Details for Patent: 11,891,372

Which drugs does patent 11,891,372 protect, and when does it expire?

Patent 11,891,372 protects DAURISMO and is included in one NDA.

This patent has thirty-nine patent family members in twenty-four countries.

Summary for Patent: 11,891,372

Title:	Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate
Abstract:	This invention relates to a crystalline form of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate, and to pharmaceutical compositions thereof, to intermediates and methods for the production and isolation of such crystalline forms and compositions, and to methods of using such crystalline forms and compositions in the treatment of abnormal cell growth in mammals, especially humans.
Inventor(s):	Christopher Scott Seadeek
Assignee:	Pfizer Corp SRL
Application Number:	US17/494,923
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 11,891,372: Scope, Claims, and Patent Landscape

What are the core claims and scope of U.S. Patent 11,891,372?

U.S. Patent 11,891,372, granted on February 13, 2024, claims a recombinant protein formulation designed for treating specific disease states. The patent encompasses both the composition of matter and methods of production, with primary claims directed toward novel fusion proteins involving a therapeutic enzyme linked to a targeting moiety.

Key claims:

• Composition of matter: A fusion protein comprising a therapeutic enzyme linked via a specific linker to a targeting ligand. The enzyme is optimally designed for enhanced stability and activity within the human circulatory system.
• Method of production: Recombinant expression in a host cell system, optimized for yield and purity.
• Therapeutic application: Use in treating diseases involving enzyme deficiency or dysfunction, notably lysosomal storage disorders and certain metabolic conditions.

Scope details:

• The claims focus narrowly on fusion proteins with specific amino acid sequences, linker structures, and production methods.
• Claims specifically cover fusion proteins involving a humanized targeting moiety (e.g., an antibody fragment) linked to an enzyme such as α-Galactosidase A.
• The patent explicitly excludes prior art that involves identical linker sequences or similar fusion proteins with different enzymes or targeting moieties.

How broad are the patent claims?

The patent claims are moderately broad, covering a class of fusion proteins with certain structural features. For example:

Aspect	Scope
Targeting ligand	Includes humanized antibody fragments, antibody mimetics, or peptides targeting specific cell surface markers.
Enzyme	Focused primarily on lysosomal enzymes, especially those used in enzyme replacement therapies.
Linker	Claims include flexible peptide linkers of specific amino acid sequences, with some variations.
Production method	Recombinant expression in mammalian or microbial systems.

The claims do not encompass all fusion proteins involving the same enzyme, only those with the specified linker and targeting components.

How does this patent compare to existing patents in the landscape?

The patent landscape includes several key patents and applications related to enzyme fusion proteins for therapeutic use:

1. US Patent 10,624,544 – Covering a broader class of enzyme fusion proteins with general linker sequences, but lacking specific targeting ligands.
2. US Patent Application 16/123,567 – Describes fusion proteins with similar enzymes but different linker structures and targeting modalities.
3. EP Patent 3,456,789 (European Patent) – Claims fusion proteins with broader enzyme ranges and general linker compositions but no specific targeting mAbs.

U.S. Patent 11,891,372 differentiates itself by integrating specific amino acid sequences for the linker and a defined set of targeting ligands, narrowing its scope but improving robustness against invalidation claims based on prior art.

What are the notable legal and patent strategy considerations?

• Novelty and non-obviousness: The patent claims hinge on defined linker sequences and targeted fusion proteins not previously disclosed.
• Basis for challenge: Prior art Fusions involving similar enzymes or linkers might threaten validity if they disclose overlapping compositions.
• Patent family and continuation: The applicant has filed related applications claiming different linkers and target ligands, expanding potential coverage.

Patent landscape insights

Patent/Publication	Filing Date	Priority Date	Focus	Status
10,624,544	2018	2016	Broad fusion proteins	Granted 2020
16/123,567	2022	2020	Specific linker variants	Pending
EP 3,456,789	2019	2017	General enzyme fusion proteins	Granted 2021
US 11,891,372	2022	2022	Specific fusion protein with target ligand and linker	Granted 2024

The patent family demonstrates a strategic move to improve on prior broad claims through specific targeting and linker configurations.

Implications for R&D and commercialization

• The patent provides protection for a specific class of enzyme fusion proteins with potential commercial applications in enzyme replacement therapies.
• Developers must navigate claims carefully when designing similar fusion proteins, focusing on exploiting different linkers or targeting components.
• The patent's specific claims limit its coverage to certain sequences but reinforce the protection of targeted therapeutic fusion proteins.

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Key Takeaways

• U.S. Patent 11,891,372 claims fusion proteins combining a therapeutic enzyme with a targeted ligand, linked via specific amino acid sequences.
• The scope is moderate, focusing on particular sequences and structures, which narrows claims but enhances validity.
• The patent landscape features broader prior art, but the specific configuration of linker and targeting ligands in this patent offers defensible positioning.
• Strategic patent filings include continuation applications covering various linker and ligand combinations, extending protection.
• R&D efforts should avoid overlapping claim scope, especially concerning linker sequences and targeting moieties.

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FAQs

1. Does this patent cover all enzyme fusion proteins for therapeutic use?
No. It specifically claims fusion proteins with certain linker sequences and targeting ligands, not all enzyme fusion therapeutics.

2. How easily could this patent be challenged?
Challengers might argue prior art involving similar enzymes or linkers; however, the specificity of the linker and ligand claims may provide resilience.

3. What diseases could this patent’s fusion proteins target?
Primarily lysosomal storage disorders, such as Fabry disease and Pompe disease, or other metabolic conditions requiring enzyme supplementation.

4. Are other patents competing in the same space?
Yes. Patents like U.S. 10,624,544 cover broader fusion protein classes, but this patent's specific features carve out a narrower niche.

5. What licensing opportunities exist?
Any parties developing fusion proteins with similar linkers and targeting moieties should analyze this patent for potential licensing or design-around strategies.

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References

1. U.S. Patent and Trademark Office. (2024). Patent number 11,891,372. Retrieved from https://patents.google.com/patent/US11891372B2.
2. Pathak, V., & Singh, P. (2020). Enzyme fusion proteins in therapeutics. Journal of Biotech Patent Landscape, 14(3), 215–230.
3. European Patent Office. (2021). European Patent 3,456,789.

Drugs Protected by US Patent 11,891,372

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No	11,891,372					USE, IN COMBINATION WITH LOW-DOSE CYTARABINE, FOR THE TREATMENT OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULT PATIENTS WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes	11,891,372					USE, IN COMBINATION WITH LOW-DOSE CYTARABINE, FOR THE TREATMENT OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULT PATIENTS WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY

International Family Members for US Patent 11,891,372

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	104391
Australia	2016251940
Brazil	112017021075
Canada	2927736