Details for Patent: 11,395,889

Which drugs does patent 11,395,889 protect, and when does it expire?

Patent 11,395,889 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: 11,395,889

Title:	Dose counter for inhaler having an anti-reverse rotation actuator
Abstract:	An inhaler includes a main body having a canister housing, a medicament canister retained in a central outlet port of the canister housing, and a dose counter having an actuation member for operation by movement of the medicament canister. The canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall. The canister housing has a longitudinal axis X which passes through the center of the central outlet port. The first inner wall canister support formation, the actuation member, and the central outlet port lie in a common plane coincident with the longitudinal axis X such that the first inner wall canister support formation protects against unwanted actuation of the dose counter by reducing rocking of the medicament canister relative to the main body of the inhaler.
Inventor(s):	Walsh; Declan (County Kilkenny, IE), Fenlon; Derek (County Wexford, IE), Kaar; Simon (County Cork, IE), Hazenberg; Jan Geert (County Kilkenny, IE), Buck; Daniel (County 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:	16/915,558
Patent Claim Types: see list of patent claims	Delivery;

United States Patent 11,395,889: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 11,395,889, hereafter referred to as the '889 patent, is a significant patent in the pharmaceutical industry, particularly in the context of inhaler devices. This patent has been at the center of a recent legal battle involving Teva Pharmaceuticals and generic drug manufacturer Amneal. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

The '889 patent, titled "Dose counter for inhaler having an anti-reverse rotation actuator," protects several inhaler products, including PROAIR HFA, QVAR 40, QVAR 80, and QVAR REDIHALER. These products are included in three New Drug Applications (NDAs)[1][4].

Claims and Scope

The patent primarily focuses on a dose counter mechanism designed for inhalers. This mechanism includes an actuation member that operates by the movement of the medicament canister. The canister housing features an inner wall and a first inner wall, among other components, to ensure accurate dose counting and prevent reverse rotation of the counter[4].

Key Components

• Dose Counter: The patent describes a dose counter with an anti-reverse rotation actuator, ensuring that the counter accurately tracks the number of doses dispensed.
• Canister Housing: The design includes an inner wall and other structural elements to house the medicament canister.
• Actuation Member: This component is crucial for the operation of the dose counter, triggered by the movement of the canister.

Patent Landscape

The '889 patent is part of a larger family of patents with 192 patent family members across 24 countries. This extensive global coverage underscores the significance of this invention in the international pharmaceutical market[1].

Related Patents

The '889 patent is one of several patents listed by Teva for its ProAir® HFA Inhalation Aerosol product. Other related patents include US Patent Nos. 8,132,712; 9,463,289; 9,808,587; and 10,561,808. These patents collectively protect various aspects of the inhaler device and its components[2][5].

Legal Disputes and Delisting

Recently, the US District Court for the District of New Jersey ordered Teva to delist the '889 patent, along with four other related patents, from the FDA's Approved Drug Products (Orange Book). This decision was made after Amneal filed an Abbreviated New Drug Application (ANDA) and counterclaimed for the delisting of these patents, arguing they were improperly listed.

Hatch-Waxman Act

Under the Hatch-Waxman Act, only three types of patents can be listed in the Orange Book: drug substance patents, drug product patents, and method of use patents. The court ruled that the '889 patent and the other listed patents did not meet these criteria, thus ordering their delisting[2][5].

Federal Trade Commission (FTC) Involvement

The FTC played a significant role in this case by submitting an amicus brief urging the court to delist the patents. The FTC argued that improper listings could delay the introduction of generic versions of the drug, which is against the spirit of promoting competition and reducing healthcare costs[2].

Impact on Generic Entry

The delisting of the '889 patent and other related patents has significant implications for the entry of generic versions of ProAir® HFA. Without these patents listed in the Orange Book, generic manufacturers like Amneal can proceed with their ANDAs, potentially leading to earlier market entry and increased competition in the inhaler market[2][5].

Global Patent Family

The '889 patent is part of a substantial global patent family, with 192 family members in 24 countries. This extensive coverage highlights the strategic importance of this patent in protecting Teva's intellectual property worldwide[1].

Conclusion

The '889 patent is a critical component in the intellectual property portfolio of Teva Pharmaceuticals, particularly for its inhaler products. However, the recent court decision to delist this patent, along with others, from the Orange Book, marks a significant shift in the patent landscape. This change is expected to facilitate the entry of generic competitors, enhancing market competition and potentially reducing healthcare costs.

Key Takeaways

• Patent Scope: The '889 patent focuses on a dose counter mechanism for inhalers with an anti-reverse rotation actuator.
• Legal Disputes: The patent was delisted from the Orange Book due to improper listing under the Hatch-Waxman Act.
• Impact on Generics: Delisting facilitates the entry of generic versions of ProAir® HFA.
• Global Coverage: The patent is part of a large global patent family with 192 family members in 24 countries.
• FTC Involvement: The FTC supported the delisting to promote competition and reduce healthcare costs.

FAQs

What products are protected by the '889 patent?

The '889 patent protects PROAIR HFA, QVAR 40, QVAR 80, and QVAR REDIHALER inhaler products.

Why was the '889 patent delisted from the Orange Book?

The '889 patent was delisted because it did not meet the criteria for listing under the Hatch-Waxman Act, as it did not claim the drug substance, drug product, or method of use.

What role did the FTC play in the delisting of the '889 patent?

The FTC submitted an amicus brief urging the court to delist the patents to prevent delays in the introduction of generic drug products and to promote competition.

How does the delisting affect generic drug manufacturers?

The delisting allows generic manufacturers to proceed with their ANDAs without the 30-month stay triggered by the listed patents, facilitating earlier market entry.

What is the global reach of the '889 patent?

The '889 patent is part of a global patent family with 192 family members in 24 countries.

Sources

1. Drug Patent Watch: Summary for Patent: 11,395,889.
2. JD Supra: Teva Ordered to Delist Inhaler Patents From FDA Orange Book.
3. USPTO: Patent Claims Research Dataset.
4. Google Patents: US11395889B2 - Dose counter for inhaler having an anti-reverse rotation actuator.
5. JD Supra: New Jersey District Court Orders Delisting Of Teva Inhaler Patents.

Drugs Protected by US Patent 11,395,889

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	11,395,889		Y
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000		DISCN	Yes	No	11,395,889		Y
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No	11,395,889		Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017		RX	Yes	No	11,395,889		Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	No	11,395,889		Y

International Family Members for US Patent 11,395,889

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