Transforming Data into Market Domination: A Detailed Analysis of the Scope and Claims of United States Patent 11,135,190
Introduction
Understanding the scope and claims of a patent is crucial for businesses looking to protect their intellectual property and navigate the complex patent landscape. This article delves into the details of United States Patent 11,135,190, focusing on its scope, claims, and the broader patent landscape it inhabits.
Overview of the Patent
United States Patent 11,135,190, titled "Levothyroxine Liquid Formulations," was granted to Fresenius Kabi USA, LLC, on October 5, 2021. This patent pertains to a pharmaceutical product comprising a liquid formulation of levothyroxine or its pharmaceutically acceptable salt, along with specific excipients and a defined pH range[1].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific elements and characteristics of the invention. Here, the patent covers a liquid formulation that includes:
- Levothyroxine or a pharmaceutically acceptable salt thereof
- Tromethamine
- Sodium iodide
- Water
- A pH range of about 9.0 to about 11.5[1].
This formulation is designed to be stable and ready-to-use, addressing a significant need in the pharmaceutical industry for reliable and consistent thyroid hormone replacement therapies.
Claims Analysis
The patent includes 16 claims, each detailing a specific aspect of the invention. Here are some key claims:
Independent Claims
- Claim 1: A liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof, tromethamine, sodium iodide, and water, with a pH of about 9.0 to about 11.5[1].
Dependent Claims
- Claim 2: The formulation of claim 1, wherein the concentration of levothyroxine is between about 10 μg/mL and about 100 μg/mL[1].
- Claim 3: The formulation of claim 1, wherein the concentration of tromethamine is between about 0.1 mg/mL and about 10 mg/mL[1].
These claims collectively define the boundaries of the invention, ensuring that any similar formulations would infringe on this patent unless they fall outside these specified parameters.
Patent Landscape
The patent landscape surrounding US 11,135,190 involves a complex web of related patents and applications. Here are some key points:
Prior Art and Related Patents
The patent cites several prior art documents and related patents, including those by Parikh et al., Jiang et al., and Psarrakis et al., which indicate the evolution of levothyroxine formulations over time[1].
Competitor Analysis
Companies like Fresenius Kabi USA, LLC, are part of a larger ecosystem that includes other pharmaceutical companies working on similar formulations. Understanding the claims and scope of this patent helps in identifying gaps and opportunities in the market.
Claim Coverage Matrix
Using a Claim Coverage Matrix, as described in patent analytics practices, can help in categorizing patents by claims and scope concepts. This tool is essential for filtering, searching, and analyzing large numbers of patent claims to determine coverage and identify potential gaps or opportunities[3].
Economic and Strategic Implications
The economic and strategic implications of this patent are significant:
Market Protection
By securing this patent, Fresenius Kabi USA, LLC, gains exclusive rights to manufacture and market this specific levothyroxine liquid formulation, protecting its market share and preventing competitors from producing similar products.
Innovation and R&D
The patent encourages further innovation in the field of thyroid hormone replacement therapies. Companies can build upon this invention, exploring new formulations and improvements that do not infringe on the existing claims.
Licensing and Collaboration
The patent can also serve as a basis for licensing agreements or collaborative research with other companies, fostering a collaborative environment that drives innovation and market growth.
Tools and Resources for Analysis
Several tools and resources are available for analyzing patent claims and scope:
Patent Claims Research Dataset
The USPTO provides a comprehensive dataset containing detailed information on claims from US patents granted between 1976 and 2014, and US patent applications published between 2001 and 2014. This dataset can be used to analyze claim-level statistics and document-level statistics, including measures of patent scope[2][5].
ClaimScape® Software
Tools like ClaimScape® software help in generating interactive claim charts that can be reviewed by technical experts to determine the applicability of scope concepts to target products or methods. This aids in identifying gaps in current coverage and highlighting future design opportunities[3].
Key Takeaways
- Specific Formulation: The patent covers a specific liquid formulation of levothyroxine with defined excipients and a pH range.
- Claims Analysis: The 16 claims define the boundaries of the invention, ensuring protection against similar formulations.
- Patent Landscape: The patent is part of a broader landscape involving related patents and applications.
- Economic Implications: The patent provides market protection, encourages innovation, and facilitates licensing and collaboration.
- Analytical Tools: Resources like the Patent Claims Research Dataset and ClaimScape® software are essential for comprehensive analysis.
FAQs
Q: What is the main subject of United States Patent 11,135,190?
A: The main subject is a liquid formulation of levothyroxine or its pharmaceutically acceptable salt, along with specific excipients and a defined pH range.
Q: What are the key components of the liquid formulation?
A: The key components include levothyroxine or its pharmaceutically acceptable salt, tromethamine, sodium iodide, and water, with a pH range of about 9.0 to about 11.5.
Q: How many claims are included in the patent?
A: The patent includes 16 claims.
Q: What is the significance of the Claim Coverage Matrix in patent analytics?
A: The Claim Coverage Matrix helps in categorizing patents by claims and scope concepts, facilitating the identification of gaps and opportunities in the market.
Q: What tools are available for analyzing patent claims and scope?
A: Tools include the Patent Claims Research Dataset and software like ClaimScape®, which generate interactive claim charts for comprehensive analysis.
Sources
- United States Patent and Trademark Office. US 11,135,190 B2 - Levothyroxine Liquid Formulations. October 5, 2021.
- United States Patent and Trademark Office. Patent Claims Research Dataset. August 28, 2017.
- Schwegman, Lundberg & Woessner, P.A. Patent Analytics. Retrieved December 21, 2024.
- Google Patents. US8071619B2 - Injectable liquid formulation of paracetamol. Retrieved December 21, 2024.
- United States Patent and Trademark Office. Patent and patent application Claims data (Stata (.dta) and MS Excel (.csv)) Retrieved December 21, 2024.
