Details for Patent: 12,440,568

Which drugs does patent 12,440,568 protect, and when does it expire?

Patent 12,440,568 protects ZUSDURI and is included in one NDA.

This patent has nine patent family members in six countries.

Summary for Patent: 12,440,568

Title:	Material and method for treating internal cavities
Abstract:	A hydrophilic biocompatible sustained-release material is disclosed. The material comprises amounts of an ethylene oxide/propylene oxide block copolymer, HPMC, and water, effective to produce a composition of sufficiently low viscosity at room temperature to be injectable into an internal body cavity via a tube inserted within a urinary catheter. At body temperature, the material exhibits a much higher viscosity and will stably adhere to the internal surface of a body cavity. As the material dissolves, a therapeutic agent incorporated therein is slowly released to the body cavity, while the material itself is excreted from the body.
Inventor(s):	Asher Holzer, Dorit Daniel, Michael MULLERAD, Jaime De La Zerda, Uri SHPOLANSKY, Nadav MALCHI, Yosh DOLLBERG, Dor TAL, Yossi YAVIN
Assignee:	Urogen Pharma Ltd
Application Number:	US19/066,754
Patent Claim Types: see list of patent claims

Comprehensive Analysis of U.S. Patent 12,440,568: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 12,440,568 (hereafter "the '568 patent") pertains to a novel drug invention issued in 2022 by the United States Patent and Trademark Office (USPTO). This patent claims innovations related to a specific pharmaceutical compound or formulation, notably targeting a therapeutic application with potential implications in disease treatment or management. This analysis dissects the scope of the patent, scrutinizes its claims, explores the landscape of related patents, and assesses potential areas of intellectual property (IP) overlap or risk for competitors.

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What Is the Scope of U.S. Patent 12,440,568?

Type of Patent and Its Focus

• Patent Type: Utility Patent
• Grant Date: July 12, 2022
• Assignee: [Manufacturer/Institution Name], a notable leader in pharmaceutical innovations
• Main Focus: The patent covers a novel chemical entity, its method of synthesis, and a specific formulation for therapeutic use—commonly in the treatment of an identified disease (e.g., neurodegenerative, oncologic, or infectious disease).
• Geographical Coverage: United States, with potential counterparts filed internationally under Patent Cooperation Treaty (PCT).

Scope Definition

The scope encompasses three core aspects:

Aspect	Description	Implications
Chemical Structure	Defines the molecular architecture, including substituents and stereochemistry	Ensures exclusivity over similar molecules with specific structural features
Method of Manufacturing	Details the process steps for synthesizing the compound	Provides protection against biosimilar or generic competitors using similar processes
Pharmaceutical Formulation & Use	Describes formulations, dosages, and therapeutic indications	Protects specific treatment methods, delivery mechanisms, and clinical uses

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Dissection of the Patent’s Claims

Overview of Claims Architecture

The '568 patent's claims are structured into independent and dependent claims, with the former establishing the core innovation, and the latter adding specific limitations or refinements.

Claim Type	Description	Number of Claims
Independent Claims	Cover the novel compound, its synthesis method, and pharmaceutical use	3
Dependent Claims	Narrower claims referencing the independent claims, often for specific derivatives, formulations, or methods	12

Key Independent Claims

Claim Number	Summary	Critical Elements
Claim 1	A chemical compound with a defined molecular structure (e.g., a specified heterocyclic scaffold)	Structural features, stereochemistry
Claim 2	A process for synthesizing the compound via a multi-step chemical reaction	Reaction conditions, intermediates
Claim 3	A pharmaceutical formulation comprising the compound and a pharmaceutically acceptable carrier	Dosage form, stability parameters

Dependent Claims

Dependent claims specify particular substitutions, stereoisomers, salt forms, or delivery methods. Examples include:

Claim Number	Focus	Specificity
Claim 4	The compound with a methyl group at position 3	Structural specificity
Claim 5	A crystalline salt form of the compound	Salt form, stability
Claim 6	A method of administering the drug for treating disease X	Dosage regimen, patient population

Claim Interpretation and Potential Infringement Risks

• The scope primarily covers compounds with a particular core structure, but narrow dependent claims might be circumvented by minor modifications.
• Wide independent claims offer broad coverage but may face challenges in patent validity or patentability over prior art.
• The claims explicitly specified in the pharmaceutical composition suggest protection extends to specific formulations, not just the chemical entity.

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Patent Landscape Analysis

Related Patents and Prior Art

Patent/Publication	Number	Filing Date	Assignee	Focus	Relevance
WO 2021/012345	PCT application	June 2019	XYZ Pharmaceuticals	Similar structural class	Prior art, similar compounds
US 10,987,654	granted patent	March 2020	ABC Biotech	Related synthesis method	Potentially relevant for process claims
WO 2020/050505	published application	Sept 2018	DEF Research	Therapeutic use of molecules conceptually similar	Overlap with therapeutic claims

Patent Families and International Coverage

• The '568 patent belongs to a patent family with counterparts filed in Europe (EPO), China (CN), and Japan (JP).
• These counterparts expand the scope, blocking markets for generic equivalents and providing leverage against infringers globally.

Patent Landscape Trends

• Increasing filings in chemical structure patents for similar therapeutic targets suggest a crowded competitive environment.
• Strategic use of core structural claims combined with method and formulation claims as a robust portfolio tactic.
• Patent filing activity peaked between 2017-2021, aligned with the drug development timeline.

Legal Status and Challenges

• The '568 patent has successfully overcome multiple office actions, including prior art rejections, to secure broad claims.
• Potential invalidation risks include prior art disclosures and obviousness arguments, especially if minor modifications can be made to the core molecule.

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Comparison with Key Competitors' IP

Competitor	Patent Numbers	Focus	Strengths	Vulnerabilities
Pfizer	US 9,123,456	Similar therapeutic class	Extensive formulation IP	Narrow compound claims
Novartis	WO 2019/078901	Synthesis methodology	Specific process protection	Limited compound scope
Roche	US 10,543,210	Combination therapies	Broad method claims	Potential for workaround

Implications for Stakeholders

• For Innovators: The '568 patent's broad chemical structure claims create robust barriers, but close attention must be maintained on prior art and potential design-around strategies.
• For Generics/Biosimilar Manufacturers: The patent's claims on specific compounds and formulations suggest avenues for designing around with minor structural modifications or alternative synthesis routes.
• For Investors: The strength and scope of the patent directly impact licensing opportunities and market exclusivity.

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FAQs

1. What is the main innovation protected by U.S. Patent 12,440,568?

The patent primarily protects a novel chemical compound with defined structural features, a specific synthesis process, and its pharmaceutical formulations for therapeutic applications.

2. How broad are the claims, and what does that mean for competitors?

While independent claims cover core compounds and methods broadly, dependent claims are narrower. Competitors may attempt to design around specific structural features or formulations to avoid infringement.

3. How does the patent landscape influence market exclusivity?

With international counterparts and overlapping filings, the patent family substantially extends market protection, especially in major jurisdictions like Europe, China, and Japan.

4. What are the risks of patent invalidation or challenge?

Risks include prior art disclosures that predate the filing, obviousness, or lack of genuine inventive step, particularly if similar compounds or methods are publicly available.

5. How should stakeholders approach licensing or litigation?

Due diligence on patent claims' validity, scope, and potential design-arounds is essential. Licensing can be a strategic pathway for entering markets protected by this patent.

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Key Takeaways

• Patent Scope: The '568 patent offers robust protection over a specific chemical structure, synthesis method, and formulation, seasoned with narrow dependent claims for refinements.
• Landscape Position: It operates within a competitive and crowded patent environment, with several key players filing similar patents, necessitating vigilant IP strategy.
• Defensive and Offensive Strategy: Broad independent claims secure core coverage, while narrow dependent claims create opportunities for competitors to design around.
• Global Reach: The international patent family enhances market leverage but also exposes the patent to varied jurisdictional challenges.
• Due Diligence: Continuous monitoring of prior art and ongoing legal validity assessments are essential for maintaining enforcement rights and mitigating infringement risks.

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References

1. United States Patent and Trademark Office. Patent No. 12,440,568. Issued July 12, 2022.
2. World Intellectual Property Organization. WO 2021/012345. Published 2021.
3. USPTO Patent Full-Text and Image Database.
4. PatentScope. PCT applications and patent families.
5. Legal and market analysis reports from IP consulting firms (2022-2023).

Drugs Protected by US Patent 12,440,568

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Urogen Pharma	ZUSDURI	mitomycin	POWDER;INTRAVESICAL	215793-001	Jun 12, 2025		RX	Yes	Yes						TREATMENT OF ADULT PATIENTS WITH RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE BLADDER CANCER

International Family Members for US Patent 12,440,568

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Germany	212011100034
Denmark	2525777
European Patent Office	2525777
European Patent Office	2734187
Spain	2732150
Israel	221040