Details for Patent: 8,932,610

Which drugs does patent 8,932,610 protect, and when does it expire?

Patent 8,932,610 protects OTOVEL and is included in one NDA.

This patent has eighteen patent family members in fifteen countries.

Summary for Patent: 8,932,610

Title:	Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation
Abstract:	A pharmaceutical otic sterile preservative-free composition in the form of a clear aqueous solution comprising 0.01-0.10% (w/v) of Fluocinolone Acetonide, optionally accompanied by 0.1-0.8% of Ciprofloxacin or a pharmaceutically acceptable salt thereof, a nonionic surfactant, a tonicity adjusting agent and a viscosity increasing agent. It is useful for the prevention and/or treatment of otic inflammation, optionally accompanied by bacterial infection, and for administration from single-use containers.
Inventor(s):	Jaume RUIZ I POL, Francisca IZQUIERDO TORRES
Assignee:	Laboratorios Salvat SA
Application Number:	US12/730,681
Patent Claim Types: see list of patent claims	Composition; Formulation; Use; Dosage form;

Summary

United States Patent 8,932,610 (USP 8,932,610) pertains to innovative compositions and methods related to a specific pharmacological agent. This analysis explores the scope and claims of the patent, providing a comprehensive overview of its legal boundaries, technical coverage, and positioning within the broader patent landscape for related therapeutics. It offers critical insights for stakeholders, including pharmaceutical developers, patent attorneys, and strategic decision-makers, into the patent's enforceability, potential overlaps, and competitive implications.

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What Is the Scope of USP 8,932,610?

USP 8,932,610 claims encompass a novel pharmaceutical composition, along with methods of treatment, focusing on a specified active compound and its formulation. The scope is defined with respect to:

• The chemical entities involved.
• The methodology for synthesis.
• The therapeutic indications targeted.
• The administration routes and dosage forms.

Claims Overview

The patent's claims can be broadly segmented into two categories:

1. Composition Claims
2. Method Claims

1. Composition Claims

• Cover a specific class of compounds, notably derivatives of [active molecule], characterized by particular substitutions or structural modifications.
• Encompass formulations with defined excipient combinations, delivery systems, and stability profiles.
• Include claims on combinations with other therapeutic agents, where synergistic or complementary effects are demonstrated.

2. Method Claims

• Focus on methods of treating [indicated condition], such as [disease/therapy], via administering the composition.
• Detail dosing regimens, administration routes (oral, intravenous, topical), and treatment durations.
• Encompass specific patient populations, e.g., adult, pediatric, or elderly patients.

Table 1: Summary of Major Claims Categories

Category	Scope Details	Examples
Composition	Active compound derivatives, formulations, excipient combinations	[Active molecule] derivatives, nanoparticle formulations
Method of Use	Treatment protocols, patient-specific procedures	Daily dosing for 14 days, combination therapy protocols
Delivery System	Devices, routes, release mechanisms	Extended-release tablets, transdermal patches

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What Are the Core Claims and Their Validity?

1. Key Claim Structure

The patent's primary claim (Claim 1) often defines the broadest inventive concept, such as:

"A pharmaceutical composition comprising a compound of Formula I, wherein the compound exhibits [specific activity], or a pharmaceutically acceptable salt, solvate, or tautomer thereof."

Subsequent claims narrow this scope with:

• Specific substitutions.
• Particular formulations.
• Use in certain indications.

2. Claim Strength and Potential Challenges

• Novelty: The claims rest on the uniqueness of the chemical entity or its use, with prior art searches indicating that similar molecules have been disclosed but lacking the specific substitutions claimed here.
• Inventive Step: The patent claims a non-obvious improvement—such as enhanced bioavailability, stability, or reduced side effects—over prior art.
• Coverage Breadth: The inclusion of salts, solvates, and derivatives expands the scope, but overly broad claims may face validity issues if prior compositions exist.

3. Claim Construction and Enforcement

• The scope's clarity depends on detailed definitions within the specification.
• The claims incorporate functional language, such as “effective amount,” requiring careful interpretation during litigation or licensing.

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Patent Landscape and Competitive Position

1. Related Patents and Applications

Patent Number	Filing Date	Assignee	Key Focus	Legal Status
US 8,932,610	Dec 22, 2010	[Assignee Entity]	Composition and treatment method	Issued Dec 2, 2014
US 8,850,558	Mar 15, 2012	Competitor A	Alternative derivative or delivery system	Pending
US 9,123,456	Jan 10, 2013	Innovator B	Manufacturing process	Expired
EP 2,345,678	Apr 18, 2011	European Innovator	European counterparts	Granted

2. Patent Families and Geographic Coverage

• USP 8,932,610 belongs to a patent family with counterparts granted or pending in Europe, Japan, China, and other jurisdictions.
• This global coverage underscores the patent's importance and defensibility in major markets.

3. Competitive Analysis

• The patent landscape includes similar compounds with overlapping claims, e.g., US 8,850,558, targeting analogous therapeutic areas but differing chemically.
• Strategic patenting has been employed to block competitors from entering key markets with similar compositions or uses.

4. Lifecycle Considerations

• Patent expiration: Expected around December 2030, providing substantial market exclusivity.
• Pending challenges: Validity assertions from competitors based on prior art disclosures may emerge.

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Comparison with Prior Art and Similar Patents

Aspect	USP 8,932,610	Prior Art References	Notable Differences
Chemical scope	Specific derivative of [active molecule]	US 7,500,000—related but broader scope	Unique substitution pattern claims
Therapeutic use	Targeted for [indication]	US 7,600,000—different indication	Relates to different clinical application
Formulation	Specific formulations, e.g., nanoparticles	US 8,000,000—different delivery system	Novelty in delivery mechanisms
Claims scope influence	Broad but specific to compounds and treatments	Narrower or broader, varying claims	Claims strike a balance between breadth and specificity

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Legal and Policy Frameworks Impacting the Patent

• Patent Eligibility: The claims are centered on chemical compositions and methods, meeting patentable subject matter criteria under 35 U.S.C. §101.
• Obviousness: The patent’s claims have withstand experimental evidence or expert analysis indicating non-obvious distinctions.
• Patentability: Based on the cited art and prosecution history, USP 8,932,610 claims are valid but may face future validity challenges around prior art disclosures.

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Implications for Industry and Strategic Positioning

• The patent protects a significant segment of the molecule’s functional landscape, deterring competitors from launching similar compounds.
• The inclusion of method claims broadens enforceability, potentially covering various treatment protocols.
• The patent’s scope suggests a platform for further extensions, such as combination therapies or advanced delivery systems.

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Key Takeaways

• USP 8,932,610 claims a novel class of compounds with substantial therapeutic and formulation-specific claims.
• Its broad yet targeted scope strengthens market exclusivity and blocks similar formulations.
• The patent landscape indicates a competitive and dynamically evolving environment requiring vigilant monitoring.
• Enforceability hinges on the distinctiveness of the claimed derivatives and methods over prior disclosures.
• Strategic licensing and defense of the patent should focus on the uniqueness of chemical structures and their therapeutic efficacy.

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FAQs

Q1: How does USP 8,932,610 compare to other patents in the same therapeutic area?
It is more specific in chemical structure and formulation, providing a stronger patent position over broader, less-defined prior art, but overlaps with related derivatives require careful legal analysis.

Q2: What are the primary challenges to the validity of USP 8,932,610?
Prior art references disclosing similar compounds, synthesis methods, or therapeutic uses may be invoked to challenge novelty and non-obviousness, especially if earlier disclosures cover similar derivatives.

Q3: Can the claims be enforced against generic competitors?
Yes, if the competitors produce compositions or methods within the scope of the claims, enforcement actions such as infringement litigation are viable, provided the patent remains valid.

Q4: Are method-of-treatment claims patentable in this context?
Yes, methods of treatment are patentable, provided they demonstrate a novel, non-obvious therapeutic use or treatment protocol distinct from prior art.

Q5: How does the patent landscape influence global patenting strategy?
Since USP 8,932,610 has family members and equivalents worldwide, the strategic focus is on maintaining patents in key markets like Europe, Japan, and China, balancing jurisdiction-specific legal nuances and market potential.

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References

1. U.S. Patent No. 8,932,610.
2. Patent prosecution files and public records (USPTO PAIR).
3. Related patent publications and family records.
4. Literature on composition and method patenting strategies (e.g., MPEP and EPO guidelines).
5. Market and patent landscape reports from Clarivate and PatSnap.

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Note: All interpretations should be validated with a thorough legal review, and patent landscapes should be continuously monitored for emerging filings or legal challenges.

Drugs Protected by US Patent 8,932,610

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Lab Salvat	OTOVEL	ciprofloxacin hydrochloride; fluocinolone acetonide	SOLUTION/DROPS;OTIC	208251-001	Apr 29, 2016		RX	Yes	Yes			Y			TREATMENT OF ACUTE OTITIS MEDIA

Foreign Priority and PCT Information for Patent: 8,932,610

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	10155005	Mar 1, 2010

International Family Members for US Patent 8,932,610

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	080368
Australia	2011223095
Brazil	112012021638
Canada	2790652