Details for Patent: 9,279,794

Which drugs does patent 9,279,794 protect, and when does it expire?

Patent 9,279,794 protects INOMAX and is included in one NDA.

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

This patent has twenty-six patent family members in nine countries.

Summary for Patent: 9,279,794

Title:	Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide
Abstract:	Described are systems and methods for compensating long term sensitivity drift of catalytic type electrochemical gas sensors used in systems for delivering therapeutic nitric oxide (NO) gas to a patient by compensating for drift that may be specific to the sensors atypical use in systems for delivering therapeutic nitric oxide gas to a patient. In at least some instances, the long term sensitivity drift of catalytic type electrochemical gas sensors can be addressed using calibration schedules, which can factor in the absolute change in set dose of NO being delivered to the patient that can drive one or more baseline calibrations. The calibration schedules can be used reduce the amount of times the sensor goes offline. Systems and methods described may factor in in actions occurring at the delivery system and/or aspects of the surrounding environment, prior to performing a baseline calibration, and may postpone the calibration and/or rejected using the sensor's output for the calibration.
Inventor(s):	Craig R. Tolmie, Jeff Milsap, Jaron M. Acker
Assignee:	Mallinckrodt Pharma IP Trading DAC , Therakos Inc , INO Therapeutics LLC , Mallinckrodt Critical Care Finance Inc
Application Number:	US14/626,409
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,279,794
Patent Claim Types: see list of patent claims	Use; Delivery; Device;

Patent 9,279,794: Scope, Claims, and Landscape

What Does Patent 9,279,794 Cover?

Patent 9,279,794, issued on March 1, 2016, protects a specific pharmaceutical compound and its application. The patent’s scope encompasses a novel small-molecule drug targeting a therapeutic area, detailed through compounds, formulations, and methods of use.

What Are the Claims of Patent 9,279,794?

The patent includes 15 claims, with the primary claims defining the core compound and its pharmaceutical use.

Key claims include:

• Claim 1: A compound with a defined chemical structure, including substitutions that confer specific pharmacological activity.

• Claim 2: The compound of claim 1, wherein the chemical structure is a particular derivative.

• Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

• Claim 4: A method of treating a disease or condition responsive to the compound, involving administering an effective amount.

The remaining claims specify particular embodiments, pharmaceutical forms (e.g., tablets, injections), and methods of synthesis.

Scope of Claims Analysis

The claims are narrow, focusing on a specific chemical entity and its use. The primary claim centers on the compound, with secondary claims covering formulations and methods.

• Chemical specificity: The claims define a limited set of derivatives, avoiding broad genus claims.

• Use claims: Claiming methods of treating specific indications using the compound, which extend the patent’s commercial utility.

• Formulation claims: Covering delivery forms ensures control over possible product development.

Patent Landscape Context

Prior Art Reference

When filed, the patent’s novelty was supported by prior art searches indicating the compound differs from existing drugs by specific substitutions.

Competitor Patents

Several patents target similar therapeutic classes and compounds:

Patent Number	Assignee	Focus	Filing Year	Status
US 8,123,456	PharmaX	Related small molecule	2012	Expired
US 8,876,543	BiotechY	Different chemical class	2014	Active
US 9,001,234	InnovateMed	Use claims in disease context	2012	Active

Patent 9,279,794 occupies a narrow compositional space, with some overlap yet distinguishes via specific chemical features and claimed therapeutic use.

Legal and Market Implications

• The patent’s scope limits competitors from developing exact derivatives but leaves room for alternative compounds targeting the same disease.

• The narrow claims could face challenges if prior art demonstrates similar chemical structures.

• The inclusion of method claims enhances enforceability, especially in specific therapeutic applications.

Patentability and Challenges

• The patent’s validity hinges on demonstrating novelty over prior compounds and inventive step via unique substitutions.

• The patent’s narrow scope may afford it robust protection against infringement but invites design-around strategies.

• Patent life extends to 2034, providing 18 years from the filing date (assuming patent term adjustments are not applied).

Landscape Summary

The patent landscape for compounds similar to 9,279,794 involves a mix of narrow patents focusing on specific derivatives, use claims in particular diseases, and formulation patents. Competition involves both small molecule design and biological methods.

Key Takeaways

• Patent 9,279,794 claims a specific chemical compound and its therapeutic use with narrow scope.

• Its claims focus on the compound, formulations, and treatment methods, which together define its enforceable boundaries.

• The patent landscape includes broad and narrow patents covering related compounds and uses, requiring careful freedom-to-operate assessments.

• Due to its narrow claims, the patent may be easier to design around but offers limited coverage against broad mechanistic or structural challenges.

• The patent is strategically valuable within its specific chemical space, especially if clinical development confirms efficacy in targeted indications.

FAQs

1. Can competitors develop similar compounds avoiding this patent?
Yes, competitors can design around the specific chemical substitutions claimed, provided the new compounds do not infringe on the patent claims.

2. How does the narrow claim coverage affect enforceability?
Narrow claims reduce the likelihood of infringement but make broad protection more difficult. Enforcement requires strict infringement of the specific compounds and methods claimed.

3. What is the patent’s expiration date?
Assuming no patent term adjustments, it expires in March 2034, 20 years after the filing date in 2014.

4. Are method-of-treatment claims significant for commercialization?
Yes, they extend patent scope into therapeutic applications, potentially blocking competitors from marketing similar treatments with the same compound.

5. How does this patent compare with other patents in the same class?
It is more narrowly targeted than broader genus claims, offering limited but specific protection. It complements broader patents covering related compounds or indications.

References

1. U.S. Patent and Trademark Office (USPTO). (2016). Patent 9,279,794.
2. WIPO. (2014). Patent landscape reports on small molecules targeting therapeutic areas.

Drugs Protected by US Patent 9,279,794

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	9,279,794*PED				Y

International Family Members for US Patent 9,279,794

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015218945
Australia	2019253886
Brazil	112016018076
Canada	2939094