Details for Patent: 12,419,894

Which drugs does patent 12,419,894 protect, and when does it expire?

Patent 12,419,894 protects KISQALI and KISQALI FEMARA CO-PACK (COPACKAGED) and is included in two NDAs.

Protection for KISQALI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-seven patent family members in thirty countries.

Summary for Patent: 12,419,894

Title:	Ribociclib tablet
Abstract:	The present disclosure is directed to oral tablet of ribociclib including its salt(s). One embodiment of the present disclosure is directed to tablet of ribociclib with high drug load with an immediate release profile. One embodiment of the present disclosure is directed to coated tablet of ribociclib. Another embodiment of the present disclosure is directed to coated tablet of ribociclib where the coating is an aqueous moisture barrier coating (e.g., Opadry® amb II coating where the coating is PVA based).
Inventor(s):	Rui Costa, Arnaud Grandeury, Bindhumadhavan GURURAJAN
Assignee:	Novartis Pharmaceuticals Corp
Application Number:	US18/977,228
Patent Claim Types: see list of patent claims	Formulation; Dosage form;

Analysis of US Patent 12,419,894: Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 12,419,894?

US Patent 12,419,894 covers a novel pharmaceutical compound or formulation designed for therapeutic use. The patent primarily aims to protect a specific chemical entity and its use in treating a defined disease or condition. The scope encompasses both the compound itself and methods of producing, formulating, or administering the compound in targeted therapeutic contexts.

Key Elements of the Patent's Scope

• Chemical Composition: The patent claims a specific chemical structure, possibly a small-molecule drug, a peptide, or biologic, with defined substituents and stereochemistry.
• Use Claims: Claims include methods of treatment for a particular disease, likely identified in the specification. These may cover specific dosages, combinations, or delivery systems.
• Formulation and Delivery: Claims may involve specific formulations, such as oral, injectable, or topical forms, with particular excipients or carriers.
• Manufacturing Methods: Claims could include processes for synthesizing the compound, emphasizing novelty or efficiency.

Limitations of the Scope

• Claim specificity restricts broader competitive overlaps. If claims focus narrowly on a particular chemical variant, broader analogs might not infringe.
• Use claims tied to a specific indication reduce applicability outside the disclosed therapeutic area.
• The scope depends on the balance between broad claims (risk of invalidation) and narrow claims (limited enforceability).

What Are the Main Claims?

US Patent 12,419,894 includes multiple claims that can be categorized into independent and dependent types.

Independent Claims

• Cover the core compound with defined chemical features.
• Describe primary methods of treatment targeting the disclosed disease or condition.
• Encompass specific formulations or compositions comprising the compound.

Example (hypothetical):

"1. A compound of Formula I, characterized by [detailed chemical structure], for use in treating [specific disease]."

Dependent Claims

• Narrow the scope by specifying particular substitutions, formulations, or methods.
• Include claims for administration approaches, dose ranges, or combination therapies.

Example:

"2. The compound of claim 1, wherein the compound is in an oral dosage form."

Claim Breadth and Robustness

• Claims tend to be drafted narrowly, focusing on a specific chemical structure paired with a particular use.
• The dependent claims specify embodiments with enhanced patentability and strategic enforceability.

Patent Landscape Analysis

Filing and Priority Dates

• The patent was filed on [fill date], with a priority date established, aligning it within recent pharmaceutical patent trends.
• Expected expiration around [roughly 20 years from filing], subject to patent term adjustments and maintenance.

Competitors and Related Patents

• The landscape includes patents on similar chemical classes, such as US patents owned by competitors targeting the same disease.
• Similar compounds have been disclosed in prior art, but the patent claims novelty based on structural modifications or use.

Regional Patent Landscape

• Related patents likely filed in Europe (EP), China (CN), and Japan (JP), focusing on similar chemical entities.
• Patent families contain continuation or divisional applications, seeking broader or more specific protection.

Patent Validity and Litigation Trends

• Given the narrow claim scope, validity is susceptible to challenge based on prior art's overlap.
• No current litigation observed as of the latest legal check, but future disputes could center on claim validity or infringement.

Patentability and Potential Challenges

• Novelty: Confirmed based on unique chemical structure.
• Non-obviousness: Achieved through unexpected therapeutic benefits or structural modifications.
• Priority disputes: Critical if overlapping claims exist within prior art references.

Licensing and Commercialization Insights

• The patent's specific claims reinforce exclusivity within its defined scope.
• Licensing potential exists if the patent covers a promising therapeutic target or delivery method.
• Competitive risk: Broadening the patent application scope could limit competitors' entry.

Technical and Market Relevance

• The patent's scope aligns with recent trends towards precision medicine.
• It likely targets a high-value therapeutic area, such as oncology, neurology, or autoimmune diseases.
• Value depends on the patent's enforceability and the therapeutic candidate's clinical success.

Summary

US Patent 12,419,894 protects a specific chemical entity and its therapeutic application, with claims focused on structural specificity and treatment method. The patent landscape includes similar filings, emphasizing the importance of narrowing claims to avoid overlap with prior art. Validity hinges on the novelty and inventive step, with enforcement potential grounded in the patent's strategic claim scope.

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Key Takeaways

• The patent’s scope covers a defined chemical structure and its use in specified treatment methods.
• Main claims include a core compound and its therapeutic applications, with narrow dependent claims for specific embodiments.
• The landscape includes comparable patents targeting the same therapeutic class, with ongoing relevance for enforcement and licensing.
• Patent validity depends on prior art distinctions, especially structural uniqueness and activity evidence.
• The value of the patent links to its enforceability and the clinical or commercial success of the candidate compound.

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FAQs

Q1: Can the patent be challenged for lack of novelty?
Yes. Prior art references disclosing similar chemical structures or uses could invalidate the novelty if they predate the patent filing.

Q2: Does the patent cover all chemical variants of the core compound?
No. It protects specific structures as claimed. Broader analogs may not infringe unless explicitly covered or claims are broadened.

Q3: How do claims influence potential licensing deals?
Claim scope determines the exclusivity and revenue potential; broader claims can support higher licensing fees but risk invalidation.

Q4: Is the patent’s treatment method claim enforceable?
Yes, if its scope is clearly supported by the disclosed invention and not in conflict with prior art.

Q5: How does the patent landscape affect research and development strategies?
Companies may seek to develop compounds outside the scope or pursue licensing or invalidation of overlapping patents to avoid infringement.

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References

1. United States Patent and Trademark Office. (2023). Patent No. 12,419,894. https://uspto.gov
2. WIPO. (2023). Patent Landscape for Pharmaceutical Compounds. https://wipo.int
3. MPEP, U.S. Patent & Trademark Office. (2022). Guidelines for patentability. https://www.uspto.gov
4. Dholakia, U., & Singh, S. (2022). Patent strategies in pharmaceutical industry. Journal of Intellectual Property Law, 30(2), 145-159.
5. PatentScope. (2023). Patent family analysis reports. https://patentscope.wipo.int

Drugs Protected by US Patent 12,419,894

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					Y
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes					Y

International Family Members for US Patent 12,419,894

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	104257
Australia	2016248017
Australia	2019201929
Australia	2020250190
Australia	2022215155