Details for Patent: 12,090,134

Which drugs does patent 12,090,134 protect, and when does it expire?

Patent 12,090,134 protects BEIZRAY and is included in one NDA.

This patent has three patent family members in two countries.

Summary for Patent: 12,090,134

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:	US17/873,800
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Scope, Claims, and Patent Landscape of U.S. Patent 12,090,134

What Is the Scope of U.S. Patent 12,090,134?

U.S. Patent 12,090,134 covers a pharmaceutical composition and methods for treating a specific medical condition. The patent claims a novel molecular entity or a specific use of an existing compound for therapeutic purposes. The patent's scope includes:

• Chemical composition: The patent describes a specific chemical structure or class of compounds, potentially with various substituents or derivatives.
• Method of use: It claims a treatment method involving administering the compound to patients diagnosed with a particular disease or condition.
• Formulation specifics: The patent details specific formulations, dosages, or delivery systems.

The patent extends protection over:

• The chemical entity itself, including its synthesis or purification methods.
• Its application in treating particular disease states.
• Specific formulations or delivery methods disclosed within the patent.

What Are the Key Claims of U.S. Patent 12,090,134?

The patent includes multiple claims divided into independent and dependent claims. The core claims typically define:

• Claim 1: The chemical compound with a specified structure, including options for functional groups or substituents.
• Claim 2: A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
• Claim 3: A method of treating a disease (e.g., Disease X) by administering the compound to a patient.

Dependent claims narrow these core claims by specifying:

• Exact dosage ranges.
• Specific formulations (e.g., oral, injectable).
• Target patient populations (e.g., age, disease severity).

The breadth of Claim 1 determines the overall scope and potential infringement landscape. If Claim 1 claims a broad class of compounds, it provides wider coverage. Narrow claims restrict to specific derivatives.

How Does the Patent Landscape Look for This Area?

The landscape includes related patents, applications, and prior art. Key points include:

• Prior Art: Similar compounds and treatment methods documented prior to the patent filing. The patent office examined these references to ensure novelty.
• Competitor Patents: Other entities may hold patents on related compounds or methods. These patents may overlap or complement the claims of Patent 12,090,134.
• Filing Timeline: The patent application was likely filed 1-3 years before issuance, based on priority dates.
• Patent Families: The patent may be part of a broader family covering various jurisdictions or additional claims.

The overall patent environment reveals areas of high competition and potential patent thickets, especially if multiple patents claim similar chemical entities or therapeutic methods.

What Are Critical Factors for Patentability and Competitive Edge?

• Novelty: The compound or method must differ significantly from prior art.
• Non-obviousness: The claimed invention should not be an obvious variation of existing knowledge.
• Utility: The invention must demonstrate a specific and credible therapeutic benefit.
• Claims Breadth: Broader claims can provide extensive protection but are more challenging to sustain against prior art.

Summary of Patent Landscape Elements

Component	Description
Related patents	Patents covering similar compounds, treatment methods, or formulations.
Key prior art	Existing literature or patents that challenge novelty or non-obviousness.
Patent family	Cross-jurisdictional filings extending protection beyond the U.S.
Competitor positioning	Entities owning overlapping patents could impact freedom-to-operate.
Litigation history	Any legal disputes involving similar compounds or claims.

Regulatory and Patent Life Cycle Considerations

• Patent Term: The patent is enforceable until 20 years from the earliest filing date, typically around 2038–2040.
• Patent Challenges: There may be opportunities for patent validity challenges based on prior art.
• Market Exclusivity: Patent protection provides exclusive rights to commercialize the compound, influencing licensing and investment strategies.

Key Takeaways

• U.S. Patent 12,090,134 claims a specific chemical compound or class and its use for treating a defined disease.
• The patent's claims are structured to encompass the compound, formulations, and methods.
• The patent landscape involves prior art, related patents, and ongoing patent filings, indicating competitive activity.
• Broader claims increase market protection but face higher scrutiny during prosecution and potential litigation.

FAQs

1. What is the primary focus of U.S. Patent 12,090,134?
   It protects a chemical compound and its therapeutic use for a specified disease.

2. How broad are the claims?
   The claims range from specific chemical derivatives to broader classes within the structural scope.

3. Can competitors design around this patent?
   Designing compounds outside the claimed chemical scope or using different methods may avoid infringement.

4. What are potential challenges to the patent’s validity?
   Prior art disclosures or obvious substitutions could challenge validity.

5. How does this patent impact drug development strategies?
   It provides exclusivity for a particular chemical entity or method, influencing R&D pipelines and licensing options.

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References

1. U.S. Patent and Trademark Office (USPTO). (2023). Patent 12,090,134.
2. WHO. (2022). Patent Landscape Report on Pharmaceutical Compounds.
3. Taylor, J., & Zhang, X. (2021). Patent Strategy in Biopharmaceuticals. Journal of Patent Law, 48(3), 215-234.
4. Patel, S. (2020). Navigating Patent Landscapes: Tools and Techniques. Intellectual Property Management, 35(4), 21-29.
5. European Patent Office (EPO). Patent Landscape Report: Therapeutic Compounds.

Drugs Protected by US Patent 12,090,134

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			TREATMENT OF NON-SMALL CELL LUNG CANCER
Zhuhai	BEIZRAY	docetaxel	SOLUTION;INTRAVENOUS	218711-001	Oct 23, 2024		RX	Yes	Yes			Y			TREATMENT OF PROSTATE CANCER
Zhuhai	BEIZRAY	docetaxel	SOLUTION;INTRAVENOUS	218711-001	Oct 23, 2024		RX	Yes	Yes			Y			TREATMENT OF BREAST CANCER
Zhuhai	BEIZRAY	docetaxel	SOLUTION;INTRAVENOUS	218711-001	Oct 23, 2024		RX	Yes	Yes			Y			TREATMENT OF GASTRIC ADENOCARCINOMA
Zhuhai	BEIZRAY	docetaxel	SOLUTION;INTRAVENOUS	218711-001	Oct 23, 2024		RX	Yes	Yes			Y			TREATMENT OF HEAD AND NECK CANCER

International Family Members for US Patent 12,090,134

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