United States Patent 5,859,037: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 5,859,037, titled "Sulfonylurea-glitazone combinations for diabetes," is a significant patent in the field of diabetes treatment. This patent, issued to pharmaceutical researchers, outlines a method for treating diabetes using a combination of sulfonylurea and glitazone antidiabetic agents. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Diabetes mellitus is a chronic metabolic disorder characterized by high blood sugar levels. The treatment often involves a combination of lifestyle changes and pharmacological interventions. The patent in question addresses the need for effective pharmacological treatments by combining two classes of antidiabetic agents: sulfonylureas and glitazones.
Scope of the Patent
The scope of US Patent 5,859,037 is defined by its claims, which describe the specific method and composition of the invention.
Method of Treatment
The patent describes a method of treating diabetes by administering a combination of a sulfonylurea antidiabetic agent and a glitazone antidiabetic agent to a subject in need of treatment. This combination is designed to improve glycemic control and reduce the risk of complications associated with diabetes[4][5].
Active Ingredients
The patent specifies several sulfonylureas and glitazones that can be used in this combination. For sulfonylureas, examples include glyburide, glibenclamide, tolbutamide, and chlorpropamide. For glitazones, the preferred agents are ciglitazone, pioglitazone, englitazone, and rosiglitazone[4][5].
Claims
The claims of the patent are the legal definitions of the invention and are crucial for understanding what is protected.
Independent Claims
The independent claims define the broadest scope of the invention. For example, Claim 1 might state: "A method of treating diabetes mellitus in a subject in need thereof, comprising administering to the subject a combination of a sulfonylurea antidiabetic agent and a glitazone antidiabetic agent"[4].
Dependent Claims
Dependent claims narrow down the scope by adding specific details or limitations to the independent claims. These could include specific dosages, administration routes, or patient populations.
Classification
The patent is classified under various categories in the International Patent Classification (IPC) system:
- A61K31/00: Medicinal preparations containing organic active ingredients, specifically sulfonylureas.
- A61K31/64: Sulfonylureas, e.g., glibenclamide, tolbutamide, chlorpropamide.
- A61P3/00: Drugs for disorders of the metabolism.
- A61P3/08: Drugs for disorders of the metabolism for glucose homeostasis.
- A61P3/10: Drugs for disorders of the metabolism for glucose homeostasis for hyperglycemia, e.g., antidiabetics[4].
Clinical Studies and Efficacy
The patent includes data from clinical studies that demonstrate the efficacy of the sulfonylurea-glitazone combination. These studies involved patients with type 2 diabetes and measured various parameters such as glycemic control, insulin sensitivity, and cardiovascular risk factors. The analysis used statistical methods like analysis of covariance (ANCOVA) and step-down tests for linear trend in dose response[4].
Patent Landscape
Understanding the broader patent landscape is crucial for assessing the novelty and non-obviousness of the invention.
Prior Art
The patent cites several prior art references, including U.S. Pat. Nos. 5,457,109 and 5,478,852, which describe specific glitazones and their use in treating diabetes. The combination of sulfonylureas and glitazones, however, was novel at the time of the patent application[4].
International Patent Offices
Similar patents may exist in other jurisdictions. For instance, the European Patent Office (EPO) and the Japan Patent Office (JPO) have databases that can be searched to identify similar inventions. The World Intellectual Property Organization (WIPO) also provides a PATENTSCOPE® Search Service for international patent applications[1].
Legal Status
The legal status of the patent is an important consideration. As of the current date, US Patent 5,859,037 has expired due to fee-related issues. This means that the invention is no longer protected by patent law, and the combination of sulfonylurea and glitazone antidiabetic agents can be freely used by others[4].
Impact on the Pharmaceutical Industry
The issuance of this patent had significant implications for the pharmaceutical industry. It encouraged further research into combination therapies for diabetes, leading to the development of more effective treatment options. The patent also highlighted the importance of intellectual property protection in driving innovation in the healthcare sector.
Key Takeaways
- Method of Treatment: The patent describes a method for treating diabetes using a combination of sulfonylurea and glitazone antidiabetic agents.
- Active Ingredients: Specific sulfonylureas and glitazones are identified as part of the combination.
- Claims: The patent includes independent and dependent claims that define the scope of the invention.
- Classification: The patent is classified under various IPC categories related to medicinal preparations and metabolic disorders.
- Clinical Studies: The patent includes data from clinical studies demonstrating the efficacy of the combination.
- Patent Landscape: The invention was novel at the time of application, and similar patents may exist in other jurisdictions.
- Legal Status: The patent has expired due to fee-related issues.
FAQs
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What is the main invention described in US Patent 5,859,037?
- The main invention is a method for treating diabetes using a combination of sulfonylurea and glitazone antidiabetic agents.
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Which specific sulfonylureas and glitazones are mentioned in the patent?
- The patent mentions glyburide, glibenclamide, tolbutamide, chlorpropamide as sulfonylureas, and ciglitazone, pioglitazone, englitazone, and rosiglitazone as glitazones.
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What is the current legal status of US Patent 5,859,037?
- The patent has expired due to fee-related issues.
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How does the patent classify the invention in the IPC system?
- The patent is classified under A61K31/00, A61K31/64, A61P3/00, A61P3/08, and A61P3/10.
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What is the significance of the clinical studies mentioned in the patent?
- The clinical studies demonstrate the efficacy of the sulfonylurea-glitazone combination in treating diabetes and improving glycemic control.
Sources
- USPTO - Search for patents[1]
- US Courts - Report on Filing Patent/Trademark[2]
- USPTO - Patent Claims Research Dataset[3]
- Google Patents - US5859037A[4]
- Justia Patents - US Patent for Sulfonylurea-glitazone combinations for diabetes[5]
