Details for Patent: 7,396,341

Which drugs does patent 7,396,341 protect, and when does it expire?

Patent 7,396,341 protects COMBIVENT RESPIMAT, STRIVERDI RESPIMAT, SPIRIVA RESPIMAT, and STIOLTO RESPIMAT, and is included in four NDAs.

Protection for SPIRIVA RESPIMAT has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-one patent family members in twenty-seven countries.

Summary for Patent: 7,396,341

Title:	Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Abstract:	A locking-stressing-mechanism with spring-actuated output drive and a counter with which an apparatus of this kind is fitted, accommodated in a two part housing the two parts of which are mounted to be rotatable relative to each other, can be blocked by means of a pre-stressed leaf spring. The leaf spring is initially accommodated in a recess in the wall of one housing part. As soon as the permitted number of actuations has been reached a push rod pushes the leaf spring out of its resting position. The leaf spring then jumps into a recess in the wall of the other housing part and the two housing parts can no longer be rotated relative to each other. The push rod may be mounted on the pointer of the counter. This blocking device can only be overcome by the application of a force which is sufficient to destroy the device. The device is suitable for blocking a high pressure atomiser or a needleless injector with which a fluid is atomised to form an aerosol or a fluid is injected into a biological tissue.
Inventor(s):	Schyra; Michael (Wuppertal, DE), Wachtel; Herbert (Bingen, DE)
Assignee:	Boehringer Ingelheim International GmbH (Ingelheim, DE)
Application Number:	10/650,869
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,396,341
Patent Claim Types: see list of patent claims	Use; Device; Dosage form;

Understanding the Scope and Claims of United States Patent 7,396,341

Introduction to Patent 7,396,341

United States Patent 7,396,341, hereafter referred to as the '341 patent, is a critical component in the patent landscape of pharmaceutical products, particularly those related to inhalation devices and medications. This patent is associated with Boehringer Ingelheim's SPIRIVA Respimat, a drug used for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.

Patent Overview

Invention Description

The '341 patent describes an inhalation device and method for delivering a medicament, specifically focusing on the design and functionality of the device. The patent covers various aspects of the inhalation device, including the atomizer and the method of atomizing fluid with a nozzle rinsing mechanism. This mechanism is crucial for ensuring the consistent delivery of the medicament to the patient[4][5].

Claims

The '341 patent includes multiple claims that define the scope of the invention. These claims typically cover the structural components of the inhalation device, the process of atomizing the fluid, and the specific features of the nozzle rinsing mechanism. Here are some key aspects of the claims:

• Structural Components: The patent claims describe the inhalation device's components, such as the housing, the medicament reservoir, and the atomizer nozzle.
• Atomization Process: The claims detail the method of atomizing the fluid, including the steps involved in creating a fine aerosol for inhalation.
• Nozzle Rinsing Mechanism: This is a critical feature that ensures the nozzle remains clear and functional by rinsing it after each use, preventing clogging and maintaining efficacy[5].

Patent Landscape Analysis

Legal Status and Expiry Dates

The '341 patent is set to expire on October 10, 2026. This expiry date is significant for generic drug manufacturers, as it marks the point at which they can seek approval to market a generic version of the drug without infringing on the patent[5].

Competitive Landscape

The patent landscape for inhalation devices and medications is highly competitive. Companies like Boehringer Ingelheim invest heavily in research and development to maintain their market position. Patent landscape analysis helps these companies understand the competitive environment, identify potential threats, and capitalize on opportunities.

• Market Developments: The landscape includes market developments such as mergers and acquisitions, in/out-licensing agreements, and litigation activities. For instance, the submission of Abbreviated New Drug Applications (ANDAs) by generic manufacturers often leads to patent infringement lawsuits, as seen in the case of SPIRIVA Respimat[2].
• Litigation and PTAB Cases: The '341 patent, along with other related patents, has been involved in various litigation and Patent Trial and Appeal Board (PTAB) cases. These cases are crucial in determining the validity and enforceability of the patent claims[2][4].

Impact on Generic Competition

ANDA Filings and Paragraph IV Certifications

Generic drug manufacturers often file ANDAs with a Paragraph IV certification, which challenges the validity or non-infringement of the listed patents. This process is a key strategy for generic companies to gain approval to market their versions of the drug before the patent expires. The '341 patent, being a part of this landscape, is subject to such challenges, which can lead to significant legal battles[2].

First Filer Status

The first generic manufacturer to file an ANDA with a Paragraph IV certification and receive FDA approval may be eligible for a 180-day exclusivity period. This exclusivity can provide a significant market advantage, making the timing and strategy of ANDA filings critical[1].

Strategic Implications

Patent Search Strategies

To navigate the complex patent landscape, companies must devise robust patent search strategies. This involves identifying relevant patents, including those pending or in process, and analyzing their legal, business, and technical implications. Sources such as the USPTO, WIPO, and EPO databases are essential for this analysis[3].

Decision-Making and Risk Management

Patent landscape analysis provides valuable insights that aid in decision-making and risk management. For example, knowing the expected expiry dates of patents like the '341 patent helps companies plan their product development and market entry strategies. It also highlights potential litigation risks and opportunities for licensing or acquiring patents[3].

Key Takeaways

• Patent Scope and Claims: The '341 patent covers specific aspects of inhalation devices, including the atomizer and nozzle rinsing mechanism.
• Legal Status and Expiry Dates: The patent is set to expire on October 10, 2026, marking a significant date for generic competition.
• Competitive Landscape: The patent landscape is highly competitive, with ongoing litigation and PTAB cases.
• Generic Competition: ANDA filings and Paragraph IV certifications are critical strategies for generic manufacturers.
• Strategic Implications: Robust patent search strategies and thorough landscape analysis are essential for decision-making and risk management.

FAQs

1. What is the '341 patent related to? The '341 patent is related to an inhalation device and method for delivering a medicament, specifically associated with Boehringer Ingelheim's SPIRIVA Respimat.

2. When is the '341 patent set to expire? The '341 patent is set to expire on October 10, 2026.

3. What is the significance of the nozzle rinsing mechanism in the '341 patent? The nozzle rinsing mechanism ensures the consistent delivery of the medicament by preventing clogging of the nozzle.

4. How do generic manufacturers challenge the '341 patent? Generic manufacturers challenge the '341 patent by filing ANDAs with a Paragraph IV certification, which asserts the patent's invalidity or non-infringement.

5. What is the impact of the '341 patent's expiry on the pharmaceutical market? The expiry of the '341 patent will allow generic manufacturers to seek FDA approval for their versions of the drug, potentially increasing competition and reducing drug prices.

Sources

1. The BioLoquitur Bulletin - Seyfarth Shaw LLP
2. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Insight.RPXCorp
3. Navigating Technological Domains with Patent Landscape Analysis - Sagacious Research
4. SPIRIVA Drug Patent Profile - DrugPatentWatch
5. Generic Spiriva Respimat Availability - Drugs.com

Drugs Protected by US Patent 7,396,341

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	7,396,341		Y
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes	7,396,341		Y			TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), CHRONIC BRONCHITIS OR EMPHYSEMA
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015		RX	Yes	Yes	7,396,341*PED				Y
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes	7,396,341*PED				Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,396,341*PED				Y

Foreign Priority and PCT Information for Patent: 7,396,341

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	102 39 443	Aug 28, 2002

International Family Members for US Patent 7,396,341

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	041060
Austria	490823
Australia	2003255479
Brazil	0313816
Canada	2497059
China	100393425