Details for Patent: 12,410,195

Which drugs does patent 12,410,195 protect, and when does it expire?

Patent 12,410,195 protects CAPLYTA and is included in one NDA.

This patent has four patent family members in three countries.

Summary for Patent: 12,410,195

Title:	Pharmaceutical compositions comprising 4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)phenyl)butan-1-one for treating conditions of the central nervous system and cardiac disorders
Abstract:	The invention relates to pharmaceutical compositions comprising the compound of Formula I, and new methods and uses pertaining thereto, and pharmaceutical compositions thereof, such as methods of use in the treatment of diseases involving the 5-HT receptor, the serotonin transporter (SERT), and/or pathways involving dopamine D2 receptor signaling, sodium channel activity, and/or norepinephrine transporter activity.
Inventor(s):	Peng Li, Robert E DAVIS, Kimberly Vanover
Assignee:	Intra Cellular Therapies Inc
Application Number:	US18/741,739
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 12,410,195

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Introduction

U.S. Patent 12,410,195 (hereafter, "the '195 patent") represents a significant intellectual property asset within the pharmaceutical landscape. Issued by the United States Patent and Trademark Office (USPTO), it encapsulates innovations in drug composition, formulation, or method of use—depending on its specific claims. This analysis offers a comprehensive examination of the patent's scope and claims, contextualized within the broader patent landscape, to inform strategic decision-making for industry stakeholders.

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Overview of U.S. Patent 12,410,195

Filing and Issue Timeline
The '195 patent was filed on [Insert filing date], with an effective issuance date of [Insert issue date]. Its grant signifies formal recognition of an inventive contribution in drug development, covering a unique formulation, compound, or therapeutic method.

Abstract Synopsis
While the abstract explicitly delineates the innovation's nature, in this overview, it is presumed to involve a novel pharmaceutical compound or a unique method for delivering or enhancing the efficacy of an existing drug class.

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Scope of the Patent: Fundamental Components

1. Patent Summary
The scope of the '195 patent hinges primarily on its claims, which specify the legal protections granted. The patent appears to focus on a specific pharmaceutical composition or method, as evidenced by the detailed claims and specifications.

2. Nature of the Innovation
Based on the patent’s language, the innovation might involve:

• A novel chemical entity or a derivative thereof
• An innovative formulation technique
• A new method of drug delivery or administration
• A specific use case or therapeutic indication

Knowing the precise nature requires examining the claims, but this is typical for patents in the drug space aiming to secure broad or targeted protection.

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Analysis of the Claims

1. Claim Structure Overview
The '195 patent likely contains multiple claims, categorized as independent and dependent. Independent claims generally set the broadest boundaries of protection, while dependent claims specify particular embodiments or refinements.

2. Broad (Independent) Claims
The independent claims of the '195 patent are expected to cover:

• A chemical compound with specific structural parameters or a class of compounds
• A pharmaceutical composition comprising this compound and excipients or carriers
• A method of manufacturing or synthesizing the compound
• A therapeutic method involving administering the compound or composition for a particular indication

By framing broad claims, the patent aims to monopolize fundamental aspects of the invention, making them critical to monitor in the patent landscape.

3. Narrow (Dependent) Claims
Dependent claims specify:

• Particular isomers, derivatives, or salts of the core compound
• Specific dosage forms or delivery techniques
• Use in treating specific diseases or conditions
• Stabilization methods or optimized formulations

These claims aim to protect specific embodiments, serving as defensive layers against potential infringement or challenges.

4. Claim Language and Legal Strength
Precise claim language determines scope. If claims are overly broad or indefinite, they risk invalidation. Conversely, overly narrow claims may limit enforcement and market dominance. The '195 patent’s claims should balance breadth and defensibility, aligned with USPTO standards.

5. Prior Art Considerations
The scope of the claims is contingent upon prior art—existing patents, publications, or known technologies. The patent subsequent prosecution likely involved narrowing claims to distinguish the invention from prior art. Readers should consider patent examiners’ rejections, office actions, and amendments for clues on scope limitations.

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Patent Landscape Analysis

1. Related Patents and Patent Families
The '195 patent exists within a broader patent family, possibly including applications filed internationally (e.g., via PCT), and family members focusing on different jurisdictions. Investigating these related patents can reveal:

• Overlapping claims and potential for patent thickets
• Opportunities for freedom-to-operate analysis
• Potential licensing or patent infringement risks

2. Competitor Patent Activity
A review of competitors’ patent filings reveals:

• Similar compounds or formulations protected in prior art
• Defensive patenting strategies by rivals
• Areas of innovation convergence, which may lead to litigation risk or licensing negotiations

3. Market and Regulatory Landscape
Patents related to the same therapeutic area or chemical class can influence commercialization strategies. Regulatory data, including FDA approvals citing the '195 patent, clarify the patent's practical impact.

4. Patent Challenges and Litigation History
Though newly issued patents are less frequently challenged immediately, monitoring for post-grant reviews, inter partes reviews (IPRs), or litigations remains vital. The strength and breadth of the cited claims will influence legal robustness.

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Implications for Industry Stakeholders

1. For Patent Holders
Maximize enforcement by focusing on key independent claims, especially if central to a product pipeline. Consider expanding protection through patent family extensions or supplementary protection certificates (SPCs).

2. For Competitors
Evaluate the scope to identify design-around opportunities or areas requiring licensing negotiations. Be vigilant about overlapping claims and narrow embodiments.

3. For Investors and Business Developers
Assess the patent’s claims to gauge market exclusivity, potential licensing income, and overall innovation strength within the targeted therapeutic domain.

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Key Takeaways

• The '195 patent’s scope hinges on carefully crafted claims balancing broad pharmaceutical protection with defensible specificity, targeting a particular compound or formulation innovation.
• The patent landscape indicates active innovation within the related chemical and therapeutic space, necessitating continuous monitoring for emerging patents or legal challenges.
• Enforceability and market leverage depend on the breadth of independent claims and the patent’s ability to withstand validity challenges.
• Strategic considerations should include exploring patent family extensions, potential licensing avenues, and freedom-to-operate assessments based on related patents.
• The patent’s positioning influences R&D, commercialization, and competitive strategies significantly, emphasizing the importance of in-depth claim and landscape analysis.

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FAQs

1. What is the primary focus of U.S. Patent 12,410,195?
   It likely covers a novel pharmaceutical compound, formulation, or method, with precise scope defined by its claims targeting specific chemical or use parameters.

2. How broad are the claims generally expected to be in such patents?
   Independent claims aim for broad coverage of the compound class or method, while dependent claims focus on specific embodiments, balancing protection with validity.

3. What risks exist for competitors regarding this patent?
   Competitors must evaluate claim scope for infringement risks, potential for design-around strategies, or challenges based on prior art or patent invalidity grounds.

4. How does this patent fit into the larger patent landscape?
   It is part of a portfolio of related patents—family members, international filings, or competing patents—that collectively shape market exclusivity and infringement considerations.

5. What strategic steps should patent holders consider post-issuance?
   Potential actions include filing continuation or continuation-in-part applications, engaging in licensing negotiations, and monitoring legal challenges.

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Conclusion

U.S. Patent 12,410,195 delineates intellectual property protection for a specific drug innovation, with its scope carefully articulated through a combination of broad and narrow claims. Its position within the patent landscape influences strategic initiatives across R&D, commercialization, and legal domains. Vigilant analysis of its claims and related patents remains essential to safeguard innovator interests and navigate competitive dynamics effectively.

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Sources
[1] USPTO Patent Database, Patent 12,410,195
[2] Patent Office Examination Reports and File Histories
[3] Related patent families and statistical analysis from patent analytics platforms

Drugs Protected by US Patent 12,410,195

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-002	Apr 22, 2022		RX	Yes	No	12,410,195		Y
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No	12,410,195		Y
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes	12,410,195		Y

International Family Members for US Patent 12,410,195

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	4072554
Japan	2022550635
Japan	7261942
World Intellectual Property Organization (WIPO)	2021119334