United States Patent 10,231,931: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,231,931, titled "Thyroid hormone oral dosage forms and methods of using the same," is a significant patent in the pharmaceutical industry, particularly in the field of endocrinology. This patent, granted to the inventors, outlines novel oral dosage forms and methods for using thyroid hormones. Here is a detailed analysis of the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Number and Authority
The patent number is US10,231,931B1, and it was granted by the United States Patent and Trademark Office (USPTO)[4].
Prior Art and Background
The patent builds upon existing knowledge in the field of thyroid hormone treatments. It addresses the need for stable and effective oral dosage forms of thyroid hormones, such as levothyroxine and triiodothyronine. The prior art includes various formulations and methods, but the patent introduces specific improvements in stability, efficacy, and patient compliance.
Claims Analysis
Independent and Dependent Claims
The patent includes a series of independent and dependent claims that define the scope of the invention. Independent claims typically outline the broadest aspects of the invention, while dependent claims narrow down the scope by adding specific details or limitations.
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Independent Claims: These claims describe the novel oral dosage forms and the methods of making and using them. For example, Claim 1 might describe a thyroid hormone oral dosage form comprising a specific combination of active ingredients and excipients that enhance stability and bioavailability[4].
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Dependent Claims: These claims build upon the independent claims by adding additional features or limitations. For instance, a dependent claim might specify the use of a particular inert gas to enhance the stability of the dosage form or the inclusion of a specific antioxidant agent to prevent degradation[4].
Claim Scope and Breadth
The scope of the claims is crucial in determining the patent's breadth and its potential impact on the market. Narrower claims, as discussed in the SSRN paper, are often associated with a higher probability of grant and a shorter examination process. In this case, the claims are specific enough to cover the novel aspects of the invention but broad enough to encompass various embodiments and applications[3].
Key Components of the Invention
Dosage Form
The patent describes novel oral dosage forms of thyroid hormones, including tablets, capsules, and other solid forms. These dosage forms are designed to improve stability, particularly over extended periods, and to enhance patient compliance.
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Stability: The formulation includes components such as hydroxypropyl methyl cellulose, microcrystalline cellulose, and silica gel to maintain the stability of the thyroid hormones over time[4].
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Bioavailability: The patent also discusses methods to enhance the bioavailability of the thyroid hormones, ensuring that the active ingredients are effectively absorbed by the body.
Methods of Use
The patent not only covers the dosage forms but also the methods of using them. This includes specific dosing regimens, storage conditions, and testing methods to ensure the efficacy and safety of the treatment.
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Dosing Regimens: The methods outline how the dosage forms should be administered to patients, including the frequency and dosage levels.
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Storage Conditions: The patent specifies the optimal storage conditions to maintain the stability of the dosage forms, such as the use of inert gases and controlled temperature and humidity environments[4].
Patent Landscape
Related Patents and Prior Art
The patent landscape in the field of thyroid hormone treatments is extensive. Other patents, such as US-6936274-B2, also address the stability and efficacy of thyroid hormone formulations. However, US10,231,931B1 introduces unique improvements and specific combinations of ingredients that differentiate it from prior art[5].
Global Patent System
The global patent system, facilitated by services like the Global Dossier and the Common Citation Document (CCD), allows for the integration of patent information across different jurisdictions. This helps in understanding the broader international landscape and potential filings related to this invention[1].
Litigation and Patentability
Patent Eligibility
The patentability of claims, especially in the context of abstract ideas and natural phenomena, is a critical issue. The Alice test, as discussed in the Contour IP Holding LLC v. GoPro, Inc. case, is a two-step process to determine whether claims are directed to patent-eligible subject matter. In the case of US10,231,931B1, the claims are specific to tangible dosage forms and methods, which are generally considered patent-eligible[2].
Potential Litigation
Given the competitive nature of the pharmaceutical industry, there is always a potential for litigation. Companies must ensure that their products do not infringe on existing patents. The detailed claims and descriptions in US10,231,931B1 provide a clear outline of what is protected, helping other innovators to design around these claims.
Economic and Market Impact
Market Dominance
Patents like US10,231,931B1 can provide significant market advantages. By securing exclusive rights to novel and improved thyroid hormone formulations, the patent holder can dominate the market segment for these treatments. This can lead to increased revenue and market share.
Innovation Incentives
The granting of this patent also serves as an incentive for further innovation. By protecting the intellectual property rights of the inventors, the patent system encourages continued research and development in the field of endocrinology and pharmaceuticals.
Key Takeaways
- Novel Dosage Forms: The patent introduces new and improved oral dosage forms of thyroid hormones.
- Enhanced Stability: The formulations are designed to improve stability and bioavailability.
- Specific Claims: The claims are detailed and specific, defining the scope of the invention clearly.
- Global Relevance: The patent is part of a broader global patent landscape, facilitated by services like the Global Dossier.
- Market Impact: The patent can provide significant market advantages and incentives for further innovation.
FAQs
Q: What is the main focus of United States Patent 10,231,931?
A: The main focus is on novel oral dosage forms and methods of using thyroid hormones, particularly levothyroxine and triiodothyronine.
Q: How does this patent improve upon existing thyroid hormone treatments?
A: It introduces specific improvements in stability, bioavailability, and patient compliance through the use of particular excipients and storage conditions.
Q: What is the significance of the Global Dossier in relation to this patent?
A: The Global Dossier facilitates the integration of patent information across different jurisdictions, helping in understanding the broader international landscape and potential filings related to this invention.
Q: How does the Alice test apply to the patentability of US10,231,931B1?
A: The claims are specific to tangible dosage forms and methods, which are generally considered patent-eligible under the Alice test.
Q: What potential economic impact could this patent have on the market?
A: The patent could provide significant market advantages, leading to increased revenue and market share for the patent holder, and also serve as an incentive for further innovation in the field.
