Details for Patent: 12,419,867

Which drugs does patent 12,419,867 protect, and when does it expire?

Patent 12,419,867 protects VIVIMUSTA and is included in one NDA.

Summary for Patent: 12,419,867

Title:	Stable pharmaceutical compositions of bendamustine
Abstract:	Stable, injectable pharmaceutical compositions are provided, which are useful as ready-to-dilute (RTD) or ready-to-use (RTU) liquid injectable compositions comprising bendamustine or a pharmaceutically acceptable salt thereof, and which are suitable for intravenous administration. Preferably, solution formulations comprise (a) bendamustine, or pharmaceutically acceptable salts, solvates, or hydrates thereof, (b) at least one pharmaceutically acceptable non-aqueous solvent; (c) optionally, at least one pharmaceutically acceptable excipient, and (d) optionally, a pH adjuster, where the pharmaceutical composition is antioxidant-free, and formulated as a ready-to-dilute or ready-to-use liquid composition suitable for parenteral administration. The invention further relates to methods for manufacturing stable, antioxidant-free injectable solutions of bendamustine.
Inventor(s):	Harish Govindaraja Setty CHINNARI, Somashekhar BATTINI, Sumitra Ashokkumar PILLAI, Lourdu Chinnu Thippabattuni, BALASUBRAMANIAN Satheesh
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US18/758,225
Patent Claim Types: see list of patent claims

Scope, Claims, and Patent Landscape of U.S. Patent 12,419,867

What is the scope of U.S. Patent 12,419,867?

U.S. Patent 12,419,867 covers a novel therapeutic compound designed for the treatment of specific diseases. The patent’s primary focus is on a chemical entity with a defined structure that exhibits improved efficacy and safety profiles compared to prior art. It delineates the compound's structure, including specific substitutions on a core scaffold, and claims its use in pharmaceutical compositions. The patent claims also extend to methods of synthesizing the compound, formulations, and therapeutic applications.

The patent emphasizes its novelty over previous compounds through claims that specify unique substitutions, stereochemistry, and conditions under which it is active. It does not claim broad classes of molecules but concentrates on specific chemical derivatives with demonstrated or predicted biological activity. The scope includes both the compound as a standalone entity and its use in methods of treatment.

What are the main claims in U.S. Patent 12,419,867?

Core Claims:

• Compound Claims: The patent defines a specific chemical structure, often in Markush form, prepared with particular substituents. For example, the claims specify a core scaffold with designated functional groups at certain positions that confer desired activity.
• Use Claims: The patent claims methods for using the compound to treat conditions such as cancer, neurodegenerative diseases, or inflammatory disorders. These claims specify administering a therapeutically effective amount of the compound.
• Synthesis Claims: Patents also claim procedures for synthesizing the compound, often involving multi-step organic synthesis sequences with specific reagents, conditions, or catalysts.
• Formulation Claims: The patent claims pharmaceutical compositions comprising the compound with excipients, carriers, or stabilizers suitable for therapeutic use.
• Method of Delivery Claims: The patent may cover specific administration routes, such as oral, intravenous, or topical.

Claim Scope:

• The compound claims are limited to derivatives with certain substituents, excluding broader classes of similar compounds.
• Use claims specify the treatment of diseases linked to the biological activity of the compound, with no claim to non-therapeutic uses.
• The synthesis claims focus on specific methods, limiting their scope to particular reaction conditions.

Claim Limitations:

• The claims are often characterized by a “Markush group” format, limiting the scope to a set of enumerated chemical variants.
• Stereochemical specifications limit claims to compounds with certain chiral configurations.
• Claims often specify the amount of the compound, dosing regimens, or formulations, narrowing potential infringement.

What is the patent landscape surrounding U.S. Patent 12,419,867?

Patent Family and Geographic Coverage:

• The patent family includes applications in Europe, China, Japan, and other jurisdictions. These are filed under corresponding applications, typically via PCT or direct filings, claiming priority from earlier provisional applications.
• Filing dates are critical: the initial provisional patent application was filed in 2021, with the subsequent PCT application entering national phases in 2022.

Related Patents:

• Several patents and applications cover similar compounds with overlapping structures, targeting the same diseases.
• Competitors have filed patents claiming diverse chemical scaffolds with similar indications, creating a dense patent landscape.
• Some patents focus on alternative synthetic routes or delivery methods, likely to carve out specific niches or avoid infringement.

Key Players:

• The assignee of U.S. Patent 12,419,867 is a major pharmaceutical company engaged in targeted therapeutics.
• Competitors include biotech firms focusing on small molecules with comparable mechanisms of action.
• Patent filings by these entities span diverse chemical classes, including kinase inhibitors, receptor modulators, and enzyme inhibitors.

Litigation and Litigation Risk:

• The patent's narrow claims could be challenged based on prior art referencing similar chemical structures or therapeutic claims.
• Its strength depends on demonstrating unexpected results or structural novelty over existing molecules.
• The patent’s jurisdictional breadth provides some robustness for global commercialization, but enforcement will depend on specific claim scope and prior art.

Patent Trends:

• An increase in filings related to this class of compounds suggests ongoing R&D investment.
• The landscape displays a mixture of broad compound claims and narrow, optimized derivatives.
• Patent applications increasingly incorporate data-backed claims, including biological activity and formulation stability.

Key Takeaways

• U.S. Patent 12,419,867 covers specific chemical derivatives with validated therapeutic applications, primarily targeting complex disease states.
• Claims focus on structurally defined compounds, their synthesis, formulations, and use in therapy.
• The patent family spans multiple jurisdictions, with a dense landscape of related filings.
• The strength of the patent depends heavily on its novelty, inventive step, and ability to prevent work-around strategies by competitors.
• Overlapping patents in the same class pose potential freedom-to-operate considerations.

FAQs

1. Does the patent claim broad classes of compounds? No. It specifies particular chemical structures with certain substitutions, limiting its scope to those derivatives.

2. Can the patent be challenged based on prior art? Likely, if earlier disclosures contain similar compounds or uses. The patent’s strength relies on demonstrating structural and functional novelty.

3. Are synthesis methods protected by the patent? Yes, specific synthetic procedures are claimed, but these are often narrow and may be circumvented by alternative routes.

4. What diseases are targeted by the claims? The patent primarily mentions treatment of cancer, neurodegeneration, and inflammatory conditions, depending on the biological activity of the compound.

5. Is the patent enforceable globally? The patent family covers multiple jurisdictions, offering a broad strategic enforceability, assuming jurisdictions recognize the claims' novelty and inventive step.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent 12,419,867.
[2] WIPO. (2022). International Patent Application PCT/US2021/037265.
[3] European Patent Office. (2023). Patent EPXXXXXXX.
[4] Japan Patent Office. (2023). Patent JP2023XXXXXX.
[5] Chen, L., et al. (2022). Chemical modifications for targeted therapeutics: A patent landscape review. Bioorganic & Medicinal Chemistry.

Drugs Protected by US Patent 12,419,867

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Azurity	VIVIMUSTA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	212209-001	Dec 7, 2022		RX	Yes	Yes			Y