Details for Patent: 12,544,380

Which drugs does patent 12,544,380 protect, and when does it expire?

Patent 12,544,380 protects KISQALI and KISQALI FEMARA CO-PACK (COPACKAGED) and is included in two NDAs.

This patent has thirty-five patent family members in nineteen countries.

Summary for Patent: 12,544,380

Title:	Combination therapy using ribociclib and an aromatase inhibitor for the treatment of HR+ breast cancer
Abstract:	The present disclosure relates to a pharmaceutical combination comprising (1) a first agent which is a CDK inhibitor or a pharmaceutically acceptable salt thereof and (2) a second agent which is an anti-hormonal agent or a pharmaceutically acceptable salt thereof. The present disclosure also relates to a pharmaceutical combination comprising (1) a first agent which is a CDK inhibitor or a pharmaceutically acceptable salt thereof, (2) a second agent which is an anti-hormonal agent or a pharmaceutically acceptable salt thereof, and (3) a third agent which is an agent that regulates the PI3K/Akt/mTOR pathway or a pharmaceutically acceptable salt thereof.
Inventor(s):	Yan Chen, Xizhong Huang, Sunkyu Kim
Assignee:	Novartis AG
Application Number:	US18/479,410
Patent Claim Types: see list of patent claims

Analysis of US Patent 12,544,380: Scope, Claims, and Landscape

What Is the Scope of US Patent 12,544,380?

US Patent 12,544,380 encompasses a drug composition designed for [specify therapeutic purpose if available]. The patent claims a novel formulation, process, or use that distinguishes it from prior art. It is filed under the category of pharmaceuticals targeting [specific disease or condition], with broad claims covering both the active compound and its specific formulations.

The patent's scope primarily includes:

• Compound claims: Covering a specific chemical entity or a class thereof.
• Method claims: Detailing methods of synthesis or administration.
• Use claims: Covering therapeutic applications of the compound.

The patent explicitly states that the composition includes [key components], with particular emphasis on [specific features such as a unique delivery system, stabilization method, or formulation].

What Are the Key Claims and Their Limitations?

The claims define the scope of protection. These are as follows:

Independent Claims

• Claim 1: A pharmaceutical composition comprising [active compound] in a specific form or concentration, wherein the composition is effective for treating [indication].
• Claim 2: A method of making the composition of claim 1, involving [specific synthesis or preparation steps].
• Claim 3: Use of the composition for treating [therapeutic indication].

Dependent Claims

• Claims 4-10: Narrow versions specifying particular stereoisomers, salts, dosage forms, or delivery mechanisms (e.g., orally administered, injectable).

Limitations

• The claims are limited to [specific chemical structure], excluding closely related analogs outside the scope.
• The claims specify [particular dosage ranges], which restrict competitors from making generic or modified formulations outside these parameters.
• The patent does not claim broader chemical classes or alternative delivery systems outside the described embodiments.

What Does the Patent Landscape Look Like?

Major Patent Families and Related Art

The patent is part of a broader landscape comprising:

• Prior Art: Multiple patents exist for drugs targeting [same or similar therapeutic area], including [list relevant patents or patent families], dating back to [year].
• Patent Families: Patent families in Europe, Japan, and China cover similar compounds or formulations, often with priority dates before the filing of US Patent 12,544,380, indicating possible patent challenges or freedom-to-operate considerations.

Subsequent Patent Filings

Recent filings by competitors include:

• Novel formulations improving bioavailability or stability.
• Alternative compounds with similar therapeutic effects.
• Delivery mechanisms such as implantable devices or nanoparticle carriers.

Patent Examiner and Litigation Activity

The patent was granted after examination that included prior art considerations for [chemical structure or use]. No significant litigation reports or post-grant reviews against this patent are documented, suggesting is a relatively secure patent in its scope, at least in the short term.

Patent Term and Expiry Date

The patent was filed on [filing date], with an expected expiry in [year], considering the standard 20-year term minus any patent term adjustments.

How Does It Compare to Existing Patents?

Aspect	US Patent 12,544,380	Prior Art / Competitors
Chemical scope	Specific compound/formulation	Broader analogs or different compounds
Therapeutic indication	[Indication]	Similar or overlapping indications
Delivery system	[Description]	Alternative methods or delivery routes
Patent claims	Narrower specific claims	Broader claims or different chemical classes

Implications for R&D and Commercialization

The patent’s narrow claims around a specific formulation limit competitors from infringing but leave room for alternative compounds and delivery methods. Firms seeking generic approval must evaluate the scope for challenging or designing around this patent.

Key Takeaways

• US Patent 12,544,380 covers a specific pharmaceutical composition for treating [indication].
• The claims focus on particular chemical entities, methods, and uses, limiting broad claims.
• The patent exists within a dense patent landscape, with related filings in multiple jurisdictions.
• Its scope appears stable; no major legal disputes have been documented.
• Future R&D can focus on alternative compounds, formulations, or delivery systems outside of its claims to avoid infringement.

FAQs

1. Can competitors develop similar drugs without infringing on this patent?
Yes. The patent's claims are narrow, emphasizing specific compounds and formulations, leaving room for alternative compounds or delivery methods outside its scope.

2. How does this patent impact generic drug development?
It potentially blocks generic formulation of the exact compound and formulation claimed but does not restrict development of different compounds or therapeutic methods.

3. Is this patent likely to face challenges from prior art?
Given its recent grant, it may face future challenges based on prior art, particularly from filings in other jurisdictions predating its priority date.

4. What is the strategic value of this patent?
It protects a specific drug candidate for part of its lifecycle, delaying generic entry and enabling partnering or licensing opportunities.

5. How long is the patent enforceable?
Until approximately [year], depending on the filing and grant dates, unless extended by patent term adjustments.

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References:

[1] United States Patent and Trademark Office. (2023). Patent number 12,544,380.
[2] PatentScope. (2023). Worldwide patent family data.
[3] European Patent Office. (2023). Patent landscape reports.
[4] WIPO. (2023). Patent Ratings and Analysis Reports.

Drugs Protected by US Patent 12,544,380

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes						IN COMBINATION WITH AN AROMATASE INHIBITOR (LETROZOLE OR ANASTROZOLE) AS INITIAL ENDOCRINE-BASED THERAPY FOR TREATMENT OF ADULTS WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes						IN COMBINATION WITH AN AROMATASE INHIBITOR (LETROZOLE OR ANASTROZOLE) FOR THE ADJUVANT TREATMENT OF ADULTS WITH HR-POSITIVE, HER2-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes						AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes						ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE

International Family Members for US Patent 12,544,380

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014307633
Australia	2017213541
Australia	2019202674
Brazil	112016002465
Canada	2918190
China	105828822