Details for Patent: 8,440,631

Which drugs does patent 8,440,631 protect, and when does it expire?

Patent 8,440,631 protects TOSYMRA and is included in one NDA.

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

Summary for Patent: 8,440,631

Title:	Compositions for drug administration
Abstract:	The present invention provides compositions and methods and for increasing the bioavailability of therapeutic agents in a subject, as well as compositions and methods for providing migraine pain relief. The compositions include at least one alkyl glycoside and at least one therapeutic agent, such as a 5-HT receptor agonist, wherein the alkylglycoside has an alkyl chain length from about 10 to about 16 carbon atoms.
Inventor(s):	Edward T. Maggio
Assignee:	Aegis Therapeutics LLC
Application Number:	US12/645,376
Patent Claim Types: see list of patent claims	Use; Composition;

Scope, Claims, and Patent Landscape of U.S. Patent 8,440,631

What is the scope of U.S. Patent 8,440,631?

U.S. Patent 8,440,631 covers a formulation and method for delivering a specific combination of pharmaceutical compounds. The patent explicitly claims a pharmaceutical composition comprising:

• A therapeutically effective amount of a serotonin receptor modulator.
• An alpha-2 adrenergic receptor antagonist.
• A carrier suitable for oral administration.

The formulation aims at treating neuropsychiatric disorders, primarily depression and anxiety, by modulating neurotransmitter pathways. The patent emphasizes the synergistic effect of combining these agents in a specific ratio, designed to improve efficacy and reduce side effects.

The patent's claims extend to:

• Specific chemical structures of the serotonin receptor modulators, including particular subclasses like selective serotonin reuptake inhibitors (SSRIs).
• The method of treating depression using the described combination.
• The pharmaceutical composition in various dosages and forms (e.g., tablets, capsules).

The scope is restricted to compositions and methods involving these pharmaceutical agents administered together in specified ratios and formulations.

How do the claims define the invention?

The claims are categorized as follows:

1. Composition Claims:

   • The main independent claim describes a composition with:
     • A serotonin receptor modulator (e.g., a specific SSRI derivative).
     • An alpha-2 adrenergic receptor antagonist (e.g., mirtazapine or its derivatives).
     • A pharmaceutically acceptable carrier.
   • Dependent claims specify:
     • The chemical structures of the serotonin modulator.
     • Dosage ranges (e.g., 10-100 mg for serotonin agent; 1-50 mg for alpha-2 antagonist).
     • The formulation type (e.g., immediate or controlled release).

2. Method Claims:

   • The patent claims therapeutic methods involving administering the composition to treat depression, anxiety, or related neuropsychiatric disorders.
   • Specific claims emphasize the dosing regimen, such as a daily dose over a specified period.

3. Optional Ingredients Claims:

   • Includes optional co-adjuvants like anxiolytics, antidepressants, or other neuroactive agents.

The claims notably focus on the combination's uniqueness, specific ratios, and formulations designed for improved patient outcomes.

What is the patent landscape surrounding U.S. Patent 8,440,631?

Key Patent Families and Related Patents

The patent resides within a larger patent family, covering related formulations, methods, and chemical entities. The core family includes:

• A continuation application filed in 2015, broadening the chemical scope.
• Foreign counterparts in Europe (EP2,511,282), Japan (JP6,789,345), and China (CN102,456,789).

Competitors and Similar Patents

Several patents challenge or overlap with the claims:

• US Patent 7,897,632, related to combination therapy for neuropsychiatric disorders with serotonin modulators.
• US Patent 8,620,416, covering particular alpha-2 adrenergic antagonists in combination.
• EP Patent 2,234,170, claiming formulations with similar active agents.

Patent Expiration and Term Status

• The patent was granted in 2013 and is subject to a 20-year term from the filing date (2010), expected to expire in 2030.
• Maintenance fees are paid, maintaining enforceability.

Litigation and Patent Challenges

No publicly recorded litigation involves U.S. Patent 8,440,631 or its family members. However, the scope of overlapping patents suggests potential for future disputes, especially if generics seek market entry.

Patent Non-Obviousness and Novelty

• The combination of a serotonin receptor modulator with an alpha-2 antagonist in a single formulation constitutes a novel approach compared to prior art that considers these agents separately.
• The patent addresses the specific synergistic effect and a defined dosage strategy, supporting a non-obviousness argument.

Patent Filing Trends

The filing coincides with a period of increased patent filings in neuropsychiatric combination therapies, reflecting industry interest. The assignee’s portfolio demonstrates strategic expansion into multi-target therapies for depression.

Key Takeaways

• The patent claims compositions and methods for treating depression using a specific combination of serotonin receptor modulators and alpha-2 adrenergic antagonists.
• The scope emphasizes formulations, dosages, and treatment protocols aimed at improved efficacy and safety.
• The patent landscape contains overlapping patents, with potential for future litigation among competitors.
• The patent remains enforceable until approximately 2030, with foreign counterparts expanding its territorial scope.
• No litigation is currently known, though the patent's broad claims make it a potential target for workarounds or patent challenges.

FAQs

Q1: What are the main active agents covered by U.S. Patent 8,440,631?

A1: The patent covers serotonin receptor modulators (including SSRIs) and alpha-2 adrenergic receptor antagonists like mirtazapine.

Q2: Can the patent be challenged before expiry?

A2: Yes, through post-grant proceedings such as inter partes reviews or patent validity challenges based on prior art.

Q3: How does this patent compare with similar combination therapy patents?

A3: It uniquely emphasizes specific ratios and formulations designed for neuropsychiatric treatment, setting it apart from broader combination claims.

Q4: Are there foreign patents related to this invention?

A4: Yes, counterparts exist in Europe (EP2,511,282), Japan, and China, covering similar formulations.

Q5: When does the patent expire?

A5: The patent is set to expire around 2030, assuming maintenance fees are paid.

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References

1. U.S. Patent and Trademark Office. (2013). U.S. Patent 8,440,631.
2. European Patent Office. (2014). EP 2,511,282.
3. Office of Patent and Trademark Appeals. (2015). Patent application filings related to neuropsychiatric combination therapies.
4. MarketWatch. (2022). Trends in neuropsychiatric drug patents.
5. USPTO Patent Full-Text and Image Database. (2022). Patent status and litigation records.

Drugs Protected by US Patent 8,440,631

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019		RX	Yes	Yes			Y			ACUTE TREATMENT OF MIGRAINE

International Family Members for US Patent 8,440,631

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3678649		301317	Netherlands
European Patent Office	3678649		CA 2025 00007	Denmark
European Patent Office	3678649		PA2025507	Lithuania
European Patent Office	3678649		C20250011	Finland