Detailed Analysis of the Scope and Claims of United States Patent 7,138,390
Introduction
United States Patent 7,138,390, titled "Steroids as agonists for FXR," is a significant patent in the field of pharmaceuticals, particularly focusing on compounds that activate the farnesoid X receptor (FXR). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background on FXR and Its Importance
FXR is a nuclear receptor that plays a crucial role in the regulation of bile acid, lipid, and glucose homeostasis. Activating FXR has been shown to have therapeutic benefits in treating various diseases, including cardiovascular diseases, cholestatic liver diseases, and metabolic disorders[4].
Patent Overview
The patent, granted to an undisclosed assignee, describes a class of steroid compounds that act as agonists for FXR. These compounds are defined by a specific formula (I), where R is ethyl, and include pharmaceutically acceptable salts, solvates, or amino acid conjugates thereof[1][2].
Scope of the Patent
Therapeutic Applications
The patent covers a wide range of therapeutic applications for the FXR agonist compounds. These include:
- Cardiovascular Disease: The compounds are used for the prevention or treatment of cardiovascular diseases, particularly atherosclerosis.
- HDL Cholesterol Increase: The method involves administering a therapeutically effective amount of the compound to increase HDL cholesterol levels.
- Triglyceride Reduction: The compounds are also used to lower triglyceride levels.
- Cholestatic Liver Disease: The invention provides methods for the prevention or treatment of cholestatic liver diseases[1].
Pharmaceutical Compositions
The patent details pharmaceutical compositions that include the FXR agonist compounds as the active ingredient, along with at least one pharmaceutical carrier or diluent. These compositions can be formulated as unit doses, such as tablets, and may contain other physiologically active ingredients[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. Key claims include:
- Compound Claims: Claims that specify the chemical structure of the FXR agonist compounds, including the formula (I) and its derivatives.
- Method Claims: Claims that describe the methods for using these compounds in the prevention or treatment of various diseases.
- Composition Claims: Claims that outline the pharmaceutical compositions containing the FXR agonist compounds[1].
Dependent Claims
Dependent claims further specify the independent claims by detailing specific aspects such as the type of pharmaceutical carriers, the dosage forms, and additional therapeutic applications.
Patent Landscape
Related Patents
Other patents, such as the one related to obeticholic acid (a known FXR agonist), also target FXR-mediated diseases. Obeticholic acid is used for similar therapeutic applications, including the treatment of cholestatic liver disease and the reduction of HDL cholesterol and triglycerides[4].
Patent Scope Metrics
Research on patent scope metrics, such as independent claim length and independent claim count, suggests that narrower claims are associated with a higher probability of grant and a shorter examination process. This is relevant as the claims in US7138390B2 are specific and detailed, indicating a well-defined scope[3].
Legal and Regulatory Aspects
Patent Status
The patent has been granted and is currently in force. However, the legal status can change due to various factors such as expiration, litigation, or post-grant reviews.
International Patent Classification
The patent is classified under several categories, including C07J9/00 for organic chemistry and A61P for specific therapeutic activities of chemical compounds or medicinal preparations[1].
Economic and Innovation Impact
Licensing and Litigation
The clarity and specificity of the claims in this patent can influence licensing and litigation outcomes. Clear and narrow claims tend to reduce the complexity and costs associated with patent litigation[3].
Innovation Incentives
The granting of this patent can incentivize further innovation in the field of FXR agonists by providing a clear framework for what is protected and what areas are open for further research and development.
Key Takeaways
- Therapeutic Applications: The patent covers a range of therapeutic applications, including cardiovascular disease, HDL cholesterol increase, triglyceride reduction, and cholestatic liver disease.
- Pharmaceutical Compositions: The patent details specific pharmaceutical compositions and formulations.
- Claims: The patent includes detailed independent and dependent claims defining the scope of the invention.
- Patent Landscape: The patent is part of a broader landscape of FXR agonist-related patents, with implications for licensing, litigation, and innovation.
FAQs
What is the primary therapeutic target of the compounds described in US7138390B2?
The primary therapeutic target is the farnesoid X receptor (FXR).
What are the main therapeutic applications of the FXR agonist compounds?
The main therapeutic applications include the prevention or treatment of cardiovascular diseases, increasing HDL cholesterol, lowering triglycerides, and treating cholestatic liver diseases.
How are the pharmaceutical compositions formulated according to the patent?
The pharmaceutical compositions are formulated as unit doses, such as tablets, and may contain other physiologically active ingredients along with the FXR agonist compounds.
What is the significance of FXR in human health?
FXR plays a crucial role in regulating bile acid, lipid, and glucose homeostasis, making it a significant target for treating various metabolic and liver diseases.
How does the patent landscape influence innovation in the field of FXR agonists?
The patent landscape, with clear and specific claims, can incentivize further innovation by providing a clear framework for what is protected and what areas are open for further research and development.
Sources
- US7138390B2 - Steroids as agonists for FXR - Google Patents
- US-7138390-B2 - Steroids as Agonists for Fxr - Unified Patents
- Patent Claims and Patent Scope - Hoover Institution
- PREPARATION, USES AND SOLID FORMS OF OBETICHOLIC ACID - Canadian Patents Database
