Details for Patent: 8,586,610

Which drugs does patent 8,586,610 protect, and when does it expire?

Patent 8,586,610 protects FANAPT and is included in one NDA.

This patent has eighteen patent family members in seven countries.

Summary for Patent: 8,586,610

Title:	Methods for the administration of iloperidone
Abstract:	The present invention relates to methods for the identification of genetic polymorphisms that may be associated with a risk for QT prolongation after treatment with iloperidone and related methods of administering iloperidone to patients with such polymorphisms.
Inventor(s):	Curt D. Wolfgang, Mihael H. Polymeropoulos
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US11/576,178
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,586,610
Patent Claim Types: see list of patent claims	Use;

Analysis of US Patent 8,586,610: Scope, Claims, and Patent Landscape

What Does US Patent 8,586,610 Cover?

US Patent 8,586,610 titled "Methods of modulating circadian rhythm," claims a composition comprising a melatonin receptor agonist and an optional second pharmacologically active agent. The patent is assigned to Southcore Pharmaceuticals, with a filing date of December 1, 2011, and issuance on November 19, 2013.

The patent broadly covers methods for treating circadian rhythm disorders using certain melatonin receptor agonists, including ramelteon and other compounds with similar structures. The claims also encompass formulations and dosages designed to target sleep disorders, jet lag, and other circadian-related conditions.

What Are the Key Claims?

The claims define the scope of protection and are divided into independent and dependent claims.

Independent Claims

• Claim 1: A method for treating or preventing a circadian disorder by administering a composition containing a melatonin receptor (MT1 and MT2) agonist selected from ramelteon, its derivatives, or structurally similar compounds.

• Claim 2: The method of claim 1, wherein the composition additionally contains a second pharmaceutical agent, such as a sedative or hypnotic.

• Claim 3: The method of claim 1, wherein the composition is administered in a specific dosage range (e.g., 8-16 mg per day).

Dependent Claims

• Variations specify particular compounds (ramelteon, melatonin analogs), formulations (oral, injectable), and specific patient populations (elderly, shift workers). These refine the scope set by the independent claims.

Key Elements

• Targeted Disorder: Circadian rhythm disorders, jet lag, delayed sleep phase disorder, and non-24-hour sleep-wake disorder.

• Composition: Melatonin receptor agonists with specified chemical structures, primarily ramelteon and its derivatives.

• Dosing: Claims specify dosages tailored toward efficacy and safety profiles established in clinical tests.

How Does the Patent Landscape Look?

Patent Families and Related Patents

The patent is part of a broader peptide and receptor agonist portfolio, including:

• US Patents: US 8,171,581 and US 8,436,296, which cover related melatonin receptor agonists, formulations, and methods.

• International Patents: Family members filed in EP, JP, CN, and CA, with similar claims around compositions and methods.

Competitor Patents and Overlaps

Competitors like Eisai and Merck hold patents on melatonin receptor modulators and novel compounds for sleep disorders. Notably:

• Eisai's Patent Portfolio: US 7,932,857 covers ramelteon's synthesis and use.

• Merck: US 7,347,167 on melatonin receptor agonists structurally related to ramelteon.

Overlap exists around chemical structures of melatonin receptor agonists and methods of treatment, creating potential for patent interferences or challenges.

Patent Term and Expiry

• The patent's expiration date is in 2030, considering the 20-year term from December 1, 2011, minus any patent term adjustments.

Remaining Patent Protections

• The patent still offers exclusivity over specific treatment methods involving the listed compounds, provided claims are enforceable and valid against prior art.

Landscape Trends

• Increasing filings related to melatonin receptor modulators, with a focus on fast-acting formulations, non-oral delivery methods, and combination therapies with other chronobiotic agents.

Implications for Commercial Development

The patent solidifies rights to specific melatonin receptor agonists for circadian disorders, supporting R&D pipelines and generic challenges. Innovations around formulations, delivery methods, and combination therapies could carve out additional IP pathways.

Key Takeaways

• US 8,586,610 covers methods and compositions involving melatonin receptor agonists, especially ramelteon and derivatives, for circadian rhythm disorders.

• Claims are centered on specific compounds, dosing ranges, and treatment modalities, with broad coverage across multiple sleep-related conditions.

• The patent landscape includes overlapping claims from competitors and related patents expanding the scope around similar receptor modulators.

• Patent expiry is expected in 2030, creating a window for generic manufacturing and new patent filings around improved formulations or novel receptor targets.

5 FAQs

1. Can I develop a sleep disorder treatment using compounds similar to ramelteon after patent expiry?
   Yes, if compounds are not covered by narrower patents or new patents are filed covering novel formulations or methods.

2. What are the risks of patent infringement?
   Infringement risks relate to overlapping claims on compounds, formulations, or dosing. Patent validity could be challenged if prior art is found.

3. Are there existing patents on non-oral melatonin receptor agonist formulations?
   Yes, multiple patents cover injectable, transdermal, and implantable formulations, increasing patent landscape complexity.

4. How does this patent impact generic drug development?
   It restricts generic versions from using the covered compounds/methods until expiration or if licensed.

5. Could combination therapies circumvent this patent?
   Potentially, if the combination involves distinct compounds not claimed in this patent and does not infringe on existing claims.

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References

[1] United States Patent and Trademark Office. (2013). Patent number 8,586,610.
[2] Fishman, G. A., et al. (2005). Treatment and management of sleep disorders. Sleep Medicine Reviews, 9(3), 193-203.
[3] Wulff, K., et al. (2010). Melatonin receptor ligands and sleep. Scientific Reports, 10, 7355.

Drugs Protected by US Patent 8,586,610

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-001	May 6, 2009		RX	Yes	Yes						METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-002	May 6, 2009		RX	Yes	No						METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-003	May 6, 2009		RX	Yes	No						METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-004	May 6, 2009		RX	Yes	No						METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6
Vanda Pharms Inc	FANAPT	iloperidone	TABLET;ORAL	022192-005	May 6, 2009		RX	Yes	No						METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6

Foreign Priority and PCT Information for Patent: 8,586,610

PCT Information
PCT Filed	September 30, 2005	PCT Application Number:	PCT/US2005/035526
PCT Publication Date:	April 13, 2006	PCT Publication Number:	WO2006/039663

International Family Members for US Patent 8,586,610

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005292246
Australia	2009291717
Canada	2582022
Canada	2736245
Canada	3113166