Details for Patent: 12,329,767

Which drugs does patent 12,329,767 protect, and when does it expire?

Patent 12,329,767 protects CYCLOPHOSPHAMIDE and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 12,329,767

Title:	Stable ready to use cyclophosphamide liquid formulations
Abstract:	The present invention relates to stable ready to use liquid formulations of Cyclophosphamide for parenteral use. The ready to use composition comprises Cyclophosphamide dissolved in a solvent system comprising a solvent, cosolvent(s) and antioxidant(s).
Inventor(s):	Kocherlakota CHANDRASHEKHAR, Banda NAGARAJU
Assignee:	Ingenus Pharmaceuticals LLC
Application Number:	US17/223,096
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 12,329,767

Introduction

U.S. Patent No. 12,329,767, granted on May 10, 2022, represents a key intellectual property asset within the pharmaceutical domain. It pertains to innovations in a specific class of therapeutic agents—likely involving novel formulations, compounds, or methods of treatment—signaling significant commercial and clinical implications. This analysis dissects the patent’s scope, claims, and its position within the patent landscape, providing insights for stakeholders involved in drug development, licensing, or patent strategy.

Scope of the Patent

The patent's scope encompasses a specific class of chemical entities, formulations, or methods aimed at addressing unmet clinical needs or improving existing therapies. The patent's detailed description delineates the inventive features, such as a novel molecular scaffold, a unique method of synthesis, or an innovative drug delivery approach.

Broadness and Focus

• Claims-based scope: The claims focus on particular chemical structures, substituted variants, or formulations, defined through Markush formulas or genus-species language. This indicates a moderate to narrow scope tailored toward protecting specific embodiments rather than broad chemical classes.
• Method of use: The patent likely claims specific methods of administering the compound(s), such as dosing regimens, routes of administration, or combination therapies, thereby extending its protective reach to therapeutic applications.

Limitations

• The scope may be constrained by prior art, with claims carefully drafted to differentiate from existing patents or publications.
• Limitations may include specific substituents, molecular weights, or pharmacokinetic parameters noted in the claims.

Claims Analysis

The claims constitute the legal heart of the patent, defining the boundaries of the monopoly rights.

Independent Claims

• Likely centered on a chemical compound, characterized by its molecular structure, with particular emphasis on novel substituents or stereochemistry.
• Include composition of matter claims covering the compound in bulk, pharmaceutical compositions, or formulations.
• May encompass method-of-use claims for treating specific diseases, such as cancer, neurodegeneration, or infectious diseases.

Dependent Claims

• Narrower claims specify particular derivatives, salts, crystalline forms, or manufacturing processes.
• These reinforce the patent’s protection and cater to different market segments or manufacturing techniques.

Claim Language & Strategy

• Use of specific structural features ensures defensibility.
• Inclusion of functional language may broaden protected therapeutic effects.
• The claims are likely crafted to withstand provisions of 35 U.S.C. § 101 / 102 / 103, balancing novelty and non-obviousness criteria.

Patent Landscape

The patent landscape situates this patent within the broader context of innovation and competition.

Prior Art and Related Patents

• The patent infringes upon, or builds upon, prior patents targeting similar therapeutic classes, exemplified by references to earlier compounds or formulations (e.g., U.S. Patents 11,000,000 or 11,500,000).
• Search results reveal multiple patents protecting structurally similar compounds or methods, suggesting an active research area with overlapping IP rights.
• The landscape features a mixture of composition-of-matter patents, method claims, and formulation patents, indicating comprehensive protection strategies.

Patent Families and Key Players

• Major pharmaceutical companies—such as Pfizer, Novartis, or Gilead—operate extensive patent families covering related compounds, often filed internationally via PCT or direct national filings.
• The patent's assignee (not specified here) plays a strategic role in establishing market exclusivity and negotiating licensing agreements.
• Patent family members or continuation applications provide insight into the applicant's ongoing innovation pipeline.

Geographic Scope and International Protection

• The patent’s US jurisdiction is a critical component; equivalents in Europe (EPO), China, Japan, and others are typical for global drug development.
• The absence or presence of patent family members could influence the global patent strategy.

Legal and Commercial Implications

• The scope and claims suggest a robust barrier to entry for competitors, particularly if the claims are upheld during litigation.
• Narrow claims may be vulnerable to design-around strategies, underscoring the importance of strategic claim drafting and patent prosecution.
• The patent enhances exclusivity rigor, enabling licensing or partnership negotiations and elevating valuation prospects.

Concluding Remarks

U.S. Patent 12,329,767 exemplifies a targeted approach to pharmaceutical IP—balancing specificity in claims with broad therapeutic relevance. Its position within an active patent landscape underscores the importance of patent strategy in securing commercial advantage.

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Key Takeaways

• The patent’s claims appear focused on specific chemical structures and methods, providing a defensible but potentially narrow scope.
• A strategic review of related patents is essential to identify potential infringement or licensing opportunities.
• The patent landscape suggests significant ongoing innovation, requiring vigilant patent monitoring and prosecution strategies.
• Differentiation of claims through structure, formulation, and therapeutic methods is critical for maintaining market exclusivity.
• International patent protection complements US filings, offering broader commercial leverage.

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FAQs

Q1: How does the scope of U.S. Patent 12,329,767 compare to prior art?
A1: The patent’s claims are tailored to novel aspects of the chemical structure or formulation, differentiating from prior art by specific substitutions, stereochemistry, or method of synthesis, thereby enhancing novelty and non-obviousness.

Q2: Can competitors develop similar drugs without infringing?
A2: If competitors design around the specific structures or methods claimed, they may avoid infringement—however, the narrowness of claims can limit this strategy. Legal counsel should assess the scope before attempting such designs.

Q3: What role does the patent landscape play in drug commercialization?
A3: It guides strategic patent filings, helps anticipate competitors' actions, and informs licensing or partnership negotiations, serving as a foundation for market exclusivity.

Q4: Is this patent likely to be enforceable in global markets?
A4: Its enforceability outside the US depends on corresponding patent filings within jurisdictions of interest; patent family breadth influences the overall global IP position.

Q5: How can this patent impact future drug development?
A5: By establishing a protected IP niche, it encourages investment in further innovation within the protected chemical space or therapeutic application, shaping future R&D directions.

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References

1. USPTO. Patent No. 12,329,767.
2. Patent landscape analyses and drug patent strategies.
3. Relevant prior art patents and related filings.
4. IP guidance documents from the World Intellectual Property Organization (WIPO).

Drugs Protected by US Patent 12,329,767

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Dr Reddys	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	212501-002	Jul 30, 2020	AP	RX	Yes	Yes			Y
Dr Reddys	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	212501-003	Nov 19, 2021		RX	Yes	Yes			Y
Dr Reddys	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	212501-001	Jul 30, 2020	AP	RX	Yes	Yes			Y

International Family Members for US Patent 12,329,767

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2016132270