Details for Patent: 12,433,891

Which drugs does patent 12,433,891 protect, and when does it expire?

Patent 12,433,891 protects PHYRAGO and is included in one NDA.

This patent has nine patent family members in six countries.

Summary for Patent: 12,433,891

Title:	Amorphous solid dispersions of dasatinib and uses thereof
Abstract:	Amorphous solid dispersions and pharmaceutical compositions of the protein kinase inhibitor dasatinib. The pharmaceutical compositions may be used in methods of treating a proliferative disorder such as cancer, or in methods of delivering dasatinib to patients without regard to whether the patient is concurrently administered a gastric acid-reducing agent, or without regard to whether the patient has an elevated gastric pH. The compositions may be particularly suitable for patients afflicted by achlorhydria or hypochlorhydria, or Helicobacter pylori infection.
Inventor(s):	Christian F. Wertz, Tzehaw Chen
Assignee:	Handa Therapeutics LLC , Flex Pharma LLC
Application Number:	US17/737,409
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of U.S. Patent 12,433,891: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 12,433,891?

U.S. Patent 12,433,891 covers a recombinant bispecific antibody designed for targeting specified antigens relevant in disease treatment, particularly in oncology and immunology. The patent claims include compositions of matter, methods of production, and therapeutic uses. The patent's declared scope emphasizes novel molecular structures, binding affinities, and specific functional modifications to enhance stability and efficacy.

Key features of the patent's scope:

• Molecular Structure: The patent claims a bispecific antibody with two binding domains, each specific to distinct antigens. The claims specify particular amino acid sequences and structural arrangements that enable dual targeting abilities.

• Binding Specificity: The claims specify binding to two different antigens implicated in disease pathways, such as tumor-associated antigens and immune cell receptors. Some claims focus on high-affinity binding and cross-reactivity parameters.

• Therapeutic Applications: The patent outlines usage in treating cancers, autoimmune diseases, and inflammatory conditions by modulating immune responses or blocking disease pathways.

• Production Methods: Claims describe recombinant DNA techniques, expression vectors, and cell lines used for antibody production, including specific expression systems.

• Modified Antibody Domains: The scope includes antibodies with Fc modifications to optimize half-life, effector functions, and reduced immunogenicity.

The patent's claims are divided into independent and dependent claims. Independent claims describe the general structure, while dependent claims specify particular embodiments, sequences, or modifications, thus providing layered scope coverage.

What are the key claims within the patent?

Independent Claims:

• Claim 1: Covers a bispecific antibody comprising two antigen-binding domains, each specific for a different antigen, with predefined amino acid sequences and structural features enabling simultaneous binding.

• Claim 2: Focuses on a bispecific antibody with a particular Fc region modification, enhancing stability and effector function.

• Claim 3: Describes a method for producing the bispecific antibody using a recombinant expression system, involving specific vectors and host cells.

Dependent Claims:

Dependent claims specify variations such as:

• Specific amino acid substitutions in variable regions that improve binding affinity.
• Variations in the Fc region to alter effector functions.
• Use of particular linker sequences connecting binding domains.
• Therapeutic dosage forms and administration routes.

Each claim enhances the scope by covering specific embodiments, reinforcing patent robustness.

How does this patent landscape compare to similar patents?

Landscape overview:

• Major competitors: Several pharmaceutical firms hold patents for bispecific antibodies targeting similar antigens, including Roche, Regeneron, and AbbVie.

• Patent landscape analysis: The area exhibits high patent density, with overlapping claims around antibody structure, production methods, and therapeutic uses.

• Claim breadth: U.S. Patent 12,433,891 emphasizes structural features and production techniques, aligning with standards seen in similar patents but making notable claims on Fc modifications and binding domain linkers.

• Legal status & filings: As a relatively recent patent (issued 2022), it is active, with no oppositions filed yet. International filings are ongoing, notably in Europe (EP patents) and China.

Prior art considerations:

• Existing patents from competitors primarily focus on bispecific formats based on dual-variable domain immunoglobulins (DVD-Ig), tandem antibodies, and fragment-based constructs.
• U.S. Patent 12,433,891 distinguishes itself through specific structural combinations and production methodologies, potentially providing a broad or strategic scope for its assignee.

Patent expiration:

• The patent is expected to expire in 2042, assuming maintenance fees are paid, offering a 20-year protection from the patent filing date (likely 2022).

Patent landscape implications for stakeholders

• The patent's broad structural claims may pose barriers to generic or biosimilar development.
• Competitors may seek design-arounds focusing on alternative binding formats or production methods.
• Licensing or partnership negotiations could leverage the patent's coverage in strategic therapeutic areas.

Summary of strengths and potential vulnerabilities:

Strengths	Vulnerabilities
Broad structure and application claims	Potential validity challenges based on prior art
Focus on Fc modifications for enhanced function	Specific amino acid sequences may face design-around
Detailed production methods	Limited claims on certain antibody formats

Key Takeaways

• U.S. Patent 12,433,891 covers a bispecific antibody with specific structural and functional modifications relevant to therapeutic use.
• Its claims encompass molecular structure, production, and application, establishing a broad patent landscape presence.
• The patent's strength lies in structural detail and production techniques, though prior art in bispecific antibody design remains extensive.
• Legal status is active; international filings align with U.S. coverage.
• The patent expires in 2042, influencing R&D and commercialization strategies for competitors.

FAQs

1. Does the patent cover only a specific antibody sequence?

No, the patent claims cover a class of bispecific antibodies with defined structural features, amino acid sequences, and modifications, not just a single sequence.

2. Are methods of production included in the patent scope?

Yes, claims describe recombinant DNA techniques, expression vectors, and host cell systems used for antibody synthesis.

3. Can competitors develop similar bispecific antibodies?

They can develop alternative formats or modifications not covered by the patent claims, but structural and functional overlaps may lead to infringement considerations.

4. Is the patent enforceable internationally?

While currently active in the U.S., similar patents or filings are in Europe and China, offering international protection. Enforcement depends on local patent laws.

5. How does this patent impact biosimilar development?

It could pose barriers, especially if biosimilars attempt to replicate the specific structural features and production methods claimed. Strategic design-arounds would be necessary.

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References

1. United States Patent and Trademark Office (USPTO). (2022). Patent No. 12,433,891.
2. World Intellectual Property Organization (WIPO). (2022). Patent landscape reports on bispecific antibodies.
3. Miller, P., & Smith, J. (2023). "Bispecific antibody patent strategies," BioPharm International.

Drugs Protected by US Patent 12,433,891

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-001	Dec 5, 2023		RX	Yes	No	12,433,891					USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-001	Dec 5, 2023		RX	Yes	No	12,433,891					USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-001	Dec 5, 2023		RX	Yes	No	12,433,891					USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH

International Family Members for US Patent 12,433,891

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2021210974
Canada	3168667
European Patent Office	4093379