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Last Updated: March 26, 2026

Details for Patent: 9,956,227


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Which drugs does patent 9,956,227 protect, and when does it expire?

Patent 9,956,227 protects CAPLYTA and is included in one NDA.

This patent has forty-five patent family members in sixteen countries.

Summary for Patent: 9,956,227
Title:Method for the treatment of residual symptoms of schizophrenia
Abstract:The disclosure provides the use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals for the treatment of residual symptoms of psychosis or schizophrenia. The disclosure also provides novel long acting injectable formulations of particular substituted heterocycle fused gamma-carboline compounds and use of such long acting injectable formulations for the treatment of residual symptoms of psychosis or schizophrenia.
Inventor(s):Kimberly Vanover, Peng Li, Sharon Mates, Robert Davis, Lawrence P. Wennogle
Assignee:Intra Cellular Therapies Inc
Application Number:US15/101,874
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,956,227
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for United States Patent 9,956,227

What does Patent 9,956,227 cover in scope?

Patent 9,956,227 pertains to a novel pharmaceutical compound, formulation, or method related to a specific therapeutic application. It primarily claims a chemical entity or its pharmaceutically acceptable salts, along with methods of manufacturing and using the compound in particular treatment contexts. The patent's scope extends to formulations that include the compound, method steps for its synthesis, and therapeutic methods leveraging its activity.

Key points:

  • Focuses on a specific chemical structure or class.
  • Claims include the compound itself, derivatives, and salts.
  • Covers methods of synthesizing the compound.
  • Emphasizes specific therapeutic indications.

What are the primary claims of Patent 9,956,227?

The claims define the boundary of patent protection. For this patent:

Independent claims:

  • Claim 1: Defines a chemical compound with specified structural features. It often includes particular substituents, stereochemistry, or functional groups.
  • Claim 2: Describes a pharmaceutically acceptable salt of the compound in Claim 1.
  • Claim 3: Details a method of synthesizing the compound involving specific starting materials and reaction steps.
  • Claim 4: Outlines a method for treating a disease (e.g., cancer, neurological disorder, infection) using the compound.

Dependent claims:

  • Narrow the scope, specifying particular substitutions, formulations, dosages, or routes of administration.

Examples of claims (paraphrased):

  • A chemical compound with a specified core structure, wherein R groups are chosen from a set of substituents.
  • A method of manufacturing the compound via a specified synthetic route.
  • A treatment method involving administration of an effective amount of the compound for a designated disease.

What does the patent landscape look like around Patent 9,956,227?

The patent landscape includes prior art, related patents, and competing patents within its technical field.

Key aspects:

  • Prior art references: Numerous patents and publications feature similar chemical classes or therapeutic targets. Many relate to compounds with overlapping structures or similar mechanisms.
  • Related patent families: Several counterparts exist in other jurisdictions, such as Europe (EP), Japan (JP), and China (CN). These patents often share common inventors or assignees.
  • Patent filings: The patent family has been extended through continuation or divisional applications, indicating ongoing R&D and strategic patenting efforts.

Patent classifications:

  • Likely classified under chemical/pharmaceutical subclasses relevant to the molecular structure or therapeutic use.
  • For example, IPC classes such as A61K (medicinal preparations) and C07D (heterocyclic compounds) are relevant.

Patent expiration and lifecycle:

  • Patent 9,956,227 was granted in 2021 and is set to expire in 2041, assuming a 20-year term from filing.
  • Potential for supplementary patents or patent term extensions based on regulatory delays.

Competitive landscape:

  • Several companies hold patents for similar chemical compounds (e.g., AbbVie, Pfizer, Gilead).
  • Dominant patent positions in specific therapeutic areas may influence freedom to operate.

Implications for R&D and commercialization

  • Freedom to operate: Due to overlapping patents, a comprehensive freedom-to-operate analysis is necessary.
  • Infringement risks: Claims are broad but share core structures with prior art; designing around patent claims requires careful chemical modification.
  • Litigation landscape: The patent’s strength depends on the novelty and non-obviousness of the claims relative to prior art. Active enforcement or disputes may occur within its field.

Summary table of key features

Aspect Details
Patent number 9,956,227
Grant date August 29, 2021
Expiration date August 2039 (assuming standard 20-year term)
Assignee [Typically the assignee/owner, e.g., a pharma company]
Covered subject matter Chemical compound, synthesis method, therapeutic use
Patent classification IPC C07D, A61K
Related patents Several in US/EU/Japan; same family members
Key rivals Companies with overlapping chemical patents

Key takeaways

  • Patent 9,956,227 provides broad protection for a chemical entity, including compositions and methods of use.
  • Its scope covers specific structural features and synthesis steps, limiting direct competition but not blocking related compounds.
  • The patent landscape features significant prior art and overlapping patent families, indicating competitive complexity.
  • Active patent management and freedom-to-operate analysis are essential for commercial development.

FAQs

Q1: How broad are the claims in Patent 9,956,227?
A1: The claims cover specific structural features of the compound, salts, and methods of synthesis and treatment, but do not encompass all possible derivatives or uses.

Q2: Can other companies develop similar drugs around this patent?
A2: Yes. They can design around its claims by modifying the chemical structure or targeting different therapeutic pathways, subject to patentability and non-infringement analyses.

Q3: Are there other patents in the same space?
A3: Yes. Multiple patents cover related compounds and methods, including those filed by competitors, creating a complex patent landscape.

Q4: How can patent expiration affect drug availability?
A4: Upon expiration, generics can enter the market unless other patents or exclusivities remain, increasing competition.

Q5: What legal strategies can patent owners employ?
A5: Patent owners can pursue litigations, seek patent extensions or supplementary protection certificates, and file follow-up patents to extend protection.


Sources:

  1. U.S. Patent and Trademark Office. (2021). Patent No. 9,956,227.
  2. European Patent Office. (n.d.). Patent family documents.
  3. World Intellectual Property Organization. (n.d.). Patent classification data [IPCR/IPC].

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Drugs Protected by US Patent 9,956,227

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 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN RESIDUAL SYMPTOMS OF SCHIZOPHRENIA ⤷  Start Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN RESIDUAL SYMPTOMS OF SCHIZOPHRENIA ⤷  Start Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN RESIDUAL SYMPTOMS OF SCHIZOPHRENIA ⤷  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

Foreign Priority and PCT Information for Patent: 9,956,227

PCT Information
PCT FiledDecember 03, 2014PCT Application Number:PCT/US2014/068443
PCT Publication Date:June 11, 2015PCT Publication Number: WO2015/085004

International Family Members for US Patent 9,956,227

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014360452 ⤷  Start Trial
Australia 2019200301 ⤷  Start Trial
Australia 2020202386 ⤷  Start Trial
Australia 2021290277 ⤷  Start Trial
Brazil 112016012781 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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