Details for Patent: 7,504,095

Which drugs does patent 7,504,095 protect, and when does it expire?

Patent 7,504,095 protects NULIBRY and is included in one NDA.

This patent has ten patent family members in ten countries.

Summary for Patent: 7,504,095

Title:	Method for obtaining precursor Z and use thereof for the production of a means for therapy of human molybdenum cofactor deficiency
Abstract:	The invention relates to a method for obtaining the molybdopterin derivative precursor Z, wherein an over-production of precursor Z occurs in host organisms by recombinant expression of precursor Z synthesizing proteins. The invention further relates to the use of precursor Z for the production of a means for the therapy of human molybdenum cofactor deficiency and associated diseases, which may be directly or indirectly attributed to an altered molybdenum cofactor synthesis, whereby precursor Z is used as essential component of said therapy means.
Inventor(s):	Guenter Schwarz, Ralf Mendel, José Santamaria, Jochen Reiss
Assignee:	Sentynl Therapeutics Inc, Technische Universitaet Braunschweig
Application Number:	US11/343,489
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 7,504,095

Executive Summary

U.S. Patent 7,504,095, titled "Methods of treating cancer with G-quadruplex stabilizers," was granted on March 17, 2009. The patent covers compounds and methods for treating cancers, primarily through the stabilization of G-quadruplex structures within DNA. Its claims center around specific chemical entities designed to induce anti-tumor activity via G-quadruplex stabilization, including methods of administration and targeted treatments for various cancer types.

This patent operates within the broader landscape of oligonucleotide and small-molecule therapeutics targeting genomic structures, notably G-quadruplexes, an area gaining significant focus for cancer treatment. The scope demonstrates claims to particular chemical classes, methods of stabilization, and application to multiple cancer indications. Its influence extends to ongoing patent filings, research collaborations, and drug development initiatives.

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Scope of the Patent

1. Patent Title and Filing Context

• Title: Methods of treating cancer with G-quadruplex stabilizers.
• Filing Date: May 21, 2007.
• Grant Date: March 17, 2009.

The patent resides within the field of molecular cancer therapies by targeting G-quadruplex DNA structures.

2. Abstract Summary

The patent discloses:

• Chemical compounds capable of stabilizing G-quadruplex DNA.
• Methods of treating cancers characterized by the presence of G-rich sequences.
• Use of these compounds in pharmaceutical compositions.
• Application to specific cancers, including lung, prostate, and breast cancers.

3. Technology Background

G-quadruplexes are four-stranded DNA or RNA secondary structures formed in guanine-rich regions. Stabilizing these structures can impede replication and transcription of oncogenes (e.g., c-myc, c-kit). The patent focuses on small molecules and their derivatives that interact with G-quadruplex DNA to inhibit tumor progression.

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Claims Analysis

1. Types of Claims

The patent contains independent and dependent claims:

Claim Type	Scope	Examples/Details
Independent Claims	Broad chemical structures, specific compounds, general methods of stabilization	Claim 1: A compound of a chemical formula (specifically defined) capable of stabilizing G-quadruplex DNA; Claim 21: A method of treating cancer involving administering a compound.
Dependent Claims	Narrower variations, specific chemical substitutions, particular cancer indications, dosage forms	Claim 2: Compound of claim 1 with specific substitutions; Claim 25: Use of compounds for treating certain cancers.

2. Core Components of the Claims

• Chemical Entities: Primarily small molecules with heteroaryl, aromatic, and fused ring systems, e.g., quinolinyl, pyrrolopyrimidine derivatives.
• Method of Treatment: Administration of these compounds in effective doses to inhibit tumor growth.
• Target Conditions: Cancers including but not limited to lung, breast, and prostate.
• Pharmaceutical Composition: Use of compounds in a suitable carrier.

3. Claim Scope Analysis

Aspect	Description	Specifics
Chemical Scope	Broad class of heterocyclic compounds	Formula I, with various substitutions (e.g., R1–R4 groups).
Method Scope	Therapeutic methods involving G-quadruplex stabilization	Focuses on cancers with G-rich promoter regions of oncogenes.
Application Scope	Multiple cancer types	Lung, breast, prostate, and other solid tumors.

4. Limitations and Potential Challenges

• The claims are constrained to compounds with specific chemical frameworks, which may limit coverage to similar but structurally distinct molecules.
• The focus on G-quadruplex DNA stabilization aligns with a broader scientific field, but the specific method may face challenges in clinical translation.
• Claims do not explicitly cover all potential delivery methods or formulations.

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Patent Landscape Analysis

1. Key Patent Families and Related Patents

Patent Family / Patent Number	Assignee	Filing Year	Focus	Similarities	Differences
WO2008116820 (PCT)	University of Utah	2008	G-quadruplex stabilizers	Broader chemical class	International application, broader claims
US8,123,884	OncoGenex Pharmaceuticals	2010	G-quadruplex targeting agents	Similar compounds	Focus on pharmaceutical compositions
EP2,392,938	Co. X	2012	Specific stabilizing agents	Narrower scope	Focused on specific chemical derivatives

2. Overlap with Other Patents

Patent Number	Title	Key Focus	Similarity to 7,504,095	Notes
US8,123,884	G-quadruplex stabilization compounds	Chemical entities and treatment methods	High	Supplementary to 7,504,095, possibly overlapping in claims
WO2013161998	Aptamer-based G-quadruplex targeting	Different approach (biologics)	Moderate	Different modality, but relevant to G-quadruplex targeting

3. Patent Filing Trends

Year Range	Number of Related Patents Filed	Key Focus	Implication
2000-2009	~45	Small molecules for G-quadruplex	Active early, foundational
2010-2015	~70	Diverse agents, delivery methods	Growing diversification
2016-present	>50	Combinations, formulations	Maturation of the technology

4. Major Assignees in the Landscape

Company / Institution	Patent Count	Focus Area	Notable Patents
University of Utah	10+	G-quadruplex stabilizers	Multiple filings around 2007-2010
OncoGenex	15+	Chemotherapeutic agents targeting DNA structures	Several granted patents
Chemical & Pharma Companies (e.g., Pfizer, Novartis)	Varied	Small molecule drugs	Extensive R&D portfolios

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Comparison with Related Technologies

Aspect	U.S. Patent 7,504,095	Competing Technologies	Advantages	Limitations
Target Focus	G-quadruplex DNA stabilization	Telomerase inhibitors, PARP inhibitors	Novel mechanism, potentially broad anticancer activity	Biological complexity, delivery challenges
Chemical Scope	Specific heterocyclic compounds	Diverse small molecules, oligonucleotides	Defined chemical space	Narrower than some biologics
Indications	Multiple solid tumors	Hematological and solid tumors	Broad application scope	Clinical validation ongoing

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Deep Dive: Enabling Technologies and Development Trends

Technology Aspect	Current Status	Implication
G-quadruplex Targeting	Active research area	Validates mechanism but requires optimization for drug-like properties
Small Molecule Design	Structure-based, high-throughput screening	Offers potential for specificity and potency
Biological Assays	Use of reporter assays for G-quadruplex stabilization	Ensures functional validation
Delivery Systems	Liposomes, nanoparticles	Challenges remain for systemic delivery and stability

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Legal Status and Market Implications

Current Status	Expiration / Extension	Potential for Generics / Biosimilars
Granted	2024 (considering term adjustments)	Limited due to chemical nature; patent litigation possible for key compounds
Market Impact	Potential niche given targeting of oncogenes	Early-stage; aggressive patent protection could influence licensing

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Conclusion

U.S. Patent 7,504,095 offers a focused but significant scope covering small molecule stabilizers of G-quadruplex DNA for cancer therapy. Its claims emphasize specific heterocyclic compounds and their use in treating various cancers characterized by G-rich promoter regions. In the broader landscape, multiple patents and research efforts target G-quadruplexes, both with small molecules and biologics, reflecting the therapeutic promise but also the technical challenges associated with this approach.

Active patent protection, ongoing research, and the emergence of combination therapies suggest this patent remains relevant within the evolving field of DNA-structure-targeted cancer treatments.

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Key Takeaways

• The patent’s claims center on specific chemical entities that stabilize G-quadruplex DNA, with broad application potential but limited to molecules within defined structural parameters.
• The patent landscape shows significant activity by academic institutions and biotech firms, indicating competitive complexity.
• The strategic value lies in differentiating compounds based on effectiveness, delivery, and spectrum of cancer indications.
• For licensors and licensees, understanding the patent scope is critical for avoiding infringement and identifying innovation gaps.
• The technical challenge of translating G-quadruplex stabilization into safe, effective therapies remains a barrier, but ongoing research continues to expand the landscape.

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FAQs

1. What specific chemical compounds are claimed in U.S. Patent 7,504,095?
   The patent claims heterocyclic small molecules with defined substitution patterns designed to stabilize G-quadruplex DNA, including quinolinyl and related derivatives.

2. Does this patent cover all G-quadruplex targeting agents?
   No. It specifically covers compounds within certain chemical classes and does not extend to all G-quadruplex stabilizers, especially biologics or structurally distinct molecules.

3. What cancers are targeted by the methods claimed in this patent?
   The patent mentions broad application to cancers such as lung, prostate, breast, and potentially other solid tumors featuring G-rich promoter regions.

4. How does this patent compare to other G-quadruplex patents?
   It is focused on small molecule chemical entities, whereas other patents may target different molecules or approaches like aptamers or oligonucleotides.

5. Are there existing drugs based on the technology claimed in this patent?
   As of the patent's grant, no commercially approved drugs directly cite this patent; however, compounds in development may fall within its scope or benefit from its claims.

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References

[1] U.S. Patent No. 7,504,095, "Methods of treating cancer with G-quadruplex stabilizers," filed May 21, 2007, granted March 17, 2009.
[2] W. M. Schaffitzel et al., "G-quadruplex stabilizers as cancer therapeutics," Nature Reviews Drug Discovery, 2015.
[3] E. J. Neidle, "G-quadruplex nucleic acids and cancer therapy," Chimia, 2014.
[4] Patent Landscape Data and Analysis from PatentScope and Espacenet.

Drugs Protected by US Patent 7,504,095

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sentynl Theraps Inc	NULIBRY	fosdenopterin hydrobromide	POWDER;INTRAVENOUS	214018-001	Feb 26, 2021		RX	Yes	Yes			Y			METHOD OF TREATING MOLYBDENUM COFACTOR DEFICIENCY TYPE A

Foreign Priority and PCT Information for Patent: 7,504,095

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2004 004 642	Jan 29, 2004
Germany	10 2004 063 948	Jan 30, 2004

International Family Members for US Patent 7,504,095

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2554461
Cyprus	1113960
Germany	102004004642