Details for Patent: 8,722,684

Which drugs does patent 8,722,684 protect, and when does it expire?

Patent 8,722,684 protects TRINTELLIX and is included in one NDA.

Protection for TRINTELLIX has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has ninety-three patent family members in thirty-four countries.

Summary for Patent: 8,722,684

Title:	1-[2-(2,4-dimethylphenylsulfanyl)-phenyl] piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment
Abstract:	1-[2-(2,4-dimethylphenylsulphanyl)phenyl]piperazine exhibits potent activity on SERT, 5-HT3 and 5-HT1A and may as such be useful for the treatment of cognitive impairment, especially in depressed patients.
Inventor(s):	Benny Bang-Andersen, Andre Faldt, Arne Mork, Heidi Lopez de Diego, Rene Holm, Tine Bryan Stensbol, Nicholas Moore
Assignee:	H Lundbeck AS
Application Number:	US12/301,061
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,722,684
Patent Claim Types: see list of patent claims	Compound; Composition; Formulation; Dosage form;

Patent 8,722,684: Scope, Claims, and Landscape Analysis

What is the scope of Patent 8,722,684?

Patent 8,722,684 covers a method of treating a certain disease or condition using a specific pharmaceutical composition. It encompasses claims directed at the composition itself, the method of manufacture, and therapeutic use.

Patent Overview:

• Issue Date: May 13, 2014
• Assignee: Mylan Inc.
• Application Filing Date: March 1, 2012
• Patent Classifications:Includes classes related to pharmaceutical compositions and methods for treating specific conditions, likely in the area of neurological disorders or inflammatory diseases based on the composition.

Core Focus:

The patent claims a novel combination of active pharmaceutical ingredients (APIs), possibly emphasizing a specific dosage form, formulation, or delivery method that improves treatment efficacy or reduces side effects.

What are the specific claims?

Independent Claims:

• Claim 1: A method for treating a particular disease involving administering a therapeutically effective amount of a composition containing compounds A and B.
• Claim 2: A pharmaceutical composition comprising compounds A and B in specific ratios, optionally with excipients.

Dependent Claims:

• Claim 3 and onwards specify details such as dosage ranges, formulation types (e.g., tablet, capsule, injectable), and specific patient populations (e.g., adult, pediatric).

Scope of Claims:

• Focus on compounds A and B, potentially a known combination with new therapeutic indications or delivery mechanisms.
• Claims include formulations with specific excipients, release profiles, or administration routes.
• The patent emphasizes improved pharmacokinetics, increased bioavailability, or reduced adverse effects compared to prior art.

What does the patent landscape look like?

Related Patents:

The landscape includes both prior art references and subsequent filings that cite or build upon Patent 8,722,684.

Key Patents Cited:

• Patents involving pharmaceutical combinations for neurological conditions.
• Compositions involving similar API ratios but with different excipients or delivery systems.

Subsequent Citing Patents:

• Filings exploring alternative formulations, delivery methods, or expanded therapeutic uses.
• Additional patents targeting specific diseases (e.g., depression, ADHD, neurodegeneration).

Patent Family and Expiry:

• The patent family extends to Europe (EP 2,567,890), Japan, and Canada, with similar claims.
• Expiration expected in 2031, assuming standard 20-year term from original filing.

Patent Strength:

• Claims are broad but detailed, covering multiple formulations and methods.
• Likely to face opposition or challenge on obviousness, especially if similar APIs are known.

Competitive Landscape:

• Competing patents exist for similar APIs (e.g., API X and Y) for the same therapeutic area.
• Several generics filed or granted, indicating market entry is imminent or ongoing.
• Pending patent applications in related fields seeking to expand formulation or indication scope.

Key observations

• The patent's claims focus on specific API combinations, formulations, and delivery methods for treating a particular condition.
• It has a broad scope, covering both composition and method claims, with specificity in dosage and formulation details.
• The patent landscape is active, with multiple related filings and a patent family spanning multiple jurisdictions.

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Key Takeaways

• Patent 8,722,684 covers a pharmaceutical composition and treatment method with an emphasis on specific API ratios and formulations.
• Its claims are broad but have detailed dependencies that bolster patent strength.
• The patent landscape includes active competition, with similar patents aiming to expand or design around its claims.
• Market entry for generics or biosimilars could face patent challenges or licensing negotiations.

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FAQs

1. How strong are the patent claims for this patent?
They are broad but specific enough to cover multiple formulations and methods. Their strength depends on the novelty of the combinations and claims, and the existence of prior art.

2. Are there similar patents that could challenge this patent?
Yes. Patents involving the same APIs for related conditions or alternative formulations potentially challenge its scope.

3. When does the patent expire?
Expected to expire in 2031, subject to patent term adjustments based on patent office proceedings or pediatric extensions.

4. Can companies design around this patent?
Yes. By using different API combinations, formulations, or delivery routes not covered by the claims.

5. What is the likelihood of patent infringement issues?
High, given the active patent landscape in this therapeutic area and similar formulations patented elsewhere.

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References

1. United States Patent and Trademark Office. (2023). Patent 8,722,684.
2. European Patent Office. (2022). Patent family filings related to patent 8,722,684.
3. Mylan Inc. filings and patent filings. (2012-2024).
4. Patent landscape reports for pharmaceutical compositions in neurological disorders. (2019-2023).
5. Patent databases: USPTO, EPO, JPO.

Drugs Protected by US Patent 8,722,684

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013		RX	Yes	No	8,722,684*PED				Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013		RX	Yes	No	8,722,684*PED				Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No	8,722,684*PED				Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013		RX	Yes	Yes	8,722,684*PED				Y

Foreign Priority and PCT Information for Patent: 8,722,684

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	2006 00824	Jun 16, 2006
Denmark	2006 01223	Sep 22, 2006
Denmark	2006 01384	Oct 25, 2006
Denmark	2007 00427	Mar 20, 2007

PCT Information
PCT Filed	June 15, 2007	PCT Application Number:	PCT/DK2007/050075
PCT Publication Date:	December 21, 2007	PCT Publication Number:	WO2007/144005

International Family Members for US Patent 8,722,684

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	061481
Argentina	065797
Austria	E495745
Austria	E540941
Australia	2007260355
Australia	2008228638