United States Patent 11,154,498: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,154,498, titled "Stabilized liquid formulation of levothyroxine," is a significant patent in the pharmaceutical industry, particularly for the treatment of thyroid disorders. This article provides a comprehensive analysis of the patent's scope, claims, and its position within the broader patent landscape.
Patent Overview
Patent Title and Number
The patent in question is U.S. Patent No. 11,154,498, focusing on a "Stabilized liquid formulation of levothyroxine."
Patent Expiry
The patent is set to expire in July 2036, approximately 11 years from the current date, assuming no extensions or amendments that could alter its expiry date[2][5].
Scope of the Patent
Subject Matter
The patent pertains to a stabilized liquid formulation of levothyroxine, a synthetic form of the thyroid hormone thyroxine (T4). This formulation is designed to improve the stability and efficacy of levothyroxine, which is crucial for patients with hypothyroidism or other thyroid-related conditions[5].
Claims
The patent claims cover several key aspects:
- Composition: The stabilized liquid formulation includes levothyroxine and specific stabilizers that prevent degradation.
- Method of Preparation: The patent details the process of preparing the stabilized liquid formulation, ensuring consistency and stability.
- Administration: The claims include methods of administering the formulation, such as oral dosing, which is a common mode of administration for levothyroxine[2].
Claims Analysis
Claim Structure
The claims are structured to protect the specific formulation, preparation method, and administration techniques. Here’s a breakdown:
- Independent Claims: These claims define the broad scope of the invention, including the composition and method of preparation.
- Dependent Claims: These claims narrow down the scope by specifying particular aspects, such as the type of stabilizers used or the concentration of levothyroxine[4].
Non-Obviousness
To be granted, the patent must meet the non-obviousness criterion, meaning the differences between the claimed invention and prior art must be significant enough that the invention would not have been obvious to a person of ordinary skill in the field. The stabilized liquid formulation of levothyroxine likely meets this criterion by introducing a novel combination of stabilizers that enhance the drug's stability and efficacy[4].
Patent Landscape
Patent Activity in the Field
The patent landscape for levothyroxine and related thyroid treatments is active. There has been significant patent activity in recent years, with multiple companies filing patents related to various aspects of levothyroxine formulations, including dosage forms, modes of administration, and stabilization techniques[5].
Key Players
Several pharmaceutical companies are actively involved in the development and patenting of levothyroxine formulations. Companies like Teva Pharmaceuticals USA Inc. have filed multiple patents and generic versions of levothyroxine, indicating a competitive and innovative environment[5].
Geographical Distribution
While the patent in question is filed in the United States, the global patent landscape for thyroid treatments is diverse. The United States, Europe, and China are among the leading regions for patent filings in the medical and pharmaceutical sectors, reflecting the global interest in advancing thyroid treatment technologies[1].
Validation and Regulatory Compliance
FDA Registration
To ensure the patented medical sensors or formulations are validated, they must be registered in the FDA medical device database. For pharmaceuticals like levothyroxine, compliance with FDA regulations is crucial, and the patent holder would need to demonstrate the safety and efficacy of the stabilized liquid formulation through clinical trials and regulatory submissions[1].
ISO Standards
Compliance with ISO standards is also essential for medical devices and pharmaceuticals. The patent holder must ensure that the manufacturing process and the final product meet these standards to guarantee quality and safety[1].
Clinical Data and Validation
Clinical Studies
The clinical data for the stabilized liquid formulation of levothyroxine would be studied through databases like PubMed, Google Scholar, and Scopus. These studies would provide evidence of the formulation's efficacy and safety, which is critical for regulatory approval and market acceptance[1].
Market Impact
The introduction of a stabilized liquid formulation of levothyroxine can significantly impact the market by offering a more stable and effective treatment option. This could lead to increased patient compliance and better treatment outcomes, making it a valuable addition to the existing treatment landscape[1].
Key Takeaways
- Patent Scope: The patent covers a stabilized liquid formulation of levothyroxine, including its composition, preparation method, and administration.
- Claims Structure: The claims are structured to protect the specific formulation and its preparation and administration methods.
- Non-Obviousness: The patent meets the non-obviousness criterion by introducing a novel combination of stabilizers.
- Patent Landscape: The patent is part of an active landscape with significant interest from pharmaceutical companies.
- Regulatory Compliance: Compliance with FDA regulations and ISO standards is essential for validation.
FAQs
Q: What is the primary focus of U.S. Patent 11,154,498?
A: The primary focus is on a stabilized liquid formulation of levothyroxine, including its composition, preparation method, and administration.
Q: When is the patent set to expire?
A: The patent is set to expire in July 2036, assuming no extensions or amendments.
Q: What are the key claims protected by the patent?
A: The patent claims protect the specific formulation, the method of preparation, and the administration techniques of the stabilized liquid levothyroxine.
Q: How does the patent meet the non-obviousness criterion?
A: The patent introduces a novel combination of stabilizers that enhance the stability and efficacy of levothyroxine, making it non-obvious to a person of ordinary skill in the field.
Q: Which companies are actively involved in the patent landscape for levothyroxine formulations?
A: Companies like Teva Pharmaceuticals USA Inc. are actively involved in the development and patenting of levothyroxine formulations.
Sources
- Frontiers in Medicine: Patent landscape review of non-invasive medical sensors for continuous monitoring of blood pressure and their validation in critical care practice.
- Pharsight: Levothyroxine Sodium patent expiration.
- SLWIP: Patent Analytics.
- Indiana University Maurer School of Law: INVENTIONS AND PATENTS FOR TREATING THYROID DISEASE.
- Pharsight: Drug Patents containing Levothyroxine Sodium.
