Understanding the Scope and Claims of United States Patent 9,956,227: A Detailed Analysis
Introduction
United States Patent 9,956,227, assigned to Intra-Cellular Therapies, Inc., is a crucial patent in the pharmaceutical landscape, particularly concerning the drug lumateperone, marketed as CAPLYTA®. This patent is part of a broader portfolio protecting the formulation, manufacture, and use of lumateperone, a novel antipsychotic medication.
Background on Lumateperone
Lumateperone is a second-generation antipsychotic used to manage both positive and negative symptoms in patients with schizophrenia. It was approved by the FDA in 2019 and has been a significant development in the treatment of psychiatric disorders[1].
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent No. 9,956,227, titled "Pharmaceutical Capsule Compositions Comprising Lumateperone Mono-Tosylate."
Inventors and Assignee
The inventors listed on this patent include Peng Li and Robert Davis, with Intra-Cellular Therapies, Inc. as the assignee[4].
Filing and Grant Dates
The patent was granted on May 1, 2018, after being filed on various provisional and non-provisional applications dating back to 2015[4].
Claims and Scope
Claim Structure
The patent includes multiple claims that cover various aspects of lumateperone formulations. Here are some key claim categories:
Composition Claims
These claims pertain to the specific formulations of lumateperone mono-tosylate in pharmaceutical capsules. For example, claims cover the combination of lumateperone with specific excipients and the dosage forms (e.g., 10.5 mg, 21 mg, and 42 mg capsules)[4].
Method of Manufacture Claims
These claims detail the processes for manufacturing the pharmaceutical compositions, including the steps involved in preparing the active pharmaceutical ingredient and the final capsule formulation[4].
Use Claims
These claims cover the therapeutic uses of lumateperone, specifically its application in treating schizophrenia and other psychiatric disorders[4].
Scope Concepts
The patent's scope is broad, covering not only the specific formulations but also the methods of manufacture and the therapeutic applications. This is crucial for protecting the intellectual property related to CAPLYTA® and ensuring that any generic versions do not infringe on these claims.
Patent Landscape and Litigation
Current Litigation
The patent is currently involved in several litigation cases where Intra-Cellular Therapies, Inc. is suing generic drug manufacturers for patent infringement. For instance, cases against DRL and Aurobindo Pharma involve allegations that these companies have submitted Abbreviated New Drug Applications (ANDAs) to the FDA seeking approval for generic versions of lumateperone capsules before the expiration of the patents-in-suit, including U.S. Patent No. 9,956,227[2][5].
Patent Portfolio
This patent is part of a comprehensive portfolio that includes multiple patents covering various aspects of lumateperone. Other patents in this portfolio include U.S. Patent Nos. 9,168,258, 9,199,995, 9,616,061, and several others, all of which contribute to the robust protection of CAPLYTA®[2][5].
Analytical Tools and Claim Coverage
Patent Analytics
To manage and analyze the complex patent landscape surrounding lumateperone, companies like Intra-Cellular Therapies, Inc. use advanced patent analytics tools. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and potential future design opportunities[3].
Claim Charts and Scope Concepts
Using tools like ClaimScape®, companies can generate interactive claim charts that help technical experts review patent coverage. These charts categorize claims into high, medium, or low value based on their current and future importance to the company, aiding in strategic decision-making regarding patent maintenance and enforcement[3].
Impact on Generic Competition
The robust patent protection, including U.S. Patent No. 9,956,227, significantly impacts the ability of generic manufacturers to enter the market. Generic companies must either wait for the patents to expire or seek to invalidate the patents through legal challenges, which can be costly and time-consuming[2][5].
Conclusion
U.S. Patent No. 9,956,227 is a pivotal patent in the protection of lumateperone, ensuring that Intra-Cellular Therapies, Inc. maintains exclusivity over the formulation, manufacture, and therapeutic use of CAPLYTA®. The patent's broad scope and the ongoing litigation highlight the importance of robust patent protection in the pharmaceutical industry.
Key Takeaways
- Patent Protection: U.S. Patent No. 9,956,227 is crucial for protecting the intellectual property related to lumateperone.
- Litigation: The patent is involved in several litigation cases against generic drug manufacturers.
- Scope and Claims: The patent covers specific formulations, methods of manufacture, and therapeutic uses of lumateperone.
- Patent Analytics: Advanced tools are used to manage and analyze the patent landscape.
- Impact on Generic Competition: The patent significantly delays the entry of generic versions into the market.
FAQs
What is the primary use of lumateperone?
Lumateperone is primarily used to manage both positive and negative symptoms in patients with schizophrenia.
Who is the assignee of U.S. Patent No. 9,956,227?
The assignee of U.S. Patent No. 9,956,227 is Intra-Cellular Therapies, Inc.
What are the key claims covered by U.S. Patent No. 9,956,227?
The patent covers composition claims, method of manufacture claims, and use claims related to lumateperone mono-tosylate.
Why is U.S. Patent No. 9,956,227 involved in litigation?
The patent is involved in litigation because generic drug manufacturers have submitted ANDAs to the FDA seeking approval for generic versions of lumateperone before the patent's expiration.
How does patent analytics help in managing the patent landscape?
Patent analytics helps in categorizing patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities.
Sources
- DrugBank: Lumateperone: Uses, Interactions, Mechanism of Action.
- RPX Corporation: Case 3:24-cv-08850 Document 1 Filed 08/29/24.
- Schwegman Lundberg & Woessner: Patent Analytics.
- Google Patents: United States Patent 11,052,084 B2.
- RPX Corporation: Case 3:24-cv-10235 Document 1 Filed 11/01/24.
