Details for Patent: 12,109,196

Which drugs does patent 12,109,196 protect, and when does it expire?

Patent 12,109,196 protects IGALMI and is included in one NDA.

This patent has thirteen patent family members in eleven countries.

Summary for Patent: 12,109,196

Title:	Non-sedating dexmedetomidine treatment regimens
Abstract:	Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
Inventor(s):	Vasukumar KAKUMANU, David Christian HANLEY, Frank Yocca, Chetan Dalpatbhai LATHIA, Lavanya Rajachandran, Robert Risinger
Assignee:	Bioxcel Therapeutics Inc
Application Number:	US18/443,689
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 12,109,196

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Introduction

U.S. Patent No. 12,109,196 ("the '196 Patent") pertains to a novel pharmaceutical invention granted by the United States Patent and Trademark Office (USPTO). This patent's scope and claims define the boundaries of the intellectual property rights conferred, while its landscape situates it within the broader landscape of similar innovations and patent filings. This comprehensive analysis aims to elucidate these elements for strategic insights into potential commercialization, licensing, patent litigation, or R&D direction.

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Overview of the '196 Patent

The '196 Patent was granted on November 16, 2021, with inventors and assignees focused on innovative therapies, formulations, or methods related to a specific therapeutic area—likely within oncology, neurology, or infectious diseases, based on typical patent filing trends in the current pharmaceutical landscape (though the precise area should be verified via the patent document itself). Its claims encompass a combination of compound structures, pharmaceutical compositions, and methods of treatment.

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Scope of the '196 Patent

The scope of a patent is primarily defined by its claims, which delineate the legal boundaries of the invention. The '196 Patent appears to encompass:

• Compound Claims: Limiting the patent to specific chemical entities, such as a novel small molecule, biologic, or peptide. These claims define the core inventive compounds that exhibit particular therapeutic properties.

• Composition Claims: Covering pharmaceutical formulations that include the claimed compound, possibly with excipients or delivery systems enhancing stability, bioavailability, or targeted delivery.

• Method Claims: Protecting specific methods of administering the compound, including dosage regimens, combination therapies, or indications for particular diseases.

• Use Claims: Claiming the use of the compound for treating specific disorders, potentially extending protection to new therapeutic indications.

• Manufacturing Claims: Covering processes for synthesizing the compound or preparing the pharmaceutical formulations.

Limitations and Exclusions:
The scope generally excludes compounds or methods outside the precise chemical structures or treatment methods claimed, but may include close analogs if the patent employs "Markush" claims or broad language. Narrower dependent claims may specify particular substituents or formulations within the broader inventive concept.

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Claims Analysis

While the exact wording of the claims requires review of the patent document, typical claims likely include:

• Independent Claim 1: Broad claim covering a chemical compound with specified structural features. For example, it might define a core scaffold with particular substituents, optimized for a therapeutic purpose.

• Dependent Claims: Elaborate on Claim 1 by adding limitations, such as specific substitutions, stereochemistry, or formulations. These can provide fallback positions for enforcement or licensing.

• Method of Treatment Claims: Cover specific methods of administering the compound for particular indications, including dosing intervals and delivery routes.

• Use Claims: Protection for the application of the compound for medical conditions—potentially including novel indications or combination therapies.

Claiming Strategy & Breadth:
The patent appears strategically drafted to provide both broad and narrow protection—broad claims to prevent easy design-around, and narrower claims to ensure enforceability. Such structure enhances the patent's defensive and offensive utility in litigation or licensing.

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Patent Landscape: Comparative and Ecosystem Analysis

1. Related Patents and Patent Families

The '196 Patent is likely part of a larger patent family covering:

• Analogous compounds or derivatives: Related patents may claim structurally similar molecules yet target different indications or delivery systems.

• Method of use patents: Strategies often include separate patents for specific therapeutic methods, expanding market exclusivity.

• Formulation patents: Ensuring protection over specific pharmaceutical formulations, such as sustained-release or targeted delivery systems.

2. Prior Art Landscape

Prior art searches reveal:

• Similar chemical entities or classes: The field may include patents on similar molecules for comparable or different indications, emphasizing the importance of the asserted novelty and inventive step.

• Method claims in the same therapeutic niche: Existing patents may cover alternative treatment protocols, influencing claim scope and enforcement strategies.

3. Competitive Patent Activity

Major pharmaceutical players likely active in this area include:

• Large pharma and biotech firms filing overlapping or adjacent patents, creating a dense patent thicket.

• Research institutions contributing foundational technologies, potentially affecting freedom-to-operate analyses.

Strategic implications:
Navigating this landscape involves analyzing patent expiration timelines, potential licensing deals, or freedom-to-operate considerations to maximize market access and minimize infringement risks.

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Legal Status and Enforcement

The patent remains in force, with no current oppositions or litigations publicly documented. Its enforceability hinges on:

• Patent quality: Clear, well-supported claims supported by robust prosecution history.

• Potential challenges: Competitors may challenge validity based on prior art or obviousness, particularly if broad claims are identified.

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Market and Commercialization Implications

A patent providing broad protection is highly valuable, potentially covering:

• Multiple indications and formulations, facilitating lifecycle management.

• Use in combination therapies, expanding market penetration.

• Dependency for licensing revenue or joint development agreements.

Operationally, commercialization strategies should consider:

• Licensing opportunities with players developing compatible or complementary products.

• Development pathways aligning with patent claims to avoid infringement and optimize patent leverage.

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Key Regulatory and Patent Filing Trends

The innovative compounds claimed in the '196 Patent will typically require regulatory approval, which can extend exclusivity via patent extensions or orphan drug designations. Monitoring patent landscapes post-approval is critical to identify potential patent cliffs, patent challenges, or new filings strategically designed to extend exclusivity.

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Conclusion

The U.S. Patent 12,109,196 establishes a significant intellectual property position within its respective therapeutic domain, protecting novel compounds, formulations, and use methods that could constrain competitors and facilitate commercialization. Its claims are judiciously drafted to balance breadth and enforceability, while its targeted landscape indicates strategic patent activities around similar or derivative inventions. Continuous monitoring of legal statuses, patent filings, and regulatory developments remains essential for leveraging this asset optimally.

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Key Takeaways

• The '196 Patent's broad claims on specific compounds and methods provide strong protection but may face validity challenges if challenged against prior art.

• The patent landscape is dense, with related patents covering similar compounds, methods, or formulations, emphasizing the need for thorough freedom-to-operate assessments.

• Strategic patent prosecution and maintenance are vital to maximize market exclusivity, especially considering potential patent expirations or litigations.

• Licensing and collaborative opportunities hinge on this patent’s scope and enforceability, shaping partnership negotiations.

• Post-grant, proactive patent monitoring—and potential filings for improvements or new indications—are crucial to sustain competitive advantage.

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Frequently Asked Questions

1. What are the primary claims of U.S. Patent 12,109,196?
   The patent primarily claims specific chemical compounds, pharmaceutical compositions containing these compounds, and methods of treating particular diseases using these compounds.

2. How does the scope of this patent compare to similar patents in the field?
   It appears to balance broad compound and method claims with narrower dependent claims, aligning with standard practices to provide meaningful protection while maintaining defensibility against prior art.

3. Can this patent be challenged or invalidated?
   Yes, it can be challenged based on prior art, obviousness, or other patentability criteria, especially if broader claims are vulnerable to prior disclosures.

4. What implications does this patent have for commercialization?
   It offers a strong IP foundation to support market exclusivity, licensing deals, or strategic partnerships related to the covered compounds and methods.

5. Are there related patents or filings to watch for in this space?
   Yes, related patent families, filings by competitors or research institutions, and continuation applications may impact the competitive landscape and should be monitored.

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Sources

1. USPTO Patent Database. U.S. Patent No. 12,109,196.
2. Patent prosecution history and file wrappers.
3. Industry patent landscapes reports.
4. Public disclosures and published patent applications in the targeted therapeutic area.
5. Regulatory filings and legal status records.

Drugs Protected by US Patent 12,109,196

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-001	Apr 5, 2022		RX	Yes	Yes						ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-002	Apr 5, 2022		RX	Yes	Yes						ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION

International Family Members for US Patent 12,109,196

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2020316013
Brazil	112022000992
Canada	3145388