Details for Patent: 7,837,235

Which drugs does patent 7,837,235 protect, and when does it expire?

Patent 7,837,235 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 patent family members in twenty-seven countries.

Summary for Patent: 7,837,235

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:	11/031,171
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,837,235
Patent Claim Types: see list of patent claims	Delivery; Device;

United States Patent 7,837,235: A Detailed Analysis

Overview of the Patent

The United States Patent 7,837,235, hereafter referred to as the '235 patent, is part of a broader patent landscape involving pharmaceutical products, specifically related to the SPIRIVA® Respimat® product. This patent is one of several that have been the subject of litigation and regulatory scrutiny.

Patent Details

• Patent Number: 7,837,235
• Title: The title of the patent is not explicitly provided in the sources, but it is associated with the SPIRIVA® Respimat® product, which is a pharmaceutical device used for the treatment of chronic obstructive pulmonary disease (COPD)[2][5].
• Assignees: The patent is held by the plaintiffs in the litigation documents, which are likely pharmaceutical companies such as Boehringer Ingelheim or related entities.

Claims and Scope

The '235 patent is part of a suite of patents that cover various aspects of the SPIRIVA® Respimat® product, including its formulation, device design, and method of use.

Infringement Allegations

In the litigation context, the '235 patent is alleged to be infringed by the defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA. The plaintiffs claim that the defendants' commercial manufacture, use, or sale of the generic product would infringe on the claims of the '235 patent[5].

Invalidity and Non-Infringement Assertions

The defendants have asserted that the '235 patent is invalid, unenforceable, and/or not infringed by their ANDA product. These assertions are part of the defendants' strategy to challenge the patent exclusivity and gain approval for their generic version of the drug[5].

Patent Landscape Analysis

Competitors and Market

The '235 patent operates within a competitive landscape where multiple pharmaceutical companies are vying for market share in the COPD treatment segment. The patent landscape analysis would reveal which organizations are actively filing patents in this field, the technologies being targeted, and the strategies employed by competitors[3].

Exclusivity and Regulatory Environment

The '235 patent benefits from various exclusivities provided under U.S. patent law and regulatory frameworks. For instance, the Hatch-Waxman Act and the Orphan Drug Act provide mechanisms for brand-name drugs to maintain exclusivity for certain periods, which can impact the timing and feasibility of generic drug approvals[1].

Litigation and Enforcement

The '235 patent has been involved in significant litigation, with the plaintiffs seeking injunctive relief, attorneys’ fees, and other remedies for alleged patent infringement. The litigation highlights the importance of patent enforcement in protecting intellectual property rights in the pharmaceutical industry[2][5].

Technical and Legal Aspects

Technical Field

The '235 patent pertains to the technical field of pharmaceutical devices and formulations, specifically those related to COPD treatment. It involves detailed descriptions of the device's mechanism, the formulation of the active ingredients, and the method of administration[4].

Legal Challenges

The patent faces legal challenges through Paragraph IV certifications filed by generic drug manufacturers. These certifications assert that the patent is invalid, unenforceable, or not infringed by the generic product. Such challenges are common in the pharmaceutical industry and often lead to complex legal battles[1][5].

Impact on the Pharmaceutical Industry

Generic Competition

The '235 patent, along with other related patents, plays a crucial role in delaying generic competition. Generic drug manufacturers must navigate these patents to gain approval for their products, which can significantly impact the timing and cost of bringing generic alternatives to market[1].

Innovation and Exclusivity

The patent system is designed to balance innovation with competition. Patents like the '235 patent provide exclusivity periods that incentivize innovation but also limit generic competition during those periods. This balance is critical for the pharmaceutical industry, where significant investments are made in research and development[1].

Key Takeaways

• Patent Scope: The '235 patent covers specific aspects of the SPIRIVA® Respimat® product, including its formulation and device design.
• Litigation: The patent is involved in significant litigation related to generic drug approvals and patent infringement.
• Regulatory Environment: The patent benefits from exclusivities under U.S. patent law and regulatory frameworks.
• Competitive Landscape: The patent operates within a competitive pharmaceutical market where multiple companies are filing patents and challenging existing ones.
• Technical and Legal Aspects: The patent involves detailed technical descriptions and faces legal challenges through Paragraph IV certifications.

FAQs

Q: What is the United States Patent 7,837,235 related to?

A: The United States Patent 7,837,235 is related to the SPIRIVA® Respimat® product, a pharmaceutical device used for the treatment of chronic obstructive pulmonary disease (COPD).

Q: Why is the '235 patent involved in litigation?

A: The '235 patent is involved in litigation due to allegations of patent infringement by generic drug manufacturers seeking FDA approval for their products.

Q: What are the main claims of the '235 patent?

A: The main claims of the '235 patent pertain to the formulation, device design, and method of use of the SPIRIVA® Respimat® product.

Q: How does the '235 patent impact generic competition?

A: The '235 patent, along with other related patents, delays generic competition by providing exclusivity periods that prevent generic drug approvals until the patents expire or are successfully challenged.

Q: What is the significance of Paragraph IV certifications in relation to the '235 patent?

A: Paragraph IV certifications are assertions by generic drug manufacturers that the '235 patent is invalid, unenforceable, or not infringed by their generic product, which is a common strategy to challenge patent exclusivity.

Sources

1. The BioLoquitur Bulletin - Seyfarth Shaw LLP
2. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - RPX Corporation
3. Patent Landscape Analysis and Search Report - InventionIP
4. Olodaterol: Uses, Interactions, Mechanism of Action - DrugBank Online
5. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - RPX Corporation

Drugs Protected by US Patent 7,837,235

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: 7,837,235

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2004 001 451	Jan 08, 2004
Germany	10 2004 001 451	Jan 8, 2004

International Family Members for US Patent 7,837,235

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004311644
Austria	E380595
Brazil	PI0418364
Canada	2552535
China	1921949
Colombia	5700802
Cyprus	1107900