Details for Patent: 9,027,967

Which drugs does patent 9,027,967 protect, and when does it expire?

Patent 9,027,967 protects COMBIVENT RESPIMAT, STIOLTO RESPIMAT, STRIVERDI RESPIMAT, and SPIRIVA 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 patent family members in twenty-seven countries.

Summary for Patent: 9,027,967

Title:	Device for clamping a fluidic component
Abstract:	A fluidic component is arranged in an elastomeric shaped part the contour of which is matched to the outer contour of the component and to the inner contour of a holder. The elastomeric shaped part is chamfered towards the fluidic component on its pressure side. When the holder is assembled the elastomeric shaped part is deformed by a projection provided on a mating part and is put under uniformly distributed internal tension, after which the elastomeric shaped part surrounds the fluidic component to its full height.
Inventor(s):	Geser; Johannes (Ingelheim, DE), Hausmann; Matthias (Dortmund, DE)
Assignee:	Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE)
Application Number:	12/641,424
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,027,967
Patent Claim Types: see list of patent claims	Delivery; Device; Use;

United States Patent 9,027,967: A Comprehensive Analysis

Introduction

United States Patent 9,027,967, hereafter referred to as the '967 patent, is a significant intellectual property asset in the pharmaceutical industry, particularly in the realm of inhalation therapies. This patent is held by Boehringer Ingelheim and protects several key products, including COMBIVENT RESPIMAT, STIOLTO RESPIMAT, STRIVERDI RESPIMAT, and SPIRIVA RESPIMAT.

Patent Overview

The '967 patent is part of a broader patent family with thirty members across twenty-seven countries, indicating its global significance and the extensive protection it offers[1].

Protected Products

• COMBIVENT RESPIMAT: A combination of albuterol sulfate and ipratropium bromide, used for the treatment of chronic obstructive pulmonary disease (COPD).
• STIOLTO RESPIMAT: A combination of tiotropium bromide and olodaterol, also used for COPD.
• STRIVERDI RESPIMAT: Contains olodaterol, used for the maintenance treatment of COPD.
• SPIRIVA RESPIMAT: Contains tiotropium bromide, used for COPD and asthma[1].

Patent Claims

The '967 patent includes various claim types such as delivery, device, and use claims. Here’s a breakdown of the strategic importance of these claims:

Claim Types

• Delivery Claims: These claims cover the method of delivering the pharmaceutical substances through the RESPIMAT device.
• Device Claims: These claims protect the design and functionality of the RESPIMAT inhaler itself.
• Use Claims: These claims specify the therapeutic uses of the products delivered by the RESPIMAT device[1][2].

Strategic Claim Management

Effective claim management is crucial for maintaining the strength and enforceability of the patent. Here are some key strategies:

Balancing Breadth and Precision

Claims must be broad enough to cover various embodiments of the invention but specific enough to distinguish it from prior art. This balance is essential for deterring infringement and maintaining a competitive edge[3].

Claim Differentiation

Using both independent and dependent claims helps to cover different features and aspects of the invention comprehensively. For example, independent claims might cover the broad method of drug delivery, while dependent claims could delve into specifics such as the design of the nozzle or the type of pharmaceutical substance used[3].

Adapting Claims to Meet USPTO Requirements

Claims must be drafted and amended to meet the requirements of the United States Patent and Trademark Office (USPTO). This includes responding effectively to examination feedback and leveraging examiner interviews to strengthen the claims[3].

Patent Litigation and Enforcement

The '967 patent has been involved in several patent infringement cases, highlighting its importance and the efforts to protect it.

Recent Litigation

In a recent case, Boehringer Ingelheim sued several defendants for submitting an Abbreviated New Drug Application (ANDA) to market a generic version of SPIRIVA RESPIMAT before the patent's expiration. The plaintiffs sought injunctive relief, attorneys’ fees, and other relief, alleging infringement of the '967 patent among others[2].

Validity and Infringement Challenges

Defendants in such cases often challenge the validity and enforceability of the patent. For instance, in the mentioned litigation, defendants alleged that the '967 patent was invalid. However, the plaintiffs argued that such claims were without adequate justification and sought a declaratory judgment of patent infringement[2].

International Protection

The '967 patent is part of an extensive international patent family, with protection in countries such as Austria, Australia, Brazil, Canada, China, and others. This global coverage is crucial for maintaining market exclusivity and preventing generic competition worldwide[1].

Pediatric Extension

The protection for SPIRIVA RESPIMAT under the '967 patent has been extended by six months due to pediatric studies, as indicated by the PED designation. This extension further prolongs the market exclusivity for this product[1].

Technological Significance

The '967 patent covers innovations related to the RESPIMAT device, which is used for producing propellant-free medicinal aerosols. This technology is significant in the field of inhalation therapies, particularly for conditions like COPD and asthma. The device ensures reliable and efficient delivery of pharmaceutical substances, which is critical for patient care[4].

Economic Impact

The economic impact of the '967 patent is substantial. By protecting key products, Boehringer Ingelheim maintains a significant market share in the inhalation therapy segment. The patent also influences the pricing and availability of generic alternatives, which can affect healthcare costs and patient access to these medications.

Key Takeaways

• The '967 patent protects several critical inhalation therapy products, including COMBIVENT RESPIMAT, STIOLTO RESPIMAT, STRIVERDI RESPIMAT, and SPIRIVA RESPIMAT.
• The patent includes various claim types such as delivery, device, and use claims.
• Effective claim management involves balancing breadth and precision, differentiating claims, and adapting to USPTO requirements.
• The patent is part of an extensive international patent family.
• It has been involved in significant patent litigation to protect its validity and enforceability.
• The patent’s protection has been extended due to pediatric studies.

FAQs

1. What products are protected by the '967 patent? The '967 patent protects COMBIVENT RESPIMAT, STIOLTO RESPIMAT, STRIVERDI RESPIMAT, and SPIRIVA RESPIMAT.

2. What types of claims are included in the '967 patent? The patent includes delivery, device, and use claims.

3. Why is international protection important for the '967 patent? International protection helps maintain market exclusivity and prevents generic competition worldwide.

4. What is the significance of the pediatric extension for SPIRIVA RESPIMAT? The pediatric extension prolongs the market exclusivity for SPIRIVA RESPIMAT by six months.

5. How does the '967 patent impact the pharmaceutical market? The patent influences the pricing and availability of generic alternatives, affecting healthcare costs and patient access to these medications.

Sources

1. Drug Patent Watch - Patent 9,027,967.
2. RPX Corporation - Plaintiffs' Approved SPIRIVA® RESPIMAT® Drug Product and Patents-in-Suit.
3. TT Consultants - Strategies for Effective Patent Claim Management.
4. Google Patents - US9027967B2 - Device for clamping a fluidic component.

Drugs Protected by US Patent 9,027,967

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			Y
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015		RX	Yes	Yes					Y
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes					Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes			Y
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 9,027,967

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2004 001 451	Jan 8, 2004

International Family Members for US Patent 9,027,967

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004311644
Austria	E380595
Brazil	PI0418364
Canada	2552535
China	1921949
Colombia	5700802