Details for Patent: 10,086,156

Which drugs does patent 10,086,156 protect, and when does it expire?

Patent 10,086,156 protects PROAIR HFA, QVAR 40, QVAR 80, and QVAR REDIHALER, and is included in three NDAs.

This patent has one hundred and ninety-two patent family members in twenty-four countries.

Summary for Patent: 10,086,156

Title:	Dose counter for inhaler and method for counting doses
Abstract:	A dose counter for a metered dose inhaler includes an incremental counting system for counting doses. The incremental counting system has a main body, an actuator arranged to be driven in response to canister motion and to drive an incremental output member in response to canister motion. The actuator and incremental output member are configured to have predetermined canister fire and count configurations in a canister fire sequence. The canister fire configuration is determined by a position of the actuator relative to a datum at which the canister fires medicament and the count configuration is determined by a position of the actuator relative to the datum at which the incremental count system makes an incremental count. The actuator is arranged to reach a position in the count configuration at or after a position in the canister fire configuration.
Inventor(s):	Walsh; Declan (Co. Kilkenny, IE), Fenlon; Derek (Co. Wexford, IE), Kaar; Simon (Co. Cork, IE), Hazenberg; Jan Geert (Co. Kilkenny, IE), Buck; Daniel (Co. Waterford, IE), Clancy; Paul (Waterford, IE), Uschold; Robert Charles (Leominster, MA), Karg; Jeffrey A. (Hopkinton, MA)
Assignee:	Ivax Pharmaceuticals Ireland (Waterford, IE) Norton (Waterford) Limited (Waterford, IE) Teva Pharmaceuticals Ireland (Waterford, IE)
Application Number:	14/699,567
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,086,156
Patent Claim Types: see list of patent claims	Delivery; Device;

United States Patent 10,086,156: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 10,086,156, titled "Dose counter for inhaler and method for counting doses," is a significant patent in the field of pharmaceuticals, particularly concerning metered dose inhalers. This patent, issued to Teva Branded Pharmaceutical Products R&D, Inc., is crucial for understanding the technological and legal landscape surrounding inhaler dose counters.

Background and Context

Metered dose inhalers (MDIs) are widely used for delivering medication to patients with respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). The patent in question addresses the critical component of these devices: the dose counter.

Patent Scope and Claims

Overview of the Patent

The patent 10,086,156 focuses on the design and functionality of dose counters for inhalers. It includes an incremental counting system that tracks the number of doses dispensed from the inhaler[4].

Key Claims

• Claim 1: This claim describes an inhaler for metered dose inhalation, comprising a main body with a canister housing, a medicament canister, and a dose counter. The dose counter has an actuation member located within the canister housing, which operates by the movement of the medicament canister[1][4].
• Incremental Counting System: The patent details a system where the dose counter moves incrementally in response to actuation input, ensuring accurate tracking of doses dispensed[4].

Dependent Claims

• The patent includes several dependent claims that elaborate on the specifics of the dose counter's design and operation. For example, claims may specify the resistance force required for the counter display to move or the configuration of the canister housing[1][4].

Technical Details

Dose Counter Mechanism

The dose counter mechanism involves a drive system that moves the counter display in a first direction from a first station to a second station in response to actuation input. A regulator is provided to ensure incremental movements of the counter display[4].

Canister and Housing Configuration

The medicament canister is moveable relative to the canister housing and is retained in a central outlet port. The canister housing has an inner wall with specific support formations to ensure proper alignment and operation of the dose counter[1].

Patent Landscape and Litigation

Litigation Involving the Patent

The patent 10,086,156 has been involved in litigation, particularly in cases where generic manufacturers have sought to challenge its validity or infringement. For instance, in the case of Teva Branded Pharm. Prods. R&D v. Cipla Ltd., Cipla filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification, asserting that the patents, including the '156 Patent, were invalid or not infringed[5].

Other Relevant Patents and Cases

Other patents related to inhaler dose counters, such as the '289 Patent and the '808 Patent, have also been subject to litigation. These patents often involve similar technologies and claims, highlighting the complex and contested nature of the patent landscape in this field[1].

Industry Impact and Significance

Innovation in Pharmaceutical Devices

The patent 10,086,156 represents a significant innovation in the design of dose counters for inhalers, ensuring accurate and reliable tracking of medication doses. This innovation is crucial for patient safety and compliance with treatment regimens.

Generic Competition and Market Access

Litigation surrounding this patent, as well as others in the same field, affects the entry of generic competitors into the market. The outcome of these cases can influence the availability and affordability of essential medications for patients[2].

Patent Quality and Scope Metrics

Independent Claim Length and Count

Research on patent scope suggests that metrics such as independent claim length and count can be used to assess the breadth and clarity of patent claims. These metrics can help evaluate the quality and potential impact of patents like the '156 Patent[3].

Challenges and Criticisms

Patent Quality Debates

There are ongoing debates about patent quality, particularly concerning the breadth and clarity of claims. Some argue that overly broad or unclear claims can hinder innovation by increasing licensing and litigation costs[3].

Conclusion and Future Implications

The United States Patent 10,086,156 is a pivotal patent in the field of inhaler dose counters, reflecting both technological innovation and the complex legal landscape surrounding pharmaceutical devices. Understanding the scope, claims, and litigation history of this patent is essential for navigating the challenges and opportunities in this sector.

Key Takeaways

• The patent 10,086,156 focuses on the design and functionality of dose counters for metered dose inhalers.
• Key claims include the incremental counting system and specific configurations of the canister housing and dose counter.
• Litigation involving this patent highlights the contested nature of the patent landscape in pharmaceutical devices.
• The patent's innovation is crucial for patient safety and compliance with treatment regimens.
• Metrics such as independent claim length and count can help assess patent quality.

Frequently Asked Questions (FAQs)

1. What is the primary focus of the United States Patent 10,086,156?

The primary focus of the patent is the design and functionality of dose counters for metered dose inhalers.

2. What are the key claims of the patent?

The key claims include the description of an inhaler with a main body, canister housing, medicament canister, and a dose counter with an incremental counting system.

3. How does the dose counter mechanism work?

The dose counter mechanism involves a drive system that moves the counter display incrementally in response to actuation input, with a regulator ensuring accurate movements.

4. What is the significance of this patent in the pharmaceutical industry?

This patent represents a significant innovation in ensuring accurate and reliable tracking of medication doses, which is crucial for patient safety and compliance.

5. What are some of the challenges and criticisms related to this type of patent?

Challenges include debates about patent quality, particularly concerning the breadth and clarity of claims, which can affect innovation and litigation costs.

Drugs Protected by US Patent 10,086,156

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	AB2	RX	Yes	Yes			Y
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000		DISCN	Yes	No			Y
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No			Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017		RX	Yes	No			Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	No			Y

International Family Members for US Patent 10,086,156

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011254958
Brazil	112012029106
Canada	2799625
Canada	2887315
Canada	2936362
Canada	3019694
Canada	3111537