United States Patent 11,395,888: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,395,888, titled "Inhalers and Related Methods," is a significant patent in the field of medical devices, particularly focusing on inhalers and the methods associated with their operation. This patent, assigned to Norton (Waterford) Limited, was granted on July 26, 2022. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
Inhalers are crucial medical devices used for delivering medicaments directly into the lungs. The patent in question addresses various aspects of inhaler design and functionality, including breath-actuated and metered dose inhalers. This technology is vital for treating respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD)[1][4].
Scope of the Patent
The scope of US Patent 11,395,888 is broad and encompasses several key components and methods related to inhalers:
Inhaler Types
The patent covers both breath-actuated and metered dose inhalers. Breath-actuated inhalers are designed to release the medicament when the user inhales, while metered dose inhalers deliver a precise amount of medication with each actuation[1].
Canister and Metering Valve
The invention includes a pressurized canister with a metering valve that controls the ejection of inhalable substances. The metering valve features a valve stem that transfers substances from the canister's interior reservoir into a metering chamber and then out through the nozzle of the inhaler[1][4].
Inhaler Housing and Interfaces
The patent also describes the inhaler housing and the interfaces between the inhaler valve stem and the valve stem block. These components are critical for the proper functioning and durability of the inhaler[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Main Claims
- The patent claims a breath-actuated metered dose inhaler with a canister fire system, a pressurized canister, and a metering valve.
- It also claims the method of metering inhalable substances in the metering valve of the canister[1][4].
Specific Components
- The claims specify the design and operation of the valve stem, the metering chamber, and the nozzle.
- They also cover the force holding unit and the cap housing attachable to the main housing of the inhaler[1].
Patent Landscape
The patent landscape surrounding US Patent 11,395,888 is complex and involves multiple patents and legal disputes.
Related Patents
- The patent is part of a larger portfolio held by Teva Branded Pharmaceutical Products R&D, Inc., and Norton (Waterford) Ltd. This portfolio includes several other patents related to inhalers, such as U.S. Patent Nos. 8,132,712, 8,931,476, 10,022,509, and others[2][5].
Litigation and Disputes
- There are ongoing legal disputes involving this patent, particularly with Cipla USA, Inc., and Cipla Ltd., which have submitted Abbreviated New Drug Applications (ANDAs) to the FDA for generic versions of Teva's QVAR RediHaler® product. Teva and Norton have alleged patent infringement and are seeking to protect their intellectual property rights[2][5].
Patent Scope and Quality
- The debate over patent scope and quality is relevant here. The patent's claims and scope are subject to scrutiny, with discussions around the breadth and clarity of the claims. Research suggests that narrower claims are associated with a higher probability of grant and a shorter examination process[3].
Technical Details and Innovations
The patent provides detailed descriptions of the technical innovations:
Metering Valve and Valve Stem
- The metering valve includes a valve stem that ensures precise metering of the inhalable substance. This is crucial for delivering the correct dosage to the patient[1][4].
Force Holding Unit and Cap Housing
- The force holding unit and cap housing are designed to ensure the secure attachment of the canister to the main housing of the inhaler, facilitating smooth operation[1].
Diaphragm and Chamber Formation
- The patent describes the formation of a chamber by a diaphragm, which plays a role in the metering process and the release of the medicament[4].
Industry Impact and Future Directions
The impact of this patent on the pharmaceutical and medical device industries is significant:
Treatment of Respiratory Conditions
- The technology described in the patent enhances the delivery of medicaments for respiratory conditions, improving patient outcomes and compliance[1].
Competitive Landscape
- The ongoing litigation and disputes highlight the competitive nature of the industry. Companies are investing heavily in research and development to protect and expand their market share[2][5].
Future Innovations
- Future innovations in inhaler technology are likely to focus on improving the precision of dosing, enhancing patient usability, and integrating digital health technologies to monitor and manage respiratory conditions more effectively.
Key Takeaways
- Inhaler Types: The patent covers both breath-actuated and metered dose inhalers.
- Metering Valve: The invention includes a precise metering valve with a valve stem.
- Legal Landscape: The patent is part of ongoing litigation involving Teva and Cipla.
- Technical Innovations: The patent details innovations in the force holding unit, cap housing, and diaphragm formation.
- Industry Impact: The technology improves medicament delivery for respiratory conditions and highlights industry competition.
Frequently Asked Questions (FAQs)
What types of inhalers are covered by US Patent 11,395,888?
The patent covers both breath-actuated and metered dose inhalers.
What is the role of the metering valve in the patent?
The metering valve controls the ejection of inhalable substances from the canister, ensuring precise dosing.
Who are the assignees of the patent?
The patent is assigned to Norton (Waterford) Limited.
What is the current legal status of the patent?
The patent is active and involved in ongoing litigation related to patent infringement.
How does the patent impact the treatment of respiratory conditions?
The patent enhances the delivery of medicaments for respiratory conditions, improving patient outcomes and compliance.
Cited Sources
- US11395888B2 - Inhalers and related methods - Google Patents
- Case 2:24-cv-09691 Document 1 Filed 10/09/24 Page 1 of 95 PageID - RPX Insight
- Patent Claims and Patent Scope - SSRN
- United States Patent - googleapis.com - US Patent 11,395,888 B2
- TEVA BRANDED PHARMACEUTICAL : Civil Action No. - RPX Insight
