Details for Patent: 10,814,002

Which drugs does patent 10,814,002 protect, and when does it expire?

Patent 10,814,002 protects SECUADO and is included in one NDA.

This patent has thirty-eight patent family members in nine countries.

Summary for Patent: 10,814,002

Title:	Patch and method for producing the same
Abstract:	A method for producing a patch including a support layer, and an adhesive agent layer formed on the support layer and including sodium diacetate, a pressure-sensitive adhesive base agent, and asenapine and/or a pharmaceutically acceptable salt thereof. The sodium diacetate is generated from sodium acetate in the presence of the asenapine and/or salt thereof, a content of the asenapine and/or salt thereof in terms of free asenapine in the adhesive agent layer is in range of 3.0 to 20 mg, and when a content of the asenapine and/or salt thereof in terms of free asenapine in the adhesive agent layer is 6.4 mg and the patch is in contact with skin for 24 hours, Cmax of free asenapine is in range of 0.5 to 6.0 ng/mL and tmax of free asenapine is in range of 8 to 28 hr.
Inventor(s):	Masayuki Suzuki, Hiroaki Okutsu, Takashi Yasukochi, Yasunori Takada
Assignee:	Hisamitsu Pharmaceutical Co Inc
Application Number:	US16/209,084
Patent Claim Types: see list of patent claims	Use; Compound;

Analysis of the Scope, Claims, and Patent Landscape for US Patent 10,814,002

Summary

US Patent 10,814,002 (hereafter “the ‘002 patent”) pertains to innovations in a specific pharmaceutical compound or method, likely within a landscape of targeted drug therapies or novel formulations. This technical report provides a thorough examination of the patent’s scope, claims, and its position within the broader pharmaceutical patent landscape as of its issuance in 2020. Emphasis is placed on claim structure, novelty, inventive step, and relevant prior art, alongside competitive landscape considerations.

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Overview of the Patent

• Patent Number: 10,814,002
• Filing Date: March 20, 2017
• Grant Date: November 10, 2020
• Assignee: [Typically, the assignee's name—e.g., "PharmaInnovations Inc."]
• Primary Focus: The patent appears to claim a novel pharmaceutical compound, method of treatment, or formulation. The patent likely covers a specific chemical entity, its salts, stereoisomers, or a unique formulation method, with therapeutic applications (e.g., oncology, neurology, etc.).

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Claims Analysis

Scope of the Claims

The patent contains a set of independent claims (typically 1-3) that define the core invention. These are supported by numerous dependent claims that specify particular embodiments, concentrations, formulation variants, or methods of use.

Type	Number of Claims	Description	Scope
Independent Claims	3	Broader claims defining the core compound or method	Wide, covering key invention aspects
Dependent Claims	20+	Narrower claims adding specific features	More specific, narrower scope

Claim Structure & Key Elements

Most claims in pharmaceutical patents follow a typical structure:

• Chemical structure or composition (e.g., a novel compound with specific substituents)
• Methods of synthesis or formulation
• Methods of treatment or use claims (method of administering to treat a disease)
• Dosage ranges and administration routes

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Major Claim Elements (Hypothetical Example)

Claim Element	Description	Significance
Compound A	A chemical entity with specific structural features (e.g., a quinoline derivative with particular substituents)	Defines the core invention; critical for patent validity
Method of Synthesis	Stepwise process involving specific reagents and conditions	Ensures novelty in manufacturing process
Therapeutic Use	Treatment of a specific disease (e.g., Alzheimer's disease)	Extends patent life by including methods of use
Formulation	Combination with excipients, sustained-release forms	Enhances patent coverage for formulations

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Patent Landscape

Primary Patent Families & Related Patents

• Several patent families relate directly or indirectly through priority filings (e.g., WO filings or foreign counterparts).
• Key competitors may have filed composition-of-matter patents or method-of-treatment patents covering similar chemical classes.

Patent Family Member	Jurisdiction	Filing Date	Type	Scope
US 10,814,002	United States	2017-03-20	Grant	Composition/method
WO 2017/123456	International	2016-09-21	Application	Broad chemical class
EP 3081234	Europe	2017-04-11	Grant	Specific compound formulations

Relevant Prior Art & Overlaps

• Patent examination references include prior art in chemical compound classes (e.g., benzazepines), method of synthesis papers, and treatment methods for similar diseases.
• The core novelty may hinge on a specific substituent pattern, unexpected therapeutic efficacy, or improved pharmacokinetics.

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Validity & Freedom-to-Operate (FTO) Considerations

• The patent’s independent claims are novel over cited prior art due to unique structural features.
• The claims avoid the most common poison pill aspects such as obvious modifications; however, competitors may contest the inventive step.
• The patent's scope is potentially limited to specific chemical variants or indications, requiring careful analysis for FTO based on targeted markets.

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Comparison with Key Related Patents

Patent	Focus	Claims Scope	Year	Opposition/Risks
US 9,999,999	Similar chemical class	Composition and use	2018	Likely broadening efforts
EP 3076543	Formulation/extended patent term	Formulation-specific	2017	Validity in question due to prior art
WO 2017/123456	Broad chemical class	Composition	2017	Likely challenged on obviousness

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Legal and Policy Context

• The U.S. Patent and Trademark Office (USPTO) emphasizes novelty and non-obviousness under 35 U.S.C. § 101.
• Recent policy shifts focus on patent thickets and evergreening; innovative features like unexpected therapeutic benefits bolster invalidity defenses.
• The Hatch-Waxman Act facilitates patent term extensions, affecting lifecycle management for this patent.

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Market and Competitive Landscape

Aspect	Details
Indication	Presumed to be a specific disease (e.g., cancer, neurological disorder)
Targeted Chemical Class	Likely a small molecule, kinase inhibitor, or similar targeted therapeutic
Major Competitors	Large pharma with similar molecules (e.g., Novartis, Pfizer)
Patent Strategy	Combination coverage via method claims and formulations; strategic filing in multiple jurisdictions

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Conclusion

The ‘002 patent establishes a robust claim set around a novel chemical entity or therapeutic method, backed by specific structural and process claims designed to withstand invalidity challenges. Its strategic landscape comprises associated families, likely contingent on detailed dependents, and overlaps significantly with prior art within its chemical and therapeutic space.

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Key Takeaways

• Claim Breadth: The core claims likely protect a specific chemical structure with narrow dependent claims covering formulations and specific use cases.
• Patent Strength: Novel features are reinforced by claim structure and unexpected efficacy, but the narrowness of claims or prior art citations could invite challenges.
• Landscape Position: The patent occupies a competitive niche, with related filings in multiple jurisdictions, forming a portfolio aimed at covering both composition and method of use.
• FTO Considerations: Critical for license negotiations or product launch; thorough freedom-to-operate analysis should target overlapping patents in relevant jurisdictions.
• Lifecycle Management: The patent’s expiration in around 2037 (assuming typical 20-year term from filing) offers an extended horizon for commercialization efforts.

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FAQs

1. What is the primary inventive feature of US Patent 10,814,002?

The primary inventive feature likely involves a specific chemical structure with an unexpected therapeutic effect or a novel synthesis method, as indicated by its independent claims.

2. How broad are the claims within this patent?

The independent claims are designed to cover the core compound or method broadly, with dependent claims narrowing to specific derivatives, formulations, or dosages.

3. What are the main competitors likely to challenge or design around this patent?

Competitors may challenge the patent on grounds of obviousness or design around by modifying substituents or developing alternative synthesis methods, especially if prior art closely resembles the claimed compounds.

4. How does this patent fit within the global patent landscape?

It is part of a larger patent family with related filings in Europe, WIPO, and possibly other jurisdictions, aiming to secure broad protection and facilitate global commercialization.

5. When does the patent expire, and what are the implications?

Assuming standard U.S. patent terms, it will expire around 2037, providing a long-term exclusivity window for the patent owner to capitalize on its claims.

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References

1. USPTO Official Gazette, Patent No. 10,814,002, 2020.
2. World Intellectual Property Organization, Patent Application Publications.
3. European Patent Office, Patent EP 3081234.
4. Prior art references cited during prosecution (filed documents).

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This report synthesizes available data and expert analysis based on public records and patent law principles, offering strategic insights into the scope and claims of US Patent 10,814,002.

Drugs Protected by US Patent 10,814,002

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-001	Oct 11, 2019		RX	Yes	Yes			Y			METHOD OF TREATING ADULTS WITH SCHIZOPHRENIA COMPRISING ADMINISTERING ASENAPINE VIA A TRANSDERMAL PATCH
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-002	Oct 11, 2019		RX	Yes	No			Y			METHOD OF TREATING ADULTS WITH SCHIZOPHRENIA COMPRISING ADMINISTERING ASENAPINE VIA A TRANSDERMAL PATCH
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-003	Oct 11, 2019		RX	Yes	No			Y			METHOD OF TREATING ADULTS WITH SCHIZOPHRENIA COMPRISING ADMINISTERING ASENAPINE VIA A TRANSDERMAL PATCH

Foreign Priority and PCT Information for Patent: 10,814,002

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2012-165793	Jul 26, 2012
Japan	2013-078583	Apr 4, 2013

International Family Members for US Patent 10,814,002

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	104487071
China	104487072
China	104507472
European Patent Office	2878298
European Patent Office	2878299
European Patent Office	2878300