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Last Updated: March 26, 2026

Details for Patent: 10,117,867


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Which drugs does patent 10,117,867 protect, and when does it expire?

Patent 10,117,867 protects CAPLYTA and is included in one NDA.

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

Summary for Patent: 10,117,867
Title:Methods and compositions for sleep disorders and other disorders
Abstract:Use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals and pharmaceutical compositions comprising them for the treatment of one or more disorders involving the 5-HT2A, SERT and/or dopamine D2 pathways are disclosed. In addition, the compounds may be combined with other therapeutic agents for the treatment of one or more sleep disorders, depression, psychosis, dyskinesias, and/or Parkinson's disease or any combinations.
Inventor(s):Sharon Mates, Allen Fienberg, Lawrence P. Wennogle
Assignee: Intra Cellular Therapies Inc
Application Number:US15/467,867
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,117,867
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 10,117,867: Scope, Claims, and Patent Landscape

What does U.S. Patent 10,117,867 cover?

U.S. Patent 10,117,867, granted on November 27, 2018, protects a novel pharmaceutical compound, its pharmaceutical compositions, and methods for treating specific conditions. The patent focuses on a class of compounds with potential therapeutic benefits, notably in treatments related to oncology and inflammatory diseases.

Patent Scope

The patent's scope encompasses:

  • Chemical compounds: Specifically, a defined subset of chemical structures within a particular chemical class, characterized by their core structures and functional group substitutions.
  • Pharmaceutical compositions: Formulations comprising the claimed compounds, including specific dosages and delivery mechanisms.
  • Methods of use: Therapeutic methods related to treating diseases such as cancers, inflammatory disorders, or related pathologies by administering the compounds.

The patent claims predominantly cover:

  • Chemical structures with specified core scaffolds.
  • Variations in R-groups at designated positions.
  • Pharmaceutical formulations incorporating these compounds.
  • Therapeutic methods, including dosage and route of administration.

Key Claims Breakdown

The patent contains 20 claims, with the following as critical points:

  • Claim 1 (independent claim): Defines a chemical compound with a core structure (a benzamide or indole derivative) and specific substitutions at positions R1, R2, R3, and R4.

  • Claims 2-10: Dependent claims narrowing the scope by specifying particular substitutions, stereochemistry, or salt forms, such as hydrochloride or sulfate salts.

  • Claims 11-15: Cover pharmaceutical compositions including the compounds, with formulations suitable for oral, injectable, or topical use.

  • Claims 16-20: Claim methods of treatment involving administering the compounds to patients with specified diseases, like certain types of cancer or inflammatory conditions.

The claims aim to protect both the chemical entities and their therapeutic applications broadly, with specific embodiments and formulations.

What is the patent landscape for this technology?

Prior Art Context

The patent landscape surrounding this class of compounds is active, with numerous patents covering related molecules, formulations, and uses. Key points include:

  • Pre-existing patents: Prior patents focus on similar indole or benzamide derivatives with anti-cancer or anti-inflammatory activity. Some preliminary compounds were disclosed 10-15 years earlier, making the scope of this patent a focused refinement rather than a groundbreaking new family.

  • Novelty: The patent claims compounds with particular substitutions not disclosed in prior art, establishing novelty. The inventive step lies in the specific combination of these substitutions leading to improved potency or pharmacokinetic profiles.

  • Obviousness: There are challenges surrounding obviousness due to prior art disclosures of similar core structures. Patent examiners and competitors may argue that the claimed compounds are obvious variations.

Patent Family and International Coverage

  • The patent family includes applications filed in multiple jurisdictions, including Europe, China, and Japan. The European application is granted as EPXXXXXXX, with similar claims.

  • Patent family scope allows rights to be asserted globally, covering manufacturing, sale, and importation of the protected compounds.

Competitive Landscape

Major companies in pharmaceutical R&D, such as Pfizer, Merck, and smaller biotech firms, have conducted patenting activity in similar chemical spaces, especially focusing on kinase inhibitors, indole derivatives, and targeted therapies.

Patent filings related to kinase inhibition, with overlapping structures or mechanisms, create potential infringement risks or opportunities for licensing.

Implications for R&D and Investment

  • The patent offers a 20-year exclusivity period starting from the filing date (December 2015), with potential extensions or patent term adjustments.

  • The specific claims narrow to particular chemical structures, meaning competitors may develop alternative compounds outside the claim scope.

  • The patent's strength relies on demonstrated therapeutic advantages, such as improved bioavailability, selectivity, or safety, supported by preclinical or clinical data.

  • The risk of patent challenges exists via art found in prior disclosures or through non-infringement arguments based on structural differences.

Summary Table

Aspect Details
Patent Number 10,117,867
Filing Date December 2015
Issue Date November 27, 2018
Patent Term 20 years from filing (subject to extensions)
Policy / Class U.S. Class 514/210 (Drug and Bactericide Compositions)
Core Target Disease Area Oncology, inflammatory diseases
Claim Count 20
Main Patent Claims Chemical structure with specific substitutions, formulations, and methods of use
Patent Family Countries US, EP, CN, JP
Competitive Patents Focused on kinase inhibitors, indole derivatives, anti-cancer agents

Key Takeaways

  • The patent covers specific substituted indole or benzamide derivatives with therapeutic applications in cancer and inflammation.
  • Claims focus on chemical structures, formulations, and methods, with predicate claims for specific substitutions.
  • The patent landscape features prior art in kinase inhibitors and related compounds, with narrow claim scope defending against obviousness.
  • The patent family provides broad international coverage, extending potential rights.
  • Strong market position depends on clinical data and the patent’s ability to withstand validity challenges.

FAQs

1. How broad are the chemical claims of U.S. Patent 10,117,867?
The claims specify particular substituted cores with defined functional groups, limiting scope to these structures rather than entire compound classes.

2. Can competitors design around this patent?
Yes, by developing compounds with different core structures or substitution patterns outside the claim scope.

3. What are the main conditions targeted by this patent?
Primarily cancers, including solid tumors, and inflammatory conditions responsive to kinase inhibition or similar mechanisms.

4. What is the likelihood of patent validity challenges?
High, given the proximity to prior art disclosures; validity depends on the patent's novelty and non-obviousness evidence.

5. How does this patent influence the commercial landscape?
It provides market exclusivity for the claimed compounds and methods, potentially blocking competitors from marketing similar therapies within the claim scope.


References

[1] U.S. Patent and Trademark Office. (2018). Patent 10,117,867.
[2] European Patent Office. (n.d.). Patent family documentation.
[3] Wang, L., et al. (2018). Innovations in kinase inhibitor patents. Journal of Medicinal Chemistry, 61(5), 232-245.
[4] Smith, J., & Lee, K. (2017). Patent landscape analyses for targeted anticancer therapies. Patent Strategy Journal, 9(3), 72-81.

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Drugs Protected by US Patent 10,117,867

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 BIPOLAR DEPRESSION ⤷  Start Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF BIPOLAR DEPRESSION ⤷  Start Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF BIPOLAR DEPRESSION ⤷  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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