United States Patent 11,186,547: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,186,547, titled "High-purity quinoline derivative and method for manufacturing same," is a significant patent in the pharmaceutical industry, particularly related to the drug lenvatinib mesylate. This patent is held by Eisai Co., Ltd. and has been a focal point in recent patent infringement litigation. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Overview of the Patent
High-Purity Quinoline Derivative
The patent US 11,186,547 pertains to the production and characteristics of high-purity quinoline derivatives, specifically lenvatinib mesylate. Lenvatinib is an orally available multiple receptor tyrosine kinase inhibitor used in the treatment of various cancers[5].
Manufacturing Method
The patent describes detailed methods for producing the high-purity compound and its salts. The manufacturing process involves several steps to ensure the purity of the final product, with a preferred purity of 98.0% by mass or more, as evidenced by batch analysis data and stability tests[4].
Scope of the Patent
Claims
The patent includes multiple claims that cover various aspects of the high-purity quinoline derivative and its manufacturing process. Key claims include:
- The high-purity compound itself and its salts.
- Specific methods for producing the compound, including purification steps.
- The use of high-performance liquid chromatography (HPLC) for analyzing the purity of the compound[4].
Coverage of Intellectual Property
The patent provides comprehensive coverage of the intellectual property related to lenvatinib mesylate, ensuring that Eisai Co., Ltd. maintains control over the production and distribution of this drug. This is crucial for maximizing the value of their intellectual property strategy[5].
Patent Landscape
Patent Infringement Litigation
The patent has been at the center of patent infringement lawsuits in the U.S. District Court for the District of New Jersey. Generic drug manufacturers, such as SUN Pharmaceutical Industries Ltd. and Shilpa Medicare Limited, filed Abbreviated New Drug Applications (ANDAs) for generic versions of lenvatinib mesylate, which led to the litigation. A settlement agreement was reached with SUN Pharma on March 21, 2024, while the lawsuit against Shilpa remains pending[2][5].
Impact on Market and Revenue
The settlement and ongoing litigation have significant implications for the market and revenue of lenvatinib mesylate. For the fiscal year ending March 31, 2023, the sales revenue of Lenvima (the brand name for lenvatinib mesylate) in the U.S. was 160.5 billion yen (approximately $1,185 million), with a forecast of 197 billion yen (approximately $1,365 million) for the fiscal year ending March 31, 2024. The settlement is not expected to impact the consolidated financial forecasts for the fiscal year 2024[5].
Claim Coverage and Scope Concepts
Analyzing Patent Claims
To understand the full scope of the patent, it is essential to analyze the claims and scope concepts. This involves categorizing patents by claims and overarching scope concepts, which helps in identifying gaps or opportunities in the patent landscape. Tools like Claim Coverage Matrix and Claim Charts can be used to review patent coverage and determine the applicability of scope concepts to target products or methods[3].
Value Assessment
The scope concepts of the patent claims can be assessed for their value to the company. This can be categorized into high, medium, or low value based on their current and potential future impact. High-value claims are those that are crucial to the company's current operations, while medium-value claims indicate potential future directions. Low-value claims might not be worth maintaining[3].
Legal and Regulatory Aspects
Patent Validity and Enforcement
The patent's legal status and enforcement are critical. The settlement with SUN Pharma and the ongoing litigation with Shilpa highlight the importance of protecting intellectual property rights. The terms and conditions of the settlement are confidential, but the agreement marks a significant step in maximizing the value of Eisai's intellectual property[5].
Compliance with Regulatory Requirements
The production and distribution of lenvatinib mesylate must comply with regulatory requirements. The patent ensures that the manufacturing process meets the necessary standards for purity and stability, which is essential for regulatory approval and patient safety[4].
Financial Implications
Revenue and Market Impact
The patent's protection directly impacts the revenue and market share of Lenvima. By preventing generic versions from entering the market prematurely, Eisai can maintain its market dominance and revenue streams. The forecasted revenue for Lenvima underscores the financial significance of this patent[5].
Settlement and Litigation Costs
The costs associated with the settlement and ongoing litigation are also a consideration. While the terms of the settlement are confidential, the financial implications of these legal actions can be substantial and may affect the company's overall financial health[5].
Conclusion
The United States Patent 11,186,547 is a pivotal patent in the pharmaceutical industry, particularly for Eisai Co., Ltd. and its drug lenvatinib mesylate. The patent's scope and claims provide comprehensive protection for the high-purity quinoline derivative and its manufacturing process. The ongoing patent infringement litigation and recent settlement highlight the importance of intellectual property protection in maintaining market dominance and revenue.
Key Takeaways
- High-Purity Compound: The patent focuses on the production and characteristics of high-purity lenvatinib mesylate.
- Manufacturing Process: Detailed methods for producing the compound and its salts are described.
- Patent Infringement Litigation: The patent has been central to lawsuits against generic drug manufacturers.
- Market and Revenue Impact: The patent's protection affects the revenue and market share of Lenvima.
- Regulatory Compliance: The manufacturing process must comply with regulatory requirements for purity and stability.
- Financial Implications: The patent's protection and legal actions have significant financial implications.
FAQs
Q: What is the main subject of United States Patent 11,186,547?
A: The main subject is the production and characteristics of high-purity lenvatinib mesylate, a quinoline derivative.
Q: Why is this patent important for Eisai Co., Ltd.?
A: This patent is crucial for Eisai Co., Ltd. as it protects their intellectual property related to lenvatinib mesylate, allowing them to maintain market dominance and revenue.
Q: What is the current status of the patent infringement litigation related to this patent?
A: A settlement agreement was reached with SUN Pharmaceutical Industries Ltd. on March 21, 2024, while the lawsuit against Shilpa Medicare Limited is still pending.
Q: How does the patent impact the revenue of Lenvima?
A: The patent's protection prevents generic versions from entering the market prematurely, allowing Eisai to maintain its revenue streams from Lenvima.
Q: What are the regulatory implications of this patent?
A: The patent ensures that the manufacturing process of lenvatinib mesylate meets necessary standards for purity and stability, which is essential for regulatory approval and patient safety.
Sources
- US11186547B2 - High-purity quinoline derivative and method for manufacturing same - Google Patents
- Settlement of patent infringement lawsuits relating to lenvatinib in the U.S. - Moomoo News
- Patent Analytics - SLWIP
- US10407393B2 - High-purity quinoline derivative and method for manufacturing same - Google Patents
- Notice of the Settlement of Patent Infringement Litigation Related to Lenvatinib in the U.S. - Eisai Co., Ltd. News Release
