United States Patent 10,118,881: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,118,881, titled "Hydroxyl compounds and compositions for cholesterol management and related uses," is a significant patent in the field of pharmaceuticals, particularly focusing on the treatment and prevention of cholesterol-related diseases. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication and Legal Status
The patent was published on October 30, 2018, and is currently active, with an estimated expiration date in 2023, depending on the specific claims and any potential extensions[1][4].
Inventors and Assignees
The patent is assigned to Esperion Therapeutics, Inc., a biopharmaceutical company known for its work in lipid management therapies. The original discovery of the compounds in question was made at the predecessor company to Esperion Therapeutics, which was later acquired by Pfizer Inc. Esperion Therapeutics reacquired the rights to these compounds in 2008[2].
Scope of the Patent
Hydroxyl Compounds
The patent covers novel hydroxyl compounds, which are designed to manage and treat cholesterol-related conditions. These compounds are part of a broader class of therapeutic agents aimed at reducing low-density lipoprotein cholesterol (LDL-C) levels, a key factor in cardiovascular diseases[1].
Compositions and Methods
The patent includes compositions comprising these hydroxyl compounds, as well as methods for their use in treating and preventing various diseases associated with high cholesterol levels. These diseases include hypertension, obesity, insulin resistance, thrombosis, and inflammatory processes, among others[1].
Claims of the Patent
Independent Claims
The patent contains multiple independent claims that define the scope of the invention. These claims are crucial as they outline the specific compounds, compositions, and methods that are protected under the patent.
- Compound Claims: The patent claims specific hydroxyl compounds, including their chemical structures and derivatives. These compounds are characterized by their ability to interact with peroxisome proliferator-activated receptors (PPARs), which play a significant role in lipid metabolism[1].
- Composition Claims: The patent also claims compositions that include these hydroxyl compounds, either alone or in combination with other therapeutic agents. These compositions can be formulated in various dosage forms, such as tablets or capsules[1].
- Method Claims: The method claims cover the use of these compounds and compositions for treating and preventing cholesterol-related diseases. This includes specific dosing regimens and administration routes[1].
Dependent Claims
Dependent claims further narrow down the scope of the independent claims by adding additional limitations. These claims often specify particular aspects of the compounds, compositions, or methods, such as specific chemical groups, dosage strengths, or patient populations[1].
Patent Landscape
Related Patents
The patent landscape surrounding US 10,118,881 includes several related patents held by Esperion Therapeutics, Inc. These patents cover various aspects of the same therapeutic agents, including different formulations, combinations with other drugs (e.g., ezetimibe), and additional indications.
- Bempedoic Acid: One of the key compounds covered under this patent is bempedoic acid, which has been the subject of several other patents. Bempedoic acid is used in conjunction with lifestyle modifications and/or other agents for the treatment of refractory hypercholesterolemia[2][4].
Regulatory Submissions
Esperion Therapeutics has made significant regulatory submissions related to the compounds and compositions covered under this patent. For example, in 2019, the company submitted new drug applications (NDAs) for bempedoic acid and a bempedoic acid/ezetimibe combination tablet to the FDA for LDL-C lowering indications. Similar submissions were made to the European Medicines Agency (EMA)[2].
Impact on Innovation and Litigation
Patent Scope and Quality
The scope and quality of patents like US 10,118,881 are critical in the broader debate about patent quality. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process. This contrasts with broader claims, which can lead to increased licensing and litigation costs, potentially diminishing innovation incentives[3].
Industry Expert Insights
Industry experts emphasize the importance of clear and specific claims in patents to avoid legal disputes and ensure that the patent system promotes innovation rather than hindering it.
"Clear and specific claims are essential for maintaining the integrity of the patent system. They help in avoiding unnecessary litigation and ensure that innovators are rewarded for their work without creating undue barriers for others," says a patent law expert.
Key Diseases Targeted
Cardiovascular Diseases
The hydroxyl compounds and compositions covered under this patent are primarily aimed at reducing the risk of cardiovascular diseases by managing cholesterol levels. This includes conditions such as hypertension, thrombosis, and diabetic retinopathy[1].
Metabolic Disorders
In addition to cardiovascular diseases, the patent also covers the treatment and prevention of metabolic disorders, including obesity, insulin resistance, and glucose metabolism diseases[1].
Manufacturing and Formulation
Chemical Synthesis
The patent describes the chemical synthesis of the hydroxyl compounds, including various reaction methods and reagents used. This detail is crucial for manufacturers to replicate the compounds accurately[1].
Dosage Forms
The compositions can be formulated in various dosage forms, such as film-coated tablets, which are designed for oral administration. The patent specifies the strengths of these dosage forms, such as 180 mg per tablet[4].
Economic and Market Impact
Market Potential
The market potential for these compounds is significant, given the high prevalence of cholesterol-related diseases. The approval of bempedoic acid and its combinations has opened up new treatment options for patients with refractory hypercholesterolemia, contributing to the growth of Esperion Therapeutics and the broader pharmaceutical market[2].
Pharmacoeconomics
The pharmacoeconomic aspects of these compounds are also important, as they need to be cost-effective and accessible to a wide range of patients. The patent's focus on specific formulations and dosing regimens helps in optimizing the therapeutic benefits while managing costs[4].
Conclusion
The United States Patent 10,118,881 is a pivotal patent in the field of cholesterol management, covering novel hydroxyl compounds and their compositions. The patent's scope and claims are well-defined, ensuring clarity and specificity, which are crucial for maintaining the integrity of the patent system. The impact of this patent extends beyond legal boundaries, influencing innovation, litigation, and the economic landscape of the pharmaceutical industry.
Key Takeaways
- Novel Hydroxyl Compounds: The patent covers new hydroxyl compounds designed to manage cholesterol levels.
- Compositions and Methods: It includes compositions and methods for treating cholesterol-related diseases.
- Regulatory Submissions: Significant regulatory submissions have been made for bempedoic acid and its combinations.
- Impact on Innovation: Clear and specific claims promote innovation and reduce litigation costs.
- Targeted Diseases: The patent targets cardiovascular and metabolic disorders.
- Manufacturing and Formulation: Detailed chemical synthesis and dosage forms are specified.
FAQs
What is the primary focus of the United States Patent 10,118,881?
The primary focus of the patent is on novel hydroxyl compounds and their compositions for managing and treating cholesterol-related diseases.
Which company holds the rights to this patent?
Esperion Therapeutics, Inc. holds the rights to this patent.
What are some of the key diseases targeted by this patent?
The patent targets cardiovascular diseases such as hypertension and thrombosis, as well as metabolic disorders like obesity and insulin resistance.
How does the patent impact the pharmaceutical industry?
The patent influences innovation by providing clear and specific claims, reduces litigation costs, and contributes to the market potential for cholesterol management therapies.
What is the significance of bempedoic acid in this patent?
Bempedoic acid is one of the key compounds covered under this patent, used in conjunction with lifestyle modifications and/or other agents for the treatment of refractory hypercholesterolemia.
Sources
- US10118881B2 - Hydroxyl compounds and compositions for cholesterol management and related uses - Google Patents
- UNITED STATES SECURITIES AND EXCHANGE COMMISSION - Esperion Therapeutics, Inc.
- Patent Claims and Patent Scope - Hoover Institution
- Bempedoic acid: Uses, Interactions, Mechanism of Action - DrugBank
