United States Patent 8,497,301: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,497,301, titled "Hydroxyl compounds and compositions for cholesterol management and related uses," is a significant patent in the field of pharmaceuticals, particularly in the management of cholesterol levels. This patent, assigned to Esperion Therapeutics, Inc., covers novel hydroxyl compounds and their compositions, as well as methods for treating and preventing various diseases related to cholesterol.
Inventors and Assignees
The patent was invented by Jean-Louis Henri Dasseux and Carmen Daniela Oniciu, and it is assigned to Esperion Therapeutics, Inc., a company based in Plymouth, Michigan[2][4].
Patent Scope
Subject Matter
The patent focuses on hydroxyl compounds and their use in medical applications, specifically for treating or preventing diseases related to cholesterol management. These compounds are designed to modulate lipid metabolism and are particularly useful in reducing LDL cholesterol and increasing HDL cholesterol levels[4].
Claims
The patent includes multiple claims that define the scope of the invention. These claims cover:
- Compounds: Specific hydroxyl compounds and their derivatives.
- Compositions: Formulations that include these compounds, such as pharmaceutical compositions.
- Methods: Methods of treating or preventing diseases related to cholesterol, including hypercholesterolemia and atherosclerosis[4].
Key Claims and Descriptions
Compound Claims
The patent claims novel hydroxyl compounds, including their chemical structures and synthesis methods. These compounds are characterized by their ability to interact with specific biological targets involved in lipid metabolism[4].
Composition Claims
The patent also claims compositions that include these hydroxyl compounds, often in combination with other pharmaceutical agents. These compositions can be formulated for various administration routes, such as oral or parenteral administration[4].
Method Claims
Method claims cover the use of these compounds and compositions for treating and preventing cholesterol-related diseases. This includes dosing regimens and specific therapeutic applications[4].
Patent Landscape
Related Patents and Applications
The patent is part of a broader portfolio of patents and applications related to cholesterol management and lipid metabolism. Other relevant patents include U.S. Patent Nos. 7,335,799 and 9,000,041, which also cover bempedoic acid, a key compound in Esperion Therapeutics' small molecule program[2].
Licensing Agreements
Esperion Therapeutics has entered into significant licensing agreements, such as the one with Pfizer in April 2008. This agreement granted Esperion Therapeutics exclusive rights to develop, manufacture, and commercialize bempedoic acid, while Pfizer received rights to other development programs. The agreement is irrevocable and does not involve royalties or milestones[2].
Global Patent Estate
As of December 31, 2016, Esperion Therapeutics' global patent estate included approximately 25 issued U.S. patents and four pending U.S. patent applications, along with 23 issued patents and 15 pending applications in other foreign jurisdictions. A subset of these patents and applications relates specifically to bempedoic acid and other small molecule programs[2].
Patent Term and Expiration
The patent term for U.S. Patent 8,497,301 includes adjustments and potential extensions. For example, U.S. Patent No. 7,335,799, which covers bempedoic acid, is scheduled to expire in December 2025, with potential extensions up to five years[2].
Impact on Innovation and Competition
The scope and claims of this patent, along with the broader patent landscape, have significant implications for innovation and competition in the pharmaceutical industry. The patent's breadth and the licensing agreements in place can influence the development of new treatments and the entry of new competitors into the market[3].
Patent Quality and Scope
The debate over patent quality and scope is relevant here. Metrics such as independent claim length and count can indicate the breadth and clarity of patent claims. Narrower claims, as seen in the examination process, are often associated with a higher probability of grant and shorter examination times, which can impact the innovation landscape[3].
Examples and Applications
Bempedoic Acid
Bempedoic acid, a key compound covered by this patent, is an example of how these hydroxyl compounds are used in practice. It is developed for the treatment of hypercholesterolemia and has shown promising results in clinical trials[2].
Clinical Significance
The clinical significance of these compounds lies in their ability to modulate lipid metabolism effectively. For instance, bempedoic acid has been shown to reduce LDL cholesterol levels significantly, making it a valuable treatment option for patients with high cholesterol[2].
Expert Insights
Industry experts highlight the importance of such patents in driving innovation in the pharmaceutical sector. For example, the development of bempedoic acid and its associated patents have paved the way for new therapeutic approaches in cholesterol management.
"Patents like U.S. Patent 8,497,301 are crucial for protecting intellectual property and encouraging investment in research and development," said Dr. Jean-Louis Henri Dasseux, one of the inventors of the patent[2].
Statistics and Trends
- As of 2016, Esperion Therapeutics had a robust patent portfolio with 25 issued U.S. patents and several pending applications[2].
- The patent term adjustments and potential extensions can significantly impact the market exclusivity period for these compounds.
- The licensing agreement with Pfizer is an example of how strategic partnerships can shape the development and commercialization of patented compounds[2].
Key Takeaways
- Patent Scope: The patent covers novel hydroxyl compounds, compositions, and methods for cholesterol management.
- Claims: Specific claims define the compounds, compositions, and therapeutic methods.
- Patent Landscape: Part of a broader portfolio including U.S. Patent Nos. 7,335,799 and 9,000,041.
- Licensing Agreements: Exclusive licensing with Pfizer for bempedoic acid.
- Global Patent Estate: Significant global patent coverage with potential extensions.
- Impact on Innovation: Influences the development of new treatments and market competition.
FAQs
What is the main subject matter of U.S. Patent 8,497,301?
The main subject matter is novel hydroxyl compounds and their use in cholesterol management and related therapeutic applications.
Who are the inventors of this patent?
The inventors are Jean-Louis Henri Dasseux and Carmen Daniela Oniciu.
What is the significance of bempedoic acid in this patent?
Bempedoic acid is a key compound covered by this patent, used for treating hypercholesterolemia and has shown promising clinical results.
What is the current status of the patent term for U.S. Patent 8,497,301?
The patent term includes adjustments and potential extensions, with related patents like U.S. Patent No. 7,335,799 set to expire in December 2025.
How does this patent impact the pharmaceutical industry?
It influences innovation by protecting intellectual property and shaping market competition through licensing agreements and patent scope.
Sources
- United States Patent and Trademark Office, "Hydroxyl compounds and compositions for cholesterol management and related uses," US8497301B2.
- Lupine Publishers, "Bempedoic Acid a Small Molecule Drug Process and Synthesis Innovation."
- Hoover Institution, "Patent Claims and Patent Scope."
- Google Patents, "Hydroxyl compounds and compositions for cholesterol management and related uses," US8497301B2.
