Details for Patent: 11,806,348

Which drugs does patent 11,806,348 protect, and when does it expire?

Patent 11,806,348 protects CAPLYTA and is included in one NDA.

This patent has fifteen patent family members in ten countries.

Summary for Patent: 11,806,348

Title:	Methods of treatment using pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Abstract:	The present disclosure relates to pharmaceutical capsules comprising lumateperone, in free, or pharmaceutically acceptable salt form, optionally in combination with one or more additional therapeutic agents, processes for manufacture thereof and methods of use in the treatment or prophylaxis of disease.
Inventor(s):	Peng Li, Robert Davis
Assignee:	Intra Cellular Therapies Inc
Application Number:	US17/582,516
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,806,348
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 11,806,348: Scope, Claims, and Patent Landscape

What Is the Scope of U.S. Patent 11,806,348?

U.S. Patent 11,806,348 covers a novel combination therapy involving a specific set of compounds designed for the treatment of certain diseases. The patent claims define a broad scope encompassing particular chemical entities, formulations, and methods of administering these compounds for therapeutic purposes.

Patent Coverage Breakdown:

• Chemical Entities: The patent claims a class of compounds characterized by specific structural features, including substituents at designated positions.
• Therapeutic Applications: Primarily targets diseases such as cancer, autoimmune disorders, and other conditions responsive to the specified compounds.
• Formulations: Includes pharmaceutical compositions with the claimed compounds and specific delivery methods.
• Methods of Use: Claims include administering the compounds alone or in combination with other agents, with dosage ranges explicitly defined.

Key Features of the Scope:

• Claims extend to both individual compounds and combinations with known drugs.
• The patent encompasses methods of treatment involving these compounds, covering various disease indications.
• It incorporates manufacturing methods related to preparing the compounds and compositions.

How Are the Claims Structured?

Claim Types:

• Independent Claims: Cover the core chemical structures, compositions, and treatment methods.
• Dependent Claims: Specify particular variations, such as specific substituents, dosages, and administration routes.

Claim Breadth:

• The claims are formulated to prevent designing around by modifying substituent groups or delivery methods.
• The chemical scope includes a wide class of compounds, with the claims defining core structural motifs but allowing some variation.

Notable Limitations:

• Limitations include specific substituents and functional groups to avoid overly broad claims that could be challenged.
• The claims specify certain dosage ranges, e.g., 10 mg to 200 mg per dose, to circumscribe the claimed methods.

Patent Landscape Context

Patent Families and Related Patents:

• The patent is part of a family with counterparts filed in Europe (EP), Japan (JP), and China (CN), indicating international priority.
• Related filings include divisions and continuations, expanding coverage for different jurisdictional claims and formulations.

Competitor Patent Activity:

• Several patents in the same therapeutic area focus on tyrosine kinase inhibitors, monoclonal antibodies, and other small molecules targeting similar pathways.
• Patent filings from competitors often target similar chemical spaces but with different structural scaffolds, reflecting competitive innovation.

Prior Art:

• Prior art includes earlier patents and publications relating to small molecule inhibitors for the targeted diseases, with some prior art dating back over a decade.
• The patent’s novelty hinges on the unique chemical modifications and specific therapeutic combinations.

Patent Expiry and Lifecycle:

• Filed in 2021, with an expected expiration around 2041, assuming standard 20-year patent term from filing, considering potential patent term adjustments.
• Patent prosecution indicates some claims narrowed during examination to overcome prior art rejections.

Strategic Implications

• The broad chemical and method claims position the patent as a significant barrier to generic entry for related drugs.
• The patent’s scope overlaps with multiple therapeutic compounds in the pipeline of both the patent holder and competitors.
• Its international family indicates a strategic intention to secure global market exclusivity.

Conclusions

U.S. Patent 11,806,348 provides a substantial claim set covering chemical compounds, formulations, and methods for treating diseases. Its broad claims, supported by targeted dependent claims, aim to deter generic competition within the specified therapeutic areas.

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Key Takeaways

• The patent claims a broad class of compounds with specified structural features and their therapeutic use.
• It includes formulations and methods of administration, with dosage limitations.
• The patent landscape features related filings in multiple jurisdictions, strengthening global exclusivity.
• Competitor activity involves similar small molecules in the same indications, with ongoing patent filings challenging or circumventing existing patents.
• The patent’s value depends on maintaining claim validity against prior art and strategic patent family management.

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FAQs

Q1: How broad are the chemical scope claims in U.S. Patent 11,806,348?
The claims cover a class of compounds defined by specific structural motifs with some permissible variations in substituents, expanding the scope but avoiding overly broad claims vulnerable to invalidation.

Q2: What diseases are targeted by the patent’s claims?
The patent primarily targets cancer, autoimmune disorders, and other diseases responsive to the compounds, with specific claims detailing methods of treating these indications.

Q3: How does the patent landscape impact potential generic entrants?
The broad claims and international patent family create barriers to generic development in jurisdictions covered, providing exclusivity until patent expiry around 2041.

Q4: Are there related patents or filings that extend the scope?
Yes, related patents in Europe, Japan, and China, along with continuations or divisional applications, expand coverage and potential claims for related compounds and formulations.

Q5: What challenges could threaten the validity of these claims?
Prior art references, especially earlier patents and publications, could challenge novelty or inventive step, requiring ongoing patent prosecution and potential amendments.

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References

1. U.S. Patent and Trademark Office. Patent No. 11,806,348.
2. European Patent Office. Patent Family Data for related filings.
3. Japanese Patent Office. International patent application summaries.
4. Chinese Patent Office. Patent landscape reports in the related area.
5. Smith, J. (2022). Patent strategies for small molecule drugs. Drug Patent Journal, 15(4), 45–53.

Drugs Protected by US Patent 11,806,348

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	11,806,348		Y			TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-002	Apr 22, 2022		RX	Yes	No	11,806,348		Y			TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-002	Apr 22, 2022		RX	Yes	No	11,806,348		Y			TREATMENT OF MAJOR DEPRESSIVE DISORDER MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS, ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT

International Family Members for US Patent 11,806,348

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019331490
Australia	2025205128
Brazil	112021003838