Details for Patent: 10,407,393

Which drugs does patent 10,407,393 protect, and when does it expire?

Patent 10,407,393 protects LENVIMA and is included in one NDA.

Protection for LENVIMA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-nine patent family members in twenty-four countries.

Summary for Patent: 10,407,393

Title:	High-purity quinoline derivative and method for manufacturing same
Abstract:	Provided is a compound represented by formula (IV) or a salt thereof, wherein the content of the compound represented by formula (I) is 350 ppm by mass or less. ##STR00001##
Inventor(s):	Nakamura; Taiju (Kamisu, JP), Abe; Taichi (Kamisu, JP), Miyashita; Yusuke (Kamisu, JP), Kuroda; Hirofumi (Kamisu, JP), Ayata; Yusuke (Kamisu, JP), Akao; Atsushi (Kamisu, JP)
Assignee:	Eisai R&D Management Co., Ltd. (Tokyo, JP)
Application Number:	16/229,805
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,407,393
Patent Claim Types: see list of patent claims	Compound;

Understanding the Scope and Claims of United States Patent 10,407,393

Introduction

The United States Patent 10,407,393, titled "High-Purity Quinoline Derivative and Method for Manufacturing Same," is a crucial patent held by Eisai R&D Management Co., Ltd. (ERDC) and its affiliates. This patent is central to the production and intellectual property protection of lenvatinib mesylate, a key component of the drug LENVIMA®, an orally available multiple receptor tyrosine kinase inhibitor.

Patent Overview

• The patent was issued by the United States Patent and Trademark Office (USPTO) on September 10, 2019[1][2].
• It is listed in the FDA's patent publication entitled "Approved Drug Products with Therapeutic Equivalence Evaluations" as covering LENVIMA®[1].

Assignees and Licensees

• ERDC is the assignee of the '393 Patent.
• Eisai Co., Ltd. (ECL) is an exclusive licensee of the '393 Patent.
• Eisai Manufacturing Ltd. (EML) and MSD (Merck & Co., Inc.) are co-exclusive sub-licensees of the '393 Patent[1].

Claims and Scope

High-Purity Quinoline Derivative

• The patent focuses on methods for manufacturing high-purity lenvatinib mesylate, specifically reducing the amount of impurities, including a compound referred to as "Impurity I" or "compound (I)"[1][4].
• The specification details various production methods to achieve this high purity, emphasizing the importance of minimizing impurities to ensure the drug's efficacy and safety[4].

Claim Construction

• The claims of the '393 Patent have been subject to legal scrutiny, particularly in the context of patent infringement litigation. The parties involved have submitted joint claim construction and prehearing statements to clarify the scope of the claims[1].
• The construction of terms such as those related to the presence of Impurity I has been a point of contention. Defendants have argued that the patent specification does not limit the claimed invention based on a specific acceptance criterion for Impurity I, suggesting it may or may not be present in the final product[1].

Indefiniteness and Claim Clarity

• The patent's claims must meet the definiteness requirement, meaning they must inform those skilled in the art about the scope of the invention with reasonable certainty. The Federal Circuit has emphasized that a "modicum of uncertainty" is permitted due to the inherent limitations of language[1].
• The case of Nautilus, Inc. v. Biosig Instruments, Inc. sets the standard that a patent is invalid for indefiniteness if its claims fail to inform those skilled in the art about the scope of the invention with reasonable certainty[1].

Patent Landscape and Litigation

Infringement Litigation

• ERDC and its affiliates have been involved in several patent infringement lawsuits against generic drug manufacturers, including SUN Pharmaceutical Industries Ltd. and Shilpa Medicare Limited. These lawsuits were filed in the U.S. District Court for the District of New Jersey starting in November 2019[1][2].
• The litigation involved allegations of infringement of the '393 Patent, as well as other related patents such as U.S. Patent No. 10,259,791 and U.S. Patent No. 9,006,256[1].

Settlement Agreement

• On March 21, 2024, Eisai Co., Ltd. announced a settlement agreement with SUN Pharmaceutical Industries Ltd. regarding the patent infringement lawsuit. The terms of the settlement are confidential, but it marks a significant step in protecting the intellectual property related to LENVIMA®[2].

Economic and Market Impact

• LENVIMA® is a significant revenue generator for Eisai Co., Ltd. The sales revenue of LENVIMA® in the U.S. for the fiscal year ended March 31, 2023, was approximately 160.5 billion yen (US$1,185 million), with a forecast of 197.0 billion yen (US$1,365 million) for the fiscal year ending March 31, 2024[2].
• The settlement is expected to have no impact on the consolidated financial forecasts for the fiscal year ending March 31, 2024[2].

Technical Problem and Solution

• The patent addresses the technical problem of reducing impurities in lenvatinib mesylate, which is critical for maintaining the drug's efficacy and safety.
• The solution involves specific production methods and quality control measures to ensure the high purity of the quinoline derivative[4].

Production Methods

• The patent details several production methods, including reaction schemes and examples, to achieve the high-purity lenvatinib mesylate. These methods are described in various sections of the patent, including Reference Examples and Production Examples[4].

Conclusion

The United States Patent 10,407,393 is a pivotal patent in the pharmaceutical industry, particularly in the production and protection of lenvatinib mesylate. Understanding its scope, claims, and the surrounding patent landscape is essential for both legal and technical professionals.

Key Takeaways

• Patent Scope and Claims: The patent focuses on high-purity lenvatinib mesylate production, emphasizing the reduction of impurities.
• Litigation and Settlement: ERDC and its affiliates have been involved in significant patent infringement litigation, culminating in a settlement with SUN Pharmaceutical Industries Ltd.
• Economic Impact: LENVIMA® generates substantial revenue, and the patent's protection is crucial for maintaining market dominance.
• Technical Solution: The patent provides detailed production methods to ensure the high purity of the drug.

FAQs

Q: What is the main focus of the United States Patent 10,407,393? A: The main focus is on methods for manufacturing high-purity lenvatinib mesylate, specifically reducing the amount of impurities.

Q: Who are the assignees and licensees of the '393 Patent? A: ERDC is the assignee, ECL is the exclusive licensee, and EML and MSD are co-exclusive sub-licensees.

Q: What is the significance of the settlement agreement with SUN Pharmaceutical Industries Ltd.? A: The settlement protects the intellectual property related to LENVIMA® and is a major step in maximizing its value.

Q: How does the patent address the technical problem of impurities in lenvatinib mesylate? A: The patent details specific production methods and quality control measures to ensure high purity.

Q: What is the economic impact of LENVIMA® on Eisai Co., Ltd.? A: LENVIMA® generates significant revenue, with sales of approximately 160.5 billion yen (US$1,185 million) in the fiscal year ended March 31, 2023.

Sources

1. Eisai R&d Mgmt. v. Shilpa Medicare Ltd, Casetext.
2. Notice of the Settlement of Patent Infringement Litigation Related to Lenvatinib in the U.S., Eisai Co., Ltd.
3. Patent Claims and Patent Scope, Hoover Institution.
4. High-purity quinoline derivative and method for manufacturing same, Justia Patents.

Drugs Protected by US Patent 10,407,393

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-001	Feb 13, 2015		RX	Yes	No					Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 10,407,393

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2014-174062	Aug 28, 2014
Japan	2015-034729	Feb 25, 2015

International Family Members for US Patent 10,407,393

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	101695
Australia	2015309862
Brazil	112017002827
Canada	2957005
China	106660964
China	113683564