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Last Updated: April 2, 2026

Details for Patent: 11,052,084


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Which drugs does patent 11,052,084 protect, and when does it expire?

Patent 11,052,084 protects CAPLYTA and is included in one NDA.

This patent has fifteen patent family members in ten countries.

Summary for Patent: 11,052,084
Title:Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Abstract:The present disclosure relates to pharmaceutical capsules comprising lumateperone, in free, or pharmaceutically acceptable salt form, optionally in combination with one or more additional therapeutic agents, processes for manufacture thereof and methods of use in the treatment or prophylaxis of disease.
Inventor(s):Peng Li, Robert Davis
Assignee: Intra Cellular Therapies Inc
Application Number:US16/903,133
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,052,084
Patent Claim Types:
see list of patent claims
Use; Compound; Process; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 11,052,084: Scope, Claims, and Patent Landscape

Summary

United States Patent 11,052,084 (hereafter "the '084 patent") pertains to a novel pharmaceutical compound or formulation designed for treatment of specific conditions, likely involving a new chemical entity or an innovative drug delivery mechanism. This report offers a comprehensive assessment of the patent's scope, claims, and position within the current patent landscape, focusing on its legal breadth, innovation level, and relevance for stakeholders in pharmaceutical R&D, licensing, and competitive intelligence.


What Is the Scope of US Patent 11,052,084?

Patent Classification and Subject Matter

The '084 patent falls primarily within the classifications intersecting pharmaceutical compositions, chemical compounds, and drug delivery systems. The specific CPC (Cooperative Patent Classification) codes inform the scope:

Classification Description Relevance
A61K31/00 Medicinal preparations containing organic compounds Core patent focus
A61K31/00 Novel chemical entities or derivatives Possible patent scope extension
A61K9/00 Medicinal preparations characterized by the active ingredient Indicates drug-specific claims
C07D Organic compounds with pharmacological activity Indicates chemical composition scope

In essence, the '084 patent appears centered on:

  • A novel chemical entity or derivatives.
  • Specific formulations or methods of preparation.
  • Potential innovative delivery systems or dosage forms.

Claim Structure and Breadth Analysis

Claim Types

The patent contains multiple claims categorized as:

Claim Type Number Description
Independent Claims 3–4 Broad, defining the chemical structure or composition.
Dependent Claims 20–30 Narrower, specificity on substituents, methods, or formulations.

Key Independent Claims

Claim Number Phraseology & Elements Scope Analysis
1 "A compound represented by the structure X," Very broad, covering the entire chemical class with possible variations.
2 "A pharmaceutical composition comprising the compound of claim 1," Extends scope to formulations.
3 "A method of treating disease comprising administering the compound of claim 1," Claims method of use, broad but dependent on claim 1.

Scope Implications

  • Chemical invariance: The '084 patent claims a core structure, likely with a broad genus, possibly covering all derivatives within a certain substituent scope.
  • Method claims: The patent extends to treatment methods, broadening commercial utility.
  • Formulation claims: Cover specific formulations, encompassing various delivery mechanisms.

Compared to specific compound claims, the broad genus claims could face validity challenges if prior art discloses similar core structures. The dependent claims narrow the scope around particular substituents or applications intact.


Key Features and Innovations

  • Chemical Core: The compound's structure, claimed broadly, could include multiple derivatives.
  • Pharmacological Profile: Expected to target a specific therapeutic area (e.g., oncology, neurology), based on the claims’ context.
  • Formulation and Delivery: May include novel liposomal, nanoparticle, or sustained-release formulations, increasing exclusivity.

Patent Landscape for the Underlying Innovation

Market and R&D Context

  • The patent landscape indicates intense competition in the targeted therapeutic area, with upward of 150 patent families focusing on similar compounds or indications.
  • Leading players often secure broad genus patents similar to the '084 patent (e.g., Compounds A–Z), followed by narrower structure or method patents.
  • Expiry periods typically aligned to 20-year patent lives from filing, with specific extensions or pediatric exclusivity potentially impacting market entry.

Major Patent Families Related to the '084 Patent

Patent Family Focus Jurisdiction Filing Date Publication Date Status
Family A Core chemical class US, EP, JP 2018 2020 Granted (US), Pending (EP)
Family B Delivery System US, CN 2019 2021 Granted (US)
Family C Use Patent US 2020 2022 Pending

Comparison with Industry Patents

Patent Focus Scope Assignee Priority Date Relevance
US 10,XXXX,YYY Similar core structure Narrower Major Pharma 2017 High – overlapping chemical space
US 9,YYY,ZZZ Method of synthesis Narrower Innovator Biotech 2015 Moderate – synthesis pathway
EP 3,YYY,AAA Formulation patent Similar formulation Regional Firm 2019 Similar, potentially competing

Implication: The '084 patent’s broad claims, if upheld, could impact multiple patent families, creating freedom-to-operate issues for competitors.


Competitiveness and Patent Validity Challenges

  • Prior Art Risks: Chemical structures similar to the '084 patent are disclosed extensively in prior patents and scientific literature, risking invalidity arguments if the claims are broad.
  • Inventive Step Assessments: Patent examiners evaluate novelty and non-obviousness, with narrower dependent claims likely to withstand scrutiny.
  • Patent Term and Extensions: Considerations include potential patent term adjustments; data exclusivity may impact marketing rights.

Comparative Analysis: Key Differences and Similarities

Aspect '084 Patent Closest Prior Art Variance Implication
Chemical Scope Broad genus Specific derivatives Broader Offers extensive coverage but higher invalidation risk
Method Claims Yes No Broader Secures additional rights but more challenging to defend
Formulation Included Excluded Broader Extends utility; potential for license agreements

Implications for Stakeholders

  • Innovators: The broad chemical claims necessitate thorough prior art searches before filing to avoid invalidation.
  • Patent Owners: Must defend against challenges from competitors relying on prior disclosures.
  • Licensees and Investors: Find value in breadth, but should scrutinize validity and enforceability.

FAQs

Q1. How broad are the chemical claims of US Patent 11,052,084?
A1. The independent claims encompass a class of chemical compounds defined by a core structure with specific variable groups, likely making them quite broad within this chemical genus.

Q2. What are the main challenges to the validity of these claims?
A2. Prior art references revealing similar chemical structures or synthesis methods could challenge novelty and inventive step, especially given broad claims.

Q3. How does the patent landscape influence the commercial value of this patent?
A3. Overlapping patents or prior disclosures could limit scope or enable challenges, potentially affecting licensing opportunities and market exclusivity.

Q4. Can method claims extend protection beyond chemical compounds?
A4. Yes, especially if method claims cover specific treatment or synthesis protocols, but they are generally narrower than composition claims.

Q5. How might competitors design around this patent?
A5. By developing chemical derivatives outside the claimed genus or alternative delivery methods not covered by the claims, competitors can circumvent the patent.


Key Takeaways

  • Scope: US Patent 11,052,084 claims a broad chemical genus, including formulations and therapeutic methods, maximizing potential coverage but increasing validity risks.
  • Claims Strategy: The combination of structure, formulation, and use claims provides a comprehensive patent position, yet must withstand prior art scrutiny.
  • Patent Landscape: The patent sits amid a dense environment of similar filings; its strength depends on the specificity and novelty of claims.
  • Legal Vigilance: Patent owners should actively defend against invalidation, especially given prior art disclosures in the domain.
  • Business Strategy: Licensing and partnerships hinge on the enforceability and breadth of the patent claims—warranting thorough freedom-to-operate assessments.

References

[1] USPTO Public PAIR records, Patent File History, 2022.
[2] CPC Classification database, European Patent Office, 2022.
[3] Patent Landscape Analyses, Deloitte Patent Insights, 2022.
[4] Industry Patent Families, PatentScope, WIPO, 2022.
[5] Prior Art References, Scientific Publications, 2018–2022.

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Drugs Protected by US Patent 11,052,084

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 ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF MAJOR DEPRESSIVE DISORDER MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS, ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT ⤷  Start Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-002 Apr 22, 2022 RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS ⤷  Start Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-002 Apr 22, 2022 RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS ⤷  Start Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF MAJOR DEPRESSIVE DISORDER MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS, ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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