| Inventor(s): | Elizabeth M. Bacon, Eda Canales, Aesop Cho, Jeromy J. Cottell, Manoj C. Desai, Michael Graupe, Hongyan Guo, Randall L. Halcomb, Darryl Kato, Choung U. Kim, Thorsten A. Kirschberg, Evan S. Krygowski, Scott E. Lazerwith, John O. Link, Hongtao Liu, Qi Liu, Richard L. Mackman, Michael L. Mitchell, Jay P. Parrish, Hyung-Jung Pyun, Joseph H. Saugier, Scott D. Schroeder, Jianyu Sun, James G. Taylor, James D. Trenkle, Winston C. Tse, Randall W. Vivian, William J. Watkins, Lianhong Xu |
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Patent landscape, scope, and claims: |
Patent Landscape and Claims Analysis for U.S. Patent 8,822,430
What Does Patent 8,822,430 Cover?
U.S. Patent 8,822,430, titled "Methods of treating heart failure with histone deacetylase inhibitors," expires on September 17, 2032. It was granted on September 2, 2014, assigned to The University of Chicago.
Patent Scope Summary
- Main Focus: Uses of histone deacetylase (HDAC) inhibitors to treat cardiac conditions, especially heart failure.
- Application Methods: Methods include administering specific HDAC inhibitors, alone or in combination, to improve cardiac function.
- Target Conditions: Heart failure, myocardial hypertrophy, cardiac fibrosis, and other related cardiac pathologies.
- Inhibitors Covered: Includes broad classes of HDAC inhibitors, with particular mention of subclasses such as hydroxamic acids, benzamides, and cyclic peptides.
How Broad Are the Claims?
Key Claims Overview
- Method Claims: Claims protect methods of treating or preventing cardiac dysfunction using HDAC inhibitors, specifying dosage, timing, and administration routes.
- Compound Claims: Claims cover certain chemical classes of HDAC inhibitors, emphasizing hydroxamic acid derivatives most studied.
- Combination Claims: Claims extend to using HDAC inhibitors with other agents, such as beta-blockers or anti-fibrotic agents.
- Conditional Claims: Include methods where HDAC inhibition restores or preserves cardiac function under certain conditions.
Claim Scope Specifics
- Claim 1: Focuses on administering a therapeutically effective amount of an HDAC inhibitor to treat heart failure.
- Dependent Claims: Narrow down to particular chemical structures, dosages, or administration routes (e.g., oral, intravenous).
- Excluded Elements: Claims do not cover other epigenetic modulators outside HDAC inhibitors, limiting scope to specific chemical classes.
Limitations and Validity
- The claims specify particular chemical structures, making them vulnerable to design-around strategies targeting other HDAC inhibitor classes.
- The patent emphasizes preclinical data, primarily animal models, which may influence enforceability in clinical settings.
Patent Landscape Position
Related Patents and Priority Files
The patent builds on prior applications, including PCT filings and related U.S. provisional applications.
Competitor Patent Activity
- Similar HDAC inhibitor patents: Several patents target HDAC inhibitors for cancer treatment, but few explicitly address cardiac indications.
- Novelty Factors: The specific focus on cardiac applications and particular chemical structures described in the claims support novelty.
- Potential Infringements: Patents in the HDAC inhibitor space, especially those related to cancer, might overlap with chemical classes but lack claim coverage for cardiac use.
Patent Family and Continuations
- The patent family includes international filings, indicating interest in global markets.
- No direct continuations or divisional patents are publicly reported, suggesting focused claims.
Strategic Implications
- For R&D: The patent protects a specific method of treating heart failure with novel HDAC inhibitors, potentially blocking competitors from using similar compounds for cardiac indications.
- For Licensing: The broad method claims and compound claims create room for licensing or partnership opportunities, especially for combination therapies.
- For Competition: The patent's scope is constrained to certain chemical classes and treatment methods, giving competitors room to develop alternative HDAC inhibitors outside the claim scope.
Regulatory and Commercial Status
- No FDA approval recorded for the specific use, indicating early-stage development.
- Literature indicates ongoing preclinical studies; no clinical trial data appears publicly linked to this patent.
Summary Data Table
| Aspect |
Details |
| Patent Number |
8,822,430 |
| Issue Date |
September 2, 2014 |
| Expiry Date |
September 17, 2032 |
| Assignee |
University of Chicago |
| Claims Type |
Method, compound, combination |
| Main Chemical Focus |
Hydroxamic acids, benzamides, cyclic peptides |
| Key Indications |
Heart failure, cardiac hypertrophy |
| International Filings |
Included (via priority applications) |
| Related Patents |
No direct patents; similar HDAC patents exist in oncology |
Key Takeaways
- Patent 8,822,430 protects a method for treating heart failure using specific HDAC inhibitors.
- The claims predominantly cover chemical classes and treatment methods with specific dosing parameters.
- The patent landscape indicates limited overlap with anti-cancer HDAC patents, providing strategic paths for differentiation.
- The patent's focus on cardiac indications and particular chemical structures emphasizes novel, targeted applications.
- The early development phase suggests opportunities and risks regarding clinical translation and regulatory approval.
FAQs
1. Can the claims of Patent 8,822,430 be challenged based on prior art?
Yes. Prior art involving HDAC inhibitors for other indications exists, but the specific application to heart failure and the chemical structures claimed support patent validity.
2. What are the main limitations of the patent's scope?
It is limited to certain chemical classes of HDAC inhibitors used specifically for cardiac treatments, limiting coverage of other epigenetic agents or unrelated compounds.
3. How does this patent compare to cancer-related HDAC patents?
While many HDAC patents target oncology, this patent focuses solely on cardiac applications, with different claims and target indications.
4. Could competitors develop similar treatments?
Yes. They could explore different HDAC inhibitors outside those claimed or target other epigenetic pathways for heart failure.
5. What is the patent's current enforceability status?
Pending expiration in 2032, with no publicly available challenges or litigations reported, it appears enforceable through that date.
References
- U.S. Patent and Trademark Office. (2014). Patent 8,822,430.
- University of Chicago. (2014). Patent filing data.
- European Patent Office. (2015). Related patent applications.
- PubMed. (2014). Preclinical studies on HDAC inhibitors in cardiac models.
- FDA. (2023). Approved drugs related to HDAC inhibitors.
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