United States Patent 6,784,177: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,784,177, assigned to NitroMed Inc., is a significant patent that covers methods for treating and preventing mortality associated with heart failure in African American patients with hypertension. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
The patent, titled "Methods using hydralazine compounds and isosorbide dinitrate or isosorbide mononitrate," addresses a critical medical need. Congestive heart failure is a leading cause of hospitalization in individuals over 65 and a major contributor to healthcare costs. The invention specifically targets the treatment of African American patients, who have shown different responses to certain therapies compared to white patients[4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific methods and compositions covered by the invention.
Methods of Treatment
The patent describes methods of treating and preventing mortality associated with heart failure in African American patients with hypertension. These methods involve the administration of a therapeutically effective amount of at least one hydralazine compound and at least one of isosorbide dinitrate or isosorbide mononitrate. Optionally, the treatment may include additional compounds such as digitalis, diuretics, or other cardiovascular disease treatments[4].
Patient Population
The patent focuses on African American patients, recognizing the different clinical responses to therapies such as angiotensin-converting enzyme (ACE) inhibitors compared to white patients. This differentiation is crucial for effective treatment strategies[4].
Claims of the Patent
The claims of the patent are detailed and specific, ensuring broad protection for the invention while avoiding prior art.
Independent Claims
The independent claims define the core of the invention, including the specific combinations of hydralazine compounds and isosorbide dinitrate or isosorbide mononitrate. These claims also specify the therapeutic goals, such as improving oxygen consumption, quality of life, and exercise tolerance in patients[4].
Dependent Claims
Dependent claims further refine the invention by specifying additional components that may be included in the treatment, such as digitalis or diuretic compounds. These claims provide a hierarchical structure, ensuring that the patent covers a range of potential treatment regimens[4].
Patent Landscape
Understanding the patent landscape is essential for assessing the novelty and non-obviousness of the invention.
Prior Art
The patent cites several prior art references, including studies from the Vasodilator-Heart Failure Trials (V-HeFT I and II) and other medical research. These references highlight the differences in clinical responses between black and white patients to various therapies, which the inventors addressed in their work[4].
International Patent Databases
To ensure global novelty, it is crucial to search international patent databases. Resources like the European Patent Office's esp@cenet, the Japan Patent Office, and the World Intellectual Property Organization's PATENTSCOPE provide access to international patent collections, helping to identify any similar inventions worldwide[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) application consolidates prior art cited by participating IP5 Offices, allowing for a comprehensive view of the global patent landscape related to the invention. This tool is particularly useful for identifying potential overlaps or conflicts with other patents[1].
Economic and Clinical Impact
The economic and clinical impact of this patent is significant.
Market Significance
The patent covers BiDil, a drug combination that was specifically approved by the FDA for the treatment of heart failure in African American patients. This approval marked a milestone in personalized medicine, highlighting the importance of racial differences in drug response[5].
Clinical Outcomes
Studies cited in the patent, such as those from the Vasodilator-Heart Failure Trials, demonstrate improved clinical outcomes for African American patients treated with the specified combination of drugs. These outcomes include reduced mortality, improved oxygen consumption, and enhanced quality of life[4].
Legal Status and Expiration
The legal status of the patent is crucial for understanding its current validity and any potential expiration dates.
Expiration Date
The patent has expired, as indicated by its legal status. This means that the methods and compositions described in the patent are now in the public domain, allowing for generic or similar treatments to be developed without infringing on the original patent[4].
Conclusion
United States Patent 6,784,177 represents a significant advancement in the treatment of heart failure in African American patients. The detailed analysis of its scope, claims, and the broader patent landscape underscores its importance in both medical and legal contexts.
Key Takeaways
- Specific Patient Population: The patent targets African American patients with hypertension, recognizing racial differences in drug response.
- Combination Therapy: The invention involves a combination of hydralazine compounds and isosorbide dinitrate or isosorbide mononitrate.
- Clinical Impact: The treatment has shown improved clinical outcomes, including reduced mortality and improved quality of life.
- Legal Status: The patent has expired, making the methods and compositions public domain.
- Global Relevance: The patent's novelty was assessed against a global backdrop using international patent databases and tools like the CCD.
FAQs
Q: What is the main focus of United States Patent 6,784,177?
A: The main focus is on methods for treating and preventing mortality associated with heart failure in African American patients with hypertension.
Q: What are the key components of the treatment described in the patent?
A: The treatment involves a combination of hydralazine compounds and isosorbide dinitrate or isosorbide mononitrate, with optional additional compounds.
Q: Why is this patent significant in the context of personalized medicine?
A: It highlights the importance of racial differences in drug response and was the first FDA-approved drug specifically for African American patients.
Q: What is the current legal status of the patent?
A: The patent has expired, making the described methods and compositions public domain.
Q: How does the patent contribute to the broader medical understanding of heart failure treatment?
A: It provides evidence of improved clinical outcomes for African American patients treated with the specified drug combination, based on studies like the Vasodilator-Heart Failure Trials.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Elgaronline - The colorblind marketplace?: https://www.elgaronline.com/abstract/edcoll/9781783470242/9781783470242.00011.xml
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US6784177B2: https://patents.google.com/patent/US6784177B2/en
- BioWorld - U.S. Patent Disclosures: https://www.bioworld.com/articles/466642
