Understanding the Scope and Claims of United States Patent 9,782,376
Introduction
United States Patent 9,782,376, assigned to Fresenius Kabi USA, LLC, pertains to liquid formulations of levothyroxine, a crucial hormone replacement therapy. This patent is significant in the pharmaceutical industry, particularly for patients requiring thyroid hormone supplementation.
Background of the Invention
Levothyroxine sodium is widely used for treating hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormones. The patent addresses the need for stable and effective liquid formulations of levothyroxine, which can be particularly beneficial for patients who have difficulty swallowing tablets or require precise dosing[1].
Claims of the Patent
The patent claims cover specific liquid formulations of levothyroxine that include:
- Levothyroxine or a Pharmaceutically Acceptable Salt: The formulation contains levothyroxine or its salt in a concentration of about 20 mcg/mL to about 100 mcg/mL.
- Tromethamine: This component is included in a concentration of about 5 mg/mL to about 20 mg/mL.
- Sodium Iodide: This is another key component of the formulation.
- pH Range: The formulation has a pH of about 9.0 to about 11.5, ensuring stability and efficacy[1].
Scope of the Patent
The scope of the patent is defined by the specific claims and the detailed description provided. Here are some key aspects:
Formulation Components
The patent specifies the exact concentrations of levothyroxine, tromethamine, and sodium iodide, along with the pH range of the formulation. This narrow scope ensures that the patented formulation is distinct and offers specific benefits, such as improved stability and bioavailability[1].
Therapeutic Use
The patent is focused on the therapeutic use of levothyroxine in liquid form, which is particularly useful for patients who cannot take tablets. This includes patients in critical conditions, such as those in a state of myxedema coma[1].
Manufacturing Process
While the patent itself does not detail the manufacturing process, related patents like US9428444B2 provide insights into the preparation of highly pure levothyroxine sodium, which could be relevant for producing the liquid formulations claimed in US 9,782,376[4].
Patent Landscape
The patent landscape surrounding US 9,782,376 involves several related patents and applications:
Related Patents
- US9428444B2: This patent describes a novel process for preparing highly pure levothyroxine sodium, which is a key component of the liquid formulations claimed in US 9,782,376[4].
- Other Related Patents: Patents like US 10,398,669 and US 9,168,238 B2 are part of the continuation and related application series, indicating a robust intellectual property strategy around levothyroxine formulations[1][2].
International Patents
The patent has international counterparts, such as WO 2017/013591 A1 and WO 2019/023791 A1, which extend the protection of the invention globally[1].
Expiration and Generic Entry
The patent's expiration date and potential generic entry are critical for understanding the competitive landscape. As of the current date, the patent is still active, but its expiration will open the market to generic versions of the liquid levothyroxine formulations[2].
Metrics for Patent Scope
To analyze the scope of the patent, metrics such as independent claim length and independent claim count can be used. These metrics help in understanding the breadth and clarity of the patent claims.
- Independent Claim Length: The length of the shortest independent claim can indicate the specificity and clarity of the patent. Shorter claims often suggest narrower and more defined scope[3].
- Independent Claim Count: The total number of independent claims can also reflect the breadth of the patent. Fewer independent claims might indicate a more focused invention[3].
Impact on Innovation and Litigation
The clarity and breadth of patent claims can significantly impact innovation and litigation. Narrower claims, as seen in US 9,782,376, are generally associated with a higher probability of grant and shorter examination processes. This can reduce licensing and litigation costs, thereby promoting innovation[3].
Expert Insights
Industry experts emphasize the importance of clear and specific patent claims. For instance, Robert Polk Wagner notes that opaque disclosures and indeterminate claims can impede innovation by increasing the complexity and cost of patent litigation[3].
Statistics and Examples
- Patent Maintenance Payments: Patents with narrower claims tend to have lower maintenance payments, indicating a more focused and valuable invention[3].
- Forward Citations: The number of forward citations can also indicate the impact and relevance of the patent. US 9,782,376, with its specific claims, may attract fewer but more relevant citations[3].
Key Takeaways
- Specific Formulations: The patent covers specific liquid formulations of levothyroxine with defined concentrations and pH ranges.
- Therapeutic Benefits: The formulations are particularly beneficial for patients who cannot take tablets, including those in critical conditions.
- Patent Landscape: The patent is part of a broader intellectual property strategy involving related patents and international counterparts.
- Metrics for Scope: Independent claim length and count are useful metrics for analyzing the scope and clarity of the patent.
- Impact on Innovation: Clear and specific claims can reduce litigation costs and promote innovation.
FAQs
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What is the primary focus of United States Patent 9,782,376?
- The primary focus is on liquid formulations of levothyroxine, including specific concentrations and pH ranges.
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Who is the assignee of the patent?
- The assignee is Fresenius Kabi USA, LLC.
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What are the key components of the liquid formulation?
- The key components include levothyroxine or its salt, tromethamine, and sodium iodide.
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Why is the pH range of the formulation important?
- The pH range of about 9.0 to about 11.5 ensures the stability and efficacy of the formulation.
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How does the patent impact innovation in the pharmaceutical industry?
- The clear and specific claims of the patent can reduce licensing and litigation costs, thereby promoting innovation.
Cited Sources
- United States Patent and Trademark Office. LEVOTHYROXINE LIQUID FORMULATIONS. US 11,135,190 B2, October 5, 2021.
- Drug Patent Watch. Pharmaceutical drugs covered by patent 9782376.
- Hoover Institution. Patent Claims and Patent Scope. August 2016.
- Google Patents. Process for the preparation of levothyroxine sodium. US9428444B2, August 30, 2016.