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Last Updated: February 12, 2025

Details for Patent: 11,026,951


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Which drugs does patent 11,026,951 protect, and when does it expire?

Patent 11,026,951 protects CAPLYTA and is included in one NDA.

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

Summary for Patent: 11,026,951
Title:Methods of treating bipolar disorder
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): Vanover; Kimberly (New York, NY), Li; Peng (New Milford, NJ), Mates; Sharon (New York, NY), Davis; Robert (San Diego, CA), Wennogle; Lawrence P. (Hillsborough, NJ)
Assignee: INTRA-CELLULAR THERAPIES, INC. (New York, NY)
Application Number:16/507,956
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

United States Patent 11,026,951: A Detailed Analysis of Scope and Claims

Introduction

United States Patent 11,026,951, titled "Methods of treating bipolar disorder," is a significant patent in the field of pharmaceuticals, particularly in the treatment of psychiatric disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

The patent, assigned to a pharmaceutical company, describes the use of specific substituted heterocycle fused gamma-carboline compounds as therapeutic agents for treating bipolar disorder. Here is a brief overview of the key aspects:

  • Publication Number: US11026951B2
  • Authority: United States
  • Prior Art Keywords: Compounds, formula, symptoms, disorder, treatment methods[2].

Claims Analysis

The patent includes several claims that define the scope of the invention. Here are some key points:

Independent Claims

Independent claims are crucial as they define the broadest scope of the invention. For US11026951B2, these claims typically involve the specific chemical structures of the gamma-carboline compounds and their use in treating bipolar disorder.

Dependent Claims

Dependent claims narrow down the scope by adding additional limitations to the independent claims. These might include specific dosages, administration methods, or particular symptoms targeted by the treatment.

Claim Length and Count

Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].

Patent Scope

The scope of a patent is critical in determining its validity and enforceability.

Breadth of Claims

The claims in US11026951B2 are specific to the treatment of bipolar disorder using particular chemical compounds. This specificity helps in avoiding overly broad claims that might be challenged for lack of clarity or validity.

Novelty and Non-Obviousness

The patent must demonstrate novelty and non-obviousness over prior art. The use of specific gamma-carboline compounds for treating bipolar disorder likely satisfies these criteria, given the detailed description of the compounds and their therapeutic effects.

Patent Examination Process

The examination process for this patent would have involved several stages:

First-Action Allowance Rate

The first-action allowance rate indicates the proportion of applications allowed without further examination. For this patent, the allowance rate would reflect the initial assessment of its novelty and non-obviousness[4].

Continuation Applications

The patent examination process can involve continuation applications, which are closely related to the original application. These continuations can introduce new subject matter or separate distinct inventions, complicating the calculation of allowance rates[4].

Global Patent Landscape

Understanding the global patent landscape is essential for assessing the international protection and implications of this patent.

International Patent Offices

The invention may have been filed in other countries through the Patent Cooperation Treaty (PCT) or directly with international patent offices such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[1].

Common Citation Document (CCD)

The CCD application consolidates prior art citations from participating IP offices, providing a single point of access to citation data. This tool would be useful in assessing the global prior art landscape for this invention[1].

Market and Commercial Implications

The commercial success of a patent depends on several factors, including market demand and competition.

Market Value

The treatment of bipolar disorder is a significant market, and the success of a new therapeutic agent can lead to substantial market value. For example, Intra-Cellular Therapies Inc.'s CAPLYTA, another treatment for psychiatric disorders, has solidified its market position and contributed significantly to the company's value[5].

Competitive Landscape

The pharmaceutical industry is highly competitive, with numerous companies developing treatments for bipolar disorder. The uniqueness and efficacy of the gamma-carboline compounds described in this patent would be crucial in differentiating the product from existing treatments.

Legal and Regulatory Aspects

Patent Assignment and Ownership

The patent assignment search tool provided by the USPTO can help track changes in ownership, which is important for licensing and enforcement purposes[1].

Office Actions and Examination Outcomes

The Patent Examination Data System (PEDS) and the Public PAIR system provide insights into the examination process, including office actions and final outcomes. These tools are essential for understanding the legal status and any challenges faced during the examination process[1].

Conclusion

United States Patent 11,026,951 represents a significant advancement in the treatment of bipolar disorder. The specific claims and scope of the patent ensure that the invention is well-defined and protected. Understanding the broader patent landscape, including international filings and market implications, is crucial for maximizing the value of this invention.

Key Takeaways

  • Specific Claims: The patent includes specific claims related to gamma-carboline compounds and their use in treating bipolar disorder.
  • Patent Scope: The scope is defined by the breadth and novelty of the claims.
  • Examination Process: The patent went through a rigorous examination process, potentially involving continuation applications.
  • Global Landscape: International patent offices and tools like the CCD are important for global protection and prior art assessment.
  • Market Implications: The patent has significant market potential, given the demand for effective treatments for bipolar disorder.

Frequently Asked Questions (FAQs)

Q: What is the main subject of United States Patent 11,026,951? A: The main subject is the use of specific gamma-carboline compounds for treating bipolar disorder.

Q: How can one search for similar patents internationally? A: One can use databases provided by international patent offices such as the EPO, JPO, and WIPO, as well as tools like the CCD[1].

Q: What is the significance of claim length and count in patent scope? A: Narrower claims, as measured by length and count, are associated with a higher probability of grant and a shorter examination process[3].

Q: How can changes in ownership of a patent be tracked? A: The USPTO's Patent Assignment Search tool can be used to track changes in ownership[1].

Q: What is the role of the PEDS system in patent examination? A: The PEDS system allows public users to search, view, and download bibliographic data for all publicly available patent applications, providing insights into the examination process[1].

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Drugs Protected by US Patent 11,026,951

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 11,026,951 ⤷  Try for Free TREATMENT OF BIPOLAR DISORDER I, BIPOLAR DISORDER II, OR BIPOLAR DEPRESSION ⤷  Try for Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No 11,026,951 ⤷  Try for Free TREATMENT OF BIPOLAR DISORDER I, BIPOLAR DISORDER II, OR BIPOLAR DEPRESSION ⤷  Try for Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes 11,026,951 ⤷  Try for Free TREATMENT OF BIPOLAR I DISORDER, BIPOLAR II DISORDER, OR BIPOLAR DEPRESSION ⤷  Try for Free
>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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