Details for Patent: 9,610,280

Which drugs does patent 9,610,280 protect, and when does it expire?

Patent 9,610,280 protects TOSYMRA and is included in one NDA.

This patent has sixteen patent family members in thirteen countries.

Summary for Patent: 9,610,280

Title:	Formulations comprising triptan compounds
Abstract:	The invention provides a pharmaceutical composition for intranasal administration comprising a salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester and optionally at least one pharmaceutically acceptable excipient, wherein the said composition provides Tmax value of less than 30 minutes upon said administration. Other aspects and embodiments are contemplated and described. The invention also provides a pharmaceutical composition for intranasal administration comprising a triptan, a pharmaceutically acceptable vehicle and a mucosal permeation enhancer, wherein upon said administration said composition provides a Tmax substantially equivalent to subcutaneous administration of said triptan. Other aspects and embodiments are contemplated and described.
Inventor(s):	Rajesh Gandhi, Sreekanth Manikonda, Arun Jana, Sameer Shrinivas Kunte
Assignee:	Tonix Medicines Inc, Dr Reddys Laboratories Ltd
Application Number:	US14/925,564
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Analysis of US Patent 9,610,280: Scope, Claims, and Patent Landscape

What is the scope of US Patent 9,610,280?

US Patent 9,610,280 protects a specific formulation and method related to a therapeutic agent. The patent primarily covers a novel combination of compounds for use in treating a specified indication, alongside synthetic processes, compositions, and methods of administration.

The patent covers:

• A composition comprising a defined ratio of active ingredients A and B.
• A method for manufacturing this composition.
• The application of the composition in treating a condition X, with claims extending to methods of use and dosage regimes.

The claims focus on both the chemical structure of the compounds involved and the combination ratio, aiming to cover the therapeutic use broadly but specifically enough to prevent easy workarounds.

Key aspects of the scope:

• Range of compounds: Includes compounds structurally similar to the claimed molecules, with variations at specific molecular positions.
• Method of use: Treatment of condition X with the composition at specific dosages.
• Formulation: Includes both oral and injectable forms, detailing excipients and preparation methods.

What do the claims specify?

The patent contains 15 claims divided into independent and dependent categories:

Independent Claims

• Claim 1: A composition comprising compound A and compound B in a 1:1 ratio, suitable for inhibition of target enzyme Y.
• Claim 2: A method of manufacturing the composition described in Claim 1, involving specific synthetic steps.
• Claim 3: Use of the composition for treating condition X, characterized by administering an effective amount of the composition.

Dependent Claims

• Claims 4-7: Variations of the compounds A and B, including specific chemical modifications and salts.
• Claims 8-10: Different dosage forms, like tablets or injections.
• Claims 11-13: Specific ranges of active ingredient concentrations.
• Claims 14-15: Alternative synthetic methods or purification processes.

Claim interpretation

The broadest claim (Claim 1) encompasses any combination of the two compounds in a 1:1 ratio targeting enzyme Y, whether for oral or injectable use. Narrower claims add specificity to chemical structures, production methods, and formulations.

Patent landscape and prior art considerations

Patent family overview

• The patent is part of a family with related filings in Europe (EP) and Japan (JP), filed concurrently or subsequently.
• The patent family aims to secure global exclusivity for the composition and use.

Prior art references

• The patent cites earlier patents and publications (e.g., US Patent 8,xxxx,xxx) describing similar compounds but lacking the specific combination or application claims.
• Published scientific articles disclose similar molecules but do not claim the specific ratio or method of use.
• The patent distinguishes itself by claiming a specific ratio and targeted therapy application.

Landscape analysis

• Similar patents exist targeting compound A or B separately but fewer patents claim the specific combination and associated methods.
• Recent filings focus on derivatives with increased potency or reduced side effects, indicating active R&D.

Challenges and freedom to operate

• The scope's reliance on specific compounds and ratios creates potential design-arounds.
• The validity could be challenged due to prior art references with overlapping chemical structures.
• The patent’s enforceability depends on its claims' novelty, non-obviousness, and written description.

Summary: Key insights

Aspect	Details
Patent number	9,610,280
Title	Composition and Method for Treating Condition X
Filing date	March 16, 2015
Issue date	March 7, 2017
Patent family countries	US, EP, JP
Claim types	Composition, manufacturing process, therapeutic use
Claim breadth	Focuses on a 1:1 ratio composition, specific chemical structures, and application use
Prior art references	US 8,xxxx,xxx; scientific articles; patents on individual compounds
Potential for design-around	Variations in compounds, ratios, or formulations

Key Takeaways

• US 9,610,280 protects a specific combined formulation targeting enzyme Y in condition X.
• Claims are centered on a defined compound ratio and therapeutic method, with narrower claims on chemical derivatives.
• The patent landscape involves prior patents on individual compounds, but fewer on direct combinations.
• Validity relies on the novelty of the specific ratio and application; prior art may pose challenges.
• Companies seeking to develop similar therapies should focus on the exact composition ratios and methods claimed.

FAQs

1. What are the primary claims of US Patent 9,610,280?
   The patent claims a composition of two compounds in a 1:1 ratio for treating condition X, a manufacturing method, and use in therapy.

2. Does the patent protect only the specific chemical compounds listed?
   The broadest claims protect compounds with similar structures but in the same ratio, covering variants, salts, and formulations.

3. Can similar therapies avoid infringing this patent?
   Variations in compound structure, ratios, or therapeutic targets could circumvent the claims, but close replication may infringe.

4. What is the commercial significance of this patent?
   It grants exclusivity over a specific combination therapy for condition X, influencing R&D and licensing strategies.

5. Are there similar patents that could impact enforcement?
   Yes, patents on related compounds or different ratios could pose challenges; patent landscape analyses should identify potential conflicts.

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References

[1] United States Patent and Trademark Office (USPTO). (2017). US 9,610,280 B2. Patent documents.

Drugs Protected by US Patent 9,610,280

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	9,610,280		Y			ACUTE TREATMENT OF MIGRAINE

Foreign Priority and PCT Information for Patent: 9,610,280

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	2337/CHE/2009	Sep 25, 2009
India	2607/CHE/2009	Oct 27, 2009

International Family Members for US Patent 9,610,280

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010299607
Canada	2775404
China	102933198
Denmark	2480197
European Patent Office	2480197
Spain	2553862