Detailed Analysis of the Scope and Claims of United States Patent 11,139,056
Introduction
The United States Patent 11,139,056, titled "Methods of treating overweight and obesity," is a significant patent in the field of weight management and obesity treatment. This patent, issued to Nalpropion Pharmaceuticals LLC, outlines innovative methods and compositions for treating overweight and obesity using a combination of naltrexone and bupropion.
Background
Obesity and overweight conditions are major health concerns globally, associated with increased risks of various adverse health outcomes, including cardiovascular diseases, diabetes, and certain types of cancer. The patent addresses this critical issue by providing a comprehensive approach to weight management.
Inventors and Assignee
The patent was invented by Preston Klassen and Kristin Taylor, and it is assigned to Nalpropion Pharmaceuticals LLC, a company focused on developing treatments for overweight and obesity[1][5].
Scope of the Patent
Compositions and Methods
The patent describes compositions, kits, uses, systems, and methods for treating overweight and obesity. The core of the invention involves the use of naltrexone plus bupropion, preferably in a sustained-release formulation. These medications are combined with a comprehensive lifestyle intervention (CLI) program, which may include web-based or telephone-based weight management programs[1][4].
Target Population
The patent specifically highlights the treatment of subjects at increased risk of adverse cardiovascular outcomes. This focus on high-risk populations underscores the importance of addressing weight-related health issues that can lead to severe cardiovascular events[1].
Comprehensive Lifestyle Intervention (CLI)
The CLI program is a crucial component of the treatment method. It includes various elements such as dietary counseling, physical activity recommendations, and behavioral support. This holistic approach aims to ensure sustainable weight loss and overall health improvement[1].
Claims of the Patent
Key Claims
- The patent claims methods for treating overweight and obesity by administering a therapeutically effective amount of sustained-release naltrexone and sustained-release bupropion to the subject.
- It also claims the use of these medications in combination with a CLI program, which can be web-based or telephone-based.
- Specific claims include the treatment of subjects at increased risk of adverse cardiovascular outcomes[1].
Pharmaceutical Formulations
The patent details the pharmaceutical formulations of naltrexone and bupropion, including their sustained-release forms and pharmaceutically acceptable salts. These formulations are designed to ensure consistent and effective drug delivery over an extended period[1][4].
Patent Landscape
Related Patents
The patent is part of a broader portfolio of patents related to weight loss and obesity treatment. Other relevant patents include:
- US9633575B2: Also related to methods of treating overweight and obesity using naltrexone plus bupropion[4].
- US11,033,543: Focuses on methods of providing weight loss therapy, particularly for patients suffering from major depression[5].
Patent Expiration Dates
The patent 11,139,056 is set to expire on June 5, 2033. This expiration date is significant as it determines the period during which the patent holders have exclusive rights to the invention. Other related patents have varying expiration dates, ranging from 2024 to 2034[2][5].
Litigation and Regulatory Status
The patent is part of ongoing litigation and regulatory processes. For instance, the FDA has determined the bioequivalence of generic versions of naltrexone and bupropion extended-release tablets, but final approval for generic versions is pending due to patent issues[2].
Impact on the Pharmaceutical Industry
Innovation in Weight Management
The patent represents a significant innovation in weight management therapies, offering a combination of pharmacological and behavioral interventions. This approach has the potential to improve treatment outcomes for patients with overweight and obesity, particularly those at high risk of cardiovascular events.
Market Competition
The absence of a generic version of Contrave (the brand name for naltrexone and bupropion combination) in the U.S. market means that Nalpropion Pharmaceuticals LLC maintains a competitive edge until the patent expires in 2033. This exclusivity period allows the company to recoup its investment in research and development[5].
Clinical Significance
Efficacy and Safety
Clinical trials and studies have shown that the combination of naltrexone and bupropion is effective in achieving significant weight loss. The inclusion of a CLI program enhances the sustainability of weight loss and improves overall health outcomes. However, as with any medication, there are potential side effects and contraindications that must be carefully managed[1].
Patient Population
The focus on patients at increased risk of adverse cardiovascular outcomes highlights the critical need for effective weight management strategies in this population. By addressing both the pharmacological and lifestyle aspects of weight loss, this treatment approach can significantly reduce the risk of cardiovascular events.
Key Takeaways
- Innovative Treatment Approach: The patent describes a novel combination of naltrexone and bupropion with a comprehensive lifestyle intervention program for treating overweight and obesity.
- Targeted Population: The treatment is specifically designed for subjects at increased risk of adverse cardiovascular outcomes.
- Patent Expiration: The patent is set to expire on June 5, 2033, which will impact the market availability of generic versions.
- Clinical Significance: The treatment has shown efficacy in clinical trials and addresses a critical health need by combining pharmacological and behavioral interventions.
FAQs
Q: What is the main focus of United States Patent 11,139,056?
A: The main focus is on methods for treating overweight and obesity using a combination of naltrexone and bupropion, preferably with a comprehensive lifestyle intervention program.
Q: Who are the inventors of this patent?
A: The inventors are Preston Klassen and Kristin Taylor.
Q: What is the role of the comprehensive lifestyle intervention (CLI) program in this patent?
A: The CLI program includes web-based or telephone-based weight management programs and is designed to support sustainable weight loss and overall health improvement.
Q: When is the patent set to expire?
A: The patent is set to expire on June 5, 2033.
Q: Are there any generic versions of the medication described in this patent available in the U.S.?
A: No, there are currently no therapeutically equivalent generic versions of Contrave available in the United States[5].
Sources
- United States Patent and Trademark Office, "Methods of treating overweight and obesity," US11139056B2.
- U.S. Food & Drug Administration, "ANDA 208043," accessdata.fda.gov.
- Cornell Law School, "The Unresolved Interpretive Ambiguity of Patent Claims," scholarship.law.cornell.edu.
- Google Patents, "Methods of treating overweight and obesity," US9633575B2.
- Drugs.com, "Generic Contrave Availability," drugs.com.
