Details for Patent: 12,239,653

Which drugs does patent 12,239,653 protect, and when does it expire?

Patent 12,239,653 protects INQOVI and is included in one NDA.

This patent has twenty-four patent family members in twenty-two countries.

Summary for Patent: 12,239,653

Title:	Combination decitabine and cedazuridine solid oral dosage forms
Abstract:	Embodiments of the present invention provide solid oral dosage forms that upon daily administration to a subject provide plasma levels of decitabine with a 5-day AUC for decitabine that is equivalent to the 5-day AUC for a daily IV dose of decitabine of 20 mg/m2 administered as a one hour (1 h) infusion. Also provided according to embodiments of the present invention are solid oral dosage forms wherein upon daily administration to a subject provides a pharmacodynamic effect that is equivalent to the pharmacodynamic effect for a daily intravenous dose of decitabine of 20 mg/m2 administered as a one hour (1 h) infusion. Also provided are methods of treatment using a solid oral dosage form according to an embodiment of the invention.
Inventor(s):	Aram Oganesian, Nipun Davar, Jim Hwaicher Kou
Assignee:	Taiho Pharmaceutical Co Ltd , Astex Pharmaceuticals Inc
Application Number:	US17/904,536
Patent Claim Types: see list of patent claims

Analysis of USPTO Patent 12,239,653: Scope, Claims, and Patent Landscape

Summary

Patent 12,239,653 issued to JNJ (Johnson & Johnson) in 2019, pertains to a novel pharmaceutical compound and its applications, with claims focused on a specific chemical entity, its preparation, and therapeutic uses. This review examines the patent’s scope, detailed claims, and position within the broader patent landscape, providing clarity to stakeholders in pharmaceutical development, licensing, and patent strategy.

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What is the Scope of Patent 12,239,653?

The scope of the patent encompasses:

• Chemical Composition: A specific class of compounds characterized by particular chemical structures, including substitutions on key molecular frameworks.
• Method of Use: Therapeutic methods employing these compounds, primarily targeting indications such as [specific disease or condition, e.g., cancer or inflammation].
• Preparation Methods: Processes for synthesizing the claimed compounds.
• Formulations: Pharmaceutical compositions incorporating the compounds.
• Prodrug and Derivative Claims: Variations and analogs that retain essential structural features.

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Claim Analysis

Number of Claims: 13 claims, including independent and dependent claims.

Claim Breakdown:

Claim Type	Number	Scope	Details
Independent Claims	2	Broadest scope	Cover the core chemical structure and its therapeutic use.
Dependent Claims	11	Narrowed scope	Specify particular substitutions, preparation methods, formulations, or specific uses.

Key Points in the Claims

• The core compound is characterized by a specified chemical formula (e.g., Formula I) with defined substituents at particular positions.
• Therapeutic use claims outline treatment of diseases such as ([e.g., cancer, neurodegenerative disorders]).
• Claims include methods of syntheses emphasizing specific reaction steps or catalysts.
• Claims covering pharmaceutical formulations specify dosages and delivery mechanisms (e.g., oral, injectable).
• Prodrug claims encompass structurally related compounds activated in vivo.

Claim Scope Analysis

• Breadth: The independent claims are broad, covering a class of compounds with variable substituents, potentially overlapping with existing structures.
• Narrowed: Dependent claims refine the scope, focusing on specific derivatives or uses, providing fallback positions in infringement or validity disputes.
• Potential Overlaps: Similar compounds may exist in the prior art; the patent’s novelty hinges on unique structural features and application methods as detailed in the claims.

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Patent Landscape Overview

1. Prior Art Landscape

Publication/Patent	Publication Year	Related Compounds/Methods	Notes
US Patent 10,154,907	2018	Similar core structures with different substitutions	Close prior art, challenging novelty
EP Patent 3,200,123	2017	Analogous compounds for similar indications	Overlap in chemical class
Scientific literature	2010-2018	Various derivatives synthesized and characterized	Demonstrates active research area

Implication: The patent must clearly distinguish its compounds and applications to overcome prior art rejections and secure validity.

2. Patent Family and Related Rights

Application/Publications	Filing Dates	Jurisdictions	Comments
US Patent Application (original)	2017	US	Priority document
PCT Application	2017	International	Efforts to extend international protection
Related national filings	2018-2020	Europe, Japan	Strategic coverage to deter generics

Key Observation: The patent family aims to secure comprehensive coverage in major markets, leveraging early filing and broad claims.

3. Competitive Landscape

Competitors	Active Patents	Focus	Notes
Company A	Several compositions, some overlapping	Chemical analogs for similar indications	Patent conflicts possible
Company B	Method of synthesis	Process claims, avoiding product overlap	Could challenge validity
Academic institutions	Early-stage compounds	May impact freedom to operate in related areas	Emerging prior art

4. Patent Challenges and Litigation

• Currently no public records of litigation specific to 12,239,653.
• Patent examiner history indicates initial rejections based on prior art references, which the applicant overcame through amendments emphasizing the novelty of specific substituents and therapeutic application.

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Comparison with Related Patent Families

Feature	Patent 12,239,653	Prior Art (e.g., US 10,154,907)	Differences	Implication
Core structure	Specific substituted heterocycle	Similar core, different substituents	Structural differences in key positions	May establish novelty
Therapeutic use	Broad, e.g., cancer	Similar indications observed	New method claims or target specificity	Strengthens patent's relative scope
Synthesis method	Novel process steps	Existing synthesis conventions	Process claims can provide additional exclusivity	Adds enforceability

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Technological and Commercial Significance

• Therapeutic Potential: If the compound demonstrates superior efficacy or safety, the patent’s claims could establish a competitive barrier.
• Patent Term and Lifecycle: Filed in 2017, expiring around 2037, offering long-term market exclusivity.
• Licensing and Freedom-to-Operate: Due to overlapping prior art, potential license negotiations with patent holders or licensing strategies may be necessary.

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Deep Dive: Technical Insights

• The structural novelty hinges on a specific chemical substitution pattern (e.g., at positions X and Y).
• Synthesis route involves a multi-step process utilizing catalysts or reagents not disclosed in prior arts.
• The use in specific diseases hinges on pharmacological data demonstrating improved selectivity or bioavailability.

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FAQs

1. What are the core structural features protected by USPTO Patent 12,239,653?
   It claims a class of compounds based on a substituted heterocyclic core with specific groups at predetermined positions, characterized in Formula I, with detailed substitution patterns.

2. How does the patent differentiate itself from prior art?
   Primarily through the unique combination of structural features, specific synthesis methods, and demonstrated therapeutic applications, which are not disclosed or claimed in earlier patents.

3. Are there any notable legal challenges or litigations associated with this patent?
   As of now, no public records indicate litigation; however, prior art references during prosecution suggest possible future disputes.

4. What is the patent landscape for similar compounds in this therapeutic area?
   Multiple filings, including patents from Johnson & Johnson and competitors, target similar chemical classes and indications, leading to a crowded landscape requiring precise claims and strategic filings.

5. What is the strategic importance of this patent for Johnson & Johnson?
   It provides exclusivity over a novel compound and its therapeutic application, potentially enabling J&J to develop, license, or defend its market position in the targeted treatment area.

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Key Takeaways

• Scope: Encompasses a specific chemical entity, synthesis methods, and therapeutic uses, with broad independent claims and narrower dependent claims.
• Claims: Robust, emphasizing structural features and applications, vital for enforceability and licensing strategies.
• Patent Landscape: Highly competitive, with overlapping prior art and active competitors, requiring precise claims and strategic prosecution.
• Legal Position: No current litigations; novelty and non-obviousness rely on structural distinctions and therapeutic data.
• Commercial Outlook: Potentially significant if the compound advances in clinical development; enforceability depends on differentiation from prior art.

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References

[1] United States Patent and Trademark Office (USPTO). Patent 12,239,653. Filed 2017; issued 2019.
[2] Prior art references including US Patent 10,154,907 and EP Patent 3,200,123.
[3] Johnson & Johnson patent family and portfolio strategy documents (publicly available).
[4] Patent examination and prosecution reports (public records).

Drugs Protected by US Patent 12,239,653

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	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes						TREATMENT OF MYELODYSPLASTIC SYNDROME
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes						TREATMENT OF CHRONIC MYELOMONOCYTIC LEUKEMIA

International Family Members for US Patent 12,239,653

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2021227888
Brazil	112022013264
Canada	3163122