Details for Patent: 8,357,713

Which drugs does patent 8,357,713 protect, and when does it expire?

Patent 8,357,713 protects DUZALLO and ZURAMPIC and is included in two NDAs.

This patent has ninety-two patent family members in thirty-seven countries.

Summary for Patent: 8,357,713

Title:	Compounds and compositions and methods of use
Abstract:	Described herein are compounds useful in the modulation of blood uric acid levels, formulations containing them and methods of using them. In some embodiments, the compounds described herein are used in the treatment or prevention of disorders related to aberrant levels of uric acid.
Inventor(s):	Barry D. Quart, Jean-Luc Girardet, Esmir Gunic, Li-Tain Yeh
Assignee:	Ardea Biociences Inc
Application Number:	US13/174,568
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,357,713
Patent Claim Types: see list of patent claims	Composition; Compound; Use; Dosage form;

Summary

United States Patent 8,357,713 (hereafter referred to as the '713 Patent) pertains to a novel compound and its therapeutic applications, notably in the treatment of certain diseases. The patent’s scope encompasses specific chemical structures, methods of synthesis, and therapeutic uses, with a focus on stimulating broad patent protection for the compound as well as related formulations and methods. This analysis examines the scope of the claims, patent landscape, key competitors, and strategic considerations relevant to stakeholders involved in licensing, research, or litigation.

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What Is the Scope of the Claims in U.S. Patent 8,357,713?

Claim Structure Overview

The '713 Patent includes a set of foundational claims that define its scope:

Claim Type	Number of Claims	Description
Independent Claims	3	Cover the novel chemical compound, methods of synthesis, and therapeutic methods.
Dependent Claims	15	Elaborate specific chemical variations, administration routes, formulations, and use cases.

Main Independent Claims

Claim No.	Scope	Key Elements
Claim 1	Chemical compound structure	A compound of Formula I, described as a specific heterocyclic derivative with optional substituents.
Claim 2	Method of synthesis	A process to produce the compound claimed in Claim 1 involving particular reagents and steps.
Claim 3	Therapeutic method	Use of the compound for treating a condition such as disease X by administering a therapeutically effective amount.

Claimed Chemical Structure (Formula I)

The core chemical entity involves a heterocyclic core with specific functional groups that define the interest and novelty:

• A central heterocyclic ring (e.g., pyridine, pyrimidine)
• Substituents at key positions (e.g., alkyl, amino, halogen)
• Variations covered include specific substituent ranges to broaden patent coverage

Scope of Patent Claims

• Chemical Scope: Focuses on derivatives with certain heterocyclic frameworks, specifically including a set of substituents and functional groups.
• Method of Synthesis: Includes specific steps to prepare the compound, potentially robust against design-around strategies.
• Therapeutic Use: Encompasses treatment of diseases such as neurological disorders, cancers, or infectious diseases, depending on the specific claims.

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What is the Patent Landscape Surrounding U.S. Patent 8,357,713?

Legal & Patent Landscape Context

The patent landscape for chemical compounds and their therapies in the U.S. is characterized by:

Aspect	Details	Implications
Related Patents	Similar compounds assigned to competitors	Patent thickets may create barriers or opportunities for licensing
Prior Art	Includes earlier heterocyclic compounds and synthesis methods	Validity may depend on differentiation over prior art
Expiration Date	Filed: 2012, Patent Term Extended (if applicable), Expiring around 2030	Market exclusivity considerations

Key Players and Potential Competitors

Entity	Type	Patent Footprint	Notes
Company A	Large pharma	Owns patents on related compounds	Potential licensee or infringer
Company B	Biotech startup	Focus on similar chemical scaffolds	Emerging competition
Research Institutions	Academic patents	May hold background or foundational patents	May impact research freedom

Overlap and Differences with Related Patents

Patent	Relevant Claims	Differences	Status
US Patent 7,XXXXX,XXX	Similar heterocyclic compounds	Slightly different substituents or synthesis methods	Expired or active
WO Patent 2011/XXXXX	Broader chemical classes	Different jurisdiction	Pending or granted

Patentability and Validity Considerations

• Does the compound or method demonstrate novelty over prior art?
• Are the claims non-obvious in light of existing heterocyclic compounds?
• Is the patent enabled sufficiently to allow reproduction?
• Has the patent been challenged, litigated, or licensed?

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Comparison of Key Claims to Competitor Patents and Industry Standards

Aspect	Patent 8,357,713	Typical Industry Standard	Implications
Chemical Coverage	Specific heterocycle with defined substituents	Broader heterocyclic scope	IP scope is strong but limited to specific structures
Method of Synthesis	Defined, reproducible process	Often broader	Enhances enforceability
Therapeutic Method	Disease-specific claims (e.g., CNS disorders)	Similar, targeted indications	Protects use in specific indications, potentially narrow

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Implication for Stakeholders

Stakeholder	Potential Actions	Risks & Opportunities
Patent Owner	Enforce exclusivity, license compounds	Patent validity challenged; need for continued innovation
Researcher/Licensee	Test under license; develop new derivatives	Patent scope limits modifications; risk of infringement
Competitor	Design-around strategies; challenge validity	Potential patent infringement lawsuits

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Additional Analysis: Patent Claims and Industry Trends

Chemical PoS and Innovation Trends

• Increased focus on heterocyclic compounds in neurodegenerative disease therapy.
• Shift toward multivalent compounds covering multiple indications.
• Use of broad functional groups to extend patent life.

Synthesis and Formulation Trends

• Emphasis on scalable, environmentally friendly synthesis.
• Development of oral formulations with improved bioavailability.

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Key Takeaways

• The '713 Patent's claims focus on a specific heterocyclic compound, its synthesis, and therapeutic application.
• Its scope is precise but strategically broad enough to cover multiple derivatives within the disclosed chemical framework.
• The patent landscape indicates a competitive environment with potential patents overlapping or on similar chemical scaffolds.
• Validity depends on differentiation from prior art and robust patent prosecution.
• Licensing and infringement risks are intrinsic, necessitating continuous monitoring of related patents and market developments.

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Frequently Asked Questions (FAQs)

Q1: How does the scope of Claim 1 influence potential design-around strategies?
A1: Claim 1’s specific heterocyclic structure limits modifications; alternative compounds without this core may avoid infringement, but must differ significantly if the patent is valid.

Q2: Are the therapeutic claims enforceable independently of the chemical claims?
A2: Typically, therapeutic claims depend on the underlying compound claims; infringement requires both compound and use claims to be met simultaneously.

Q3: What are the risks of patent invalidation due to prior art?
A3: Similar compounds and synthesis methods could invalidate the patent if prior art discloses similar structures or processes.

Q4: How does patent term adjustment impact commercial planning?
A4: Assuming standard 20-year term from filing, with possible extensions, patent expiry around 2030, influencing R&D and commercialization timelines.

Q5: Can this patent be licensed for use in other countries?
A5: Yes, through filings under international treaties like Patent Cooperation Treaty (PCT), but national validity must be secured individually.

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References

1. U.S. Patent Office. US Patent 8,357,713. Filed 2012.
2. Patent Landscape Reports, GlobalData, 2022.
3. PatentScope, World Intellectual Property Organization, 2023.
4. Industry Reports on Heterocyclic Drug Development, IQVIA, 2021.
5. Patent Analysis and Litigation Trends, LexisNexis, 2022.

Drugs Protected by US Patent 8,357,713

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No	8,357,713		Y			TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No	8,357,713		Y			TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No	8,357,713		Y			REDUCTION OF SERUM URIC ACID LEVELS

International Family Members for US Patent 8,357,713

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2217577		2016016	Norway
European Patent Office	2217577		CA 2019 00003	Denmark
European Patent Office	2217577		PA2019003	Lithuania