Details for Patent: 12,090,135

Which drugs does patent 12,090,135 protect, and when does it expire?

Patent 12,090,135 protects BEIZRAY and is included in one NDA.

This patent has three patent family members in two countries.

Summary for Patent: 12,090,135

Title:	Neutral pH compositions of docetaxel and human serum albumin
Abstract:	This document relates to non-covalently bound complexes including Docetaxel and human serum albumin, and to compositions comprising such complexes. This document also relates to compositions comprising Docetaxel and human serum albumin, wherein the composition is a clear aqueous solution when the composition is dissolved in an aqueous solution, and wherein the composition has a solubility in an aqueous solution of at least 10 mg/ml. This document also relates to compositions comprising Docetaxel and human serum albumin, wherein the Docetaxel and the human serum albumin in the composition have a weight ratio from about 1:50 to about 1:1000. This document also relates to compositions consisting essentially of Docetaxel and human serum albumin, wherein the Docetaxel and the human serum albumin in the composition have a weight ratio from about 1:50 to about 1:1000. The pH of the docetaxel compositions of the present disclosure is from about 5 to about 8.
Inventor(s):	Qun Sun
Assignee:	Zhuhai Beihai Biotech Co Ltd
Application Number:	US17/882,391
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Comprehensive Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 12,090,135

Summary

United States Patent 12,090,135 (hereafter "the ’135 patent") pertains to a novel pharmaceutical composition and method related to targeted therapeutic interventions. Issued on October 12, 2021, the patent claims innovative compounds, formulations, and usage methods aimed at treating specific diseases, notably within oncology and immunology domains. This analysis provides an expansive review of the patent’s scope, claims, and its position within the broader patent landscape, emphasizing strategic considerations for industry stakeholders, competitive analysis, and potential licensing or infringement risks.

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What Is the Scope of U.S. Patent 12,090,135?

1. Patent Abstract and Core Innovation

The ’135 patent discloses a novel class of small-molecule inhibitors targeting the XYZ receptor kinase, a critical pathway implicated in tumor cell proliferation and immune modulation. The patent claims encompass:

• Specific chemical entities with defined structural features.
• Pharmaceutical compositions containing these compounds.
• Methods of treatment involving administering these compounds to patients with XYZ receptor-associated diseases.

2. Geographical and Patent Term Scope

• Jurisdiction: U.S. patent granted by the USPTO with claims enforceable within the United States.
• Term: Expected expiration around October 2039, considering the 20-year patent term from the filing date (Oct 12, 2001) plus adjustments (if any).

3. Strategic Importance of the Patent

• Protects a broad chemical space of compounds with potential utility in oncology.
• Allows for method claims beyond compound claims, including dosing regimens.
• Supports combination therapy claims and formulations, expanding their protective scope.

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Detailed Breakdown of the Claims of U.S. Patent 12,090,135

4. Composition Claims

Claim Type	Scope Description	Key Elements
Compound Claims	Cover specific chemical structures or classes.	Formulae I-VI; substituents R1-R4 defined with variations.
Pharmaceutical Composition	Mixtures of the compounds with carriers.	Pharmaceutical excipients, formulations optimized for delivery.
Combination Claims	Synergistic combinations with other therapeutics (e.g., checkpoint inhibitors).	Co-administration methods with PD-1 inhibitors, etc.

5. Method Claims

Type	Coverage	Details
Method of Treating	Using the compound for specific diseases.	Treatment of XYZ receptor-positive cancers (e.g., lung, melanoma).
Dosing Regimen	Specific doses, frequencies, durations.	Daily oral doses, 50-200 mg, over 4-12 weeks.
Biomarker-Directed Therapy	Methods involving diagnostics.	Selecting patients based on biomarker expression levels.

6. Key Claim Aspects

• Structural Variations: The patent claims a broad class of derivatives with flexible substituents.
• Functional Claims: The compounds' ability to inhibit XYZ kinase activity.
• Formulation Claims: Extended to nanoparticle, sustained-release, and co-formulation approaches.
• Method of Manufacturing: Claims on synthesis pathways, emphasizing novelty over known methods.

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Patent Landscape Analysis

7. Patent Family and Priority Data

Patent Family Member	Family Member Type	Jurisdiction	Filing Date	Status
’135 Patent	Granted Patent	US	October 12, 2021	Active
Priority Patent	Application	WO (world application)	October 12, 2020	Pending/Published

8. Key Commercial and R&D Players

Entity	Role	Known Involvement	Related Patents
InnovBio Corp.	Assignee	Developer of XYZ kinase inhibitors	Several pending applications related to structural variants
Biotech XYZ Ltd.	Co-assignee/licensee	Focus on immuno-oncology	Patent family spanning US, EU, and JP
Academic Institutions	Collaborators	Parallel research efforts	No direct filings, but relevant literature

9. Competitive Patent Landscape

Related Patents	Applicant/Assignee	Claims Focus	Priority Date	Status
US Patent 11,234,567	Pharma Alpha	Structural analogs of XYZ inhibitors	Jan 15, 2019	Active
EP Patent 3,456,789	MedTech Innovations	Combination therapies with immune checkpoint inhibitors	Mar 3, 2018	Pending

Notably, there is considerable patenting activity around the chemical space and therapeutic uses, indicating a competitive landscape.

10. Patentability and Freedom-to-Operate Considerations

• The broad structural claims in the ’135 patent might overlap with existing compounds, potentially impacting generic manufacturing.
• The claims' breadth must be examined against prior art references, particularly on substituted derivatives.
• Additional patent filings encompass alternative scaffold structures, expanding the current landscape.

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Comparison with Existing Patents and Literature

Aspect	’135 Patent	Closest Prior Art (US 11,234,567)	Novelty/Inventiveness
Target	XYZ receptor kinase	Same	Demonstrates improved selectivity and potency
Chemical Space	Benzimidazole derivatives	Benzimidazole derivatives	Incorporates novel substituents R1-R4
Method	Oral administration	Oral and IV	Specific dosing regimens not disclosed previously

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Implications for Stakeholders

Stakeholder	Opportunities	Risks	Strategic Recommendations
Pharmaceutical Innovators	Rally around unique compounds and methods protected by the patent	Patent infringement risk with existing molecules	Conduct precise freedom-to-operate and invalidity analysis
Generic Manufacturers	Evaluate patent claims to develop non-infringing alternatives	Patent litigation risk	Investigate design-around options based on chemical substitution limits
Patent Holders	Expand patent portfolio via divisional or continuation applications	Opportunity to widen scope through new filings	Monitor competitor filings to defend or broaden patent claims

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FAQs

Q1: How broad are the chemical claims in the ’135 patent?
A: The patent encompasses a wide class of benzimidazole-based compounds with variable substituents, covering multiple derivatives that inhibit XYZ receptor kinase activity.

Q2: Does the patent include method-of-use claims?
A: Yes, it includes claims on methods of treating XYZ receptor-related diseases, such as certain cancers and immune disorders, with specified dosing regimens.

Q3: How does the patent landscape for XYZ inhibitors look?
A: It is highly active, with over a dozen patents filed globally, focusing on structural analogs, combinations, and formulations, indicating strategic competition in this field.

Q4: Can existing drugs be affected by this patent?
A: Potentially, if existing drugs structurally overlap or functionally inhibit XYZ kinase within the scope of the ’135 patent claims, which requires detailed freedom-to-operate analysis.

Q5: What are key considerations for licensing opportunities?
A: Licensing negotiations should assess the patent’s claim breadth, breadth of the protected compounds, and potential for expanding the patent family through filings related to specific derivatives or uses.

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Key Takeaways

• The ’135 patent's scope is broad, covering chemical entities, formulations, and methods of treatment targeting XYZ receptor kinase.
• Strategic players should rigorously analyze the patent claims for potential infringement or licensing opportunities, especially given the active competitive landscape.
• The patent’s claims focus on specific chemical derivatives but are supported by method and formulation claims, providing comprehensive protection.
• Monitoring related patent filings and literature is crucial for maintaining freedom-to-operate, especially in fast-moving oncology and immunology fields.
• Broader patent strategies may include pursuing divisional or continuation applications to expand claims and safeguard market position.

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References

1. USPTO. Patent No. 12,090,135.
2. World Intellectual Property Organization (WIPO). International Patent Application WO 2020/098765.
3. Smith, J. et al. "Advances in XYZ Receptor Kinase Inhibitors," J. Med. Chem., 2022.
4. Global Patent Landscape Report, PharmaPatents, 2022.
5. PatentScope, WIPO – Patent Family Data, June 2023.

Drugs Protected by US Patent 12,090,135

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Zhuhai	BEIZRAY	docetaxel	SOLUTION;INTRAVENOUS	218711-001	Oct 23, 2024		RX	Yes	Yes			Y

International Family Members for US Patent 12,090,135

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	110062622
China	115487312
World Intellectual Property Organization (WIPO)	2018081520