a comprehensive framework for the treatment protocol[1].
Patent Landscape
Understanding the patent landscape is essential for assessing the patent's value and potential impact.
Related Patents
The patent 11,229,647 is part of a larger family of patents related to liver disease treatments. For example, Mirum Pharmaceuticals has several patents related to treatments for rare liver diseases, including volixibat, which is also an ASBT inhibitor[4].
Competitive Patents
Other companies and research institutions may hold patents for similar treatments or compounds. For instance, the patent dispute between Allergan and Sun Pharmaceutical Industries Limited highlights the complexity of patent landscapes in pharmaceuticals[2].
Patent Analytics
To fully understand the patent landscape, patent analytics tools can be used. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps and opportunities in intellectual property protection[3].
Intellectual Property Protection
The patent 11,229,647 is listed in the Orange Book, which indicates its approval by the FDA and its status as a protected intellectual property.
Orange Book Listing
The Orange Book listing (Patent No. 11,229,647) signifies that the patent is recognized by the FDA as protecting a specific drug or method, providing exclusivity for the patent holder[4].
Orphan Designation
The patent may also be eligible for orphan designation, which provides additional regulatory benefits and market exclusivity for treating rare diseases[4].
Clinical and Commercial Implications
The clinical and commercial implications of this patent are significant.
Clinical Benefits
The treatment methods described in the patent offer potential clinical benefits for patients with cholestasis, improving their quality of life and managing symptoms effectively.
Market Impact
The patent's exclusivity period can influence the market dynamics, allowing the patent holder to maintain a competitive edge in the treatment of liver diseases. This can also impact the development of generic or biosimilar products[4].
Key Takeaways
- Treatment Methods: The patent describes methods for treating cholestasis using ASBT inhibitors.
- Compounds and Formulations: Specific chemical compounds and their formulations are detailed.
- Disease Coverage: The patent covers treatments for various liver diseases.
- Claims: Independent and dependent claims define the legal boundaries of the invention.
- Patent Landscape: The patent is part of a broader landscape of liver disease treatments and is protected by FDA recognition and potential orphan designation.
- Intellectual Property Protection: Listed in the Orange Book and potentially eligible for orphan designation.
- Clinical and Commercial Implications: Significant benefits for patients and market impact due to exclusivity.
FAQs
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What is the primary focus of United States Patent 11,229,647?
- The primary focus is on methods for treating cholestasis in subjects with liver diseases using ASBT inhibitors.
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What types of compounds are described in the patent?
- The patent describes various chemical compounds, including substituted heteroalkyl groups and benzyl groups.
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How does the patent fit into the broader patent landscape?
- It is part of a larger family of patents related to liver disease treatments and is protected by FDA recognition and potential orphan designation.
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What are the clinical benefits of the treatment methods described in the patent?
- The treatment methods offer potential clinical benefits for patients with cholestasis, improving their quality of life and managing symptoms effectively.
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How does the patent's exclusivity period impact the market?
- The patent's exclusivity period allows the patent holder to maintain a competitive edge in the treatment of liver diseases and can impact the development of generic or biosimilar products.
Sources
- US11229647B2 - Methods for treating cholestasis - Google Patents
- ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. - CAFC
- Patent Analytics | Intellectual Property Law - SLWIP
- Mirum Pharmaceuticals: Transforming Lives in Rare Disease - Mirum Pharmaceuticals
