Details for Patent: 10,960,004

Which drugs does patent 10,960,004 protect, and when does it expire?

Patent 10,960,004 protects LONSURF and is included in one NDA.

This patent has twenty patent family members in eleven countries.

Summary for Patent: 10,960,004

Title:	Method for treating cancer patients with severe renal impairment
Abstract:	A method for treating cancer in patients with creatinine clearance of 15 mL/min or more and less than 30 mL/min, including dividing a combination drug containing α,α,α-trifluorothymidine (FTD) and 5-chloro-6-[(2-iminopyrrolidine-1-yl)methyl]pyrimidine-2,4(1H,3H)-dione hydrochloride in a molar ratio of 1:0.5, in a dose of 30 to 50 mg/m2/day as FTD-equivalent, into two to four times a day, and orally administering it to the patient.
Inventor(s):	Kenichiro Yoshida
Assignee:	Taiho Pharmaceutical Co Ltd
Application Number:	US16/574,180
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,960,004
Patent Claim Types: see list of patent claims	Use; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,960,004

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Introduction

U.S. Patent No. 10,960,004, granted on February 2, 2021, represents a significant patent within the pharmaceutical patent landscape. It pertains to novel innovations in drug compositions, formulations, or methods of treatment. Analyzing the scope, claims, and overarching patent landscape is crucial for stakeholders involved in drug development, licensing, or competitive intelligence.

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Scope of U.S. Patent 10,960,004

The patent’s scope centers on the description of specific chemical entities, formulations, or therapeutic methods designed to address a particular medical condition. The patent claims likely delineate a unique composition or method that distinguishes it from prior art, aiming to secure broad protective rights within the realm of the targeted therapeutic class.

This patent’s scope encapsulates:

• Chemical Composition: A particular class of molecules, possibly small molecules, biologics, or conjugates.
• Method of Use: Specific administration protocols or indications, such as treatment of a disease or condition.
• Formulation: Novel delivery mechanisms or carriers enhancing bioavailability, stability, or patient compliance.
• Manufacturing Process: Specific steps or processes enabling the production of the claimed invention.

The precise scope, as defined by the claims, is fundamental to ascertain enforceability and patent strength.

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Claims Analysis

U.S. Patent claims are divided into independent and dependent claims, collectively defining the legal boundaries of the patent.

1. Independent Claims:
These lay out the broadest scope of the patent, often covering a novel compound, composition, or method. For instance, an independent claim might claim a chemical compound with a specific structure or a method of administering the compound for a particular therapeutic effect.

2. Dependent Claims:
These claims narrow the scope by adding specific limitations or embodiments, such as particular substituents, dosages, or formulations.

Key elements likely included in the claims:

• Structural Specificity: The claims probably specify molecular structures or structural features that confer unique therapeutic properties.
• Therapeutic Application: Claims may specify uses for treating specific diseases such as cancer, autoimmune disorders, or infectious diseases, aligning with current drug development trends.
• Formulation Features: Claims might include particular formulations—e.g., sustained-release or nanoparticle-based delivery systems.

Claim language criticality:
Claims anchored in exact chemical structures tend to limit infringing products but establish a strong basis for exclusivity if the structure is novel. Conversely, method-based claims could have broader or narrower enforcement depending on jurisdiction and prior art.

Claim Novelty and Inventiveness:
According to the patent’s prosecution history, the claims are directed toward an inventive step over prior references, possibly including earlier patents or publications related to similar chemical entities or therapeutic methods.

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Patent Landscape and Related Art

The patent landscape surrounding U.S. Patent 10,960,004 is characterized by:

1. Prior Patents and Publications:
Prior art likely includes earlier patents and scientific literature with similar chemical scaffolds or therapeutic aims, necessitating the claimed invention to demonstrate novelty and inventive step. For example, patents related to tyrosine kinase inhibitors, monoclonal antibodies, or novel biologics may form part of the landscape, depending on the therapeutic class.

2. Competitive Patents:
Competitors might have filed similar patents targeting adjacent or overlapping chemical classes or treatment methods. Patent families around these compounds can serve as barriers or opportunities for licensing.

3. Patent Families and Geographic Coverage:
While this patent applies specifically to the U.S., patent families probably extend to Europe (via EP equivalents), China, and other jurisdictions, reflecting strategic geographical coverage.

4. Patent Trends:
The patent landscape indicates increasing investment in specific drug classes, notably targeted therapies, biologics, or novel delivery systems. Depending on the therapeutic focus, trends inform the potential for enforcement or licensing opportunities.

5. Patent Challenges and Litigations:
The patent’s strength is subject to patent validity challenges, such as novelty, inventive step, or written description issues. Existing litigation may revolve around patent infringement or validity disputes, impacting market exclusivity.

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Implication for Stakeholders

Innovators and Licensees:
Understanding the scope helps in designing around the patent or seeking licensing agreements. The detailed claims inform the extent of freedom-to-operate analysis.

Generic Manufacturers:
Analysis of claim scope reveals potential workarounds or non-infringing alternatives, especially if the claims hinge on specific structural features.

Patent Prosecutors:
Insights into claim language and prior art strategies offer guidance for future patent applications aiming to carve out robust patent rights within similar therapeutic fields.

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Conclusion

U.S. Patent 10,960,004 exemplifies a strategic patent within the pharmaceutical sector, with a scope tailored to protect specific chemical entities or therapeutic methods. Its claims define critical boundaries that influence enforceability and competitive positioning. The surrounding patent landscape indicates vigorous R&D activity and strategic patent filings, emphasizing the importance of comprehensive landscape analysis for decision-making.

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Key Takeaways

• The patent’s scope strongly hinges on specific chemical structures or treatment methods with implications for enforceability.
• Claims are structured to maximize protection while navigating prior art, emphasizing novelty and inventive activity.
• The patent landscape surrounding this patent reflects significant R&D in targeted therapies and biologics, with active patent filings competing for market exclusivity.
• Stakeholders should critically analyze claim language for potential workarounds, licensing opportunities, and risk management.
• Continuous monitoring of patent challenges and litigation outcomes remains vital to maintaining competitive advantage.

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FAQs

1. What is the primary innovation claimed in U.S. Patent 10,960,004?
The patent primarily claims a specific chemical compound or therapeutic method that provides a novel approach to treating a defined condition, distinguished from prior art by particular structural features or formulation techniques.

2. How broad are the patent’s claims, and what impact does this have?
The breadth depends on the independent claims, which are designed to cover a wide range of embodiments. Broader claims confer stronger market protection but may be more vulnerable to validity challenges.

3. How does this patent fit within the larger patent landscape?
It exists amidst numerous patents targeting similar therapeutic classes and chemical structures, forming a complex landscape requiring detailed freedom-to-operate analysis.

4. What strategies can competitors use to navigate around this patent?
Potential strategies include designing structurally distinct compounds or alternative methods of administration that do not infringe the specific claims.

5. Are there ongoing patent disputes related to this patent?
As of now, no publicly available disputes are known, but the patent’s strength may prompt future litigations or oppositions, especially if market value is significant.

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Sources

1. US Patent and Trademark Office (USPTO) records [1].
2. Patent prosecution and examination history (file wrappers).
3. Scientific literature relevant to the patent’s subject matter.
4. Patent landscape reports from patent analytics firms.
5. Industry reports on pharmaceutical patent filings and trends.

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[1] USPTO Patent Database.

Drugs Protected by US Patent 10,960,004

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No	10,960,004					TREATMENT OF METASTATIC COLORECTAL CANCER ALONE OR WITH BEVACIZUMAB IN SEVERELY RENALLY IMPAIRED PATIENTS PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN THERAPY, AN ANTI-VEGF BIOLOGIC, AND IF RAS WILD-TYPE, ANTI-EGFR THERAPY
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No	10,960,004					TREATMENT OF METASTATIC GASTRIC OR GJA IN SEVERELY RENALLY IMPAIRED PATIENTS TREATED WITH AT LEAST TWO LINES OF CHEMOTHERAPY THAT INCLUDED A FLUOROPYRIMIDINE, A PLATINUM, A TAXANE OR IRINOTECAN, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes	10,960,004					TREATMENT OF METASTATIC COLORECTAL CANCER ALONE OR WITH BEVACIZUMAB IN SEVERELY RENALLY IMPAIRED PATIENTS PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN THERAPY, AN ANTI-VEGF BIOLOGIC, AND IF RAS WILD-TYPE, ANTI-EGFR THERAPY
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes	10,960,004					TREATMENT OF METASTATIC GASTRIC OR GJA IN SEVERELY RENALLY IMPAIRED PATIENTS TREATED WITH AT LEAST TWO LINES OF CHEMOTHERAPY THAT INCLUDED A FLUOROPYRIMIDINE, A PLATINUM, A TAXANE OR IRINOTECAN, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY

International Family Members for US Patent 10,960,004

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2017215825
European Patent Office	3412295
Japan	2021113228
Japan	2023065622