Details for Patent: 8,291,904

Which drugs does patent 8,291,904 protect, and when does it expire?

Patent 8,291,904 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-four patent family members in thirteen countries.

Summary for Patent: 8,291,904

Title:	Gas delivery device and system
Abstract:	A gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
Inventor(s):	Bathe; Duncan P. (Fitchburg, WI), Klaus; John (Cottage Grove, WI), Christensen; David (Cambridge, WI)
Assignee:	INO Therapeutics LLC (Hampton, NJ)
Application Number:	13/493,493
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,291,904
Patent Claim Types: see list of patent claims	Delivery; Device; Use;

United States Patent 8,291,904: A Comprehensive Analysis

Overview of the Patent

The United States Patent 8,291,904, titled "Gas delivery device and system," was granted to address the needs of precise gas delivery, particularly in medical contexts. This patent is part of a broader portfolio related to gas delivery systems, especially relevant in the field of respiratory therapy and critical care.

Background and Context

The patent is associated with the development of advanced gas delivery systems, which are crucial in medical treatments involving gases such as nitric oxide. Companies like Mallinckrodt Hospital Products IP Ltd., INO Therapeutics LLC, and Ikaria, Inc. have been involved in the development and litigation surrounding these patents, highlighting their significance in the medical industry[2].

Scope of the Patent

The patent describes a gas delivery system that includes a gas delivery device, a control module, and a gas delivery mechanism. Here are the key components:

Gas Delivery Device

• This device is designed to deliver gases precisely and safely. It includes features such as valves, sensors, and communication modules to ensure accurate and controlled gas flow[1].

Control Module

• The control module is the brain of the system, responsible for regulating the gas flow based on predefined parameters. It can include a CPU, memory, and a transceiver for communication with other devices[1].

Gas Delivery Mechanism

• This mechanism involves the actual delivery of the gas to the patient. It can include components like bellows, connecting tubes, and patient circuits to ensure efficient and safe gas delivery[1].

Claims of the Patent

The patent includes several claims that define the scope of the invention:

Independent Claims

• These claims outline the core components of the gas delivery system, including the gas delivery device, control module, and gas delivery mechanism.
• For example, Claim 1 describes a gas delivery system comprising a gas delivery device with a valve and a sensor, a control module with a CPU and memory, and a gas delivery mechanism[1].

Dependent Claims

• These claims further specify the details of the independent claims, such as the types of gases that can be delivered (e.g., nitric oxide), the communication protocols used, and the safety features integrated into the system[1].

Patent Landscape

The patent landscape surrounding US 8,291,904 is complex and involves multiple stakeholders:

Related Patents

• This patent is part of a family of patents related to gas delivery systems. Other patents, such as U.S. Patent Nos. 8,282,966, 8,293,284, and 8,431,163, also cover various aspects of gas delivery and treatment[2].

Litigation and Disputes

• The patent has been involved in litigation, with companies like Mallinckrodt and INO Therapeutics asserting infringement claims against other entities. This highlights the commercial significance and the competitive nature of the gas delivery market[2].

Regulatory Environment

• The FDA plays a crucial role in regulating gas delivery systems, especially those involving inhaled nitric oxide. Future products and systems must comply with FDA regulations, which can impact the patent's application and enforcement[5].

Technological Impact

The technological impact of this patent is significant:

Precision and Safety

• The system ensures precise and safe delivery of gases, which is critical in medical treatments. The integration of sensors and control modules helps in maintaining the desired gas flow and concentration[1].

Communication and Integration

• The patent includes features for communication between the gas delivery device and other medical equipment, enhancing the overall efficiency and safety of the treatment process[1].

Economic and Market Impact

The economic and market impact of this patent is substantial:

Market Competition

• The patent is part of a competitive landscape where companies are continually innovating and litigating to protect their intellectual property. This competition drives innovation and improves the quality of gas delivery systems[2].

Cost and Accessibility

• The precise and safe delivery of gases can reduce healthcare costs by minimizing the risk of complications and improving patient outcomes. This can make such treatments more accessible and affordable[1].

Future Developments and Trends

The future of gas delivery systems is likely to involve further advancements in technology and regulatory compliance:

Advanced Materials and Designs

• Future developments may include the use of advanced materials and designs that enhance the efficiency and safety of gas delivery systems[1].

Regulatory Harmonization

• There is a trend towards regulatory harmonization, with initiatives like the Common Citation Document (CCD) and the Global Dossier aiming to streamline the patent process across different jurisdictions[4].

Key Takeaways

• Precise Gas Delivery: The patent ensures precise and safe delivery of gases, critical in medical treatments.
• Technological Integration: The system integrates sensors, control modules, and communication protocols to enhance efficiency and safety.
• Regulatory Compliance: The patent is subject to FDA regulations, and future developments must comply with these standards.
• Market Impact: The patent is part of a competitive landscape that drives innovation and improves the quality of gas delivery systems.

Frequently Asked Questions

What is the primary purpose of the gas delivery system described in US 8,291,904?

The primary purpose is to deliver gases precisely and safely, particularly in medical treatments involving gases like nitric oxide.

Which companies are associated with the development and litigation of this patent?

Companies like Mallinckrodt Hospital Products IP Ltd., INO Therapeutics LLC, and Ikaria, Inc. are associated with the development and litigation of this patent.

How does the control module in the gas delivery system function?

The control module regulates the gas flow based on predefined parameters using a CPU, memory, and a transceiver for communication.

What is the significance of the FDA in the context of this patent?

The FDA plays a crucial role in regulating gas delivery systems, and future products must comply with FDA regulations to ensure safety and efficacy.

How does this patent impact the market for gas delivery systems?

The patent is part of a competitive landscape that drives innovation and improves the quality of gas delivery systems, enhancing market competition and patient care.

Cited Sources

1. US8291904B2 - Gas delivery device and system - Google Patents
2. 15-170.pdf - District of Delaware
3. Patent Claims Research Dataset - USPTO
4. Search for patents - USPTO
5. Requests that the FDA require that all future inhaled nitric oxide drug products and nitric oxide delivery systems be reviewed by the Center - Regulations.gov

Drugs Protected by US Patent 8,291,904

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 Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No					Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes					Y

International Family Members for US Patent 8,291,904

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011328891
Australia	2013257484
Australia	2015200792
Australia	2017204422
Australia	2017276262
Brazil	112013017498
Canada	2779766