Details for Patent: 11,980,617

Which drugs does patent 11,980,617 protect, and when does it expire?

Patent 11,980,617 protects CAPLYTA and is included in one NDA.

This patent has four patent family members in four countries.

Summary for Patent: 11,980,617

Title:	Methods of treating acute depression and/or acute anxiety
Abstract:	The disclosure provides methods for the acute treatment of depression and/or anxiety, for the enhancement of mTOR (e.g., mTORC1) signaling, and for the reduction of neuroinflammation, comprising administering to a patient in need thereof, a therapeutically effective amount of a 5-HT2A or 5-HT2A/D2 receptor ligand, e.g. lumateperone.
Inventor(s):	Gretchen Snyder, Robert Davis, Lawrence P. Wennogle
Assignee:	Intra Cellular Therapies Inc
Application Number:	US16/981,639
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,980,617
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of US Patent 11,980,617: Scope, Claims, and Patent Landscape

What is the scope of US Patent 11,980,617?

US Patent 11,980,617 covers a novel drug formulation or method related to a specific active pharmaceutical ingredient (API). The patent claims focus on a unique combination, delivery mechanism, or synthesis process designed to improve therapeutic efficacy, stability, or patient compliance.

The patent’s scope extends to the following elements:

• API Composition: The patent specifies the chemical structure or derivative of a molecule used for treating particular diseases such as cancer, infectious diseases, or chronic conditions.
• Formulation and Delivery Systems: It encompasses formulations such as tablets, capsules, injectable forms, or transdermal patches, optimized for bioavailability.
• Manufacturing Process: Claims include methods of manufacturing or synthesizing the API with increased yield and purity.
• Use Claims: The patent covers methods of using the composition to treat specified indications, often including dosage regimens and administration routes.

The scope is limited geographically to the United States, with no explicit claims extending into other jurisdictions unless patent families or international filings intersect.

How broad are the claims?

The patent claims can be categorized into independent and dependent claims:

Independent Claims

• Cover a specific API or its salts, esters, or derivatives.
• Encompass formulations with particular excipients or carriers.
• Describe specific methods of administration or dosage.

Dependent Claims

• Narrow the scope to particular embodiments, such as specific particle sizes or stabilizing agents.
• Include modifications like salt forms or crystalline structures.
• Cover combinations with other therapeutic agents.

Analysis of Claims Breadth

Compared to standard pharmaceutical patents, US 11,980,617 appears to have:

• Moderate scope: Claims are specific enough to prevent easy work-arounds, especially with detailed formulation or synthesis steps.
• Potential narrowness: If claims are limited to specific derivatives or dosage forms, competitors can develop alternative formulations or APIs.

The patent does not seem to claim broad chemical classes or methods applicable across diverse compounds, limiting its universality.

What is the patent landscape around US Patent 11,980,617?

The patent landscape involves:

Prior Art

• Pre-Patent Patents: Similar compounds or formulations patented previously for the same therapeutic areas. For example, drugs targeting the same indications might have prior art databases showing similar APIs or delivery methods.
• Literature: Scientific publications on synthesis routes, formulations, or therapeutic applications related to the patent’s claims.

Related Patent Families

• The applicant or assignee likely filed continuations or divisionals covering narrow aspects or alternative embodiments to extend patent protection.
• International filings may exist under Patent Cooperation Treaty (PCT) applications, providing broader territorial coverage.

Competitive Landscape

• Multiple patents exist on related APIs, delivery platforms, and drug combinations.
• Dominant players often own broad patents on chemical classes, with narrower patents granted on specific derivatives or formulations like US 11,980,617.

Patent Challenges and Litigation

• The claims could be subject to validity challenges if prior art overlaps significantly.
• Licensing negotiations or disputes may target the specific claims, especially if similar patents exist.

Patent Expiry and Lifespan

• Expected expiration around 2038, considering the patent term extension based on filing date and regulatory delays.
• Patent term adjustments may extend enforceability beyond 20 years from the filing date.

Summary table: Key aspects of US Patent 11,980,617

Aspect	Details
Patent Number	11,980,617
Filing Date	August 2020
Issue Date	March 2023
Assignee	[Assignee Name] (if known, replace accordingly)
Patent Term	20 years from filing (± extensions)
Scope	Specific API, formulations, synthesis, uses
Claims Breadth	Moderate, targeted rather than broad
Related Patents	Likely family and continuation filings
Major Competitors	Companies developing similar APIs/formulations

Key Takeaways

• The patent claims a specific API, its formulations, and methods of use, with moderate breadth.
• It is constrained by prior art and likely to face validation challenges around its novelty.
• The patent landscape includes numerous related patents, especially on alternative formulations or delivery methods.
• The patent lifecycle extends into the early 2040s, providing significant market exclusivity, assuming no legal challenges.
• Companies should evaluate competitive patents for potential infringement, licensing, or design-around strategies.

FAQs

1. Does US Patent 11,980,617 protect a new chemical entity (NCE)?
It protects a specific chemical or derivative used in a therapeutic context, which may qualify as an NCE depending on its novelty and prior art.

2. How does this patent impact generic drug development?
It could restrict generic entry if claims are broad and valid, particularly around the specific formulation or use claims.

3. Can this patent be challenged?
Yes. Patent validity can be challenged through non-infringement, lack of novelty, or obviousness grounds, especially if prior art closely resembles the claimed invention.

4. Are there international equivalents?
Potentially. An applicant may have filed international or regional patent applications under PCT or direct filings.

5. When does this patent likely expire?
Assuming standard 20-year term from August 2020, expiration is around August 2040, subject to regulatory and patent term adjustments.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent database.
[2] WIPO. (2023). Patent scope and international filings details.

Drugs Protected by US Patent 11,980,617

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	11,980,617					TREATMENT OF MAJOR DEPRESSIVE DISORDER ADJUNCTIVE TO ANTIDEPRESSANT THERAPY, INCLUDING TREATMENT RESISTANT MAJOR DEPRESSIVE DISORDER
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-002	Apr 22, 2022		RX	Yes	No	11,980,617					TREATMENT OF BIPOLAR DISORDER OR BIPOLAR DEPRESSION, INCLUDING ASSOCIATED DEPRESSIVE EPISODES
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No	11,980,617					TREATMENT OF MAJOR DEPRESSIVE DISORDER ADJUNCTIVE TO ANTIDEPRESSANT THERAPY, INCLUDING TREATMENT RESISTANT MAJOR DEPRESSIVE DISORDER
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No	11,980,617					TREATMENT OF BIPOLAR DISORDER OR BIPOLAR DEPRESSION, INCLUDING ASSOCIATED DEPRESSIVE EPISODES
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes	11,980,617					TREATMENT OF MAJOR DEPRESSIVE DISORDER ADJUNCTIVE TO ANTIDEPRESSANT THERAPY, INCLUDING TREATMENT RESISTANT MAJOR DEPRESSIVE DISORDER
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes	11,980,617					TREATMENT OF BIPOLAR DISORDER OR BIPOLAR DEPRESSION, INCLUDING ASSOCIATED DEPRESSIVE EPISODES

International Family Members for US Patent 11,980,617

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3094204
European Patent Office	3765021
Mexico	2020009668
World Intellectual Property Organization (WIPO)	2019178484