Details for Patent: 8,479,730

Which drugs does patent 8,479,730 protect, and when does it expire?

Patent 8,479,730 protects ARCAPTA NEOHALER, SEEBRI, and UTIBRON, and is included in three NDAs.

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

Summary for Patent: 8,479,730

Title:	Inhaler device
Abstract:	An inhaler device (1) for powdered medicaments. The device (1) has a body (5) that has a recess (50) for holding a capsule containing a powdered medicament to be inhaled, at least one air passage (90) that is tangentially disposed to the recess (50) , and a mouthpiece (30) that includes a coaxially disposed inhalation passage (70) that communicates with the recess (50) of the body (5). The body (5) has a pair of opposed spring (105) biased push-buttons (40) that each include at least one piercing element (95) for piercing the capsule when loaded in the recess (50). The medicament is released from the pierced capsule when air is drawn through the air passage(s) (90) into the recess (50) and swirled about therein. The mouthpiece (30) is pivotally attached to the edge of the body (5) so that it is pivotable between an open loading position and a closed dispensing position about an axis that is perpendicular to the longitudinal axis of the inhaler (1).
Inventor(s):	Ziegler; Dominik (Basel, CH), Smetham; Grant (Cambridge, GB), Citterio; Mauro (Osnago, IT)
Assignee:	Novartis AG (Basil, CH)
Application Number:	11/568,466
Patent Claim Types: see list of patent claims	Dosage form; Delivery; Device; Compound;

United States Patent 8,479,730: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,479,730, titled "Inhaler device," is a significant innovation in the field of respiratory medicine, particularly for the delivery of powdered medicaments. This patent, granted for an inhaler device designed to treat respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD), offers a comprehensive solution for patients and manufacturers alike.

Overview of the Patent

Purpose and Design

The patent describes an inhaler device specifically designed for delivering powdered medicaments. The device includes a body with a recess to hold a capsule containing the powdered medicament, at least one air passage tangentially disposed to the recess, and a mouthpiece with a coaxially disposed inhalation passage that communicates with the recess[1].

Key Components

• Body and Recess: The body of the inhaler has a recess to hold a capsule containing the powdered medicament. This recess is designed to allow the capsule to spin within it, enhancing the dispersion of the medicament[1].
• Air Passage: The air passage is tangentially disposed to the recess, facilitating the swirling of air and medicament when inhaled[1].
• Mouthpiece: The mouthpiece is pivotally attached to the edge of the body and includes an inhalation passage that communicates with the recess. It can pivot between an open loading position and a closed dispensing position[1].
• Capsule-Piercing Mechanism: The device features a pair of opposed spring-biased push-buttons, each with at least one piercing element (preferably a needle or sharpened pin) to pierce the capsule when loaded[1].

Scope of the Patent

Claims

The patent claims cover several critical aspects of the inhaler device:

• The body with a recess for holding a capsule.
• The air passage(s) tangentially disposed to the recess.
• The mouthpiece with an inhalation passage communicating with the recess.
• The capsule-piercing means, specifically the spring-biased push-buttons with piercing elements[1].

Use in Respiratory Diseases

The patent is particularly relevant for the treatment of asthma and COPD through pulmonary inhalation. The device is designed to ensure efficient delivery of powdered medicaments directly to the lungs, improving the efficacy of treatment[1].

Patent Landscape

Competing Patents and Litigation

The landscape surrounding inhaler patents is complex and often contentious. For instance, the case involving Teva and Amneal over the ProAir HFA inhaler highlights issues with improper patent listings in the FDA's Orange Book. Such listings can delay the approval of generic products, affecting competition and patient access to affordable medications[2][4].

Regulatory Scrutiny

The Federal Trade Commission (FTC) has been actively involved in ensuring that pharmaceutical companies do not abuse the patent system. The FTC has issued warnings and filed amicus briefs to prevent improper patent listings that could harm competition and delay the entry of generic products[4].

Patent Analytics and Claim Coverage

Importance of Claim Analysis

Patent analytics plays a crucial role in understanding the scope and coverage of patents like US 8,479,730. Tools such as Claim Coverage Matrices and Claim Charts help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in the patent landscape[3].

Scope Concepts and Claim Charts

Using software like ClaimScape®, companies can generate interactive claim charts to review patent coverage with technical experts. This helps in determining whether a particular scope concept is applicable to a target product or method, highlighting areas where claim coverage may be lacking[3].

Impact on the Market

Competition and Generic Entry

The proper listing and enforcement of patents like US 8,479,730 can significantly impact the market. Improper listings can delay the entry of generic products, as seen in the Teva vs. Amneal case, where the FTC intervened to ensure fair competition and timely approval of generic alternatives[2][4].

Patient Access and Affordability

The availability of generic inhalers, facilitated by the correct management of patents, is crucial for patient access to affordable treatments. Companies like Teva, Amneal, and others must navigate the patent landscape carefully to ensure that patients receive the medications they need without undue delays or costs[4].

Future Directions and Opportunities

Innovation and Improvement

The design of the inhaler device under US 8,479,730 offers several opportunities for innovation and improvement. Future developments could focus on enhancing the efficiency of the capsule-piercing mechanism, improving the ergonomics of the device, or integrating new materials and technologies to make the inhaler more user-friendly and effective[1].

Regulatory Compliance

Companies involved in the development and marketing of inhaler devices must remain vigilant about regulatory compliance. Ensuring that patents are properly listed and that claims are accurately defined is essential to avoid legal disputes and maintain a competitive edge in the market[2][4].

Key Takeaways

• The US 8,479,730 patent describes an innovative inhaler device for delivering powdered medicaments, particularly for treating asthma and COPD.
• The device features a body with a recess for a capsule, tangential air passages, and a pivotally attached mouthpiece with a capsule-piercing mechanism.
• The patent landscape is complex, with regulatory bodies like the FTC ensuring that patents are not improperly listed to delay generic competition.
• Proper patent analytics and claim coverage analysis are crucial for navigating the patent landscape and identifying opportunities for innovation.
• The correct management of patents is vital for ensuring patient access to affordable treatments.

FAQs

What is the main purpose of the US 8,479,730 patent?

The main purpose of the US 8,479,730 patent is to describe an inhaler device designed for delivering powdered medicaments, particularly for treating respiratory diseases such as asthma and COPD.

How does the inhaler device described in the patent work?

The device works by using a body with a recess to hold a capsule containing the medicament, air passages to swirl the medicament, and a mouthpiece with a capsule-piercing mechanism to release the medicament when inhaled.

Why is the FTC involved in patent disputes related to inhalers?

The FTC is involved to ensure that pharmaceutical companies do not improperly list patents in the FDA's Orange Book, which can delay the approval of generic products and harm competition.

What is the significance of patent analytics in managing patents like US 8,479,730?

Patent analytics helps in understanding the scope and coverage of patents, identifying gaps or opportunities, and ensuring that claims are accurately defined and enforced.

How does the patent landscape impact patient access to affordable treatments?

The proper management of patents and avoidance of improper listings ensure that generic products can enter the market timely, making treatments more affordable and accessible to patients.

Sources

1. US8479730B2 - Inhaler device - Google Patents
2. New Jersey District Court Orders Delisting Of Teva Inhaler Patents - Litigation, Intellectual Property, and Technology Law
3. Patent Analytics | Intellectual Property Law - SLWIP
4. FTC Files Amicus Brief in Asthma Inhaler Patent Dispute - Federal Trade Commission

Drugs Protected by US Patent 8,479,730

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011		DISCN	Yes	No	8,479,730		Y
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015		DISCN	Yes	No	8,479,730		Y
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No	8,479,730		Y

Foreign Priority and PCT Information for Patent: 8,479,730

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0410712.4	May 13, 2004

PCT Information
PCT Filed	May 12, 2005	PCT Application Number:	PCT/EP2005/005182
PCT Publication Date:	December 01, 2005	PCT Publication Number:	WO2005/113042

International Family Members for US Patent 8,479,730

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	051353
Austria	E502666
Australia	2005245095