United States Patent 9,265,911: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,265,911, titled "Gas delivery device and system," is a significant patent in the field of medical technology, particularly in the delivery of therapeutic gases. This patent, held by Mallinckrodt, is part of a broader portfolio related to the treatment of respiratory conditions using inhaled nitric oxide (iNO). Here, we will delve into the scope, claims, and the surrounding patent landscape of this invention.
Background
The patent in question is part of a series of patents related to the INOmax® product, which is used for treating hypoxic respiratory failure in neonates and other patients. The patents cover various aspects of the treatment, including methods for identifying patients who should not receive conventional iNO treatment and the devices used for gas delivery[2].
Scope of the Patent
Overview
The U.S. Patent 9,265,911 describes a gas delivery device and system designed to deliver therapy gas, specifically nitric oxide, to patients. The scope of this patent encompasses both the hardware and the methodology involved in the gas delivery process.
Key Components
The patent details several key components of the gas delivery system:
- Gas Source: The system includes a gas source that provides the therapy gas, which is nitric oxide in this case.
- Valve and Control Module: A valve attachable to the gas source, which is controlled by a valve actuator to regulate the flow of gas. The control module ensures the delivery of the gas in an amount effective to treat or prevent hypoxic respiratory failure[5].
- Memory and Processor: The system includes a memory to store gas data such as gas identification, expiration date, and concentration. A processor and transceiver communicate this data to the control module to verify the gas parameters before delivery[5].
Claims of the Patent
Method Claims
The patent includes method claims that outline the steps involved in delivering the therapy gas. For example:
- Claim 10 describes a method that includes comparing the drug data stored in the memory with the actual gas being delivered to ensure it meets the required specifications. If the comparison indicates a mismatch, the delivery of the therapy gas is prevented or ceased[5].
Device Claims
The device claims describe the physical components and their functionalities:
- Claim 1 of the patent describes a gas delivery device comprising a gas source, a valve with an inlet and outlet, a valve actuator, and a control module. The device also includes a circuit with a memory, processor, and transceiver to manage and verify the gas data[5].
Patent Landscape
Related Patents
The U.S. Patent 9,265,911 is part of a larger family of patents related to the INOmax® product. Other relevant patents include:
- Heart Failure Patents (HF Patents): These patents, such as U.S. Patent Nos. 8,282,966; 8,293,284; 8,795,741; 8,431,163; and 8,846,112, cover methods for identifying infants who should not receive conventional iNO treatment due to specific health conditions[1].
- Delivery System Infrared Patents (DSIR Patents): These patents, including U.S. Patent Nos. 8,573,209; 8,776,794; 8,776,795; 9,265,911; and 9,295,802, focus on the gas delivery systems and devices[1].
Litigation and Legal Challenges
The patents related to INOmax® have been involved in significant litigation. For instance, Mallinckrodt has faced challenges from Praxair Distribution, Inc. and Praxair Inc., which sought declaratory judgments of invalidity and de-listing of the patents. The District Court of Delaware allowed the addition of new patents to the existing lawsuit to conserve judicial and party resources[2].
Supreme Court Petition
In a notable development, Mallinckrodt filed a certiorari petition with the Supreme Court to challenge a Federal Circuit decision that held certain method-of-treatment claims patent-ineligible. This petition highlights the ongoing legal battles and the need for clarity in patent eligibility jurisprudence, particularly for method-of-treatment claims[1].
Impact on Innovation
The uncertainty surrounding patent eligibility, as seen in the Federal Circuit's decisions and the subsequent Supreme Court petition, has significant implications for innovation. Industry experts, including former Chief Judge Paul Michel and current PTO Director Andrei Iancu, have emphasized that inconsistent decisions harm the patent system and innovation. The case involving U.S. Patent 9,265,911 and related patents underscores the need for clear guidelines to ensure that method-of-treatment claims are not unfairly deemed patent-ineligible[1].
Key Takeaways
- Comprehensive System: The patent covers a comprehensive gas delivery system, including hardware and methodology.
- Method and Device Claims: The patent includes both method and device claims, ensuring broad protection for the invention.
- Litigation: The patent is part of ongoing litigation involving challenges to its validity and patent eligibility.
- Impact on Innovation: The legal challenges surrounding this patent highlight the broader issues with patent eligibility and their impact on innovation.
FAQs
What is the main subject of U.S. Patent 9,265,911?
The main subject of U.S. Patent 9,265,911 is a gas delivery device and system designed to deliver therapy gas, specifically nitric oxide, to patients.
What are the key components of the gas delivery system described in the patent?
The key components include a gas source, a valve with an actuator, a control module, and a circuit with memory, processor, and transceiver to manage and verify gas data.
Which other patents are related to U.S. Patent 9,265,911?
The patent is part of a larger family of patents related to the INOmax® product, including Heart Failure Patents (HF Patents) and Delivery System Infrared Patents (DSIR Patents).
What legal challenges has Mallinckrodt faced regarding these patents?
Mallinckrodt has faced challenges from Praxair Distribution, Inc. and Praxair Inc., seeking declaratory judgments of invalidity and de-listing of the patents. Additionally, Mallinckrodt has petitioned the Supreme Court to challenge a Federal Circuit decision on patent eligibility.
How does the patent landscape affect innovation in this field?
The uncertainty surrounding patent eligibility, as seen in the Federal Circuit's decisions and the subsequent Supreme Court petition, can harm innovation by creating confusion and inconsistent application of patent laws.
What is the significance of the Supreme Court petition filed by Mallinckrodt?
The petition seeks to clarify patent eligibility jurisprudence, particularly for method-of-treatment claims, which is crucial for maintaining an "island of stability" in patent law and supporting innovation in medical treatments.
Sources
- Mallinckrodt Files Certiorari Petition in iNO v. Praxair - McDonnell Boehnen Hulbert & Berghoff LLP
- District of Delaware: 15-170.pdf - District of Delaware
- Patent Claims Research Dataset - USPTO
- U.S. Patent Number 9,265,911 - Law360
- US9265911B2 - Gas delivery device and system - Google Patents
